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. - Full Text View

Sponsored by:	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 (40KD) [PEGASYS] Drug: ribavirin [Copegus]	Phase III

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Ribavirin Peginterferon Alfa-2a

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
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

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:	September 2008
Estimated Study Completion Date:	September 2014

Arms	Assigned Interventions
1: Experimental	Drug: peginterferon alfa-2a (40KD) [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	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Show 42 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	NV21928, 2008-002022-10
Study First Received:	October 23, 2008
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00800735
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Interferon-alpha
Liver Diseases
Hepatitis, Chronic
Ribavirin
Interferons
Hepatitis, Viral, Human
Hepatitis

Virus Diseases
Digestive System Diseases
Peginterferon alfa-2a
Hepatitis C
Interferon Alfa-2a
Hepatitis C, Chronic

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Flaviviridae Infections
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances

Physiological Effects of Drugs
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009