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IMPROVE Study(The Individualized Management With PEGASYS and Ribavirin Offering Viral Eradication): A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Copegus (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Non-Genotype 2/3.

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

Phase: Phase 3

Status: Completed

Sponsored by: Hoffmann-La Roche

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

Summary

This study will compare the efficacy and safety of 48 weeks and 72 weeks treatment with PEGASYS plus ribavirin in patients with non-genotype 2/3 chronic hepatitis C who, after 12 weeks of study treatment, have undetectable HCV-RNA or a >=2 log10 drop in HCV-RNA. Patients will be randomized to receive PEGASYS 180 micrograms sc weekly plus ribavirin (1000-1400mg) po daily for either 48 or 72 weeks, followed by 24 weeks of treatment-free follow-up. Patients with detectable HCV-RNA and <2 log10 drop in HCV-RNA at week 12 will discontinue therapy. The anticipated time on study treatment is 1-2 years, and the target sample size is 500 individuals.

Clinical Details

Official title: A Randomized, Open Label Study to Evaluate the Effect of 48 or 72 Weeks of Treatment With Pegasys Plus Copegus Combination Therapy on Sustained Viral Response in Non-genotype 2/3 Patients With Chronic Hepatitis C Who Show a Response at Week 12

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Sustained virologic response

Secondary outcome:

SVR

Viral kinetics

AEs, laboratory parameters

Eligibility

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

Criteria:

Inclusion Criteria:

- adult patients, >=18 years of age;

- evidence of CHC;

- evidence of hepatitis C non-genotype 2 or 3;

- compensated liver disease.

Exclusion Criteria:

- infection with HCV genotype 2 or 3;

- history of having received systemic antiviral therapy with activity against CHC <=3

months prior to start of study;

- hepatitis A, hepatitis B or HIV infection;

- history or evidence of a medical condition associated with chronic liver disease

other than CHC.

Locations and Contacts

Calgary, Alberta T2N 4Z6, Canada

Edmonton, Alberta T6G 2X8, Canada

Edmonton, Alberta T5H 4B9, Canada

Abbotsford, British Columbia V2S 3N5, Canada

Vancouver, British Columbia V5Z 1M9, Canada

Vancouver, British Columbia V6Z 2K5, Canada

Vernon, British Columbia V1T 1W9, Canada

Victoria, British Columbia V8V 3P9, Canada

Halifax, Nova Scotia B3H 2Y9, Canada

East York, Ontario M4C 3E7, Canada

Hamilton, Ontario L8L 2X2, Canada

Kingston, Ontario K7L 5G2, Canada

London, Ontario N6A 5A5, Canada

Mississauga, Ontario L5M 4N4, Canada

Ottawa, Ontario K1H 8L6, Canada

Toronto, Ontario M5G 1L7, Canada

Toronto, Ontario M5G 1X5, Canada

Toronto, Ontario M6H 3M1, Canada

Woodbridge, Ontario L4L 4Y7, Canada

Montreal, Quebec H1T 2M4, Canada

Montreal, Quebec H3A 1A1, Canada

Saskatoon, Saskatchewan S7N 0W8, Canada

Milwaukee, Wisconsin 53210, United States

Additional Information

Starting date: June 2007
Last updated: August 17, 2015

Page last updated: August 23, 2015

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