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A Study of Combination Treatment With Peginterferon Alfa-2a (Pegasys) Plus Ribavirin (Copegus) in Participants With Chronic Hepatitis C

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00800748
First received: December 1, 2008
Last updated: February 1, 2016
Last verified: February 2016
  Purpose
This 3 arm study will assess the safety and efficacy of combination treatment with peginterferon alfa-2a + ribavirin in participants with chronic hepatitis C. Three groups of participants will be studied; 1) those with elevated alanine transaminase (ALT) level, 2) those with normal ALT level, and 3) those with human immunodeficiency virus (HIV) co-infection. Participants with genotype 1, 4, 5 or 6 will receive peginterferon alfa-2a 180 micrograms (mcg) subcutaneous (SC) once weekly (qw) + ribavirin 1000-1200 milligrams (mg) orally (PO) daily (dependent on body weight) for 48 weeks, those with genotype 2 or 3 will receive peginterferon alfa-2a 180 mcg SC qw + ribavirin 800 mg PO daily for 24 weeks, and all participants with HIV co-infection will receive peginterferon alfa-2a 180 mcg SC qw + ribavirin 800 mg PO daily for 48 weeks. The anticipated time on study treatment is 48 weeks, and the target sample size is 300 individuals.

Condition Intervention Phase
Hepatitis C, Chronic
Drug: Peginterferon alfa-2a
Drug: Ribavirin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open, Phase IV, Multicentric Study, Evaluating Safety and Efficacy of Ribavirin (Copegus®) and Peginterferon Alfa-2a (Pegasys®) Combination in Specific Groups

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Incidence of adverse events [ Time Frame: up to approximately 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of participants with sustained viral response [ Time Frame: 24 weeks after the end of treatment (Week 48) ] [ Designated as safety issue: No ]
  • Percentage of participants with viral response rate [ Time Frame: Week 12 after the end of treatment (Week 48) ] [ Designated as safety issue: No ]

Enrollment: 373
Study Start Date: January 2006
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Participants with genotype 1, 4, 5 or 6 will receive peginterferon alfa-2a 180 mcg SC qw + ribavirin 1000-1200 mg PO daily (dependent on body weight) for 48 weeks.
Drug: Peginterferon alfa-2a
Peginterferon alfa-2a will be administered at a dose of 180 mcg SC weekly for 48 weeks to participants with genotype 1, 2, 3, 4, 5, 6 and to particpants with HIV co-infection, or for 24 weeks to participants with genotype 2, and 3.
Other Name: Pegasys
Drug: Ribavirin
Ribavirin will be administered at a dose of 1000-1200 mg PO daily for 48 weeks to participants with genotype 1, 4, 5, 6 or 800mg po daily for 24 weeks to participants with genotype 2, and 3.
Other Name: Copegus
Experimental: Group B
Participants with with genotype 2 or 3 will receive peginterferon alfa-2a 180 mcg SC qw + ribavirin 800 mg PO daily for 24 weeks.
Drug: Peginterferon alfa-2a
Peginterferon alfa-2a will be administered at a dose of 180 mcg SC weekly for 48 weeks to participants with genotype 1, 2, 3, 4, 5, 6 and to particpants with HIV co-infection, or for 24 weeks to participants with genotype 2, and 3.
Other Name: Pegasys
Drug: Ribavirin
Ribavirin will be administered at a dose of 1000-1200 mg PO daily for 48 weeks to participants with genotype 1, 4, 5, 6 or 800mg po daily for 24 weeks to participants with genotype 2, and 3.
Other Name: Copegus
Experimental: Group C
Participants with HIV co-infection will receive peginterferon alfa-2a 180 mcg SC qw + ribavirin 800 mg PO daily for 48 weeks.
Drug: Peginterferon alfa-2a
Peginterferon alfa-2a will be administered at a dose of 180 mcg SC weekly for 48 weeks to participants with genotype 1, 2, 3, 4, 5, 6 and to particpants with HIV co-infection, or for 24 weeks to participants with genotype 2, and 3.
Other Name: Pegasys
Drug: Ribavirin
Ribavirin will be administered at a dose of 1000-1200 mg PO daily for 48 weeks to participants with genotype 1, 4, 5, 6 or 800mg po daily for 24 weeks to participants with genotype 2, and 3.
Other Name: Copegus

  Eligibility

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

Inclusion Criteria:

  • Adult participants, greater than or equal to (>=) 18 years of age
  • Chronic hepatitis C, with detectable serum hepatitie C virus (HCV) ribonucleic acid (RNA)
  • Scheduled for treatment with peginterferon alfa-2a
  • Compensated liver disease
  • Women in fertile age must be informed about obligation of using adequate contraception during and 6 month post treatment with ribavirin (Copegus®)
  • Men with a sexual partner in fertile age must be informed about obligatory contraception preventing pregnancy during the course of treatment with ribavirin (Copegus®)as well as 6 months after treatment cessation
  • Female participants in the study must have a negative pregnancy test performed not sooner than within 2 weeks preceding the planned inclusion to the study
  • Men with a sexual partner in fertile age must produce a negative result of the partner's pregnancy test performed not sooner than within 2 weeks preceding the planned partner's inclusion to the study

Exclusion Criteria:

  • Chronic liver disease other than chronic hepatitis C
  • Active hepatitis A virus or hepatitis B virus infection
  • Therapy with any systemic antiviral, antineoplastic or immunomodulatory treatment less than or equal to (<=) 6 months prior to first dose of study drug
  • Hemoglobin <120 grams per liter (g/L) in female subjects or <130 g/L in male subjects (the result must not be older than 2 weeks prior to inclusion to the study)
  • The platelet count <90 x 10^9/liter (the result must not be older than 2 weeks prior to inclusion to the study
  • Neutrofils count <1.5 x 10^9/liter (the result must not be older than 2 weeks prior to inclusion to the study)
  • Subjects with increased risk of anaemia, or subjects, at risk of serious health problems resulting from anaemia or decrease of hemoglobin (e.g., subjects with serious cardiovascular or cerebrovascular disease)
  • History or presence of a serious mental disease, especially depression, which, according to investigator's opinion, does not allow administration of peginterferon alfa-2a (Pegasys®)
  • History or presence of a disease consequent to immunodeficiency (e.g., inflammatory diseases of intestine, idiopathic thrombocytopenic purpura, systemic lupus erythematodes, rheumatoid arthritis)
  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: NCT00800748

Locations
Czech Republic
Beroun, Czech Republic
Brno, Czech Republic, 62500
Ceska Lipa, Czech Republic
Ceské Budejovice, Czech Republic, 370 87
Chomutov, Czech Republic
Decin, Czech Republic, 0
Havirov, Czech Republic
Havlickuv Brod, Czech Republic
Hradec Kralove, Czech Republic, 500 12
Hradec Kralove, Czech Republic
Jablonec/nisou, Czech Republic, 466 60
Jihlava, Czech Republic
Karlovy Vary, Czech Republic
Kolin, Czech Republic
Liberec, Czech Republic
Melnik, Czech Republic
Most, Czech Republic
Olomouc, Czech Republic
Opava, Czech Republic
Ostrava, Czech Republic, 708 52
Pardubice, Czech Republic
Praha 2, Czech Republic, 128 08
Praha, Czech Republic, 00000
Praha, Czech Republic, 140 00
Praha, Czech Republic, 180 01
Praha, Czech Republic
Prostejov, Czech Republic
Usti Nad Labem, Czech Republic
Slovakia
Banska Bystrica, Slovakia, 957 17
Bratislava, Slovakia, 833 05
Bratislava, Slovakia, 851 07
Kosice, Slovakia, 040 01
Kosice, Slovakia, 04001
Martin, Slovakia, 036 59
Trencin, Slovakia, 911 07
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00800748     History of Changes
Other Study ID Numbers: ML19387  2005-003932-23 
Study First Received: December 1, 2008
Last Updated: February 1, 2016
Health Authority: Czech Republic: State Institute for Drug Control

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

ClinicalTrials.gov processed this record on September 30, 2016