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A Study of Pegasys (Peginterferon Alfa-2a) Administered Alone or in Combination With Copegus (Ribavirin) in Patients With Chronic Hepatitis C Who Have Participated in Previous Pegasys Trials

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ClinicalTrials.gov Identifier: NCT01853254
Recruitment Status : Completed
First Posted : May 14, 2013
Results First Posted : September 4, 2013
Last Update Posted : September 4, 2013
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
This open-label, non-randomized, single arm study will provide treatment or re-treatment with Pegasys (peginterferon alfa-2a) as monotherapy or in combination with Copegus (ribavirin) to patients with chronic hepatitis C infection. Patients who have received prior Pegasys monotherapy or combination therapy or who were considered eligible for treatment with Pegasys in previous donor protocols will be eligible to participate in this study. Treatment will be on investigator's decision according to the approved label for up to 48 weeks, with a 24-week safety follow-up.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: Peginterferon alfa-2a Drug: Ribavirin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 272 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multicenter Protocol Providing Pegylated Interferon Alfa-2a (Pegasys®) as Monotherapy or in Combination With Ribavirin (Copegus®) for Patients With Chronic Hepatitis C Who Have Participated in Previous Roche or Roche Partner Protocols
Study Start Date : September 2003
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Peginterferon alfa-2a monotherapy or combined with ribavirin
The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy.
 Drug: Peginterferon alfa-2a
Both combination and monotherapy for both genotype 2/3 and genotype non-2/3: 180 μg subcutaneously once weekly.
Other Name: Pegasys

Drug: Ribavirin
For genotype 2/3, 800 mg orally daily, in 2 split doses for 24 weeks. For genotype non-2/3, 1000 mg orally daily for participants weighing < 75 kg or 1200 mg orally daily for participants weighing ≥ 75 kg, in 2 split doses, for 48 weeks.
Other Name: Copegus


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With at Least 1 Adverse Event [ Time Frame: From Baseline to the end of the study (up to 72 weeks) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, ≥ 18 years of age.
  • Chronic hepatitis C.
  • Compensated liver disease (Child-Pugh Class A).
  • Previous participation in a donor protocol in which treatment or re-treatment with Pegasys alone or in combination with Copegus was recommended or deemed appropriate after study completion.
  • Have completed safety and efficacy assessments as defined in the donor protocol without violation or any major deviation.
  • Have not received any other anti-hepatitis C virus treatment after the completion of the donor protocol.
  • For females of childbearing potential, a negative pregnancy test within 24 hours prior to first dose of study drug.
  • Fertile patients (male and female) must use 2 reliable forms of contraception (combined) for the duration of the study (treatment and follow-up) in accordance with the locally approved label for Copegus.

Exclusion Criteria:

  • Pregnant or breastfeeding women.
  • Male partners of women who are pregnant.
  • Patients with hemoglobinopathies.
  • Hepatic decompensation (Child-Pugh Class B or C) before or during treatment.
  • Non-responder patients (defined as patients previously treated with Pegasys and Copegus combination therapy at standard doses for at least 12 weeks who did not achieve at least a 2-log drop from their baseline viral load).
  • Liver disease other than chronic hepatitis C, including hepatic carcinoma.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01853254


Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Chair: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01853254    
Other Study ID Numbers: NV17590
First Posted: May 14, 2013    Key Record Dates
Results First Posted: September 4, 2013
Last Update Posted: September 4, 2013
Last Verified: June 2013
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
 RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Hepatitis, Chronic
Ribavirin
Peginterferon alfa-2a
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents