<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/NCT03241823</url>
  </required_header>
  <id_info>
    <org_study_id>AOHF</org_study_id>
    <nct_id>NCT03241823</nct_id>
  </id_info>
  <brief_title>Assessment of Patients With Hepatitis C Virus Related Liver Cirrhosis After Sustained Response to Direct Acting Anti Viral Drugs.</brief_title>
  <official_title>Assessment of Hepatic Fibrosis, Hemodynamics, and Disease Severity of Patients With Hepatitis C Virus Related Liver Cirrhosis After Sustained Response to Direct Acting Anti Viral Drugs.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hepatitis C Virus (HCV) infection is a major global health challenge; it is estimated that&#xD;
      more than 80 million people are chronically infected worldwide, with 3-4 million new&#xD;
      infections and 350,000 deaths occurring each year because of HCV-related complications .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In 2015, a national Egyptian health issue survey was conducted to describe the prevalence of&#xD;
      hepatitis C virus infection. The prevalence of hepatitis C virus antibody was found to be&#xD;
      10.0% and that of Hepatitis C virus Ribonucleic acid (HCV RNA ) to be 7.0% in the age group&#xD;
      between 15-59 years. While In children, 1-14 years old, the prevalence of Hepatitis C virus&#xD;
      (HCV) antibody and Hepatitis C virus Ribonucleic acid (HCV RNA) were 0.4% and 0.2%&#xD;
      respectively.&#xD;
&#xD;
      The primary goal of HCV therapy is to cure the infection, i.e. to achieve a sustained&#xD;
      virological response (SVR) defined as undetectable Hepatitis C virus Ribonucleic acid (HCV&#xD;
      RNA )12 weeks or 24 weeks after treatment completion. The infection is cured in more than 99%&#xD;
      of patients who achieve asustained virological response (SVR). Asustained virological&#xD;
      response (SVR) is generally associated with normalization of liver enzymes and improvement or&#xD;
      disappearance of liver necroinflammation and fibrosis in patients without cirrhosis. Patients&#xD;
      with severe liver disease remain at risk of life-threatening complications; however hepatic&#xD;
      fibrosis may regress and the risk of complications such as hepatic failure and portal&#xD;
      hypertension is reduced .&#xD;
&#xD;
      Previous data suggest that the risk of Hepatocellular carcinoma and all-cause mortality is&#xD;
      significantly reduced, but not eliminated, in cirrhotic patients who clear Hepatitis C Virus&#xD;
      compared to untreated patients and non-sustained virological responders . Hepatitis C Virus&#xD;
      is also associated with a number of extrahepatic manifestations and effective viral&#xD;
      suppression induces reversal of most of them .&#xD;
&#xD;
      Studies in those with hepatitis C-related decompensated cirrhosis have demonstrated that&#xD;
      sustained virological response can indeed be achieved in the majority of these individuals,&#xD;
      and short-term follow-up from these studies has shown that Sustained virological response is&#xD;
      often accompanied by improvement in measures of decompensation including Model for End-Stage&#xD;
      Liver Disease (MELD) score and Child-Turcotte-Pugh (CPT) score. Moreover, because hepatitis C&#xD;
      recurrence after Orthotopic liver transplantation is associated with worse outcomes,&#xD;
      achieving Sustained virological response before transplant in a decompensated population with&#xD;
      chronic hepatitis C will likely allow these patients to achieve long-term outcomes not&#xD;
      different from non-Hepatitis C virus-infected populations .&#xD;
&#xD;
      In the SOLAR-1 and SOLAR-2 studies, those with decompensated cirrhosis with genotypes 1 and 4&#xD;
      were randomized to receive sofosbuvir/ledipasvir with low-dose ribavirin for 12 or 24 weeks .&#xD;
      No difference was seen in Sustained virological response in the 12- or 24-week arms, and the&#xD;
      therapy was well tolerated. Moreover, these studies both reported improvement in Model for&#xD;
      End-Stage Liver Disease (MELD) score and Child-Turcotte-Pugh (CPT) scores 4 weeks after&#xD;
      therapy had been stopped with longer-term follow-up results expected.&#xD;
&#xD;
      Liver stiffness measurement by transient elastography is a noninvasive, painless, rapid, and&#xD;
      objective method for the evaluation of fibrosis or cirrhosis . Systemic reviews and&#xD;
      meta-analyses have demonstrated the high sensitivity and specificity of Liver stiffness&#xD;
      measurement in the diagnosis of hepatic cirrhosis.&#xD;
&#xD;
      In a systematic review conducted at 2007, repoted that at a threshold of approximately 0.60,&#xD;
      the sensitivity and specificity of the FibroTest were 47% (35-59%) and 90% (87-92%). For&#xD;
      FibroScan (threshold approximately 8 kPa), corresponding values were 64% (50-76%) and 87%&#xD;
      (80-91%), respectively.&#xD;
&#xD;
      In another systematic review conducted at 2010, reported that the pooled estimates for&#xD;
      sensitivity of fibroscan were 87% (84%-90%), specificity 91% (89%-92%) in stage IV fibrosis&#xD;
      (cirrhosis). While in patients with stages II-IV fibrosis, they reported that the pooled&#xD;
      estimates for sensitivity were 70% (67%-73%), specificity 84% (80%-88%).&#xD;
