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A Study of Combination Therapy With PEGASYS (Peginterferon Alfa-2a (40KD)) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 2 or 3 Who Do Not Achieve a Rapid Viral Response.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00623428
First received: February 18, 2008
Last updated: February 4, 2013
Last verified: February 2013
History of Changes
  Purpose

This study will evaluate the efficacy and safety of PEGASYS + Copegus combination therapy given for 24 weeks versus 48 weeks in patients with chronic hepatitis C, genotype 2/3. Patients receiving PEGASYS (180 micrograms sc weekly) + Copegus (800-1200mg po daily) who do not achieve a rapid viral response at week 4 will enter the study between treatment week 6 and 8, and will receive study medication. Those who have an early virological response at week 12, and are still taking medication at week 24, will then be randomized to one of 2 study groups. Group 1 will stop treatment at this point and will have a 48 week post-treatment observation period, and Group 2 will stay on medication for a further 24 weeks, followed by a 24 week post-treatment observation period. The anticipated time on study treatment is 6-12 months, and the target sample size is 100-500 individuals.


Condition Intervention Phase
Hepatitis C, Chronic
 Drug: peginterferon alfa-2a [Pegasys]
Drug: Copegus
 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 of the Effects of 24 vs 48 Weeks of Combination Therapy With PEGASYS (Peginterferon Alfa-2a 40KD) Plus COPEGUS (Ribavirin) on Sustained Virological Response in Patients With Chronic Hepatitis C, Genotype 2 or 3 Who do Not Achieve a Rapid Viral Response.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • SVR [ Time Frame: 24 weeks post-treatment (week 48 for Group 1, and week 72 for Group 2). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients with non-detectable HCV-RNA [ Time Frame: End of treatment (week 24 for Group 1 and week 48 for Group 2) ] [ Designated as safety issue: No ]
  • Percentage of patients with >=2 log10 drop in HCV-RNA [ Time Frame: Treatment week 12 ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 233
Study Start Date: April 2008
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 24 weeks (18 weeks on study)
Drug: Copegus
800-1200mg po daily for 24 weeks (18 on study)
Active Comparator: 2 Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 48 weeks (42 on study)
Drug: Copegus
800-1200mg po daily for 48 weeks (42 on study)

  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;
  • serological evidence of chronic hepatitis C (CHC);
  • CHC genotype 2 or 3;
  • receiving PEGASYS + Copegus according to local standard of care and no RVR;
  • compensated liver disease.

Exclusion Criteria:

  • pegylated interferon, standard interferon or ribavirin therapy at any time prior to initiation of current therapy with PEGASYS + Copegus;
  • coinfection with hepatitis A or B, or HIV;
  • history or other evidence of decompensated liver disease.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00623428

  Show 101 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00623428     History of Changes
Other Study ID Numbers: MV21371, 2007-004993-15
Study First Received: February 18, 2008
Last Updated: February 4, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
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
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013