Hepatitis C, Chronic
Conditions
Keywords
HCV, Hepatitis C
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.
Interventions
DRUGLegalon® SIL (Silibinin)
Silibinin 20 mg/Kg/day
DRUGPegylated interferon alfa2b
1.5 µg/kg once-weekly
DRUGRibavirin
At weight-based dose 800-1400 mg/day (BID, OS)
Sponsors
Rottapharm
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Undetectable HCV-RNA at 24 Weeks After the end of the Study Treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Undetectable HCV-RNA | 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. |
| HCV-RNA decrease ≥ 2 log10 IU/mL | 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 |
| Normalization of Serum Alanine Aminotransferase | 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; |
| Number of Participants with adverse events (AEs) | Up to 24 weeks after the end of treatment (e.g. up to week 49 or 73) | — |
Countries
Egypt
Outcome results
None listed