Trials / Unknown
UnknownNCT00299923
Study for Patients With Chronic HCV (GT 1 or 3) Who Relapsed to Previous (Peg)Interferon/ Ribavirin Combination Therapy
Randomized, Open-Label, Multicenter Study Examining the Effects of Duration of Treatment of PEGASYS® in Combination With Daily COPEGUS® + Amantadine in Patients With Chronic HCV After Relapse to Previous (Peg)IFN + Ribavirin Therapy.
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 300 (planned)
- Sponsor
- University of Hamburg-Eppendorf · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this study is, to compare the relapse rate in chronic HCV patients with genotype 1 or 3 under the combination of standard dose Peg-Interferon alfa-2a (PEG-IFN alfa-2a), Ribavirin (RBV) and Amantadine (AMA) given for 72 weeks (group A), versus the same combination, given for 48 weeks (group B) in patients who relapsed to previous combination therapy to conventional or pegylated (PEG) Interferon alfa and Ribavirin. Relapse ist defined as percentage of patients with non-detectable HCV-RNA at end of therapy (week 48 GT1/ week 24 GT 3) who become HCV-RNA positive during a follow-up period of 24 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Peginterferon alfa-2a, Ribavirin, Amantadine |
Timeline
- Start date
- 2005-11-01
- First posted
- 2006-03-07
- Last updated
- 2007-03-09
Locations
27 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT00299923. Inclusion in this directory is not an endorsement.