<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/NCT01683786</url>
  </required_header>
  <id_info>
    <org_study_id>MISP39068</org_study_id>
    <nct_id>NCT01683786</nct_id>
  </id_info>
  <brief_title>36 vs 48 Wks Peg-Intron Plus Ribavirin for HCV Patients Without Rapid Virologic Response But Without HCV RNA at wk 8</brief_title>
  <official_title>An Open Label, Randomized, Parallel Design Estimation Pilot Study to Compare the Effectiveness of 36 vs 48 Wks PegIntron Plus Ribavirin Treatment for HCV Patients Without Rapid Virologic Response(RVR) But With Undetectable HCV RNA at wk 8</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose:&#xD;
&#xD;
      To compare the effectiveness of 36 weeks versus 48 weeks pegintron plus ribavirin treatment&#xD;
      for hepatitis C virus(HCV) patients without rapid virologic response(RVR), but with&#xD;
      undetectable HCV RNA at wk 8.&#xD;
&#xD;
      Study Design:&#xD;
&#xD;
      a multi-site, prospective, open label, randomized, pilot trial. Approximately 60 HCV Genotype&#xD;
      1 patients who fail to achieve RVR but achieve undetectable HCV RNA at week 8 (&lt;50 IU/ml)&#xD;
      will be recruited into 2 arms(30 in each arm). Patients must receive pegylated interferon-α2b&#xD;
      at 1.5 μg/kg of body weight/week and ribavirin 800~1400 mg/day for 12 wks before entering&#xD;
      this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose:&#xD;
&#xD;
      To compare the effectiveness of 36 wks versus 48 wks pegintron plus ribavirin treatment for&#xD;
      HCV patients without RVR, but with undetectable HCV RNA at wk 8.&#xD;
&#xD;
      Study Design:&#xD;
&#xD;
      This is a multi-site, prospective, open label, randomized, pilot trial. Approximately 60 HCV&#xD;
      Genotype 1 patients who fail to achieve RVR at wk 4 but achieve undetectable HCV RNA at wk 8&#xD;
      (&lt;50 IU/ml) will be recruited into 2 arms(30 in each arm). Patients must receive pegylated&#xD;
      IFN-α2b at 1.5 μg/kg of body weight/week and ribavirin 800~1400 mg/day for 12 wks before&#xD;
      entering this study.&#xD;
&#xD;
      Study Duration:&#xD;
&#xD;
      The estimated recruitment period is 12 months; the follow-up duration is 72 weeks (longest&#xD;
      treatment period plus 6 month- f/u period); the total study duration (FPE-&gt;LPLV) is estimated&#xD;
      to be 2.5 years&#xD;
&#xD;
      Statistical Analysis and Sample Size Justification:&#xD;
&#xD;
      A. The study is not primarily designed for hypothesis testing; thus the sample size&#xD;
      calculation is not based on the primary objective, Approximately 60 subjects (30 in each arm)&#xD;
      will be recruited into this study B. For descriptive statistics, the continuous variables&#xD;
      will be expressed as mean ± standard deviation, and the categorical variables will be&#xD;
      performed the number of cases and the corresponding percentages.&#xD;
&#xD;
      The primary analysis will focus on the efficacy response to the shortened HCV treatment&#xD;
      course (36 wks) compared with standard course (48 wks). The between-group difference for&#xD;
      efficacy endpoint will be assessed by the difference in the percentage of virologic responder&#xD;
      after 24 wks of HCV treatment. For univariate analyses, comparisons of independent samples&#xD;
      (shortened vs. standard course) will be assessed with Student's t test. The comparisons of&#xD;
      categorical variables will be assessed using the chi-square test. Regarding the multivariate&#xD;
      analysis, the proportion of patients achieving virologic responder will be compared among&#xD;
      groups using a logistic regression analysis with terms of potential confounding factors. The&#xD;
      OR estimates will be derived from the logistic regression model and the corresponding 95% CIs&#xD;
      will be used to quantify the each effect of treatment course length and confounding factors.&#xD;
&#xD;
      All randomized patients who take at least one dose of HCV regimen will be included in safety&#xD;
      assessment. Fisher's exact test will be used to compare between-group incidences of AEs. For&#xD;
      patients with any clinical AEs, treatment related AEs, serious AEs, or discontinuations&#xD;
      because of AEs, the data among groups will be provided as well. Statistical significance will&#xD;
      be determined at the 0.05 level for all tests.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2011</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2014</primary_completion_date>
  <phase>Phase 4</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>The rate of sustained virologic response</measure>
    <time_frame>At 24 weeks after end of treatment</time_frame>
    <description>The comparison of the rates of sustained virologic response (SVR) defined as the proportion of patients with loss of serum HCV RNA at week 24 of post-treatment between patient groups (36 vs 48 weeks of treatment period)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the factors associated with sustained virologic response(SVR) between groups</measure>
    <time_frame>24 weeks after the end of treatment</time_frame>
    <description>the SVR assessment is defined as 24 weeks after the end of treatment, which mean 48 weeks after randomization for the shorten treatment arm and 60 weeks after randomization for the standard treatment arm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the rate of end-of-treatment response(EOT)</measure>
    <time_frame>At the end of treatment (36 or 48 weeks of treatment period)</time_frame>
    <description>The comparison of the rates of end-of-treatment response (EOT) defined as the proportion of patients with loss of serum HCV RNA at the end of treatment between patient groups (36 vs 48 weeks of treatment period)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The relapse rate</measure>
    <time_frame>At 24 weeks after end of treatment</time_frame>
