A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) With or Without Ribavirin in Patients With Chronic Hepatitis C Who Have Participated in Previous Roche or Roche Partner Protocols.
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Purpose
This single arm study will provide treatment or re-treatment with PEGASYS as monotherapy or in combination with ribavirin (Copegus), to patients with chronic hepatitis C (CHC) who have participated in a previous Roche or Roche partner protocol where access to treatment or re-treatment was promised or deemed appropriate following completion of the original protocol ('donor' protocol). Patients who qualify for treatment or re-treatment will begin PEGASYS monotherapy,at a maximum dose of 180 micrograms weekly, or combination therapy with Copegus ,800-1200mg daily, as continuation of treatment after the wash-out period defined in their donor protocol. PEGASYS treatment is not to exceed approved treatment duration of 24 weeks in genotype 2/3 and 48 weeks in genotype non-2/3 with a treatment-free follow up period of 24 weeks. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C, Chronic |
Drug: peginterferon alfa-2a [Pegasys] Drug: ribavirin [Copegus] |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label Study of the Safety of Pegasys Alone or in Combination With Ribavirin in Patients With Chronic Hepatitis C Who Have Participated in Previous Studies |
- Serious adverse events,deaths, dose modifications and premature withdrawals for safety reasons. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
| Enrollment: | 18 |
| Study Start Date: | April 2009 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc once weekly
Drug: ribavirin [Copegus]
800mg (genotype 2/3) or 1000-1200mg (genotype non-2/3).
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- adult patients, >=18 years of age;
- CHC patients with compensated liver disease (Child-Pugh A) who have participated in a donor protocol where access to treatment or re-treatment with PEGASYS monotherapy or in combination with Copegus was promised or deemed appropriate after completion of the donor protocol.
Exclusion Criteria:
- evidence of decompensated liver disease (Child B or C cirrhosis).
Contacts and Locations
Show 23 Study Locations| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00800735 History of Changes |
| Other Study ID Numbers: | NV21928, 2008-002022-10 |
| Study First Received: | October 23, 2008 |
| Last Updated: | April 8, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections |
Flaviviridae Infections Ribavirin Peginterferon alfa-2a Interferon-alpha Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013