The Individualized Management With Pegylated-interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) Offering Viral Eradication: A Study of Pegylated-interferon Alfa-2a Plus Ribavirin in Participants With Chronic Hepatitis C (CHC) Non-genotype 2/3 (IMPROVE)
NCT ID: NCT00483938
Last Updated: 2017-01-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
236 participants
INTERVENTIONAL
2007-06-30
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pegylated-interferon Alfa-2a + Ribavirin (Group A)
Participants with HCV RNA levels greater than (\>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (\>=) 15 IU/mL at Week 8, and either HCV RNA less than (\<) 15 IU/mL or \>=2 times logarithmic (2 log10) drop at Week 12, will receive pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 milligrams (mg) orally daily for 48 weeks.
Pegylated-interferon Alfa-2a
Participants will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for the specified duration.
Ribavirin
Participants will receive ribavirin 1000 to 1400 mg orally daily for the specified duration.
Pegylated-interferon Alfa-2a + Ribavirin (Group B)
Participants with HCV RNA levels \>15 IU/mL at Week 4, HCV RNA \>=15 IU/mL at Week 8, and either HCV RNA \<15 IU/mL or \>=2 log10 drop at Week 12, will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks.
Pegylated-interferon Alfa-2a
Participants will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for the specified duration.
Ribavirin
Participants will receive ribavirin 1000 to 1400 mg orally daily for the specified duration.
Pegylated-interferon Alfa-2a + Ribavirin (Group C)
Participants with HCV-RNA levels \>15 IU/mL at Week 4, and HCV-RNA \<15 IU/mL at Week 8, will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks.
Pegylated-interferon Alfa-2a
Participants will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for the specified duration.
Ribavirin
Participants will receive ribavirin 1000 to 1400 mg orally daily for the specified duration.
Pegylated-interferon Alfa-2a + Ribavirin (Group D)
Participants with HCV-RNA levels \>15 IU/mL at Week 4, and HCV-RNA \<15 IU/mL at Week 8, will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
Pegylated-interferon Alfa-2a
Participants will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for the specified duration.
Ribavirin
Participants will receive ribavirin 1000 to 1400 mg orally daily for the specified duration.
Pegylated-interferon Alfa-2a + Ribavirin (Group E)
Participants with HCV-RNA levels \<15 IU/mL at Week 4, will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
Pegylated-interferon Alfa-2a
Participants will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for the specified duration.
Ribavirin
Participants will receive ribavirin 1000 to 1400 mg orally daily for the specified duration.
Pegylated-interferon Alfa-2a + Ribavirin (Group F)
Participants with HCV-RNA levels \<15 IU/mL at Week 4, will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
Pegylated-interferon Alfa-2a
Participants will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for the specified duration.
Ribavirin
Participants will receive ribavirin 1000 to 1400 mg orally daily for the specified duration.
Pegylated-interferon Alfa-2a + Ribavirin (Group NR)
Participants who do not have any change in HCV-RNA levels at Weeks 4, 8, and 12 will not be randomized (NR) to any of the other groups. Participants will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
Pegylated-interferon Alfa-2a
Participants will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for the specified duration.
Ribavirin
Participants will receive ribavirin 1000 to 1400 mg orally daily for the specified duration.
Interventions
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Pegylated-interferon Alfa-2a
Participants will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for the specified duration.
Ribavirin
Participants will receive ribavirin 1000 to 1400 mg orally daily for the specified duration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* evidence of hepatitis C non-genotype 2 or 3;
* compensated liver disease.
Exclusion Criteria
* history of having received systemic antiviral therapy with activity against CHC \<=3 months prior to start of study;
* hepatitis A, hepatitis B or human immunodeficiency virus (HIV) infection;
* history or evidence of a medical condition associated with chronic liver disease other than CHC.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Milwaukee, Wisconsin, United States
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Edmonton, Alberta, Canada
Abbotsford, British Columbia, Canada
Vancouver, British Columbia, Canada
Vancouver, British Columbia, Canada
Vernon, British Columbia, Canada
Victoria, British Columbia, Canada
Halifax, Nova Scotia, Canada
East York, Ontario, Canada
Hamilton, Ontario, Canada
Kingston, Ontario, Canada
London, Ontario, Canada
Mississauga, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Woodbridge, Ontario, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Countries
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References
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Lee SS, Sherman M, Ramji A, Greenbloom S, Elkashab M, Pluta H, Hilzenrat N, Balshaw R, Usaty C, Myers RP. Randomised clinical trial: the efficacy of treatment, guided by a shorter duration of response, using peginterferon alfa-2a plus ribavirin for hepatitis C virus other than genotypes 2 or 3. Aliment Pharmacol Ther. 2012 Jan;35(1):37-47. doi: 10.1111/j.1365-2036.2011.04911.x. Epub 2011 Nov 2.
Other Identifiers
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ML21035
Identifier Type: -
Identifier Source: org_study_id
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