Trial record 3 of 18 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. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Interferons
Ribavirin
Peginterferon alfa-2b
Silymarin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antioxidants
Protective Agents

ClinicalTrials.gov processed this record on August 28, 2014