Status:
WITHDRAWN
Randomized Study for the Assessment of Silibinin (Legalon® SIL) in the Treatment of naïve Genotype 4 Patients With Chronic Hepatitis C
Lead Sponsor:
Rottapharm
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
21-45 years
Phase:
PHASE2
PHASE3
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 tr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01871662
Start Date
August 1 2013
End Date
February 1 2016
Last Update
March 5 2015
Active Locations (1)
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1
Al-Manial University Hospital, Kasr El-Aini Faculty Medicine, Cairo University
Cairo, Egypt