&#xD;
      Multicenter observational, cohort, prospective study included 90 patients with hepatitis C&#xD;
      genotype 1 treated with telaprevir or boceprevir who had advanced fibrosis evidenced by liver&#xD;
      stiffness and achieved Sustained virological response reported that liver stiffness was&#xD;
      significantly reduced 2 weeks after treatment. This suggested the possibility of liver&#xD;
      cirrhosis regression evidenced by liver stiffness after sustained virological response in a&#xD;
      significant proportion of patients .&#xD;
&#xD;
      In a study included 182 Egyptian patients with HCV infection to validate and compare the&#xD;
      diagnostic performance of Fibroscan , APRI Score , FIB4 for the prediction of hepatic&#xD;
      fibrosis and treatment outcome in HCV infected patients receiving pegylated interferon and&#xD;
      ribavirin, the authors reported that Fibroscan and noninvasive scores as APRI , FIB4 can be&#xD;
      used as good predictors of liver fibrosis in chronic hepatitis C. However, they are not good&#xD;
      predictors of response to pegylated interferon and ribavirin .&#xD;
&#xD;
      In a study 2010, they concluded that liver stiffness measurement can be useful for monitoring&#xD;
      regression of liver fibrosis during entecavir treatment in patients with chronic hepatitis B&#xD;
      virus infection.&#xD;
&#xD;
      A few studies showed a consistent relationship between Doppler Ultrasonography findings and&#xD;
      liver histology. showed that Doppler Ultrasound findings are sensitive to haemo dynamic&#xD;
      changes in liver fibrosis. Doppler Ultrasonography scoring was significantly related to liver&#xD;
      fibrosis staging.&#xD;
&#xD;
      The Doppler Ultrasound signs for portal hypertension are: (1) reduced portal vein blood flow&#xD;
      velocity (time-averaged mean vel. &lt; 14-16 cm/s2), with sensitivity and specificity between&#xD;
      80-88% and 80-96%, respectively; (2) portal vein congestion index &gt; 0.08. This parameter,&#xD;
      however, is not used routinely, probably due to its being difficult to measure and its lower&#xD;
      reproducibility; and (3) measurements of the hepatic arterial Resistive Index are less&#xD;
      useful. In the course of Liver cirrhosis, the appearance of clinically significant portal&#xD;
      hypertension worsens prognosis and Doppler ultrasound is very useful in evaluating portal&#xD;
      hypertension. . astudy showed a significant reverse correlation between the velocities of the&#xD;
      main portal vein and fibrous staging of the liver.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 1, 2017</start_date>
  <completion_date type="Anticipated">March 2019</completion_date>
  <primary_completion_date type="Anticipated">January 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in liver fibrosis</measure>
    <time_frame>1 year.</time_frame>
    <description>Using non-invasive measures &quot;Fibroscan&quot;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes occurring in liver haemodynamics</measure>
    <time_frame>1 year.</time_frame>
    <description>Using Doppler ultrasound.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in severity of liver disease</measure>
    <time_frame>1 year</time_frame>
    <description>Using Child-Pugh score.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Hepatitis C</condition>
  <condition>Liver Cirrhosis</condition>
  <arm_group>
    <arm_group_label>Patients with hepatitis c virus related liver cirrhosis</arm_group_label>
    <description>Patients with chronic hepatitis C virus whose ultrasound shows liver cirrhosis, fibroscan &quot;F3 and F4, Child score &quot;A and B&quot;, of any MELD score, who achieved Sustained Virological Response after direct acting antiviral drugs (Sofosbuvir, Daclatasvir ± Ribavirin).</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Abdominal ultrasound .</intervention_name>
    <description>Abdominal ultrasound for each patient before and after treatment.</description>
    <arm_group_label>Patients with hepatitis c virus related liver cirrhosis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Model for End-Stage Liver Disease</intervention_name>
    <description>Model for End-Stage Liver Disease before and after treatment.</description>
    <arm_group_label>Patients with hepatitis c virus related liver cirrhosis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Fibro Scan.</intervention_name>
    <description>Liver stiffness by Fibro scan before and after treatment.</description>
    <arm_group_label>Patients with hepatitis c virus related liver cirrhosis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Child-Turcotte-Pugh score.</intervention_name>
    <description>Child-Turcotte-Pugh score before and after treatment</description>
    <arm_group_label>Patients with hepatitis c virus related liver cirrhosis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        100 patients with chronic hepatitis C virus related liver cirrhosis who achieved Sustained&#xD;
        virological response after direct acting antiviral drugs (Sofosbuvir, Daclatasvir ±&#xD;
        Ribavirin) and other available suitable regimens for 12 or 24 weeks will be selected from&#xD;
        Assuit unit of treatment of viral hepatitis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age: ≥ 18 years.&#xD;
