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A Study of Combination Treatment With PEGASYS (Peginterferon Alfa-2a (40KD) Plus COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C.
This study is ongoing, but not recruiting participants.
Sponsored by: Hoffmann-La Roche
Information provided by: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00800748
  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 (40KD) [PEGASYS]
Drug: ribavirin [Copegus]
Phase IV

MedlinePlus related topics: Hepatitis Hepatitis C
Drug Information available for: Ribavirin Peginterferon Alfa-2a
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

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 ]

Estimated Enrollment: 400
Study Start Date: January 2006
Estimated Study Completion Date: May 2010
Arms Assigned Interventions
1: Experimental Drug: peginterferon alfa-2a (40KD) [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)
2: Experimental Drug: peginterferon alfa-2a (40KD) [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)
3: Experimental Drug: peginterferon alfa-2a (40KD) [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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00800748

Locations
Czech Republic
BRNO, Czech Republic, 62500
PRAHA, Czech Republic
PRAHA, Czech Republic, 00000
OLOMOUC, Czech Republic
KARLOVY VARY, Czech Republic, 360 73
JABLONEC/NISOU, Czech Republic, 466 60
PRAHA, Czech Republic, 180 01
PRAHA 2, Czech Republic, 128 08
MELNIK, Czech Republic
HRADEC KRALOVE, Czech Republic, 500 12
OSTRAVA, Czech Republic, 708 52
OPAVA, Czech Republic
CESKÉ BUDEJOVICE, Czech Republic, 370 87
USTI NAD LABEM, Czech Republic
BEROUN, Czech Republic
HAVLICKUV BROD, Czech Republic
HRADEC KRALOVE, Czech Republic
LIBEREC, Czech Republic, 460 63
HAVIROV, Czech Republic
PARDUBICE, Czech Republic, 532 03
PROSTEJOV, Czech Republic
MOST, Czech Republic
DECIN, Czech Republic
KOLIN, Czech Republic
CESKA LIPA, Czech Republic
CHOMUTOV, Czech Republic, 43012
JIHLAVA, Czech Republic, 586 33
Slovakia
BRATISLAVA, Slovakia, 833 05
BRATISLAVA, Slovakia, 851 07
TRENCIN, Slovakia, 911 07
KOSICE, Slovakia, 04001
MARTIN, Slovakia, 036 59
KOSICE, Slovakia, 040 01
BANSKA BYSTRICA, Slovakia, 957 17
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche, +1 973 235 5000
  More Information

Responsible Party: Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers: ML19387
Study First Received: December 1, 2008
Last Updated: January 15, 2009
ClinicalTrials.gov Identifier: NCT00800748  
Health Authority: Czech Republic: State Institute for Drug Control

Study placed in the following topic categories:
Interferon-alpha
Liver Diseases
Hepatitis, Chronic
Ribavirin
Interferons
Hepatitis, Viral, Human
Hepatitis
Virus Diseases
Digestive System Diseases
Peginterferon alfa-2a
Hepatitis C
Interferon Alfa-2a
Hepatitis C, Chronic

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Flaviviridae Infections
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009