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) (IMPROVE)
November 25, 2016 updated by: Hoffmann-La Roche
The Individualized Management With Pegasys and Ribavirin Offering Viral Eradication (IMPROVE) Trial
This study will compare the efficacy and safety of treatment with pegylated-interferon alfa-2a plus ribavirin in participants with non-genotype 2/3 CHC who, after 12 weeks of study treatment, have undetectable hepatitis C virus (HCV)-ribonucleic acid (RNA) or a greater than or equal to (>=) 2 log10 drop in HCV-RNA.
Participants will be randomized to receive pegylated-interferon alfa-2a 180 micrograms subcutaneously weekly plus ribavirin (1000-1400 milligram [mg]) orally daily for the specified duration, followed by 24 weeks of treatment-free follow-up.
Participants with detectable HCV-RNA and less than (<) 2 log10 drop in HCV-RNA at week 12 will discontinue therapy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
236
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2N 4Z6
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Edmonton, Alberta, Canada, T5H 4B9
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Edmonton, Alberta, Canada, T6G 2X8
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British Columbia
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Abbotsford, British Columbia, Canada, V2S 3N5
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Vancouver, British Columbia, Canada, V5Z 1M9
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Vancouver, British Columbia, Canada, V6Z 2K5
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Vernon, British Columbia, Canada, V1T 1W9
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Victoria, British Columbia, Canada, V8V 3P9
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 2Y9
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Ontario
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East York, Ontario, Canada, M4C 3E7
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Hamilton, Ontario, Canada, L8L 2X2
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Kingston, Ontario, Canada, K7L 5G2
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London, Ontario, Canada, N6A 5A5
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Mississauga, Ontario, Canada, L5M 4N4
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Ottawa, Ontario, Canada, K1H 8L6
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Toronto, Ontario, Canada, M5G 1L7
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Toronto, Ontario, Canada, M5G 1X5
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Toronto, Ontario, Canada, M6H 3M1
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Woodbridge, Ontario, Canada, L4L 4Y7
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Quebec
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Montreal, Quebec, Canada, H1T 2M4
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Montreal, Quebec, Canada, H3A 1A1
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7N 0W8
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Wisconsin
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Milwaukee, Wisconsin, United States, 53210
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 human immunodeficiency virus (HIV) infection;
- history or evidence of a medical condition associated with chronic liver disease other than CHC.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
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Participants will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for the specified duration.
Other Names:
Participants will receive ribavirin 1000 to 1400 mg orally daily for the specified duration.
Other Names:
|
|
Experimental: 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.
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Participants will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for the specified duration.
Other Names:
Participants will receive ribavirin 1000 to 1400 mg orally daily for the specified duration.
Other Names:
|
|
Experimental: 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.
|
Participants will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for the specified duration.
Other Names:
Participants will receive ribavirin 1000 to 1400 mg orally daily for the specified duration.
Other Names:
|
|
Experimental: 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.
|
Participants will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for the specified duration.
Other Names:
Participants will receive ribavirin 1000 to 1400 mg orally daily for the specified duration.
Other Names:
|
|
Experimental: 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.
|
Participants will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for the specified duration.
Other Names:
Participants will receive ribavirin 1000 to 1400 mg orally daily for the specified duration.
Other Names:
|
|
Experimental: 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.
|
Participants will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for the specified duration.
Other Names:
Participants will receive ribavirin 1000 to 1400 mg orally daily for the specified duration.
Other Names:
|
|
Experimental: 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.
|
Participants will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for the specified duration.
Other Names:
Participants will receive ribavirin 1000 to 1400 mg orally daily for the specified duration.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Participants With Sustained Virological Response (SVR) (Groups A and B)
Time Frame: At 24-week untreated follow-up visit (up to 72 weeks for Group A, up to 96 weeks for Group B)
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SVR was defined as success if the participant had HCV RNA levels <15 IU/mL as measured by COBAS AmpliPrep/COBAS TaqMan® HCV test at the 24-week untreated follow-up visit (HCV-RNA levels obtained at least 18 weeks after last dose of either pegylated-Interferon alfa-2a or ribavirin were considered if the 24-week untreated follow-up visit data were missing).
Percentage of participants with SVR for Groups A and B was reported in this analysis.
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At 24-week untreated follow-up visit (up to 72 weeks for Group A, up to 96 weeks for Group B)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Percentage of Participants With SVR (Groups C, D, E, and F)
Time Frame: At 24-week untreated follow-up visit (up to 60, 72, 48, and 72 weeks for Groups C, D, E, and F, respectively)
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SVR was defined as success if the participant had HCV RNA levels <15 IU/mL as measured by COBAS AmpliPrep/COBAS TaqMan® HCV test at the 24-week untreated follow-up visit (HCV-RNA levels obtained at least 18 weeks after last dose of either pegylated-Interferon alfa-2a or ribavirin were considered if the 24-week untreated follow-up visit data were missing).
Percentage of participants with SVR for Groups C, D, E, and F was reported in this analysis.
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At 24-week untreated follow-up visit (up to 60, 72, 48, and 72 weeks for Groups C, D, E, and F, respectively)
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Percentage of Participants With Virological Responses (Groups A, B, C, D, E, and F)
Time Frame: Week 12 (Groups C, D, E, and F), and end of treatment (Weeks 48, 72, 36, 48, 24, and 48 for Groups A, B, C, D, E, and F, respectively)
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End of treatment response (ETR) was defined as "Success" if the HCV-RNA levels were <15 IU/mL at the end of treatment.
Early virological response (EVR) was defined as >=2 log10 decrease in serum HCV RNA or undetectable serum HCV RNA (<15 IU/mL) at Week 12. Complete EVR was defined as "Success", if the HCV-RNA levels were <15 IU/mL at Week 12. Partial EVR was defined as "Success", if there was a >=2 log10 drop in HCV-RNA at Week 12 compared to baseline but with a level that was still >=15 IU/mL at that time point.
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Week 12 (Groups C, D, E, and F), and end of treatment (Weeks 48, 72, 36, 48, 24, and 48 for Groups A, B, C, D, E, and F, respectively)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
June 7, 2007
First Submitted That Met QC Criteria
June 7, 2007
First Posted (Estimate)
June 8, 2007
Study Record Updates
Last Update Posted (Estimate)
January 23, 2017
Last Update Submitted That Met QC Criteria
November 25, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis, Chronic
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis C, Chronic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites
- Antineoplastic Agents
- Immunologic Factors
- Interferons
- Interferon-alpha
- Ribavirin
- Peginterferon alfa-2a
- Interferon alpha-2
Other Study ID Numbers
- ML21035
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.