Trials / Withdrawn
WithdrawnNCT01871662
Randomized Study for the Assessment of Silibinin (Legalon® SIL) in the Treatment of naïve Genotype 4 Patients With Chronic Hepatitis C
A Randomized, Single Center, Comparative Study to Evaluate the Efficacy and Safety of Silibinin (Legalon® SIL) in Combination With Ribavirin or With Peginterferon and Ribavirin, Versus Peginterferon and Ribavirin Based Standard of Care (SoC) in Treatment of naïve Genotype 4 Patients With Chronic Hepatitis C
- Status
- Withdrawn
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Rottapharm · Industry
- Sex
- All
- Age
- 21 Years – 45 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to explore whether silibinin plus ribavirin with/without peg-interferon can be more effective than the peg-interferon plus ribavirin based standard of care (SoC) in the treatment of patients infected with hepatitis C virus genotype 4.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Legalon® SIL (Silibinin) | Silibinin 20 mg/Kg/day |
| DRUG | Pegylated interferon alfa2b | 1.5 µg/kg once-weekly |
| DRUG | Ribavirin | At weight-based dose 800-1400 mg/day (BID, OS) |
Timeline
- Start date
- 2013-08-01
- Primary completion
- 2016-02-01
- Completion
- 2016-02-01
- First posted
- 2013-06-07
- Last updated
- 2015-03-05
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT01871662. Inclusion in this directory is not an endorsement.