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Randomized Study for the Assessment of Silibinin (Legalon® SIL) in the Treatment of naïve Genotype 4 Patients With Chronic Hepatitis C

NCT01871662 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2015-03-05

No results posted yet for this study

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

  • Hepatitis C, Chronic

Interventions

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)

Sponsors & Collaborators

  • Rottapharm

    lead INDUSTRY

Principal Investigators

  • Gamal Esmat, MD · Al-Manial University Hospital, Kasr El-Aini Faculty Medicine, Cairo University, Egypt

  • Samer El-Kamary, MD · University of Maryland School of Medicine,Baltimore, USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01871662 on ClinicalTrials.gov