<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03764345</url>
  </required_header>
  <id_info>
    <org_study_id>Sof-Led-HCV-Ped</org_study_id>
    <nct_id>NCT03764345</nct_id>
  </id_info>
  <brief_title>Eight Weeks Sofosbovir/Ledipasvir in HCV Infected Children Aged 4 to 10 Years</brief_title>
  <official_title>Sofosbovir/Ledipasvir in HCV Infected Children Aged From 4 to 10 Years</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Liver Institute, Egypt</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Liver Institute, Egypt</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recently the era of direct-acting antiviral drugs for hepatitis C treatment has changed the&#xD;
      world map of HCV. Results in adults are promising. FDA approved only two drugs in the&#xD;
      pediatric age group 12 to 17 years. Younger children are still on the wait list for&#xD;
      treatment. The current study aimed to treat children aged between 3 and 12 years with half&#xD;
      the adult dose of Sofosbuvir/Ledipasvir combination (Heterosofir).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The WHO has declared hepatitis C a global health problem, with ∼ 3% of the world's population&#xD;
      (roughly 170-200 million individuals) infected with HCV. Egypt has the highest prevalence of&#xD;
      HCV in the world, ranging from 6 to 28%, with an average of ∼ 13.8% in the general&#xD;
      population. Ap-proximately 90% of Egyptian HCV isolates belong to a single subtype, 4a.&#xD;
&#xD;
      Hepatitis C virus (HCV) is a major cause of chronic liver disease and a prin-cipal reason for&#xD;
      liver transplant; approximately 170 million people worldwide are chronically infected. There&#xD;
      is general consensus that HCV elimination is associated with strong and sustained CD4+ and&#xD;
      CD8+ T cell res-ponses that target multiple epitopes within the different HCV proteins,&#xD;
      however, they are not maintained in patients who develop chronic disease . A variety of&#xD;
      factors purportedly contribute to the dimi-nished T cell responses observed in chronically&#xD;
      infected patients, including an im-paired dendritic cell (DC) function.&#xD;
&#xD;
      The successful development of direct-acting antivirals (DAAs) that are active against&#xD;
      hepatitis C virus has transformed chronic hepatitis C infection from a con-dition requiring&#xD;
      complex therapies with unsatisfactory outcomes to one that can be easily treated with few&#xD;
      contraindications and side-effects. Since 2011, the US Food and Drug Administration (FDA) and&#xD;
      the European Medicines Agency (EMA) have approved eight oral DAA regimens for the treatment&#xD;
      of adults with chronic hepatitis C. Investigation into DAAs for children has been slower.&#xD;
&#xD;
      For adolescents aged 12-17 years, the safety and efficacy of the fixed-dose combination&#xD;
      sofosbuvir and ledipasvir for genotype 1 or 4 infection and of combination sofosbuvir plus&#xD;
      ribavirin for genotype 2 or 3 infection have been described in full-length articles.&#xD;
&#xD;
      A recent study explored the safety and efficacy of combination sofosbuvirplus ribavirin in&#xD;
      Pakistani children (aged 5-18 years) with hepatitis C virus genotype 1, 2, or 3 infection.&#xD;
      Further results have been presented as ab-stracts for the fixed-dose combination sofosbuvir&#xD;
      and ledipasvir in children aged 6-11 years for the fixed-dose combination ombitasvir,&#xD;
      pari-taprevir, and ritonavir with or without dasabuvir and with or without ribavirin in&#xD;
      adolescents aged 12-17 years with genotype 1 or 4 infection and for combination sofosbuvir&#xD;
      plus daclatasvir with or without ribavirin in Egyp-tian adolescents aged 12-17 years with&#xD;
      genotype 4 infection.&#xD;
&#xD;
      Dendritic cells are professional antigen presenting cells characterized by a po-tent capacity&#xD;
      to elicit primary T cell responses. Two major subsets of DC can be identified from human&#xD;
      peripheral blood: plasmacytoid (p) DC and conventional or myeloid (m) DC. Each subset&#xD;
      represents 0.3-0.5% of the normal human peripheral blood mononuclear cell (PBMC) population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 6, 2018</start_date>
  <completion_date type="Actual">July 2, 2019</completion_date>
  <primary_completion_date type="Actual">July 2, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Side effect 1 Number of patients with fatigue</measure>
    <time_frame>8 weeks</time_frame>
    <description>Number of patients with fatigue</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Side effect 2 Number of patients with Headache</measure>
    <time_frame>8 weeks</time_frame>
    <description>Number of patients with Headache</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Side effect 3 Number of patients with nausea</measure>
    <time_frame>8 weeks</time_frame>
    <description>Number of patients with nausea</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Side effect 4 Number of patients with diarrhea</measure>
    <time_frame>8 weeks</time_frame>
    <description>Number of patients with diarrhea</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Side effect 5 Number of patients with insomnia</measure>
    <time_frame>8 weeks</time_frame>
    <description>Number of patients with insomnia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Side effect 6 Number of patients with weakness</measure>
    <time_frame>8 weeks</time_frame>
    <description>Number of patients with weakness</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Side effect 7 Number of patients with bradycardia</measure>
    <time_frame>8 weeks</time_frame>
    <description>Number of patients with bradycardia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Side effect 8 Number of patients with cough</measure>
    <time_frame>8 weeks</time_frame>
    <description>Number of patients with cough</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Side effect 9 Number of patients with myalgia</measure>
    <time_frame>8 weeks</time_frame>
    <description>Number of patients with myalgia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Side effect 10 Number of patients with dysapnea</measure>
    <time_frame>8 weeks</time_frame>
    <description>Number of patients with dysapnea</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Side effect 11 Number of patients with irritability</measure>
    <time_frame>8 weeks</time_frame>
    <description>Number of patients with irritability</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Side effect 12 Number of patients with dizziness</measure>
    <time_frame>8 weeks</time_frame>
    <description>Number of patients with dizziness</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Side effect 13 Number of patients with depression</measure>
    <time_frame>8 weeks</time_frame>
    <description>Number of patients with depression</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Side effect 14 Number of patients with skin rash</measure>
    <time_frame>8 weeks</time_frame>
    <description>Number of patients with skin rash</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HCV-RNA PCR by the end of therapy</measure>
    <time_frame>8 weeks</time_frame>
    <description>HCV-RNA PCR at week 8</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HCV-RNA PCR after 20 weeks for SVR</measure>
    <time_frame>20 weeks</time_frame>
    <description>HCV-RNA PCR at week 20</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Treatment safety-1 Alanine transaminase serum level</measure>
    <time_frame>8 weeks</time_frame>
    <description>Alanine transaminase serum level</description>
  </other_outcome>
  <other_outcome>
    <measure>Treatment safety-2 Aspartate transaminase serum level</measure>
    <time_frame>8 weeks</time_frame>
    <description>Aspartate transaminase serum level</description>
  </other_outcome>
  <other_outcome>
    <measure>Treatment safety-2 Degree of liver fibrosis</measure>
    <time_frame>8 weeks</time_frame>
    <description>Liver Stiffness measurement before and after end of therapy</description>
  </other_outcome>
  <other_outcome>
    <measure>Treatment tolerability-1 Patient height</measure>
    <time_frame>20 weeks</time_frame>
    <description>measurement of Height</description>
  </other_outcome>
  <other_outcome>
    <measure>Treatment tolerability-2 Body weight</measure>
    <time_frame>20 weeks</time_frame>
    <description>measurement of weight</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Hepatitis C, Chronic</condition>
  <condition>Children, Only</condition>
  <arm_group>
    <arm_group_label>Sofosbovir/Ledipasvir Daily</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive oral daily dose of Sofosbovir/Ledipasvir (200/45mg) daily for 8 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sofosbovir/Lepipasvir (200/45mg) tablet (Heterosofir)</intervention_name>
    <description>Patients receive oral daily dose of Sofosbovir/Ledipasvir (200/45mg) daily for 8 weeks</description>
    <arm_group_label>Sofosbovir/Ledipasvir Daily</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children with chronic HCV&#xD;
&#xD;
          -  age 3- 12 y old&#xD;
&#xD;
          -  weight 17- 35kg&#xD;
&#xD;
          -  Basal HCV viremia less than 6.8 log IU/mL&#xD;
&#xD;
          -  Treatment-naive&#xD;
&#xD;
          -  No cirrhosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with dual HBV and HCV infection or associated with chronic hepatitis other&#xD;
             than chronic HCV&#xD;
&#xD;
          -  age below 3 years or above 12 years&#xD;
&#xD;
          -  body weight less than 17 or more than 35 Kg&#xD;
&#xD;
          -  HCV/HIV coinfection.&#xD;
&#xD;
          -  Patients with HCV infection and HCC.&#xD;
&#xD;
          -  Patients with HCV infection and underlying cardiac comorbidities&#xD;
&#xD;
          -  Decompensated patients with HCV&#xD;
&#xD;
          -  Hypoalbuminemia of &lt; 3.5g/dL.&#xD;
&#xD;
          -  International normalised ratio (INR) &gt;2.&#xD;
&#xD;
          -  Advanced fibrosis scoring by transient elastography (F 4 broScan)&#xD;
&#xD;
          -  Any concomitant malignancy.&#xD;
&#xD;
          -  Parents' refusal for participation of their children in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Behairy E Behairy, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Liver Institute, Menoufia University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hanaa A El-Araby, Prof</last_name>
    <role>Study Director</role>
    <affiliation>National Liver Institute, Menoufia University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohamed A El-Guindi, Prof</last_name>
    <role>Study Director</role>
    <affiliation>National Liver Institute, Menoufia University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hosam M Basiouny, MD</last_name>
    <role>Study Chair</role>
    <affiliation>National Liver Institute, Menoufia University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ola A Fouad, MD</last_name>
    <role>Study Chair</role>
    <affiliation>National Liver Institute, Menoufia University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ayman M Marey, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Faculty of Medicine, Zagazig University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bassam A Ayoub, MD</last_name>
    <role>Study Chair</role>
    <affiliation>National Liver Institute, Menoufia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pediatric Hepatology, Gastroenterology and Nutrition Department, National Liver Institute, Menoufia University</name>
      <address>
        <city>Shebin El-Koom</city>
        <state>Menofiya</state>
        <zip>32511</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Balistreri WF, Murray KF, Rosenthal P, Bansal S, Lin CH, Kersey K, Massetto B, Zhu Y, Kanwar B, German P, Svarovskaia E, Brainard DM, Wen J, Gonzalez-Peralta RP, Jonas MM, Schwarz K. The safety and effectiveness of ledipasvir-sofosbuvir in adolescents 12-17 years old with hepatitis C virus genotype 1 infection. Hepatology. 2017 Aug;66(2):371-378. doi: 10.1002/hep.28995. Epub 2017 Jun 19.</citation>
    <PMID>27997679</PMID>
  </reference>
  <reference>
    <citation>Deuffic-Burban S, Mohamed MK, Larouze B, Carrat F, Valleron AJ. Expected increase in hepatitis C-related mortality in Egypt due to pre-2000 infections. J Hepatol. 2006 Mar;44(3):455-61. doi: 10.1016/j.jhep.2005.08.008. Epub 2005 Sep 15.</citation>
    <PMID>16310281</PMID>
  </reference>
  <reference>
    <citation>El-Sayed M, Hassany M, Asem N. A pilot study for safety and efficacy of 12 weeks sofosbuvir plus daclatasvir with or without ribavirin in Egyptian adoles-cents with chronic hepatitis C virus Infection. Journal of Hepatology 2017,66:S178</citation>
  </reference>
  <reference>
    <citation>El-Serag HB. Hepatocellular carcinoma and hepatitis C in the United States. Hepatology. 2002 Nov;36(5 Suppl 1):S74-83. doi: 10.1053/jhep.2002.36807.</citation>
    <PMID>12407579</PMID>
  </reference>
  <reference>
    <citation>Gowans EJ, Jones KL, Bharadwaj M, Jackson DC. Prospects for dendritic cell vaccination in persistent infection with hepatitis C virus. J Clin Virol. 2004 Aug;30(4):283-90. doi: 10.1016/j.jcv.2004.03.006.</citation>