    <description>The comparison of the relapse rates defined as the proportion of patients without detectable serum HCV RNA at the end of treatment but with detectable HCV RNA at 24 weeks after end of treatment between patient groups (36 vs 48 weeks of treatment period)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Hepatitis C Infection</condition>
  <arm_group>
    <arm_group_label>Pegintron + Riba for 36 wks in total</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pegylated IFN-α2b at 1.5 µg/kg of body weight/week and ribavirin 800~1400 mg/day for 24 weeks (36 weeks in total HCV treatment)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pegintron + Riba for 48 wks in total</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pegylated IFN-α2b at 1.5 µg/kg of body weight/week and ribavirin 800~1400 mg/day for 36 weeks (48 weeks in total HCV treatment)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pegintron + Riba</intervention_name>
    <description>Pegylated IFN-α2b at 1.5 µg/kg of body weight/week and ribavirin 800~1400 mg/day</description>
    <arm_group_label>Pegintron + Riba for 36 wks in total</arm_group_label>
    <arm_group_label>Pegintron + Riba for 48 wks in total</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged 20y/o or older&#xD;
&#xD;
          2. Positive for the HCV antibody and HCV RNA detected with abnormal ALT (≧ 1X) before&#xD;
             initiating PegIFN plus RBV treatment&#xD;
&#xD;
          3. HCV Genotype 1&#xD;
&#xD;
          4. Have failed to achieve RVR at week 4 but achieve undetectable HCV RNA at week 8 (&lt; 50&#xD;
             IU/ml) with PegIFN plus RBV treatment&#xD;
&#xD;
          5. Have received PegIFN plus RBV treatment for 12weeks with good compliance (who have&#xD;
             received &gt;80% of expected PegIFN and RBV doses and completed at least 80% of the&#xD;
             expected duration (80/80/80 adherence) and achieve EVR before entering this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects with decompensated liver disease or overt cirrhosis by ultrasound.&#xD;
&#xD;
          2. With prior exposures to interferon (standard or pegylated) treatment before baseline.&#xD;
&#xD;
          3. With human immunodeficiency virus&#xD;
&#xD;
          4. With hepatitis B infection&#xD;
&#xD;
          5. With neutrophil count &lt; 1500 mm3,&#xD;
&#xD;
          6. With platelet count &lt; 90000 mm3,&#xD;
&#xD;
          7. With hemoglobin level &lt; 12g/dL for men or &lt; 11 g/dL for women&#xD;
&#xD;
          8. With serum creatinine level &gt; 1.5 mg/dL&#xD;
&#xD;
          9. With clinically significant cardiac or cardiovascular abnormalities, organ grafts,&#xD;
             systemic infections, clinically significant bleeding disorders, evidence of malignant&#xD;
             neoplastic diseases&#xD;
&#xD;
         10. Female patients with pregnancy or lactation. Pregnancy in partners of male patients.&#xD;
&#xD;
         11. Hypersensitive to study drugs cases.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tsung-Hui Hu, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Medical Foundation, Kaohsiung Branch</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tsung-Hui Hu, M.D.</last_name>
    <phone>886-7-7317123</phone>
    <phone_ext>8301</phone_ext>
    <email>Dr.hu@msa.hinet.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kaohsiung Veterans General Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>81362</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hsien-Chung Yu, M.D.</last_name>
      <phone>886-7-3422121</phone>
      <phone_ext>2074</phone_ext>
      <email>hcyu@vghks.gov.tw</email>
    </contact>
    <investigator>
      <last_name>Tsung-Hui Hu, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Chang Gung Medical Foundation, Kaohsiung Branch</name>
      <address>
        <city>Kaohsiung</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tsung-Hui Hu, M.D.</last_name>
      <phone>886-7-7317123</phone>
      <phone_ext>8301</phone_ext>
      <email>Dr.hu@msa.hinet.net</email>
    </contact>
    <investigator>
      <last_name>Tsung-Hui Hu, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Pingtung Christian Hospital</name>
      <address>
        <city>Pingtung</city>
        <zip>900</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lian-Feng Lin, M.D.</last_name>
      <phone>886-8-7368686</phone>
      <phone_ext>2032</phone_ext>
      <email>lin.lian.feng@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Lian-Feng Lin, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Chi Mei Medical Center - Liouying Branch</name>
      <address>
        <city>Tainan</city>
        <zip>736</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jyh-Jou Chen, M.D.</last_name>
      <phone>886-6-6226999</phone>
      <phone_ext>72008</phone_ext>
      <email>jjchen@mail.chimei.org.tw</email>
    </contact>
    <investigator>
      <last_name>Jyh-Jou Chen, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Shin Kong Wu Ho-Su Memorial Hosipital</name>
      <address>
        <city>Taipei</city>
        <zip>111</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chao-Sheng Liao, M.D.</last_name>
      <phone>886-2-28332211</phone>
      <phone_ext>2031</phone_ext>
      <email>M000642@ms.skh.org.tw</email>
    </contact>
    <investigator>
      <last_name>Chao-Sheng Liao, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>January 31, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <last_update_submitted>September 11, 2012</last_update_submitted>
  <last_update_submitted_qc>September 11, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis C</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peginterferon alfa-2b</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>March 22, 2016</submitted>
    <returned>April 20, 2016</returned>
  </pending_results>
  <!-- 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/NCT01683786
org study id: MISP39068
nct id: NCT01683786
lead sponsor: 
collaborator: 
has dmc: No
Purpose:

      To compare the effectiveness of 36 weeks versus 48 weeks pegintron plus ribavirin treatment
      for hepatitis C virus(HCV) patients without rapid virologic response(RVR), but with
      undetectable HCV RNA at wk 8.

      Study Design:

      a multi-site, prospective, open label, randomized, pilot trial. Approximately 60 HCV Genotype
      1 patients who fail to achieve RVR but achieve undetectable HCV RNA at week 8 (<50 IU/ml)
      will be recruited into 2 arms(30 in each arm). Patients must receive pegylated interferon-α2b
      at 1.5 μg/kg of body weight/week and ribavirin 800~1400 mg/day for 12 wks before entering
      this study.
Purpose:

      To compare the effectiveness of 36 wks versus 48 wks pegintron plus ribavirin treatment for
      HCV patients without RVR, but with undetectable HCV RNA at wk 8.

      Study Design:

      This is a multi-site, prospective, open label, randomized, pilot trial. Approximately 60 HCV
      Genotype 1 patients who fail to achieve RVR at wk 4 but achieve undetectable HCV RNA at wk 8
      (<50 IU/ml) will be recruited into 2 arms(30 in each arm). Patients must receive pegylated
      IFN-α2b at 1.5 μg/kg of body weight/week and ribavirin 800~1400 mg/day for 12 wks before
      entering this study.

