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.

This study is currently recruiting participants.

Verified March 2011 by Hoffmann-La Roche

First Received on October 23, 2008. Last Updated on March 15, 2011 History of Changes

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00800735

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 III

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

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Ribavirin Peginterferon Alfa-2a

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Serious adverse events,deaths, dose modifications and premature withdrawals for safety reasons. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	32
Study Start Date:	April 2009
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	February 2011 (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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00800735

Contacts

Contact: Please reference Study ID Number: NV21928

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Show 30 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Disclosures Group, 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:	March 15, 2011
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 February 09, 2012