| February 10, 2004 |
| May 13, 2009 |
| |
| |
| SVR [ Time Frame: 24 weeks post-treatment (ie week 40 or week 48) ] [ Designated as safety issue: No ] |
| Efficacy: Sustained virologic response 24 weeks post-treatment |
| 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 ]
|
| Efficacy: End-of-treatment virologic response, virologic response 12 weeks post- treatment
Safety: Vital signs, laboratory tests, clinical adverse events |
| |
| 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. |
| |
| Phase IV |
| Interventional |
| Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| Hepatitis C, Chronic |
- Drug: peginterferon alfa-2a (40KD) [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. |
| |
| Completed |
| 1469 |
| March 2006 |
|
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 |
| Clinical Trials, Study Director, Hoffmann-La Roche |
| NV17317 |
| Hoffmann-La Roche |
|
| Study Director: |
Clinical Trials |
Hoffmann-La Roche, +1 973 235 5000 |
|
|
| Hoffmann-La Roche |
| May 2009 |