&#xD;
          2. Disease status: patients with hepatitis C Virus related liver cirrhosis child A&amp; B&#xD;
             (scores 5-9).&#xD;
&#xD;
          3. Previous treatment: treatment naïve and treatment experienced.&#xD;
&#xD;
          4. HCV RNA: Negative at any point between 12-24 weeks post treatment to confirm&#xD;
             successful eradication of the virus.&#xD;
&#xD;
          5. Negative HBsAg and HIV antibody.&#xD;
&#xD;
          6. Normal kidney function test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Child C liver cirrhosis (Child score ≥ 10).&#xD;
&#xD;
          2. HCV coinfection with HBV or HIV.&#xD;
&#xD;
          3. Patients with high risk of infection (I.V drug users, patients with blood disease&#xD;
             requiring blood transfusion).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ibrahim Taha, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sherif Kamel, MD</last_name>
    <phone>00201222303690</phone>
    <email>shereef_kamel@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sahar Hassany, MD</last_name>
    <phone>00201010431017</phone>
    <email>saharhassany@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Assuit Unit of Treatment of Viral Hepatitis.</name>
      <address>
        <city>Assuit</city>
        <zip>71111</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <contact>
      <last_name>Waleed Hassan, MD</last_name>
      <phone>00201020066191</phone>
      <email>wallo403a@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Arase Y, Kobayashi M, Suzuki F, Suzuki Y, Kawamura Y, Akuta N, Kobayashi M, Sezaki H, Saito S, Hosaka T, Ikeda K, Kumada H, Kobayashi T. Effect of type 2 diabetes on risk for malignancies includes hepatocellular carcinoma in chronic hepatitis C. Hepatology. 2013 Mar;57(3):964-73. doi: 10.1002/hep.26087. Epub 2013 Feb 7.</citation>
    <PMID>22991257</PMID>
  </reference>
  <reference>
    <citation>Bruno S, Di Marco V, Iavarone M, Roffi L, Crosignani A, Calvaruso V, Aghemo A, Cabibbo G, Vigano M, Boccaccio V, Craxi A, Colombo M, Maisonneuve P. Survival of patients with HCV cirrhosis and sustained virologic response is similar to the general population. J Hepatol. 2016 Jun;64(6):1217-23. doi: 10.1016/j.jhep.2016.01.034. Epub 2016 Apr 5.</citation>
    <PMID>27059129</PMID>
  </reference>
  <reference>
    <citation>Charlton M, Everson GT, Flamm SL, Kumar P, Landis C, Brown RS Jr, Fried MW, Terrault NA, O'Leary JG, Vargas HE, Kuo A, Schiff E, Sulkowski MS, Gilroy R, Watt KD, Brown K, Kwo P, Pungpapong S, Korenblat KM, Muir AJ, Teperman L, Fontana RJ, Denning J, Arterburn S, Dvory-Sobol H, Brandt-Sarif T, Pang PS, McHutchison JG, Reddy KR, Afdhal N; SOLAR-1 Investigators. Ledipasvir and Sofosbuvir Plus Ribavirin for Treatment of HCV Infection in Patients With Advanced Liver Disease. Gastroenterology. 2015 Sep;149(3):649-59. doi: 10.1053/j.gastro.2015.05.010. Epub 2015 May 15.</citation>
    <PMID>25985734</PMID>
  </reference>
  <reference>
    <citation>Claudon M, Dietrich CF, Choi BI, Cosgrove DO, Kudo M, Nolsoe CP, Piscaglia F, Wilson SR, Barr RG, Chammas MC, Chaubal NG, Chen MH, Clevert DA, Correas JM, Ding H, Forsberg F, Fowlkes JB, Gibson RN, Goldberg BB, Lassau N, Leen EL, Mattrey RF, Moriyasu F, Solbiati L, Weskott HP, Xu HX; World Federation for Ultrasound in Medicine; European Federation of Societies for Ultrasound. Guidelines and good clinical practice recommendations for Contrast Enhanced Ultrasound (CEUS) in the liver - update 2012: A WFUMB-EFSUMB initiative in cooperation with representatives of AFSUMB, AIUM, ASUM, FLAUS and ICUS. Ultrasound Med Biol. 2013 Feb;39(2):187-210. doi: 10.1016/j.ultrasmedbio.2012.09.002. Epub 2012 Nov 5.</citation>
    <PMID>23137926</PMID>
  </reference>
  <reference>
    <citation>Enomoto M, Mori M, Ogawa T, Fujii H, Kobayashi S, Iwai S, Morikawa H, Tamori A, Sakaguchi H, Sawada A, Takeda S, Habu D, Shiomi S, Kawada N. Usefulness of transient elastography for assessment of liver fibrosis in chronic hepatitis B: Regression of liver stiffness during entecavir therapy. Hepatol Res. 2010 Sep;40(9):853-61. doi: 10.1111/j.1872-034X.2010.00687.x.</citation>
    <PMID>20887589</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>August 5, 2017</last_update_submitted>
  <last_update_submitted_qc>August 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Ibrahim Taha</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Liver Cirrhosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03241823
org study id: AOHF
nct id: NCT03241823
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Hepatitis C Virus (HCV) infection is a major global health challenge; it is estimated that
      more than 80 million people are chronically infected worldwide, with 3-4 million new
      infections and 350,000 deaths occurring each year because of HCV-related complications .
In 2015, a national Egyptian health issue survey was conducted to describe the prevalence of
      hepatitis C virus infection. The prevalence of hepatitis C virus antibody was found to be
      10.0% and that of Hepatitis C virus Ribonucleic acid (HCV RNA ) to be 7.0% in the age group
      between 15-59 years. While In children, 1-14 years old, the prevalence of Hepatitis C virus
      (HCV) antibody and Hepatitis C virus Ribonucleic acid (HCV RNA) were 0.4% and 0.2%
      respectively.

