<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/NCT02216045</url>
  </required_header>
  <id_info>
    <org_study_id>Mashhad UMS</org_study_id>
    <nct_id>NCT02216045</nct_id>
  </id_info>
  <brief_title>Effect of Camel Milk on Chronic Hepatitis C</brief_title>
  <acronym>HCV</acronym>
  <official_title>Investigating the Effects of Camel Milk Products on the Laboratory Markers in the Patients With Chronic Hepatitis C, Genotype 2 &amp; 3</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mashhad University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mashhad University of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Camel milk as the new modality for treatment of chronic hepatitis C. The purpose of this&#xD;
      study is to evaluate effectiveness and safety of camel milk in combination with Peginterferon&#xD;
      Alfa-2a and Ribavirin in genotype 2,3 chronic hepatitis C virus .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators enrolled 40 patients into the study. Group 1(Intervention ) : received&#xD;
      PEGASYS( Peginterferon ) One subcutaneous injection containing 0.5 ml solution with180 mcg&#xD;
      per week plus COPEGUS( Ribavirin ) tablets (body-weight adjusted dose: &lt; 75 kg = 1000 mg and&#xD;
      ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily and 250 ml of raw camel milk will be&#xD;
      consumed in 10 minutes orally twice daily for 12 weeks.&#xD;
&#xD;
      Group 2 ( control ): received PEGASYS( Peginterferon ) One subcutaneous injection containing&#xD;
      0.5 ml solution with180 mcg per week plus COPEGUS( Ribavirin ) tablets (body-weight adjusted&#xD;
      dose: &lt; 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily for 12&#xD;
      weeks.&#xD;
&#xD;
      Follow up period is 1,2,3 months after treatment. The patients are visited every 4 weeks with&#xD;
      biochemistry lab tests. The patients are checked with quantitative HCV RNA (Ribonucleic Acid)&#xD;
      on the first months after initiation of the treatment to assess early virologic response and&#xD;
      at the end of the study for complete response rate and on the third month after treatment&#xD;
      completion for sustained response rate. The patients with undetectable HCV RNA are considered&#xD;
      as responders.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Early Virologic Responses(EVR)</measure>
    <time_frame>After 4 weeks of Treatment</time_frame>
    <description>Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment by PEG IFN ( interferon) + RBV.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Early Virologic Responses(EVR)</measure>
    <time_frame>4 weeks after of treatment</time_frame>
    <description>Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment by PEG IFN + RBV+camel milk</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complete early virological response (cEVR)</measure>
    <time_frame>12 weeks after initiation of treatment</time_frame>
    <description>defined by undetectable HCV RNA at 12 weeks post initiation of dual therapy by PEG IFN + RBV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>o Complete early virological response (cEVR)</measure>
    <time_frame>12 weeks after initiation of treatment</time_frame>
    <description>defined by undetectable HCV RNA at 12 weeks post initiation of dual therapy by PEG IFN + RBV+camel milk</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>o Sustained virological response (SVR)</measure>
    <time_frame>12 weeks after initiation of treatment</time_frame>
    <description>defined by HCV RNA below the detection limit based on quantitative PCR 12 weeks after stopping treatment by PEG IFN +RBV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>o Sustained virological response (SVR)</measure>
    <time_frame>12 weeks after initiation of treatment</time_frame>
    <description>defined by HCV RNA below the detection limit based on quantitative PCR(polymerase chain reaction ) 12 weeks after stopping treatment by PEG IFN +RBV+camel milk</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>o Normalization of ALT( Alanine Aminotransferase)</measure>
    <time_frame>during the treatment and 12 weeks of treatment</time_frame>
    <description>Proportion of patients who have ALT below the upper limit of normal (ULN) during the treatment by PEG IFN +RBV and 12 weeks after the end of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>o Normalization of ALT</measure>
    <time_frame>during the treatment and 12 weeks of treatment</time_frame>
    <description>Proportion of patients who have ALT below the upper limit of normal (ULN) during the treatment by PEG IFN +RBV+camel milk and 12 weeks after of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>o Adverse events(AE)</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>Number of participants experiencing adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>o Adverse events(AE)</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>Number of participants discontinuing study treatment because of adverse events</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Chronic Hepatitis C</condition>
  <arm_group>
    <arm_group_label>Peginterferon ,Ribavirin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>drug :Peginterferon, Ribavirin,</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Peginterferon, Ribavirin, camel milk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>drug :Peginterferon, Ribavirin, camel milk</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Peginterferon, Ribavirin, camel milk</intervention_name>
