A Study Evaluating Slow Response/Non-Rapid Response in Patients With Chronic Hepatitis C, Genotype 1, 2, 3 & 4 Treated With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)

December 20, 2017 updated by: Hoffmann-La Roche

A Multi-Center Study Evaluating the Rate of Genotype 1, 2, 3 & 4 Chronic Hepatitis C Patients With Slow Response / Non-rapid Viral Response to Anti-Viral Treatment of Pegasys (Peginterferon Alfa 2a) in Combination With Copegus (Ribavirin)

This multi-center study will evaluate the viral response in patients with chronic hepatitis C, genotype 1, 2, 3 & 4 on standard anti-viral treatment with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). Patients will receive weekly subcutaneous Pegasys plus daily oral Copegus for 24 weeks (genotype 2 & 3) or 48 weeks (genotype 1 & 4). Patients identified as slow responders/non-rapid virological responders will be eligible for an additional 24 weeks of treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1013

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Afula, Israel, 18101
        • Haemek Hospital; Gastroenterology
      • Ashdod, Israel, 77444
        • Clalit City Ashdod MC; Liver Clinic
      • Ashkelon, Israel, 78278
        • Barzilai MC; Gastroenterology
      • Bat Yam, Israel
        • Batyamon; Liver Unit
      • Beer Sheva, Israel, 84105
        • Soroka Medical Center; Gastroenterology
      • Beer Sheva, Israel, 8410101
        • Soroka Medical Center; Liver Unit
      • Haifa, Israel, 31096
        • Rambam Medical Center; Gastroenterology - Liver Unit
      • Haifa, Israel, 33394
        • Bnei-Zion Medical Center; Gastroenterology
      • Haifa, Israel, 34362
        • Carmel Hospital; Liver Unit
      • Holon, Israel, 58100
        • Wolfson Hospital; Gastroenterology Unit
      • Jerusalem, Israel, 91120
        • Hadassah Hospital; Liver Unit
      • Jerusalem, Israel, 95146
        • Clalit Strauss MC
      • Kfar Saba, Israel, 44281
        • Meir Medical Center; Gastroenterology
      • Nahariya, Israel, 22100
        • Naharyia / Western Galilee MC; Gastro Unit
      • Nazareth, Israel
        • Holy Family Medical Center; Gastroenterology
      • Petach Tikva, Israel
        • Hasharon Mc; Gastroenterology
      • Petach Tikva, Israel, 49100
        • Rabin Medical Center; Gastroenterology - Liver Unit
      • Ramat Gan, Israel, 52621
        • Chaim Sheba Medical Center; Gastroenterology
      • Rehovot, Israel, 76100
        • Kaplan Medical Center; Gastroenterology Unit
      • Rishon Lezion, Israel, 75299
        • Clalit Pinsker Rishon; Liver Clinic
      • Safed, Israel, 13110
        • Rebecca Sieff; Gastroenterology
      • Tel Aviv, Israel, 6423906
        • Sourasky / Ichilov Hospital; Gastroenterology - Liver Unit
      • Tel Aviv, Israel, 64353
        • Clalit Zamenhoff
      • Tel Aviv, Israel, 67891
        • Maccabi Health Services MC
      • Tiberias, Israel
        • Poria Hospital; Gastroenterology
      • Zerifin, Israel, 6093000
        • Assaf Harofeh; Gastroenterology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Serologic evidence of chronic hepatitis C, genotype 1, 2, 3 or 4 by anti-HCV antibody test
  • Documented pre-treatment HCV RNA quantitative result
  • Compensated liver disease (Child-Pugh Grade A)
  • Patient receiving standard combination treatment of Pegasys (peginterferon alfa-2a and Copegus (ribavirin)

Exclusion Criteria:

  • Decompensated liver disease (Child-Pugh Class B or C cirrhosis)
  • Co-infection with active hepatitis A and/or hepatitis B
  • History or evidence of a medical condition associated with liver disease other than HCV
  • Signs and symptoms of hepatocellular carcinoma
  • History of poorly controlled thyroid disease, elevated TSH or any clinical manifestations of thyroid disease
  • Therapy with antineoplastic treatment </= 6 months prior to study day
  • Diabetes mellitus in subjects receiving an insulin therapy
  • Evidence of severe retinopathy
  • Pregnant or breast-feeding women, and male partners of women who are pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Arm
Drug: peginterferon alfa-2a [Pegasys]
standard treatment, subcutaneously weekly
Drug: ribavirin [Copegus]
standard treatment, orally daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Partial Early Virological Response (pEVR) to Study Treatment
Time Frame: Week 12
The rate of participants with pEVR to study treatment was defined as ≥ 2 log reduction in HCV-RNA level from baseline value to Week 12 of study treatment but with detectable HCV-RNA at Week 12.
Week 12
Percentage of Participants With Complete Early Virologic Response (cEVR) to Study Treatment
Time Frame: Week 12
The rate of participants with a cEVR to study treatment was defined as negative HCV-RNA level at Week 12 of study treatment
Week 12
Percentage of Participants With Undetectable HCV-RNA at End of Treatment Response (ETR) at Week 24
Time Frame: Week 24
The rate of participants with undetectable HCV-RNA at ETR at Week 24 was defined as at least a 2-log decrement in HCV-RNA from the start of treatment, but with detectable HCV-RNA at Week 12 of study treatment and undetectable HCV-RNA at Week 24 of study treatment
Week 24
Percentage of Participants With Rapid Virologic Response (RVR) at Week 4
Time Frame: Week 4
The rate of participants with RVR was defined as negative HCV-RNA level at Week 4 of study treatment.
Week 4
Percentage of Participants Without a RVR (Non-RVR) at Week 4 of Standard Treatment
Time Frame: Week 4
The rate of participants without a RVR (non-RVR) was defined as detectible HCV-RNA level at Week 4 of standard treatment.
Week 4
Percentage of Participants With Non-RVR and Undetectable HCV-RNA at Week 24
Time Frame: Week 24
The rate of participants with non-RVR and undetectable HCV-RNA at Week 24 was defined as detectable HCV-RNA level at Week 4 of study treatment and undetectable HCV-RNA at Week 24 of study.
Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With pEVR to Study Treatment at Week 12
Time Frame: Week 12
The rate of participants with pEVR to study treatment was defined as ≥ 2 log reduction in HCV-RNA level from baseline value to Week 12 of study treatment but with detectable HCV-RNA at Week 12.
Week 12
Percentge of Participants With a cEVR to Study Treatmen at Week 12 of Study Treatment
Time Frame: Week 12
The rate of participants with a cEVR to study treatment was defined as negative HCV-RNA level at Week 12 of study treatment.
Week 12
Percentage of Participants With Undetectable HCV-RNA at Week 24, But With Detectable HCV-RNA atWeek 12 and Undetectable HCV-RNA at Week 24
Time Frame: Week 24
The rate of participants with undetectable HCV-RNA at ETR at Week 24 was defined as at least a 2-log decrement in HCV-RNA from the start of treatment, but with detectable HCV-RNA at Week 12 of study treatment and undetectable HCV-RNA at Week 24 of study treatment.
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2008

Primary Completion (Actual)

June 10, 2013

Study Completion (Actual)

June 10, 2013

Study Registration Dates

First Submitted

September 5, 2011

First Submitted That Met QC Criteria

September 5, 2011

First Posted (Estimate)

September 7, 2011

Study Record Updates

Last Update Posted (Actual)

October 23, 2018

Last Update Submitted That Met QC Criteria

December 20, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML21779

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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