      The primary goal of HCV therapy is to cure the infection, i.e. to achieve a sustained
      virological response (SVR) defined as undetectable Hepatitis C virus Ribonucleic acid (HCV
      RNA )12 weeks or 24 weeks after treatment completion. The infection is cured in more than 99%
      of patients who achieve asustained virological response (SVR). Asustained virological
      response (SVR) is generally associated with normalization of liver enzymes and improvement or
      disappearance of liver necroinflammation and fibrosis in patients without cirrhosis. Patients
      with severe liver disease remain at risk of life-threatening complications; however hepatic
      fibrosis may regress and the risk of complications such as hepatic failure and portal
      hypertension is reduced .

      Previous data suggest that the risk of Hepatocellular carcinoma and all-cause mortality is
      significantly reduced, but not eliminated, in cirrhotic patients who clear Hepatitis C Virus
      compared to untreated patients and non-sustained virological responders . Hepatitis C Virus
      is also associated with a number of extrahepatic manifestations and effective viral
      suppression induces reversal of most of them .

      Studies in those with hepatitis C-related decompensated cirrhosis have demonstrated that
      sustained virological response can indeed be achieved in the majority of these individuals,
      and short-term follow-up from these studies has shown that Sustained virological response is
      often accompanied by improvement in measures of decompensation including Model for End-Stage
      Liver Disease (MELD) score and Child-Turcotte-Pugh (CPT) score. Moreover, because hepatitis C
      recurrence after Orthotopic liver transplantation is associated with worse outcomes,
      achieving Sustained virological response before transplant in a decompensated population with
      chronic hepatitis C will likely allow these patients to achieve long-term outcomes not
      different from non-Hepatitis C virus-infected populations .