    <description>Peginterferon One subcutaneous injection containing 0.5 ml solution with180 mcg PegIFNα-2a per week for 12 weeks.&#xD;
Ribavirin (RBV) tablets (body-weight adjusted dose: &lt; 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily for for 12 weeks .&#xD;
camel milk 250 ml of raw camel milk will be consumed in 10 minutes orally twice daily for 12 weeks.</description>
    <arm_group_label>Peginterferon, Ribavirin, camel milk</arm_group_label>
    <other_name>PEGASYS® COPEGUS®. Dromedary milk (camel milk )</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Peginterferon, Ribavirin</intervention_name>
    <description>Peginterferon (PegIFNα-2a) One subcutaneous injection containing 0.5 ml solution with180 mcg PegIFNα-2a per week for 12 weeks.&#xD;
Ribavirin (RBV) tablets (body-weight adjusted dose: &lt; 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily for for 12 weeks.</description>
    <arm_group_label>Peginterferon ,Ribavirin</arm_group_label>
    <other_name>PEGASYS® (Peginterferon ) , COPEGUS® (Ribavirin)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HCV (hepatitis C virus ) RNA positive&#xD;
&#xD;
          -  Age age groups (18 to 70 years)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ongoing pregnancy or breast feeding&#xD;
&#xD;
          -  Hx of HCC(hepatocellular carcinoma )&#xD;
&#xD;
          -  Hx of alcoholic liver disease&#xD;
&#xD;
          -  Hx of bleeding from esophageal varices&#xD;
&#xD;
          -  Hx of hemochromatosis&#xD;
&#xD;
          -  Hx of autoimmune hepatitis&#xD;
&#xD;
          -  Hx of Suicidal attempt&#xD;
&#xD;
          -  Hx of cerebrovascular dis&#xD;
&#xD;
          -  Hx of severe retinopathy&#xD;
&#xD;
          -  Hx of severe psoriasis&#xD;
&#xD;
          -  Hx of scleroderma&#xD;
&#xD;
          -  Hx of metabolic liver disease&#xD;
&#xD;
          -  Hx of SLE(systemic lupus erythematosus )&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Seyyd Musa Al-Reza Hosseini, professor.As</last_name>
    <role>Study Chair</role>
    <affiliation>Ghaem Gastrointestinal Clinic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mehdi Yousefi, MD.Phd</last_name>
    <role>Study Director</role>
    <affiliation>Faculty of Traditional Medicine Clinic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohammadreza Noras, Phd student</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculty of Traditional Medicine Clinic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ali Taghipour, MD.Phd</last_name>
    <role>Study Director</role>
    <affiliation>MUMS Faculty of Health Sciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Said Zibae, MD.Phd</last_name>
    <role>Study Director</role>
    <affiliation>Razi vaccine and serum Research Institue of Mashhd</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Traditional Medicine</name>
      <address>
        <city>Mashhad</city>
        <state>Khorasan-e-Razavi</state>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mashhad University of Medical Sciences</name>
      <address>
        <city>Mashhad</city>
        <state>Khorasan-e-Razavi</state>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>July 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>July 28, 2016</last_update_submitted>
  <last_update_submitted_qc>July 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mashhad University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>mohammadreza noras</investigator_full_name>
    <investigator_title>Phd student</investigator_title>
  </responsible_party>
  <keyword>Hepatitis C ,Chronic Hepatitis C ,camel milk</keyword>
  <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 C, Chronic</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Hepatitis, Chronic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ribavirin</mesh_term>
    <mesh_term>Peginterferon alfa-2a</mesh_term>
    <mesh_term>Interferon-alpha</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>individual participant data (IPD) is confidential in researchers .</ipd_description>
  </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/NCT02216045
org study id: Mashhad UMS
nct id: NCT02216045
lead sponsor: 
has dmc: Yes
Camel milk as the new modality for treatment of chronic hepatitis C. The purpose of this
      study is to evaluate effectiveness and safety of camel milk in combination with Peginterferon
      Alfa-2a and Ribavirin in genotype 2,3 chronic hepatitis C virus .
The investigators enrolled 40 patients into the study. Group 1(Intervention ) : received
      PEGASYS( Peginterferon ) One subcutaneous injection containing 0.5 ml solution with180 mcg
      per week plus COPEGUS( Ribavirin ) tablets (body-weight adjusted dose: < 75 kg = 1000 mg and
      ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily and 250 ml of raw camel milk will be
      consumed in 10 minutes orally twice daily for 12 weeks.

      Group 2 ( control ): received PEGASYS( Peginterferon ) One subcutaneous injection containing
      0.5 ml solution with180 mcg per week plus COPEGUS( Ribavirin ) tablets (body-weight adjusted
      dose: < 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily for 12
      weeks.

      Follow up period is 1,2,3 months after treatment. The patients are visited every 4 weeks with
      biochemistry lab tests. The patients are checked with quantitative HCV RNA (Ribonucleic Acid)
      on the first months after initiation of the treatment to assess early virologic response and
      at the end of the study for complete response rate and on the third month after treatment
      completion for sustained response rate. The patients with undetectable HCV RNA are considered
      as responders.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Early Virologic Responses(EVR)
time frame: After 4 weeks of Treatment
description: Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment by PEG IFN ( interferon) + RBV.
measure: Early Virologic Responses(EVR)
time frame: 4 weeks after of treatment
description: Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment by PEG IFN + RBV+camel milk
measure: Complete early virological response (cEVR)
time frame: 12 weeks after initiation of treatment
description: defined by undetectable HCV RNA at 12 weeks post initiation of dual therapy by PEG IFN + RBV
measure: o Complete early virological response (cEVR)
time frame: 12 weeks after initiation of treatment
description: defined by undetectable HCV RNA at 12 weeks post initiation of dual therapy by PEG IFN + RBV+camel milk
measure: o Sustained virological response (SVR)
time frame: 12 weeks after initiation of treatment
description: defined by HCV RNA below the detection limit based on quantitative PCR 12 weeks after stopping treatment by PEG IFN +RBV
measure: o Sustained virological response (SVR)
time frame: 12 weeks after initiation of treatment
description: defined by HCV RNA below the detection limit based on quantitative PCR(polymerase chain reaction ) 12 weeks after stopping treatment by PEG IFN +RBV+camel milk
measure: o Normalization of ALT( Alanine Aminotransferase)
time frame: during the treatment and 12 weeks of treatment
description: Proportion of patients who have ALT below the upper limit of normal (ULN) during the treatment by PEG IFN +RBV and 12 weeks after the end of treatment.
measure: o Normalization of ALT
time frame: during the treatment and 12 weeks of treatment
description: Proportion of patients who have ALT below the upper limit of normal (ULN) during the treatment by PEG IFN +RBV+camel milk and 12 weeks after of treatment.
measure: o Adverse events(AE)
time frame: Up to 12 weeks
description: Number of participants experiencing adverse events
measure: o Adverse events(AE)
time frame: Up to 12 weeks
description: Number of participants discontinuing study treatment because of adverse events
arm group label: Peginterferon ,Ribavirin
arm group type: Active Comparator
description: drug :Peginterferon, Ribavirin,
arm group label: Peginterferon, Ribavirin, camel milk
arm group type: Experimental
description: drug :Peginterferon, Ribavirin, camel milk
intervention type: Drug
intervention name: Peginterferon, Ribavirin, camel milk
description: Peginterferon One subcutaneous injection containing 0.5 ml solution with180 mcg PegIFNα-2a per week for 12 weeks.
Ribavirin (RBV) tablets (body-weight adjusted dose: < 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily for for 12 weeks .
camel milk 250 ml of raw camel milk will be consumed in 10 minutes orally twice daily for 12 weeks.
arm group label: Peginterferon, Ribavirin, camel milk
other name: PEGASYS® COPEGUS®. Dromedary milk (camel milk )
intervention type: Drug
intervention name: Peginterferon, Ribavirin
description: Peginterferon (PegIFNα-2a) One subcutaneous injection containing 0.5 ml solution with180 mcg PegIFNα-2a per week for 12 weeks.
Ribavirin (RBV) tablets (body-weight adjusted dose: < 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily for for 12 weeks.
arm group label: Peginterferon ,Ribavirin
other name: PEGASYS® (Peginterferon ) , COPEGUS® (Ribavirin)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Seyyd Musa Al-Reza Hosseini, professor.As
role: Study Chair
affiliation: Ghaem Gastrointestinal Clinic
last name: Mehdi Yousefi, MD.Phd
role: Study Director
affiliation: Faculty of Traditional Medicine Clinic
last name: Mohammadreza Noras, Phd student
role: Principal Investigator
affiliation: Faculty of Traditional Medicine Clinic
last name: Ali Taghipour, MD.Phd
role: Study Director
affiliation: MUMS Faculty of Health Sciences
last name: Said Zibae, MD.Phd
role: Study Director
affiliation: Razi vaccine and serum Research Institue of Mashhd
facility: 
facility: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: Mashhad University of Medical Sciences
investigator full name: mohammadreza noras
investigator title: Phd student
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic
mesh term: Ribavirin
mesh term: Peginterferon alfa-2a
mesh term: Interferon-alpha
sharing ipd: No
ipd description: individual participant data (IPD) is confidential in researchers .