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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: January 22, 2016
Last verified: January 2016

February 10, 2004
January 22, 2016
December 2003
March 2006   (final data collection date for primary outcome measure)
Percentage of Participants With Sustained Virological Response (SVR) [ Time Frame: Week 40 (for 16-week treatment group); Week 48 (for 24-week treatment group) ] [ Designated as safety issue: No ]
SVR was defined as the percentage of participants with undetectable HCV RNA at 24 weeks after the completion of the study treatment. The negative assessment was required to be the last one collected at or after week 36 (ie, on or after study Day 253) for the 16-week treatment group or at or after week 44 (ie, on or after study Day 309) for the 24-week treatment group.
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Complete list of historical versions of study NCT00077636 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With Virological Response at The End of Study Treatment [ Time Frame: Week 16 (for 16-week treatment group); Week 24 (for 24-week treatment group) ] [ Designated as safety issue: No ]
    Virological response was defined as the percentage of participants with undetectable HCV RNA at the completion of the study treatment. The negative assessment was required to be the last one collected in the Week 16 time window for the 16-week treatment group or in the Week 24 time window for the 24-week treatment group.
  • Percentage of Participants Virological Response 12 Weeks Post-Treatment [ Time Frame: Week 28 (for 16-week treatment group); Week 36 (for 24-week treatment group) ] [ Designated as safety issue: No ]
    Virological response 12 weeks post-treatment was defined as the percentage of participants with undetectable HCV RNA 12 weeks after the completion of the study treatment . The negative assessment was required to be the last one collected in the week 28 time window for the 16- week treatment group or in the week 36 time window for the 24-week treatment group.
  • Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Week 40 and Week 48 ] [ Designated as safety issue: No ]
    An adverse event was defined as any untoward medical occurrence that occurred during he course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
  • Percentage of Participants With Marked Laboratory Abnormalities [ Time Frame: Up to Week 40 and Week 48 ] [ Designated as safety issue: No ]
    Participants with changes in Hematocrit: Fraction 0.36 - 0.60 g/dL, Hemoglobin: 11.0 -20.0 g/dL, WBC 3.0 - 18.0 g/dL, Platelets 100 - 700 g/dL, Basophils 0.00 - 0.30 g/dL, Lymphocytes 1.00 - 6.30 g/dL, Monocytes 0.08 - 2.00 g/dL, Neutrophils 1.50 or more g/dL, Eosinophils 0.00 - 1.50 g/dL , PTT 0 - 50 seconds, Alkaline Phosphatase 0 - 190 and ASAT 0 - 50 U/L, ALAT 0 - 60 U/L, Gamma - GT 0 - 120 U/L, Total Protein 55 - 87 g/L ;Albumin 27.0 or more g/L, Total Bilirubin 0 - 34.2 μmol/L, BUN 0 - 14.3 mmol/L, Creatinine 0 - 154 μmol/L, Free T3, T4 5 - 40 pmol/L, TSH 0.0 - 10.0 mU/L, Cholesterol 0.0 - 8.3 mmol/L; Triglycerides 0.00 - 2.83 mmol/L, Chloride 95 - 115 mmol/L; Potassium 3.0 - 6.0 mmol/L; Sodium 130 - 150 mmol/L, miscellaneous: Calcium 2.00 - 2.90 mmol/L; Phosphate 0.75 - 1.60 mmol/L; Blood Glucose (Random) 2.80 - 11.10 mmol/L, Uric Acid 0 - 600 μmol/L, Proteinuria, Glycosuria, Hematuria (Qualitative 0 to 4+) 0 - 1 were analysed for the laboratory abnormality.
  • Participants With Marked Abnormal Vital Signs [ Time Frame: Up to Week 40 and Week 48 ] [ Designated as safety issue: No ]
    Participants with changes in Systolic and diastolic blood pressure, heart rate were analysed abnormal vital signs.
  • Number of Participants With Highest Triglyceride Level [ Time Frame: Up to Week 40 and Week 48 ] [ Designated as safety issue: No ]
    Participants with triglyceride level above normal (i.e. < 200 mg/dL) were analysed.
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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.
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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C, Chronic
  • Drug: Copegus
    400mg po bid for 16 weeks
  • Drug: Copegus
    400mg po bid for 24 weeks
  • Drug: peginterferon alfa-2a [Pegasys]
    180 micrograms sc weekly for 16 weeks
  • Drug: peginterferon alfa-2a [Pegasys]
    180 micrograms sc weekly for 24 weeks
  • Experimental: 1
    Interventions:
    • Drug: Copegus
    • Drug: peginterferon alfa-2a [Pegasys]
  • Experimental: 2
    Interventions:
    • Drug: Copegus
    • Drug: peginterferon alfa-2a [Pegasys]
Shiffman ML, Suter F, Bacon BR, Nelson D, Harley H, Solá 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   (Adult, Senior)
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
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Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
January 2016

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