A Study of Combination Treatment With PEGASYS (Peginterferon Alfa-2a (40KD) Plus COPEGUS (Ribavirin) in Patients 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: May 5, 2014
Last verified: May 2014
  Purpose

This 3 arm study will assess the safety and efficacy of combination treatment with PEGASYS + Copegus in patients with chronic hepatitis C. Three groups of patients will be studied; 1) those with elevated ALT level, 2) those with normal ALT level, and 3) those with HIV co-infection. Patients with genotype 1, 4, 5 or 6 will receive PEGASYS 180 micrograms sc once weekly + Copegus 1000-1200mg po daily (dependent on body weight) for 48 weeks, those with genotype 2 or 3 will receive PEGASYS 180 micrograms sc once weekly + Copegus 800mg po daily for 24 weeks, and all patients with HIV co-infection will receive PEGASYS 180 micrograms sc once weekly + Copegus 800mg po daily for 48 weeks. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: peginterferon alfa-2a [Pegasys]
Drug: ribavirin [Copegus]
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 Label Study Assessing the Safety and Effect on Viral Response of Combination Therapy With PEGASYS + COPEGUS in Selected Groups of Patients With Chronic Viral Hepatitis C

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Occurrence rate and intensity of adverse events [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sustained viral response [ Time Frame: End of treatment (weeks 24 or 48) ] [ Designated as safety issue: No ]
  • Viral response rate [ Time Frame: At week 12, and at end of treatment (weeks 24 or 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: 1 Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 48 weeks (genotype 1, 4, 5, 6), or 24 weeks (genotype 2, 3)
Drug: ribavirin [Copegus]
1000-1200mg po daily for 48 weeks (genotype 1, 4, 5, 6) or 800mg po daily for 24 weeks (genotype 2,3)
Experimental: 2 Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 48 weeks (genotype 1, 4, 5, 6), or 24 weeks (genotype 2, 3)
Drug: ribavirin [Copegus]
1000-1200mg po daily for 48 weeks (genotype 1, 4, 5, 6) or 800mg po daily for 24 weeks (genotype 2,3)
Experimental: 3 Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 48 weeks
Drug: ribavirin [Copegus]
800mg po daily for 48 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;
  • chronic hepatitis C, with detectable serum HCV RNA;
  • scheduled for treatment with PEGASYS;
  • compensated liver disease.

Exclusion Criteria:

  • chronic liver disease other than chronic hepatitis C;
  • active HAV or HBV infection;
  • therapy with any systemic antiviral, antineoplastic or immunomodulatory treatment <= 6 months prior to first dose of study drug.
  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, Czech Republic, 00000
Praha, Czech Republic
Praha, Czech Republic, 180 01
Praha, Czech Republic, 140 00
Praha 2, Czech Republic, 128 08
Prostejov, Czech Republic
Usti Nad Labem, Czech Republic
Slovakia
Banska Bystrica, Slovakia, 957 17
Bratislava, Slovakia, 851 07
Bratislava, Slovakia, 833 05
Kosice, Slovakia, 04001
Kosice, Slovakia, 040 01
Martin, Slovakia, 036 59
Trencin, Slovakia, 911 07
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: NCT00800748     History of Changes
Other Study ID Numbers: ML19387
Study First Received: December 1, 2008
Last Updated: May 5, 2014
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
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 19, 2014