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

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C, Chronic

Intervention: Copegus (Drug); Copegus (Drug); peginterferon alfa-2a [Pegasys] (Drug); peginterferon alfa-2a [Pegasys] (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

Summary

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.

Clinical Details

Official title: A Randomized, Double-blind Study of the Effect of PEGASYS and Ribavirin Combination Therapy on Viral Kinetics and Virologic Response in Interferon-na´ve Patients With Chronic Hepatitis C Genotype 1 Infection

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Viral response compared to baseline\n

Secondary outcome:

SVR and end of treatment virological response\n\n

Virological response

AEs, laboratory parameters, vital signs, Beck Depression Inventory

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Santurce 00909, Puerto Rico

La Jolla, California 92037-1030, United States

Long Beach, California 90822, United States

San Diego, California 92105, United States

San Diego, California 92154, United States

Farmington, Connecticut 06030, United States

Bradenton, Florida 34209, United States

Gainesville, Florida 32610-0214, United States

Jacksonville, Florida 32207, United States

Wellington, Florida 33414, United States

Honolulu, Hawaii 96817, United States

Chicago, Illinois 60612, United States

Iowa City, Iowa 52242, United States

Boston, Massachusetts 02111, United States

St Louis, Missouri 63104, United States

Manhasset, New York 11030, United States

Chapel Hill, North Carolina 27599-7584, United States

Statesville, North Carolina 28677, United States

Cincinnati, Ohio 45267-0595, United States

Philadelphia, Pennsylvania 19104, United States

Pittsburgh, Pennsylvania 15213, United States

Houston, Texas 77030, United States

Salt Lake City, Utah 84121, United States

Charlottesville, Virginia 22906-0013, United States

Richmond, Virginia 23249, United States

Additional Information

Starting date: January 2004
Last updated: August 17, 2015

Page last updated: August 23, 2015

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