An Observational Study of Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) on Predictive Values of RVR on Sustained Virological Response in Different Stages of Liver Fibrosis in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1

November 1, 2016 updated by: Hoffmann-La Roche

An Observational Study of Peginterferon-alfa-2a (Pegasys) and Ribavirin (Copegus) on Predictive Values of RVR on Sustained Virological Response (SVR) in Different Stage of Liver Fibrosis in Treatment-naïve Patients With Genotype 1 Chronic Hepatitis C

This observational study will evaluate the predictive value of rapid virological response (RVR) and early virological response (EVR) on sustained virological response (SVR) by stage of liver fibrosis in treatment-naïve patients with chronic hepatitis C genotype 1 initiated on treatment with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). Patients will be followed for 48 weeks of treatment and up to 24 weeks of follow-up.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

196

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

  • Poland
      • Bydgoszcz, Poland, 85-030
      • Bytom, Poland, 41-902
      • Chorzow, Poland, 41-500
      • Ciechanow, Poland, 06-400
      • Debica, Poland, 39-200
      • Katowice, Poland, 40-752
      • Koszalin, Poland, 75-581
      • Lancut, Poland, 37-100
      • Lodz, Poland, 91-357
      • Mielec, Poland, 39-300
      • Pulawy, Poland, 24-100
      • Radom, Poland, 26-600
      • Walbrzych, Poland, 58-300
      • Warszawa, Poland, 04-141

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

Sampling Method

Probability Sample

Study Population

Treatment-naïve patients with chronic hepatitis C genotype 1 initiated on treatment with Pegasys and Copegus

Description

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Chronic hepatitis C genotype 1
  • Treatment-naïve, i.e. have not been previously treated with pegylated interferon, standard interferon and ribavirin
  • Confirmed serum positive HCV RNA
  • Liver fibrosis confirmed histologically or by fibroscan up to 24 months before treatment

Exclusion Criteria:

  • Any contraindications according to the Summary of Product Characteristics for Pegasys or Copegus
  • Co-infection with hepatitis B or HIV
  • Post-transplant patients
  • End stage renal disease (creatinine clearance < 15 ml/min)
  • Patients treated with immunotherapy
  • Pregnant women and male partners of women who are pregnant
  • Female patients of childbearing potential and male patients with female partners of childbearing potential who are unable or unwilling to use effective and continuous contraception during the treatment and for 4 months (females) and 7 months (males) thereafter

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

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sustained virological response (SVR) rate, in relation to rapid virological response (RVR) in different stages of liver fibrosis in treatment-naïve patients with chronic hepatitis C genotype 1
Time Frame: approximately 3 years
approximately 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety: Incidence of adverse events
Time Frame: approximately 3 years
approximately 3 years
Sustained virological response (SVR) rate, in relation to early virological response (EVR) in different stages of liver fibrosis in treatment naïve patients with chronic hepatitis C genotype 1
Time Frame: approximately 3 years
approximately 3 years
Response rates (RVR, EVR, SVR) according to host/virus/treatment-related factors in different stages of liver fibrosis (F>/=3 and </=3)
Time Frame: approximately 3 years
approximately 3 years

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

July 1, 2012

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

December 12, 2012

First Submitted That Met QC Criteria

December 12, 2012

First Posted (Estimate)

December 17, 2012

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

  • ML28344

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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