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.

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: August 4, 2014
Last verified: August 2014
  Purpose

This study will compare the efficacy and safety of 48 weeks and 72 weeks treatme nt with PEGASYS plus ribavirin in patients with non-genotype 2/3 chronic hepatit is 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 microg rams 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-R NA and <2 log10 drop in HCV-RNA at week 12 will discontinue therapy. The anticip ated time on study treatment is 1-2 years, and the target sample size is 500 ind ividuals.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: peginterferon alfa-2a [Pegasys]
Drug: ribavirin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Sustained virologic response [ Time Frame: 24 weeks post-transplant ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SVR [ Time Frame: At intervals post-transplant ] [ Designated as safety issue: No ]
  • Viral kinetics [ Time Frame: At intervals during study ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 226
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: 1 Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 48 weeks
Drug: ribavirin
1000-1400mg po daily for 48 weeks
Active Comparator: 2 Drug: peginterferon alfa-2a [Pegasys]
180micrograms sc weekly for 72 weeks
Drug: ribavirin
1000-1400mg po daily for 72 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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, T6G 2X8
Edmonton, Alberta, Canada, T5H 4B9
Canada, British Columbia
Abbotsford, British Columbia, Canada, V2S 3N5
Vancouver, British Columbia, Canada, V6Z 2K5
Vancouver, British Columbia, Canada, V5Z 1M9
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, M6H 3M1
Toronto, Ontario, Canada, M5G 1L7
Toronto, Ontario, Canada, M5G 1X5
Woodbridge, Ontario, Canada, L4L 4Y7
Canada, Quebec
Montreal, Quebec, Canada, H3A 1A1
Montreal, Quebec, Canada, H1T 2M4
Canada, Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional 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
Last Updated: August 4, 2014
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on September 18, 2014