Clinical trial NCT01871662: Randomized Study for the Assessment of Silibinin (Legalon® SIL) in the Treatment of naïve Genotype 4 Patients With Chronic Hepatitis C
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Hepatitis C, Chronic
Keywords: HCV
Hepatitis C
Lead sponsor: Rottapharm
Sponsor class: INDUSTRY
First posted: 2013-06-07
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Undetectable HCV-RNA at 24 Weeks After the end of the Study Treatment
timeFrame: 24 weeks after the end of treatment (e.g. at week 49 or 73)
Secondary outcomes:
measure: Undetectable HCV-RNA
timeFrame: 4 weeks after the beginning of the study treatment
measure: HCV-RNA decrease ≥ 2 log10 IU/mL
timeFrame: 12 weeks after the beginning of the study treatment
measure: Undetectable HCV-RNA
timeFrame: At the end of study treatment (e.g. at week 25 or 49)
measure: Normalization of Serum Alanine Aminotransferase
timeFrame: 4 weeks after the beginning of study treatment, at EOT and at 24 weeks after the completion of the study treatment
measure: Number of Participants with adverse events (AEs)
timeFrame: Up to 24 weeks after the end of treatment (e.g. up to week 49 or 73)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Manial University Hospital, Kasr El-Aini Faculty Medicine, Cairo University
Study officials:
affiliation: Al-Manial University Hospital, Kasr El-Aini Faculty Medicine, Cairo University, Egypt
name: Gamal Esmat, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland School of Medicine,Baltimore, USA
name: Samer El-Kamary, MD
role: STUDY_CHAIR
References: