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

March 4, 2015 updated by: Rottapharm

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Al-Manial University Hospital, Kasr El-Aini Faculty Medicine, Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient must be willing to give written informed consent
  • Male and female patients; age between 21 and 45 years inclusive
  • Chronic hepatitis C infection with genotype 4 confirmed by genotypic testing at screening or within 6 months of screening period
  • Patients eligible to be treated with RBV and Peg-IFN as per the instructions present in their prescribing information documents
  • No history of prior interferon therapy (treatment naïve)
  • Detectable HCV-RNA levels
  • Normal BUN and creatinine
  • Ability to communicate, participate, and comply with the requirements of the entire study

Exclusion Criteria:

  • Liver transplant patients
  • Co-Infection with HIV and/or HBV
  • ALT >10-fold the upper limit of normal i.e. > 400 U/L
  • Evidence of hepatocellular carcinoma (HCC)
  • Fibroscan® at screening with a score ≥ 14.5 kPa
  • Evidence of liver disease due to causes other than chronic HCV infection
  • Evidence of poorly controlled diabetes (defined as HbA1c > 8%)
  • History of alcohol or drug abuse within the last 12 months
  • History or clinical evidence of liver decompensation, e.g. presence of ascites or encephalopathy, or bleeding from esophageal varices
  • Serum albumin levels < 3.2 g/dL
  • INR > 1.3 N
  • Total Bilirubin levels > 2.0 mg/dL unless explained by Gilbert's disease
  • Platelet Count < 100,000 µL
  • Absolute Neutrophil counts < 1500 µL (mm3)
  • Active or suspected non-hepatic malignancy or history of malignancy within the last 5 years
  • Body Mass Index < 16 or > 35 kg/m2

  • Females of childbearing potential:

    • Pregnancy (i.e. positive urine pregnancy test at screening) or lactation
    • Failure to agree to practice adequate contraception methods (e.g. oral contraceptives, intra-uterine device (IUD), transdermal contraceptive patch)
  • Male patients not vasectomized, who do not agree to abstain from intercourse or who do not use a condom

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group C: RIB + Peg-IFN
Ribavirin(800-1400 mg/day,divided BID PO) + Peg-IFN alfa2b (1.5 μg/kg/week SC)for 25 weeks if RVR has been achieved or 49 weeks if EVR has been achieved
Drug: Pegylated interferon alfa2b
1.5 µg/kg once-weekly
Other Names:
  • PEG-INTRON®
Drug: Ribavirin
At weight-based dose 800-1400 mg/day (BID, OS)
Other Names:
  • REBETOL®
Experimental: Group B:Legalon® SIL + RIB + Peg-IFN
Silibinin (20 mg/Kg/day) for 6 days, followed by Silibinin + ribavirin (800-1400 mg/day, divided BID PO) + Peg-IFN alfa2b (1.5 μg/kg/week SC) for 15 days, followed by ribavirin (800-1400 mg/day, divided BID PO) + Peg-IFN alfa2b (1.5 μg/kg/week SC) + 2 days of Silibinin per week for 9 weeks, followed by ribavirin (800-1400 mg/day, divided BID PO) + Peg-IFN alfa2b (1.5 μg/kg/week SC) for 13 weeks if RVR has been achieved (for a total of 25 weeks of treatment) or 37 weeks if EVR has been achieved (for a total of 49 weeks of treatment)
Drug: Pegylated interferon alfa2b
1.5 µg/kg once-weekly
Other Names:
  • PEG-INTRON®
Drug: Ribavirin
At weight-based dose 800-1400 mg/day (BID, OS)
Other Names:
  • REBETOL®
Drug: Legalon® SIL (Silibinin)
Silibinin 20 mg/Kg/day
Experimental: Group A: Legalon® SIL + RIB
Silibinin (20 mg/Kg/day) for 6 days, followed by Silibinin + ribavirin (800-1400 mg/day, divided BID PO) for 15 days, followed by ribavirin (800-1400 mg/day, divided BID PO) + 2 days of Silibinin per week for 9 weeks, followed by ribavirin (800-1400 mg/day, divided BID PO) for 13 weeks if RVR has been achieved (for a total of 25 weeks of treatment) or 37 weeks if EVR has been achieved (for a total of 49 weeks of treatment)
Drug: Ribavirin
At weight-based dose 800-1400 mg/day (BID, OS)
Other Names:
  • REBETOL®
Drug: Legalon® SIL (Silibinin)
Silibinin 20 mg/Kg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Undetectable HCV-RNA at 24 Weeks After the end of the Study Treatment
Time Frame: 24 weeks after the end of treatment (e.g. at week 49 or 73)
The primary efficacy endpoint is the proportion of patients with Sustained Virological Response (SVR), i.e. undetectable HCV-RNA level lasting for 24 weeks after the completion of the study treatment course.
24 weeks after the end of treatment (e.g. at week 49 or 73)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Undetectable HCV-RNA
Time Frame: 4 weeks after the beginning of the study treatment
Proportion of patients with Rapid Viral Response (RVR), i.e. undetectable HCV-RNA levels 4 weeks after the beginning of the study treatment course.
4 weeks after the beginning of the study treatment
HCV-RNA decrease ≥ 2 log10 IU/mL
Time Frame: 12 weeks after the beginning of the study treatment
Number and percentage of patients with Early Viral Response (EVR), i.e. HCV-RNA decrease ≥ 2 log10 IU/mL 12 weeks after the beginning of the study treatment course
12 weeks after the beginning of the study treatment
Undetectable HCV-RNA
Time Frame: At the end of study treatment (e.g. at week 25 or 49)
Proportion of patients with End Of Treatment (EOT) Response, i.e. undetectable HCV-RNA levels at the end of the study treatment (e.g. at the end of treatment at week 25 or 49)
At the end of study treatment (e.g. at week 25 or 49)
Normalization of Serum Alanine Aminotransferase
Time Frame: 4 weeks after the beginning of study treatment, at EOT and at 24 weeks after the completion of the study treatment
Proportion of patients with a normalization of Serum Alanine Aminotransferase (ALT <40 U/L) values 4 weeks after the beginning of study treatment, at EOT and at 24 weeks after the completion of the study treatment course;
4 weeks after the beginning of study treatment, at EOT and at 24 weeks after the completion of the study treatment
Number of Participants with adverse events (AEs)
Time Frame: Up to 24 weeks after the end of treatment (e.g. up to week 49 or 73)
Up to 24 weeks after the end of treatment (e.g. up to week 49 or 73)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rottapharm

Investigators

  • Principal Investigator: Gamal Esmat, MD, Al-Manial University Hospital, Kasr El-Aini Faculty Medicine, Cairo University, Egypt
  • Study Chair: Samer El-Kamary, MD, University of Maryland School of Medicine,Baltimore, USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Anticipated)

February 1, 2016

Study Completion (Anticipated)

February 1, 2016

Study Registration Dates

First Submitted

May 30, 2013

First Submitted That Met QC Criteria

June 4, 2013

First Posted (Estimate)

June 7, 2013

Study Record Updates

Last Update Posted (Estimate)

March 5, 2015

Last Update Submitted That Met QC Criteria

March 4, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LEG-SIL-2-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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