An Observational Study to Assess the Effect of Cumulative Ribavirin Dose in Participants With Chronic Hepatitis C

February 29, 2016 updated by: Hoffmann-La Roche
The purpose of this open-label, non-randomized, single-arm, multicentre observational study is to investigate the influence of the cumulative dose (total administered dose/ planned dose) of ribavirin on the sustained virologic response (SVR) in participants who have been receiving combination therapy with pegylated interferon alfa-2a (Pegasys) and ribavirin (Copegus).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

697

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

  • Hungary
      • Ajka, Hungary, H-8400
      • Balassagyarmat, Hungary, 2660
      • Bekescsaba, Hungary, 5600
      • Budapest, Hungary, 1083
      • Budapest, Hungary, 1088
      • Budapest, Hungary, 1097
      • Budapest, Hungary, H-1125
      • Budapest, Hungary, 1067
      • Debrecen, Hungary, 4032
      • Debrecen, Hungary, H-4031
      • Gyor, Hungary, 9004
      • Gyula, Hungary, 5700
      • Kaposvar, Hungary, 7400
      • Kecskemet, Hungary, 6000
      • Miskolc, Hungary, 3529
      • Miskolc, Hungary, H-3501
      • Nyíregyháza, Hungary, 4400
      • Pecs, Hungary, 7624
      • Pecs, Hungary, 7623
      • Sopron, Hungary, 9400
      • Szeged, Hungary, 6720
      • Szekszard, Hungary, 7100
      • Szolnok, Hungary, 5000
      • Szombathely, Hungary, 9700
      • Székesfehérvár, Hungary, 8000
      • Tatabánya, Hungary, 2800
      • Zalaegerszeg, Hungary, 8900

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

Non-Probability Sample

Study Population

Treatment naive participants with confirmed chronic hepatitis C who are started on combined Pegasys-Copegus treatment in accordance with current guidelines and SPCs, and whose treatment has been approved by the Interferon Committee.

Description

Inclusion Criteria:

  • Participants with serologically confirmed chronic hepatitis C
  • Participants using and accepting a double method of contraception

Exclusion Criteria:

  • Participants not approved by the national treatment guideline or the Interferon Committee for combined pegylated interferon-ribavirin treatment
  • Contraindications in the summary of product characteristics of pegylated interferon alpha-2a and ribavirin
  • Participants previously treated with pegylated interferon and/or ribavirin
  • Hepatitis B and Human Immunodeficiency Virus co-infections

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
Intervention / Treatment
Pegasys + Copegus
Treatment naive participants with confirmed chronic hepatitis C who are started on combined Pegasys-Copegus treatment in accordance with current guidelines and SPCs, and whose treatment has been approved by the Interferon Committee.
Biological: Peginterferon alfa-2a
Participants received pegylated interferon subcutaneous injection in accordance with current guidelines and SPCs.P
Other Names:
  • Pegasys
Drug: Ribavirin
Participants received ribavirin 200 mg film-coated tablet in accordance with current guidelines and SPCs.
Other Names:
  • Copegus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Sustained Virological Response (SVR) According to Cumulative Dose of Ribavirin
Time Frame: 24 weeks after EOT (maximum up to 96 Weeks)
Determination of hepatitis C virus (HCV) titers was performed using COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C, at Weeks 4, 12 and 24 of the treatment period (and, optionally, at the end of treatment [EOT] visit), and at the end of the 24-week follow-up period. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each cumulative dose group is presented. Cumulative dose was calculated as: (administered dose divided by planned dose) multiplied by 100.
24 weeks after EOT (maximum up to 96 Weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Virologic Response
Time Frame: Week 4, 12, 24 and at EOT (maximum up to 72 weeks)
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response.
Week 4, 12, 24 and at EOT (maximum up to 72 weeks)
Percentage of Participants With Virologic Response According to Starting Dose of Ribavirin
Time Frame: Up to EOT (maximum up to 72 weeks)
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response. Percentage of participants achieving virological response in each dose group is presented.
Up to EOT (maximum up to 72 weeks)
Percentage of Participants With SVR According to Starting Dose of Ribavirin
Time Frame: 24 weeks after EOT (maximum up to 96 weeks)
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each dose group is presented.
24 weeks after EOT (maximum up to 96 weeks)
Percentage of Participants With Virologic Response According to Body Weight-normalized Dose of Ribavirin
Time Frame: Up to EOT (maximum up to 72 weeks)
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response. Percentage of participants achieving virological response in each body weight-normalized (measured in milligram per kilogram per day [mg/kg/day]) dose group is presented.
Up to EOT (maximum up to 72 weeks)
Percentage of Participants With SVR According to Body Weight-normalized Dose of Ribavirin
Time Frame: 24 weeks after EOT (maximum up to 96 weeks)
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each body weight-normalized dose group is presented.
24 weeks after EOT (maximum up to 96 weeks)
Percentage of Participants With Virologic Response According to Dose Reduction of Ribavirin
Time Frame: Up to EOT (maximum up to 72 weeks)
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response. Percentage of participants achieving virological response in each dose-reduction group (none, dose reduction within 12 weeks, dose reduction after 12 weeks, dose reduction not specified) is presented.
Up to EOT (maximum up to 72 weeks)
Percentage of Participants With SVR According to Dose Reduction of Ribavirin
Time Frame: 24 weeks after EOT (maximum up to 96 weeks)
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each dose-reduction group (none, dose reduction within 12 weeks, dose reduction after 12 weeks, dose reduction not specified) is presented.
24 weeks after EOT (maximum up to 96 weeks)
Percentage of Participants With Virologic Response According to Interleukin-28B (IL-28B) Polymorphism
Time Frame: Up to EOT (maximum up to 72 weeks)
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response. Percentage of participants achieving virological response for each IL-28B allele (CC allele, CT allele, TT allele) is presented.
Up to EOT (maximum up to 72 weeks)
Percentage of Participants With SVR According to IL-28B Polymorphism
Time Frame: 24 weeks after EOT (maximum up to 96 Weeks)
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR for each IL-28B allele (CC allele, CT allele, TT allele) is presented.
24 weeks after EOT (maximum up to 96 Weeks)
Percentage of Participants With Viral Relapse or Breakthrough
Time Frame: Up to 24 weeks after EOT (maximum up to 96 weeks)
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough is reported.
Up to 24 weeks after EOT (maximum up to 96 weeks)
Percentage of Participants With Viral Relapse or Breakthrough According to Cumulative Dose of Ribavirin
Time Frame: Up to 24 weeks after EOT (maximum up to 96 weeks)
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with viral relapse or breakthrough in each cumulative dose group is presented. Cumulative dose was calculated as: (administered dose divided by planned dose) multiplied by 100. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each cumulative dose group (<60%, 60-69%, 70-79%, 80-89%, and >90%) is reported.
Up to 24 weeks after EOT (maximum up to 96 weeks)
Percentage of Participants With Viral Relapse or Breakthrough According to Starting Dose of Ribavirin
Time Frame: Week 4, 12, 24, at EOT Visit, 24 weeks after EOT (maximum up to 96 weeks)
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each dose group (600 mg, 800 mg, 1000 mg, 1200 mg, and 1400 mg) is presented.
Week 4, 12, 24, at EOT Visit, 24 weeks after EOT (maximum up to 96 weeks)
Percentage of Participants With Viral Relapse or Breakthrough According to Body Weight-normalized Dose of Ribavirin
Time Frame: Up to 24 weeks after EOT (maximum up to 96 weeks)
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each body weight-normalized dose group (<5mg/kg/day, 5-10 mg/kg/day, 10-15 mg/kg/day, 15-20 mg/kg/day, and >20 mg/kg/day) is presented.
Up to 24 weeks after EOT (maximum up to 96 weeks)
Percentage of Participants With Viral Relapse or Breakthrough According to Dose Reduction of Ribavirin
Time Frame: Up to 24 weeks after EOT (maximum up to 96 weeks)
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each dose-reduction group (none, dose reduction within 12 weeks, dose reduction after 12 weeks, dose reduction not specified) is presented.
Up to 24 weeks after EOT (maximum up to 96 weeks)

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

May 1, 2009

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

September 22, 2015

First Submitted That Met QC Criteria

September 22, 2015

First Posted (Estimate)

September 23, 2015

Study Record Updates

Last Update Posted (Estimate)

March 28, 2016

Last Update Submitted That Met QC Criteria

February 29, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML22453

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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