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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00483938
First received: June 7, 2007
Last updated: November 25, 2016
Last verified: November 2016
  Purpose
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.

Condition Intervention Phase
Hepatitis C, Chronic
Drug: Pegylated-interferon Alfa-2a
Drug: Ribavirin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Individualized Management With Pegasys and Ribavirin Offering Viral Eradication (IMPROVE) Trial

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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) ]
    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.


Secondary Outcome Measures:
  • 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) ]
    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.

  • 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) ]
    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.


Enrollment: 236
Study Start Date: June 2007
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Pegylated-interferon Alfa-2a
Participants will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for the specified duration.
Other Name: Pegasys
Drug: Ribavirin
Participants will receive ribavirin 1000 to 1400 mg orally daily for the specified duration.
Other Name: Copegus
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.
Drug: Pegylated-interferon Alfa-2a
Participants will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for the specified duration.
Other Name: Pegasys
Drug: Ribavirin
Participants will receive ribavirin 1000 to 1400 mg orally daily for the specified duration.
Other Name: Copegus
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.
Drug: Pegylated-interferon Alfa-2a
Participants will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for the specified duration.
Other Name: Pegasys
Drug: Ribavirin
Participants will receive ribavirin 1000 to 1400 mg orally daily for the specified duration.
Other Name: Copegus
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.
Drug: Pegylated-interferon Alfa-2a
Participants will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for the specified duration.
Other Name: Pegasys
Drug: Ribavirin
Participants will receive ribavirin 1000 to 1400 mg orally daily for the specified duration.
Other Name: Copegus
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.
Drug: Pegylated-interferon Alfa-2a
Participants will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for the specified duration.
Other Name: Pegasys
Drug: Ribavirin
Participants will receive ribavirin 1000 to 1400 mg orally daily for the specified duration.
Other Name: Copegus
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.
Drug: Pegylated-interferon Alfa-2a
Participants will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for the specified duration.
Other Name: Pegasys
Drug: Ribavirin
Participants will receive ribavirin 1000 to 1400 mg orally daily for the specified duration.
Other Name: Copegus
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.
Drug: Pegylated-interferon Alfa-2a
Participants will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for the specified duration.
Other Name: Pegasys
Drug: Ribavirin
Participants will receive ribavirin 1000 to 1400 mg orally daily for the specified duration.
Other Name: Copegus

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483938

Locations
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53210
Canada, Alberta
Calgary, Alberta, Canada, T2N 4Z6
Edmonton, Alberta, Canada, T5H 4B9
Edmonton, Alberta, Canada, T6G 2X8
Canada, British Columbia
Abbotsford, British Columbia, Canada, V2S 3N5
Vancouver, British Columbia, Canada, V5Z 1M9
Vancouver, British Columbia, Canada, V6Z 2K5
Vernon, British Columbia, Canada, V1T 1W9
Victoria, British Columbia, Canada, V8V 3P9
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
East York, Ontario, Canada, M4C 3E7
Hamilton, Ontario, Canada, L8L 2X2
Kingston, Ontario, Canada, K7L 5G2
London, Ontario, Canada, N6A 5A5
Mississauga, Ontario, Canada, L5M 4N4
Ottawa, Ontario, Canada, K1H 8L6
Toronto, Ontario, Canada, M5G 1L7
Toronto, Ontario, Canada, M5G 1X5
Toronto, Ontario, Canada, M6H 3M1
Woodbridge, Ontario, Canada, L4L 4Y7
Canada, Quebec
Montreal, Quebec, Canada, H1T 2M4
Montreal, Quebec, Canada, H3A 1A1
Canada, Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00483938     History of Changes
Other Study ID Numbers: ML21035
Study First Received: June 7, 2007
Results First Received: November 25, 2016
Last Updated: November 25, 2016

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis, Chronic
Interferons
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 25, 2017