Trial record 3 of 17 for:    silibinin

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

This study is not yet open for participant recruitment.
Verified June 2013 by Rottapharm
Sponsor:
Information provided by (Responsible Party):
Rottapharm
ClinicalTrials.gov Identifier:
NCT01871662
First received: May 30, 2013
Last updated: June 4, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: Legalon® SIL (Silibinin)
Drug: Pegylated interferon alfa2b
Drug: Ribavirin
Phase 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Rottapharm:

Primary Outcome Measures:
  • Undetectable HCV-RNA at 24 Weeks After the end of the Study Treatment [ Time Frame: 24 weeks after the end of treatment (e.g. at week 49 or 73) ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Undetectable HCV-RNA [ Time Frame: 4 weeks after the beginning of the study treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks after the beginning of the study treatment ] [ Designated as safety issue: No ]
    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

  • Undetectable HCV-RNA [ Time Frame: At the end of study treatment (e.g. at week 25 or 49) ] [ Designated as safety issue: No ]
    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)

  • Normalization of Serum Alanine Aminotransferase [ Time Frame: 4 weeks after the beginning of study treatment, at EOT and at 24 weeks after the completion of the study treatment ] [ Designated as safety issue: No ]
    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) [ Time Frame: Up to 24 weeks after the end of treatment (e.g. up to week 49 or 73) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: August 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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
Drug: Pegylated interferon alfa2b
1.5 µg/kg once-weekly
Other Name: PEG-INTRON®
Drug: Ribavirin
At weight-based dose 800-1400 mg/day (BID, OS)
Other Name: REBETOL®
Experimental: 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)
Drug: Legalon® SIL (Silibinin)
Silibinin 20 mg/Kg/day
Drug: Pegylated interferon alfa2b
1.5 µg/kg once-weekly
Other Name: PEG-INTRON®
Drug: Ribavirin
At weight-based dose 800-1400 mg/day (BID, OS)
Other Name: REBETOL®
Experimental: 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)
Drug: Legalon® SIL (Silibinin)
Silibinin 20 mg/Kg/day
Drug: Ribavirin
At weight-based dose 800-1400 mg/day (BID, OS)
Other Name: REBETOL®

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01871662

Contacts
Contact: Massimo D'Amato, MD +39 039 7390319 massimo.damato@rottapharm.com

Locations
Egypt
Al-Manial University Hospital, Kasr El-Aini Faculty Medicine, Cairo University Not yet recruiting
Cairo, Egypt
Principal Investigator: Gamal Esmat, MD         
Sponsors and Collaborators
Rottapharm
Investigators
Principal Investigator: Gamal Esmat, MD Al-Manial University Hospital, Kasr El-Aini Faculty Medicine, Cairo University, Egypt
Study Chair: Samer El-Kamary, MD University of Maryland School of Medicine,Baltimore, USA
  More Information

No publications provided

Responsible Party: Rottapharm
ClinicalTrials.gov Identifier: NCT01871662     History of Changes
Other Study ID Numbers: LEG-SIL-2-02
Study First Received: May 30, 2013
Last Updated: June 4, 2013
Health Authority: Egypt: Ministry of Health and Population
Egypt: Institutional Review Board
United States: Institutional Review Board

Keywords provided by Rottapharm:
HCV
Hepatitis C

Additional relevant MeSH terms:
Silybin
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferon-alpha
Interferon Alfa-2a
Interferon Alfa-2b
Interferons
Ribavirin
Peginterferon alfa-2b
Reaferon
Silymarin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on April 16, 2014