    <PMID>15163415</PMID>
  </reference>
  <reference>
    <citation>Hashmi MA, Cheema HA. Effectiveness and Safety of Sofosbuvir in Treatment-NaiveChildren with Hepatitis C Infection. J Coll Physicians Surg Pak. 2017 Jul;27(7):423-426.</citation>
    <PMID>28818165</PMID>
  </reference>
  <reference>
    <citation>Indolfi G, Serranti D, Resti M. Direct-acting antivirals for children and adolescents with chronic hepatitis C. Lancet Child Adolesc Health. 2018 Apr;2(4):298-304. doi: 10.1016/S2352-4642(18)30037-3. Epub 2018 Feb 24.</citation>
    <PMID>30169301</PMID>
  </reference>
  <reference>
    <citation>Kamal SM, Madwar MA, Peters T, Fawzy R, Rasenack J. Interferon therapy in patients with chronic hepatitis C and schistosomiasis. J Hepatol. 2000 Jan;32(1):172-4. doi: 10.1016/s0168-8278(00)80207-x. No abstract available.</citation>
    <PMID>10673085</PMID>
  </reference>
  <reference>
    <citation>Murray KF, Balistreri W, Bansal S, Whitworth S, Evans H, Gonzalez-Peralta R, et al. Ledipasvir/sofosbuvir±ribavirin for 12 or 24 weeks is safe and effective in children 6-11 years old with chronic hepatitis C infection. Journal of Hepatology 2017,66:S57-S58</citation>
  </reference>
  <reference>
    <citation>O'Doherty U, Peng M, Gezelter S, Swiggard WJ, Betjes M, Bhardwaj N, Steinman RM. Human blood contains two subsets of dendritic cells, one immunologically mature and the other immature. Immunology. 1994 Jul;82(3):487-93.</citation>
    <PMID>7525461</PMID>
  </reference>
  <reference>
    <citation>Takaki A, Wiese M, Maertens G, Depla E, Seifert U, Liebetrau A, Miller JL, Manns MP, Rehermann B. Cellular immune responses persist and humoral responses decrease two decades after recovery from a single-source outbreak of hepatitis C. Nat Med. 2000 May;6(5):578-82. doi: 10.1038/75063.</citation>
    <PMID>10802716</PMID>
  </reference>
  <reference>
    <citation>Thorne C, Indolfi G, Turkova A, Giaquinto C, Nastouli E. Treating hepatitis C virus in children: time for a new paradigm. J Virus Erad. 2015 Jul 1;1(3):203-5.</citation>
    <PMID>27482412</PMID>
  </reference>
  <reference>
    <citation>Wirth S, Rosenthal P, Gonzalez-Peralta RP, Jonas MM, Balistreri WF, Lin CH, Hardikar W, Kersey K, Massetto B, Kanwar B, Brainard DM, Shao J, Svarovskaia E, Kirby B, Arnon R, Murray KF, Schwarz KB. Sofosbuvir and ribavirin in adolescents 12-17 years old with hepatitis C virus genotype 2 or 3 infection. Hepatology. 2017 Oct;66(4):1102-1110. doi: 10.1002/hep.29278. Epub 2017 Aug 26.</citation>
    <PMID>28543053</PMID>
  </reference>
  <reference>
    <citation>Schulze Zur Wiesch J, Ciuffreda D, Lewis-Ximenez L, Kasprowicz V, Nolan BE, Streeck H, Aneja J, Reyor LL, Allen TM, Lohse AW, McGovern B, Chung RT, Kwok WW, Kim AY, Lauer GM. Broadly directed virus-specific CD4+ T cell responses are primed during acute hepatitis C infection, but rapidly disappear from human blood with viral persistence. J Exp Med. 2012 Jan 16;209(1):61-75. doi: 10.1084/jem.20100388. Epub 2012 Jan 2.</citation>
    <PMID>22213804</PMID>
  </reference>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>September 15, 2019</last_update_submitted>
  <last_update_submitted_qc>September 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Liver Institute, Egypt</investigator_affiliation>
    <investigator_full_name>Mostafa M. Sira</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis C, Chronic</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03764345
org study id: Sof-Led-HCV-Ped
nct id: NCT03764345
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Recently the era of direct-acting antiviral drugs for hepatitis C treatment has changed the
      world map of HCV. Results in adults are promising. FDA approved only two drugs in the
      pediatric age group 12 to 17 years. Younger children are still on the wait list for
      treatment. The current study aimed to treat children aged between 3 and 12 years with half
      the adult dose of Sofosbuvir/Ledipasvir combination (Heterosofir).
The WHO has declared hepatitis C a global health problem, with ∼ 3% of the world's population
      (roughly 170-200 million individuals) infected with HCV. Egypt has the highest prevalence of
      HCV in the world, ranging from 6 to 28%, with an average of ∼ 13.8% in the general
      population. Ap-proximately 90% of Egyptian HCV isolates belong to a single subtype, 4a.