      In the SOLAR-1 and SOLAR-2 studies, those with decompensated cirrhosis with genotypes 1 and 4
      were randomized to receive sofosbuvir/ledipasvir with low-dose ribavirin for 12 or 24 weeks .
      No difference was seen in Sustained virological response in the 12- or 24-week arms, and the
      therapy was well tolerated. Moreover, these studies both reported improvement in Model for
      End-Stage Liver Disease (MELD) score and Child-Turcotte-Pugh (CPT) scores 4 weeks after
      therapy had been stopped with longer-term follow-up results expected.

      Liver stiffness measurement by transient elastography is a noninvasive, painless, rapid, and
      objective method for the evaluation of fibrosis or cirrhosis . Systemic reviews and
      meta-analyses have demonstrated the high sensitivity and specificity of Liver stiffness
      measurement in the diagnosis of hepatic cirrhosis.

      In a systematic review conducted at 2007, repoted that at a threshold of approximately 0.60,
      the sensitivity and specificity of the FibroTest were 47% (35-59%) and 90% (87-92%). For
      FibroScan (threshold approximately 8 kPa), corresponding values were 64% (50-76%) and 87%
      (80-91%), respectively.

      In another systematic review conducted at 2010, reported that the pooled estimates for
      sensitivity of fibroscan were 87% (84%-90%), specificity 91% (89%-92%) in stage IV fibrosis
      (cirrhosis). While in patients with stages II-IV fibrosis, they reported that the pooled
      estimates for sensitivity were 70% (67%-73%), specificity 84% (80%-88%).

      Multicenter observational, cohort, prospective study included 90 patients with hepatitis C
      genotype 1 treated with telaprevir or boceprevir who had advanced fibrosis evidenced by liver
      stiffness and achieved Sustained virological response reported that liver stiffness was
      significantly reduced 2 weeks after treatment. This suggested the possibility of liver
      cirrhosis regression evidenced by liver stiffness after sustained virological response in a
      significant proportion of patients .

      In a study included 182 Egyptian patients with HCV infection to validate and compare the
      diagnostic performance of Fibroscan , APRI Score , FIB4 for the prediction of hepatic
      fibrosis and treatment outcome in HCV infected patients receiving pegylated interferon and
      ribavirin, the authors reported that Fibroscan and noninvasive scores as APRI , FIB4 can be
      used as good predictors of liver fibrosis in chronic hepatitis C. However, they are not good
      predictors of response to pegylated interferon and ribavirin .

      In a study 2010, they concluded that liver stiffness measurement can be useful for monitoring
      regression of liver fibrosis during entecavir treatment in patients with chronic hepatitis B
      virus infection.

