| July 12, 2004 |
| May 13, 2009 |
| |
| |
| Sustained virological response rate [ Time Frame: 24 weeks post-treatment ] [ Designated as safety issue: No ] |
| Efficacy: Sustained virologic response rate 24 weeks post-treatment |
| Complete list of historical versions of study NCT00087646 on ClinicalTrials.gov Archive Site |
- Percentage of patients with >=2log drop in HCV-RNA [ Time Frame: Weeks 12 and 24 ] [ Designated as safety issue: No ]
- Percentage of patients with undetectable HCV-RNA [ Time Frame: Weeks 12, 24 and end of treatment ] [ Designated as safety issue: No ]
|
| Efficacy: Percentage of patients with non-detectable HCV-RNA at Wks 12, 24, and EOT, percentage of patients with at least a 2 log drop of HCV-RNA at Wks 12 and 24
Safety: AE rate and profile, lab values |
| |
| REPEAT Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Therapy in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Who Did Not Respond to Previous PegIntron (Peginterferon Alfa-2b (12KD))/Ribavirin Combination Therapy |
| A Randomized, Open-Label Study of the Effect of PEGASYS Combined With Ribavirin on Sustained Virologic Response in Patients With Chronic Hepatitis C Who Did Not Respond to Previous Pegintron/Ribavirin Combination Therapy |
This 4 arm study is designed for patients with CHC who have not responded to peginterferon alfa-2b (12KD)/ribavirin combination therapy. In these patients, the effects of lengthening the duration of treatment, as well as including an initial 12-week period of high-dose PEGASYS (360 micrograms sc), are compared with the standard combination therapy of PEGASYS (180 micrograms sc) and ribavirin (1000-1200mg po). The anticipated time on study treatment is 1-2 years 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: Ribavirin
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| |
| |
| |
| Completed |
| 948 |
| May 2008 |
|
Inclusion Criteria:
- adult patients >=18 years of age;
- CHC infection;
- 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;
- Lack of response to previous treatment with peginterferon alfa-2b (12KD)/ribavirin combination therapy given for >=12 weeks.
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.
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Belgium, Brazil, Canada, France, Germany, Greece, Italy, Portugal, Spain, Sweden, Switzerland, Turkey, United Kingdom |
| |
| NCT00087646 |
| Clinical Trials, Study Director, Hoffmann-La Roche |
| MV17150 |
| Hoffmann-La Roche |
|
| Study Director: |
Clinical Trials |
Hoffmann-La Roche, +1 973 235 5000 |
|
|
| Hoffmann-La Roche |
| May 2009 |