      Hepatitis C virus (HCV) is a major cause of chronic liver disease and a prin-cipal reason for
      liver transplant; approximately 170 million people worldwide are chronically infected. There
      is general consensus that HCV elimination is associated with strong and sustained CD4+ and
      CD8+ T cell res-ponses that target multiple epitopes within the different HCV proteins,
      however, they are not maintained in patients who develop chronic disease . A variety of
      factors purportedly contribute to the dimi-nished T cell responses observed in chronically
      infected patients, including an im-paired dendritic cell (DC) function.

      The successful development of direct-acting antivirals (DAAs) that are active against
      hepatitis C virus has transformed chronic hepatitis C infection from a con-dition requiring
      complex therapies with unsatisfactory outcomes to one that can be easily treated with few
      contraindications and side-effects. Since 2011, the US Food and Drug Administration (FDA) and
      the European Medicines Agency (EMA) have approved eight oral DAA regimens for the treatment
      of adults with chronic hepatitis C. Investigation into DAAs for children has been slower.

      For adolescents aged 12-17 years, the safety and efficacy of the fixed-dose combination
      sofosbuvir and ledipasvir for genotype 1 or 4 infection and of combination sofosbuvir plus
      ribavirin for genotype 2 or 3 infection have been described in full-length articles.

      A recent study explored the safety and efficacy of combination sofosbuvirplus ribavirin in
      Pakistani children (aged 5-18 years) with hepatitis C virus genotype 1, 2, or 3 infection.
      Further results have been presented as ab-stracts for the fixed-dose combination sofosbuvir
      and ledipasvir in children aged 6-11 years for the fixed-dose combination ombitasvir,
      pari-taprevir, and ritonavir with or without dasabuvir and with or without ribavirin in
      adolescents aged 12-17 years with genotype 1 or 4 infection and for combination sofosbuvir
      plus daclatasvir with or without ribavirin in Egyp-tian adolescents aged 12-17 years with
      genotype 4 infection.

      Dendritic cells are professional antigen presenting cells characterized by a po-tent capacity
      to elicit primary T cell responses. Two major subsets of DC can be identified from human
      peripheral blood: plasmacytoid (p) DC and conventional or myeloid (m) DC. Each subset
      represents 0.3-0.5% of the normal human peripheral blood mononuclear cell (PBMC) population.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Side effect 1 Number of patients with fatigue
time frame: 8 weeks
description: Number of patients with fatigue
measure: Side effect 2 Number of patients with Headache
time frame: 8 weeks
description: Number of patients with Headache
measure: Side effect 3 Number of patients with nausea
time frame: 8 weeks
description: Number of patients with nausea
measure: Side effect 4 Number of patients with diarrhea
time frame: 8 weeks
description: Number of patients with diarrhea
measure: Side effect 5 Number of patients with insomnia
time frame: 8 weeks
description: Number of patients with insomnia
measure: Side effect 6 Number of patients with weakness
time frame: 8 weeks
description: Number of patients with weakness
measure: Side effect 7 Number of patients with bradycardia
time frame: 8 weeks
description: Number of patients with bradycardia
measure: Side effect 8 Number of patients with cough
time frame: 8 weeks
description: Number of patients with cough
measure: Side effect 9 Number of patients with myalgia
time frame: 8 weeks
description: Number of patients with myalgia
measure: Side effect 10 Number of patients with dysapnea
time frame: 8 weeks
description: Number of patients with dysapnea
measure: Side effect 11 Number of patients with irritability
time frame: 8 weeks
description: Number of patients with irritability
measure: Side effect 12 Number of patients with dizziness
time frame: 8 weeks
description: Number of patients with dizziness
measure: Side effect 13 Number of patients with depression
time frame: 8 weeks
description: Number of patients with depression
measure: Side effect 14 Number of patients with skin rash
time frame: 8 weeks
description: Number of patients with skin rash
measure: HCV-RNA PCR by the end of therapy
time frame: 8 weeks
description: HCV-RNA PCR at week 8
