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
  Purpose
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.

Condition Intervention Phase
Hepatitis C, Chronic
Drug: Copegus
Drug: peginterferon alfa-2a [Pegasys]
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 1469
Study Start Date: December 2003
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Copegus
400mg po bid for 16 weeks
Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 16 weeks
Experimental: 2 Drug: Copegus
400mg po bid for 24 weeks
Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 24 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00077636

  Show 132 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00077636     History of Changes
Other Study ID Numbers: NV17317 
Study First Received: February 10, 2004
Results First Received: December 15, 2015
Last Updated: January 22, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferon-alpha
Peginterferon alfa-2a
Ribavirin
Anti-Infective Agents
Antimetabolites
Antiviral Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 26, 2016