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A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C Infection (CHC).

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00077649
First received: February 10, 2004
Last updated: June 15, 2010
Last verified: June 2010
History of Changes

February 10, 2004
June 15, 2010
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Viral response compared to baseline [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00077649 on ClinicalTrials.gov Archive Site
  • SVR and end of treatment virological response [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Virological response [ Time Frame: Week 60 ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters, vital signs, Beck Depression Inventory [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
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A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C Infection (CHC).
A Randomized, Double-blind Study of the Effect of PEGASYS and Ribavirin Combination Therapy on Viral Kinetics and Virologic Response in Interferon-naïve Patients With Chronic Hepatitis C Genotype 1 Infection

The effects of treatment with different doses of PEGASYS in combination with different doses of ribavirin will be evaluated in patients with CHC genotype 1 who have a high viral titer, body weight greater than 85kg (187lbs) and no prior treatment with interferon. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hepatitis C, Chronic
  • Drug: peginterferon alfa-2a [Pegasys]
    180 micrograms sc weekly for 48 weeks
  • Drug: peginterferon alfa-2a [Pegasys]
    270 micrograms sc weekly for 48 weeks
  • Drug: Copegus
    600mg po bid for 48 weeks
  • Drug: Copegus
    800mg po bid for 48 weeks
  • Active Comparator: 1
    Interventions:
    • Drug: peginterferon alfa-2a [Pegasys]
    • Drug: Copegus
  • Experimental: 2
    Interventions:
    • Drug: peginterferon alfa-2a [Pegasys]
    • Drug: Copegus
  • Experimental: 3
    Interventions:
    • Drug: peginterferon alfa-2a [Pegasys]
    • Drug: Copegus
  • Experimental: 4
    Interventions:
    • Drug: peginterferon alfa-2a [Pegasys]
    • Drug: Copegus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
188
April 2006
Not Provided

Inclusion Criteria:

  • adult patients >=18 years of age;
  • body weight >85kg (187lbs);
  • CHC (genotype 1);
  • liver biopsy (in <24 calendar months of first dose), with results consistent with CHC infection;
  • use of 2 forms of contraception during study and 6 months after the study in both men and women.

Exclusion Criteria:

  • women who are pregnant or breastfeeding;
  • male partners of women who are pregnant;
  • conditions associated with decompensated liver disease;
  • other forms of liver disease, including liver cancer;
  • human immunodeficiency virus infection;
  • previous treatment with an interferon, ribavirin, viramidine, levovirin or amantadine.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00077649
NV17318
Not Provided
Clinical Trials, Study Director, Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP