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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00077636
First received: February 10, 2004
Last updated: April 7, 2014
Last verified: April 2014

February 10, 2004
April 7, 2014
December 2003
March 2006   (final data collection date for primary outcome measure)
SVR [ Time Frame: 24 weeks post-treatment (ie week 40 or week 48) ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00077636 on ClinicalTrials.gov Archive Site
  • Virological response [ Time Frame: End of treatment (ie week 16 or week 24) ] [ Designated as safety issue: No ]
  • Virological response [ Time Frame: 12 weeks post-treatment (ie week 28 or week 36) ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters, vital signs. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
ACCELERATE Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C (CHC) Infection.
A Randomized, Open-label Study of the Effect of PEGASYS and Ribavirin Combination Therapy on Sustained Virologic Response in Interferon-naïve Patients With Chronic Hepatitis C Genotype 2 or 3 Infection

This study will evaluate the efficacy and safety of different durations of treatment with PEGASYS combined with ribavirin in patients with CHC genotype 2 or 3 infection who have never previously received interferon (IFN) therapy. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C, Chronic
  • Drug: peginterferon alfa-2a [Pegasys]
    180 micrograms sc weekly for 16 weeks
  • Drug: peginterferon alfa-2a [Pegasys]
    180 micrograms sc weekly for 24 weeks
  • Drug: Copegus
    400mg po bid for 16 weeks
  • Drug: Copegus
    400mg po bid for 24 weeks
  • Experimental: 1
    Interventions:
    • Drug: peginterferon alfa-2a [Pegasys]
    • Drug: Copegus
  • Experimental: 2
    Interventions:
    • Drug: peginterferon alfa-2a [Pegasys]
    • Drug: Copegus
Shiffman ML, Suter F, Bacon BR, Nelson D, Harley H, Sola R, Shafran SD, Barange K, Lin A, Soman A, Zeuzem S; ACCELERATE Investigators. Peginterferon alfa-2a and ribavirin for 16 or 24 weeks in HCV genotype 2 or 3. N Engl J Med. 2007 Jul 12;357(2):124-34.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1469
March 2006
March 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients >=18 years of age;
  • CHC infection (genotype 2 or 3);
  • 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 IFN, pegylated IFN, ribavirin, viramidine, levovirin, or amantadine.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   France,   Germany,   Italy,   New Zealand,   Puerto Rico,   Spain
 
NCT00077636
NV17317
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2014

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