<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT2015041720178N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-05-03</date_registration>
      <primary_sponsor>Iran University of Medical Sciences,Rasoul Akram Hospital,Colorectal Research Center</primary_sponsor>
      <public_title>Efficacy of  vitB12 plus standard chronic HCV treatment  versus standard chronic HCV treatment on sustained virologic response rate</public_title>
      <acronym></acronym>
      <scientific_title>A  comparison  of vitB12 plus standard chronic HCV treatment with standard chronic HCV treatment on sustained virologic response rate</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>74</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/17892</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Chronic viral hepatitis C.</hc_freetext>
      <i_freetext>Intervention 1: control:: Peg-IFNa2b 1.5 mg/kg/week subcutaneously and ribavirin  ; according to body weight(1000 mg/day for weighing &lt;75 kg, 1200 mg/day for weighing &gt;75 kg in genotype 1 or 4 and  a single ribavirin dose of 800 mg/day in genotype 2 or 3 . Intervention 2: Intervention: : Peg-IFNa2b 1.5 mg/kg/week subcutaneously and ribavirin  ; according to body weight(1000 mg/day for weighing &lt;75 kg, 1200 mg/day for weighing &gt;75 kg in genotype 1 or 4 and  a single ribavirin dose of 800 mg/day in genotype 2 or 3 plus vitamin B12  5000 microgram  intramuscular&#13;
injection every 4 weeks for the duration of the antiviral therapy.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Marjan Mokhtare</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sattarkhan Street, Niayesh Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6655 4790</telephone>
        <email>mokhtare.m@iums.ac.ir-marjanmokhtare@yahoo.com-mokhtaredr@gmail.com</email>
        <affiliation>Colorectal Research Center, Rasoul Akram Hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marjan Mokhtare</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Colorectal Research Center, Rasoul Akram Hospital,Niayesh Street,Sattarkhan Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6655 4790</telephone>
        <email>mokhtare.m@iums.ac.ir-marjanmokhtare@yahoo.com-mokhtaredr@gmail.com</email>
        <affiliation>Colorectal Research Center, Rasoul Akram Hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:naive HCV hepatitis patients that refer to Rasoul Akram Hospital,Gastroenterology Clinic.&#13;
Exclusion criteria:age&lt;18 and age&gt;70,previous treatment with interferon and/or ribavirin,concomitant causes of liver disease, such as HBV infection and  autoimmune Hepatitis, alcohol user,  HIV infection, hepatocellular carcinoma, decompensated cirrhosis, severe concurrent disease and contraindications to treatment including uncontrolled depression,psychosis, epilepsy, autoimmune diseases, poorlycontrolled hypertension, diabetes, heart failure and chronic obstructive pulmonary disease.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B18.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic viral hepatitis C</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>control:: Peg-IFNa2b 1.5 mg/kg/week subcutaneously and ribavirin  ; according to body weight(1000 mg/day for weighing &lt;75 kg, 1200 mg/day for weighing &gt;75 kg in genotype 1 or 4 and  a single ribavirin dose of 800 mg/day in genotype 2 or 3 .</i_keyword>
      <i_keyword>Intervention: : Peg-IFNa2b 1.5 mg/kg/week subcutaneously and ribavirin  ; according to body weight(1000 mg/day for weighing &lt;75 kg, 1200 mg/day for weighing &gt;75 kg in genotype 1 or 4 and  a single ribavirin dose of 800 mg/day in genotype 2 or 3 plus vitamin B12  5000 microgram  intramuscular&#13;
injection every 4 weeks for the duration of the antiviral therapy.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sustained virologic response rate. Timepoint: 24 weeks after treatment completion. Method of measurement: Quantitative HCV-PCR.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>HCV genotype pattern. Timepoint: at the begining of treatment. Method of measurement: HCV genotyping.</sec_outcome>
      <sec_outcome>Drug adverse effect  rate. Timepoint: During treatment. Method of measurement: Data gathering sheet.</sec_outcome>
      <sec_outcome>Non-responder rate. Timepoint: 12 and 24 weeks after start treatment. Method of measurement: Quantitative HCV-PCR.</sec_outcome>
      <sec_outcome>Rapid viral response rate. Timepoint: 4 weeks after start treatment. Method of measurement: Quantitative HCV-PCR.</sec_outcome>
      <sec_outcome>Complete early viral response rate. Timepoint: 12  weeks after start treatment. Method of measurement: Quantitative HCV-PCR.</sec_outcome>
      <sec_outcome>Dropout rate. Timepoint: During treatment. Method of measurement: Data gathering sheet.</sec_outcome>
      <sec_outcome>Liver steatosis and fibrosis rate. Timepoint: at first time before treatment. Method of measurement: liver fibroscan and/or biopsy.</sec_outcome>
      <sec_outcome>Patient compliance rate. Timepoint: at the end of treatment. Method of measurement: Data gathering sheet.</sec_outcome>
      <sec_outcome>The end-oftreatment viral response rate. Timepoint: at the end of treatment. Method of measurement: Quantitative HCV-PCR.</sec_outcome>
      <sec_outcome>Virological breakthrough rate. Timepoint: During treatment. Method of measurement: Quantitative HCV-PCR.</sec_outcome>
      <sec_outcome>Relapse rate. Timepoint: during 24 weeks after completing treatment. Method of measurement: Quantitative HCV-PCR.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Iran University of Medical Sciences,Rasoul Akram Hospital,Colorectal Research Center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-04-15</approval_date>
        <contact_name>Iran University of Medical Sciences Ethics Committee</contact_name>
        <contact_address>Iran University of Medical Sciences,West Shahid Hemmat Highway,Intersection of Chamran and Sheikh Fazlollah Noori,Tehran Iran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
