A Study of Extended Therapy of PEGASYS (Peginterferon Alfa-2a) in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C and Slow Response

May 5, 2017 updated by: Hoffmann-La Roche

An Open-Label, Multi-Center Study Evaluating the Effect on Viral Activity and the Safety and Tolerability of Extended Treatment of Pegasys® (Peginterferon Alfa 2a ) in Combination With Copegus® (Ribavirin) in Genotype 1, 2 and 3 Chronic Hepatitis C Patients Defined as Slow Responders/Non-RVR

This open-label, multi-center study will evaluate the safety and tolerability and the effect on viral activity of a combined PEGASYS and COPEGUS extended therapy in patients with chronic hepatitis C with genotype 1, 2 and 3. Patients who completed 48 weeks (genotype 1) or 24 weeks (genotype 2 and 3) of standard treatment with PEGASYS and COPEGUS and were identified as slow virological responders will be enrolled in this study in order to receive additional 24 weeks of treatment. PEGASYS 180 micrograms will be administered sc once weekly and COPEGUS will be administered as 800 mg, or 1000-1200 mg daily oral doses. The anticipated time on study treatment is 24 weeks. The target sample size is 50-150 patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

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
      • Bat Yam, Israel
        • Batyamon; Liver Unit
      • Beer Sheva, Israel, 84105
        • Soroka Medical Center; Gastroenterology
      • 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, 49100
        • Rabin Medical Center; Gastroenterology - Liver Unit
      • Rehovot, Israel, 76100
        • Kaplan Medical Center; Gastroenterology Unit
      • Rishon Lezion, Israel, 75299
        • Clalit Pinsker Rishon; Liver Clinic
      • Safed, Israel, 13110
        • Rebecca Sieff Medical Center; Liver Unit
      • 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
  • Chronic hepatitis C, genotype 1, 2, 3
  • Compensated liver disease
  • Patients who completed 48 weeks or 24 weeks of standard treatment with PEGASYS and COPEGUS and were identified as slow virological responders

Exclusion Criteria:

  • Decompensated liver disease
  • Signs or symptoms of hepatocellular carcinoma
  • Uncontrolled hypoglycaemia, hyperglycaemia and diabetes mellitus

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single arm
Drug: COPEGUS
COPEGUS 800 mg or 1000-1200 mg po for 24 weeks
Drug: peginterferon alfa-2a [Pegasys]
PEGASYS 180 micrograms sc once weekly for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
End of Treatment Response Rate at Week 72 in Genotype 1
Time Frame: Week 72
End of treatment response rate at Week 72 was reported for genotype 1.
Week 72
End of Treatment Response in Genotype 2 and 3
Time Frame: Week 48
End of treatment response rate at Week 48 was reported for genotype 2 and 3.
Week 48
Sustained Viral Response (SVR) Rates in CHC Genotype 1
Time Frame: Week 96
Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 1.
Week 96
SVR Rates in Genotype 2 and 3.
Time Frame: Week 72
Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 2 and 3.
Week 72

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Adverse Event (AE)
Time Frame: Week 96
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Week 96

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

December 1, 2009

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

December 15, 2009

First Submitted That Met QC Criteria

December 15, 2009

First Posted (Estimate)

December 16, 2009

Study Record Updates

Last Update Posted (Actual)

October 3, 2017

Last Update Submitted That Met QC Criteria

May 5, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML21778

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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