A Study of Combination Treatment With Pegasys (Peginterferon Alfa) and Copegus (Ribavirin)in Patients With Chronic Hepatitis C

November 1, 2016 updated by: Hoffmann-La Roche

Safety and Tolerability of Ribavirin (Ro 20-9963) in Combination With Peginterferon Alfa in Patients With Chronic Hepatitis C

This 2 arm open-label study will assess the safety and tolerability of combination treatment with Peginterferon alfa (Pegasys) and Ribavirin (Copegus) in patients with chronic hepatitis C. Patients will be assigned to receive Peginterferon alfa (Pegasys) 180 mcg sc once a week and Ribavirin (Copegus) 800 - 1200 mg po daily for either 24 or 48 weeks. Allocation to the treatment arms is to the discretion of the investigator (mainly according to genotype). Adverse events will be monitored throughout the study and hematologic parameters every 2 weeks and twice during the 24-week follow-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2695

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
      • Ashkelon, Israel, 78278
      • Bat Yam, Israel
      • Beer Sheva, Israel, 84105
      • Hadera, Israel, 38100
      • Haifa, Israel, 34362
      • Haifa, Israel, 31096
      • Haifa, Israel, 33394
      • Holon, Israel, 58100
      • Jerusalem, Israel, 91120
      • Kfar Saba, Israel, 44281
      • Nahariya, Israel, 22100
      • Nazareth, Israel
      • Petach Tikva, Israel, 49100
      • Petach Tikva, Israel
      • Ramat Gan, Israel, 52621
      • Rehovot, Israel, 76100
      • Safed, Israel, 13110
      • Tel Aviv, Israel, 6423906
      • Zerifin, Israel, 6093000

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 infection
  • compensated liver disease
  • negative pregnancy test and in both males and females use of 2 forms of contraception during study and 6 months after treatment

Exclusion Criteria:

  • history or other evidence of a medical condition associated with chronic liver disease other than HCV
  • hepatitis A, hepatitis B or HIV infection
  • hepatocellular carcinoma
  • severe concomitant disease

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: Copegus (ribavirin)
800 - 1200 mg po daily for 24 weeks
Drug: Copegus (ribavirin)
800 - 1200 mg po daily for 48 weeks
Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc once weekly for 24 weeks
Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc once weekly for 48 weeks
Experimental: B
Drug: Copegus (ribavirin)
800 - 1200 mg po daily for 24 weeks
Drug: Copegus (ribavirin)
800 - 1200 mg po daily for 48 weeks
Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc once weekly for 24 weeks
Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc once weekly for 48 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
safety and tolerability with regard to clinical AEs and laboratory parameters
Time Frame: assessed every 2 weeks throughout study and after 8 weeks follow-up
assessed every 2 weeks throughout study and after 8 weeks follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
safety with regard to hematological parameters
Time Frame: assessed every 2 weeks throughout study and after 8 and 24 weeks of follow up
assessed every 2 weeks throughout study and after 8 and 24 weeks of follow up

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

October 1, 2002

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

July 6, 2009

First Submitted That Met QC Criteria

July 15, 2009

First Posted (Estimate)

July 16, 2009

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML16837

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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