Phase 4
Completed N=1,469
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.
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT00077636 ↗
Enrolled (actual)
1,469
Serious AEs
5.6%
Results posted
Jan 2016
Primary outcomePrimary: Percentage of Participants With Sustained Virological Response (SVR) — 65; 76 percentage of participants — p=<.0001
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virological Response (SVR) |
65; 76 | <.0001 sig |
| SECONDARY Percentage of Participants With Virological Response at The End of Study Treatment |
94; 92 | 0.1941 |
| SECONDARY Percentage of Participants Virological Response 12 Weeks Post-Treatment |
59; 69 | 0.0003 sig |
| SECONDARY Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
97; 99; 5; 6 | — |
| SECONDARY Percentage of Participants With Marked Laboratory Abnormalities |
18; 21; 15; 16; 24; 22 | — |
| SECONDARY Participants With Marked Abnormal Vital Signs |
4; 3; 2; 2; 9; 2 | — |
| SECONDARY Number of Participants With Highest Triglyceride Level |
280; 284; 117; 138; 17; 14 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00077636). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.