      A few studies showed a consistent relationship between Doppler Ultrasonography findings and
      liver histology. showed that Doppler Ultrasound findings are sensitive to haemo dynamic
      changes in liver fibrosis. Doppler Ultrasonography scoring was significantly related to liver
      fibrosis staging.

      The Doppler Ultrasound signs for portal hypertension are: (1) reduced portal vein blood flow
      velocity (time-averaged mean vel. < 14-16 cm/s2), with sensitivity and specificity between
      80-88% and 80-96%, respectively; (2) portal vein congestion index > 0.08. This parameter,
      however, is not used routinely, probably due to its being difficult to measure and its lower
      reproducibility; and (3) measurements of the hepatic arterial Resistive Index are less
      useful. In the course of Liver cirrhosis, the appearance of clinically significant portal
      hypertension worsens prognosis and Doppler ultrasound is very useful in evaluating portal
      hypertension. . astudy showed a significant reverse correlation between the velocities of the
      main portal vein and fibrous staging of the liver.
observational model: Cohort
time perspective: Prospective
measure: Changes in liver fibrosis
time frame: 1 year.
description: Using non-invasive measures "Fibroscan"
measure: Changes occurring in liver haemodynamics
time frame: 1 year.
description: Using Doppler ultrasound.
measure: Changes in severity of liver disease
time frame: 1 year
description: Using Child-Pugh score.
arm group label: Patients with hepatitis c virus related liver cirrhosis
description: Patients with chronic hepatitis C virus whose ultrasound shows liver cirrhosis, fibroscan "F3 and F4, Child score "A and B", of any MELD score, who achieved Sustained Virological Response after direct acting antiviral drugs (Sofosbuvir, Daclatasvir ± Ribavirin).
intervention type: Diagnostic Test
intervention name: Abdominal ultrasound .
description: Abdominal ultrasound for each patient before and after treatment.
arm group label: Patients with hepatitis c virus related liver cirrhosis
intervention type: Diagnostic Test
intervention name: Model for End-Stage Liver Disease
description: Model for End-Stage Liver Disease before and after treatment.
arm group label: Patients with hepatitis c virus related liver cirrhosis
intervention type: Diagnostic Test
intervention name: Fibro Scan.
description: Liver stiffness by Fibro scan before and after treatment.
arm group label: Patients with hepatitis c virus related liver cirrhosis
intervention type: Diagnostic Test
intervention name: Child-Turcotte-Pugh score.
description: Child-Turcotte-Pugh score before and after treatment
arm group label: Patients with hepatitis c virus related liver cirrhosis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ibrahim Taha, MSc
role: Principal Investigator
affiliation: Assiut University
last name: Sherif Kamel, MD
phone: 00201222303690
email: shereef_kamel@yahoo.com
last name: Sahar Hassany, MD
phone: 00201010431017
email: saharhassany@yahoo.com
facility: 
contact: 
country: Egypt
citation: Arase Y, Kobayashi M, Suzuki F, Suzuki Y, Kawamura Y, Akuta N, Kobayashi M, Sezaki H, Saito S, Hosaka T, Ikeda K, Kumada H, Kobayashi T. Effect of type 2 diabetes on risk for malignancies includes hepatocellular carcinoma in chronic hepatitis C. Hepatology. 2013 Mar;57(3):964-73. doi: 10.1002/hep.26087. Epub 2013 Feb 7.
PMID: 22991257
citation: Bruno S, Di Marco V, Iavarone M, Roffi L, Crosignani A, Calvaruso V, Aghemo A, Cabibbo G, Vigano M, Boccaccio V, Craxi A, Colombo M, Maisonneuve P. Survival of patients with HCV cirrhosis and sustained virologic response is similar to the general population. J Hepatol. 2016 Jun;64(6):1217-23. doi: 10.1016/j.jhep.2016.01.034. Epub 2016 Apr 5.
PMID: 27059129
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responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Ibrahim Taha
investigator title: principal investigator
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis
mesh term: Liver Cirrhosis
mesh term: Fibrosis
sharing ipd: Undecided