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 (40KD) [PEGASYS] Drug: Copegus	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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 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
1: Active Comparator	Drug: peginterferon alfa-2a (40KD) [PEGASYS] 180 micrograms sc weekly for 48 weeks Drug: Copegus 600mg po bid for 48 weeks
2: Experimental	Drug: peginterferon alfa-2a (40KD) [PEGASYS] 180 micrograms sc weekly for 48 weeks Drug: Copegus 800mg po bid for 48 weeks
3: Experimental	Drug: peginterferon alfa-2a (40KD) [PEGASYS] 270 micrograms sc weekly for 48 weeks Drug: Copegus 600mg po bid for 48 weeks
4: Experimental	Drug: peginterferon alfa-2a (40KD) [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

Hide Study Locations

Locations

United States, California

LONG BEACH, California, United States, 90822

LA JOLLA, California, United States, 92037-1030

SAN DIEGO, California, United States, 92154

SAN DIEGO, California, United States, 92105
United States, Connecticut

FARMINGTON, Connecticut, United States, 06030
United States, Florida

SARASOTA, Florida, United States, 34243

JACKSONVILLE, Florida, United States, 32207

GAINESVILLE, Florida, United States, 32610-0214

WELLINGTON, Florida, United States, 33414
United States, Hawaii

HONOLULU, Hawaii, United States, 96817
United States, Illinois

CHICAGO, Illinois, United States, 60612
United States, Iowa

IOWA CITY, Iowa, United States, 52242
United States, Massachusetts

BOSTON, Massachusetts, United States, 02111
United States, Missouri

ST LOUIS, Missouri, United States, 63104
United States, New York

MANHASSET, New York, United States, 11030
United States, North Carolina

CHAPEL HILL, North Carolina, United States, 27599-7080

CHARLOTTE, North Carolina, United States, 28203
United States, Ohio

CINCINNATI, Ohio, United States, 45267-0595
United States, Pennsylvania

PHILADELPHIA, Pennsylvania, United States, 19104

PITTSBURGH, Pennsylvania, United States, 15213
United States, Texas

HOUSTON, Texas, United States, 77030
United States, Utah

SALT LAKE CITY, Utah, United States, 84121
United States, Virginia

RICHMOND, Virginia, United States, 23249

CHARLOTTESVILLE, Virginia, United States, 22906-0013
Puerto Rico

SANTURCE, Puerto Rico, 00909

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	NV17318
Study First Received:	February 10, 2004
Last Updated:	May 13, 2009
ClinicalTrials.gov Identifier:	NCT00077649 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Liver Diseases
Flaviviridae Infections
Hepatitis, Chronic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Ribavirin
Physiological Effects of Drugs
Hepatitis, Viral, Human
Therapeutic Uses
Hepatitis C
Angiogenesis Modulating Agents

Growth Inhibitors
RNA Virus Infections
Growth Substances
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Virus Diseases
Hepatitis
Digestive System Diseases
Peginterferon alfa-2a
Interferon Alfa-2a
Hepatitis C, Chronic

ClinicalTrials.gov processed this record on November 22, 2009