A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C Infection (CHC). - Full Text View

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00077649

Purpose

The effects of treatment with different doses of PEGASYS in combination with different doses of ribavirin will be evaluated in patients with CHC genotype 1 who have a high viral titer, body weight greater than 85kg (187lbs) and no prior treatment with interferon. 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: Copegus	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Double-blind Study of the Effect of PEGASYS and Ribavirin Combination Therapy on Viral Kinetics and Virologic Response in Interferon-naïve Patients With Chronic Hepatitis C Genotype 1 Infection

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Ribavirin Peginterferon Alfa-2a Interferons

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Viral response compared to baseline [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

SVR and end of treatment virological response [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
Virological response [ Time Frame: Week 60 ] [ Designated as safety issue: No ]
AEs, laboratory parameters, vital signs, Beck Depression Inventory [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	188
Study Completion Date:	April 2006

Arms	Assigned Interventions
Active Comparator: 1	Drug: peginterferon alfa-2a [Pegasys] 180 micrograms sc weekly for 48 weeks Drug: Copegus 600mg po bid for 48 weeks
Experimental: 2	Drug: peginterferon alfa-2a [Pegasys] 180 micrograms sc weekly for 48 weeks Drug: Copegus 800mg po bid for 48 weeks
Experimental: 3	Drug: peginterferon alfa-2a [Pegasys] 270 micrograms sc weekly for 48 weeks Drug: Copegus 600mg po bid for 48 weeks
Experimental: 4	Drug: peginterferon alfa-2a [Pegasys] 270 micrograms sc weekly for 48 weeks Drug: Copegus 800mg po bid for 48 weeks

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;
body weight >85kg (187lbs);
CHC (genotype 1);
liver biopsy (in <24 calendar months of first dose), with results consistent with CHC infection;
use of 2 forms of contraception during study and 6 months after the study in both men and women.

Exclusion Criteria:

women who are pregnant or breastfeeding;
male partners of women who are pregnant;
conditions associated with decompensated liver disease;
other forms of liver disease, including liver cancer;
human immunodeficiency virus infection;
previous treatment with an interferon, ribavirin, viramidine, levovirin or amantadine.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00077649

Show 25 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00077649 History of Changes
Other Study ID Numbers:	NV17318
Study First Received:	February 10, 2004
Last Updated:	June 15, 2010
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

Interferons
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012