      Study Duration:

      The estimated recruitment period is 12 months; the follow-up duration is 72 weeks (longest
      treatment period plus 6 month- f/u period); the total study duration (FPE->LPLV) is estimated
      to be 2.5 years

      Statistical Analysis and Sample Size Justification:

      A. The study is not primarily designed for hypothesis testing; thus the sample size
      calculation is not based on the primary objective, Approximately 60 subjects (30 in each arm)
      will be recruited into this study B. For descriptive statistics, the continuous variables
      will be expressed as mean ± standard deviation, and the categorical variables will be
      performed the number of cases and the corresponding percentages.

      The primary analysis will focus on the efficacy response to the shortened HCV treatment
      course (36 wks) compared with standard course (48 wks). The between-group difference for
      efficacy endpoint will be assessed by the difference in the percentage of virologic responder
      after 24 wks of HCV treatment. For univariate analyses, comparisons of independent samples
      (shortened vs. standard course) will be assessed with Student's t test. The comparisons of
      categorical variables will be assessed using the chi-square test. Regarding the multivariate
      analysis, the proportion of patients achieving virologic responder will be compared among
      groups using a logistic regression analysis with terms of potential confounding factors. The
      OR estimates will be derived from the logistic regression model and the corresponding 95% CIs
      will be used to quantify the each effect of treatment course length and confounding factors.

      All randomized patients who take at least one dose of HCV regimen will be included in safety
      assessment. Fisher's exact test will be used to compare between-group incidences of AEs. For
      patients with any clinical AEs, treatment related AEs, serious AEs, or discontinuations
      because of AEs, the data among groups will be provided as well. Statistical significance will
      be determined at the 0.05 level for all tests.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The rate of sustained virologic response
time frame: At 24 weeks after end of treatment
description: The comparison of the rates of sustained virologic response (SVR) defined as the proportion of patients with loss of serum HCV RNA at week 24 of post-treatment between patient groups (36 vs 48 weeks of treatment period)
measure: the factors associated with sustained virologic response(SVR) between groups
time frame: 24 weeks after the end of treatment
description: the SVR assessment is defined as 24 weeks after the end of treatment, which mean 48 weeks after randomization for the shorten treatment arm and 60 weeks after randomization for the standard treatment arm
measure: the rate of end-of-treatment response(EOT)
time frame: At the end of treatment (36 or 48 weeks of treatment period)
description: The comparison of the rates of end-of-treatment response (EOT) defined as the proportion of patients with loss of serum HCV RNA at the end of treatment between patient groups (36 vs 48 weeks of treatment period)
measure: The relapse rate
time frame: At 24 weeks after end of treatment
description: The comparison of the relapse rates defined as the proportion of patients without detectable serum HCV RNA at the end of treatment but with detectable HCV RNA at 24 weeks after end of treatment between patient groups (36 vs 48 weeks of treatment period)
arm group label: Pegintron + Riba for 36 wks in total
arm group type: Experimental
description: Pegylated IFN-α2b at 1.5 µg/kg of body weight/week and ribavirin 800~1400 mg/day for 24 weeks (36 weeks in total HCV treatment)
arm group label: Pegintron + Riba for 48 wks in total
arm group type: Active Comparator
description: Pegylated IFN-α2b at 1.5 µg/kg of body weight/week and ribavirin 800~1400 mg/day for 36 weeks (48 weeks in total HCV treatment)
intervention type: Drug
intervention name: Pegintron + Riba
description: Pegylated IFN-α2b at 1.5 µg/kg of body weight/week and ribavirin 800~1400 mg/day
arm group label: Pegintron + Riba for 36 wks in total
arm group label: Pegintron + Riba for 48 wks in total
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Tsung-Hui Hu, M.D.
role: Principal Investigator
affiliation: Chang Gung Medical Foundation, Kaohsiung Branch
last name: Tsung-Hui Hu, M.D.
phone: 886-7-7317123
phone ext: 8301
email: Dr.hu@msa.hinet.net
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Taiwan
responsible party type: Sponsor
mesh term: Hepatitis C
mesh term: Peginterferon alfa-2b
submitted: March 22, 2016
returned: April 20, 2016