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

NCT ID: NCT01871662

Last Updated: 2015-03-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2016-02-29

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Pegylated interferon alfa2b

Intervention Type: DRUG

1.5 µg/kg once-weekly

Ribavirin

Intervention Type: DRUG

At weight-based dose 800-1400 mg/day (BID, OS)

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)

Group Type: EXPERIMENTAL

Legalon® SIL (Silibinin)

Intervention Type: DRUG

Silibinin 20 mg/Kg/day

Pegylated interferon alfa2b

Intervention Type: DRUG

1.5 µg/kg once-weekly

Ribavirin

Intervention Type: DRUG

At weight-based dose 800-1400 mg/day (BID, OS)

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)

Group Type: EXPERIMENTAL

Legalon® SIL (Silibinin)

Intervention Type: DRUG

Silibinin 20 mg/Kg/day

Ribavirin

Intervention Type: DRUG

At weight-based dose 800-1400 mg/day (BID, OS)

Interventions

Legalon® SIL (Silibinin)

Silibinin 20 mg/Kg/day

Intervention Type: DRUG

Pegylated interferon alfa2b

1.5 µg/kg once-weekly

Intervention Type: DRUG

Ribavirin

At weight-based dose 800-1400 mg/day (BID, OS)

Intervention Type: DRUG

Other Intervention Names

PEG-INTRON®; REBETOL®

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rottapharm

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gamal Esmat, MD

Role: PRINCIPAL_INVESTIGATOR

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

Samer El-Kamary, MD

Role: STUDY_CHAIR

University of Maryland School of Medicine,Baltimore, USA

Locations

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

Cairo, , Egypt

Countries

Egypt

Other Identifiers

LEG-SIL-2-02

Identifier Type: -

Identifier Source: org_study_id