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

Hepatitis C, Chronic Clinical Trial

— HEPASIL  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01871662
• Other study ID #: LEG-SIL-2-02
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: May 30, 2013
• Last updated: March 4, 2015
• Start date: August 2013
• Est. completion date: February 2016

Study information

• Verified date: March 2015
• Source: Rottapharm
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and PopulationEgypt: Institutional Review BoardUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Legalon® SIL (Silibinin)
Silibinin 20 mg/Kg/day
• Pegylated interferon alfa2b
1.5 µg/kg once-weekly
• Ribavirin
At weight-based dose 800-1400 mg/day (BID, OS)

Locations

Country	Name	City	State
Egypt	Al-Manial University Hospital, Kasr El-Aini Faculty Medicine, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Rottapharm

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Undetectable HCV-RNA at 24 Weeks After the end of the Study Treatment	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)	No
Secondary	Undetectable HCV-RNA	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	No
Secondary	HCV-RNA decrease = 2 log10 IU/mL	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	No
Secondary	Undetectable HCV-RNA	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)	No
Secondary	Normalization of Serum Alanine Aminotransferase	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	No
Secondary	Number of Participants with adverse events (AEs)		Up to 24 weeks after the end of treatment (e.g. up to week 49 or 73)	Yes