measure: HCV-RNA PCR after 20 weeks for SVR
time frame: 20 weeks
description: HCV-RNA PCR at week 20
measure: Treatment safety-1 Alanine transaminase serum level
time frame: 8 weeks
description: Alanine transaminase serum level
measure: Treatment safety-2 Aspartate transaminase serum level
time frame: 8 weeks
description: Aspartate transaminase serum level
measure: Treatment safety-2 Degree of liver fibrosis
time frame: 8 weeks
description: Liver Stiffness measurement before and after end of therapy
measure: Treatment tolerability-1 Patient height
time frame: 20 weeks
description: measurement of Height
measure: Treatment tolerability-2 Body weight
time frame: 20 weeks
description: measurement of weight
arm group label: Sofosbovir/Ledipasvir Daily
arm group type: Experimental
description: Patients receive oral daily dose of Sofosbovir/Ledipasvir (200/45mg) daily for 8 weeks
intervention type: Drug
intervention name: Sofosbovir/Lepipasvir (200/45mg) tablet (Heterosofir)
description: Patients receive oral daily dose of Sofosbovir/Ledipasvir (200/45mg) daily for 8 weeks
arm group label: Sofosbovir/Ledipasvir Daily
criteria: 
gender: All
minimum age: 3 Years
maximum age: 12 Years
healthy volunteers: No
last name: Behairy E Behairy, Prof
role: Principal Investigator
affiliation: National Liver Institute, Menoufia University
last name: Hanaa A El-Araby, Prof
role: Study Director
affiliation: National Liver Institute, Menoufia University
last name: Mohamed A El-Guindi, Prof
role: Study Director
affiliation: National Liver Institute, Menoufia University
last name: Hosam M Basiouny, MD
role: Study Chair
affiliation: National Liver Institute, Menoufia University
last name: Ola A Fouad, MD
role: Study Chair
affiliation: National Liver Institute, Menoufia University
last name: Ayman M Marey, Prof
role: Study Chair
affiliation: Faculty of Medicine, Zagazig University
last name: Bassam A Ayoub, MD
role: Study Chair
affiliation: National Liver Institute, Menoufia University
facility: 
country: Egypt
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PMID: 27997679
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PMID: 16310281
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PMID: 12407579
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PMID: 15163415
citation: Hashmi MA, Cheema HA. Effectiveness and Safety of Sofosbuvir in Treatment-NaiveChildren with Hepatitis C Infection. J Coll Physicians Surg Pak. 2017 Jul;27(7):423-426.
PMID: 28818165
citation: Indolfi G, Serranti D, Resti M. Direct-acting antivirals for children and adolescents with chronic hepatitis C. Lancet Child Adolesc Health. 2018 Apr;2(4):298-304. doi: 10.1016/S2352-4642(18)30037-3. Epub 2018 Feb 24.
PMID: 30169301
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PMID: 10673085
citation: Murray KF, Balistreri W, Bansal S, Whitworth S, Evans H, Gonzalez-Peralta R, et al. Ledipasvir/sofosbuvir±ribavirin for 12 or 24 weeks is safe and effective in children 6-11 years old with chronic hepatitis C infection. Journal of Hepatology 2017,66:S57-S58
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PMID: 7525461
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PMID: 10802716
citation: Thorne C, Indolfi G, Turkova A, Giaquinto C, Nastouli E. Treating hepatitis C virus in children: time for a new paradigm. J Virus Erad. 2015 Jul 1;1(3):203-5.
PMID: 27482412
citation: Wirth S, Rosenthal P, Gonzalez-Peralta RP, Jonas MM, Balistreri WF, Lin CH, Hardikar W, Kersey K, Massetto B, Kanwar B, Brainard DM, Shao J, Svarovskaia E, Kirby B, Arnon R, Murray KF, Schwarz KB. Sofosbuvir and ribavirin in adolescents 12-17 years old with hepatitis C virus genotype 2 or 3 infection. Hepatology. 2017 Oct;66(4):1102-1110. doi: 10.1002/hep.29278. Epub 2017 Aug 26.
PMID: 28543053
citation: Schulze Zur Wiesch J, Ciuffreda D, Lewis-Ximenez L, Kasprowicz V, Nolan BE, Streeck H, Aneja J, Reyor LL, Allen TM, Lohse AW, McGovern B, Chung RT, Kwok WW, Kim AY, Lauer GM. Broadly directed virus-specific CD4+ T cell responses are primed during acute hepatitis C infection, but rapidly disappear from human blood with viral persistence. J Exp Med. 2012 Jan 16;209(1):61-75. doi: 10.1084/jem.20100388. Epub 2012 Jan 2.
PMID: 22213804
responsible party type: Principal Investigator
investigator affiliation: National Liver Institute, Egypt
investigator full name: Mostafa M. Sira
investigator title: Assistant Professor
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic