Study of Combining Boceprevir With Peginterferon Alfa-2b and Ribavirin in the Treatment-naive Patients Infected With Genotype 4 Chronic Hepatitis C Infection

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2012 by Theodor Bilharz Research Institute
Sponsor:
Information provided by (Responsible Party):
Ibrahim Mostafa, Theodor Bilharz Research Institute
ClinicalTrials.gov Identifier:
NCT01653236
First received: July 26, 2012
Last updated: July 30, 2012
Last verified: July 2012
  Purpose

Hypothesis Combination of Boceprevir with Ribavirin in treatment-naïve patients with genotype 4 chronic hepatitis C infection will increase the proportion of patients achieving sustained viral response compared to standard treatment alone.


Condition Intervention Phase
Genotype 4 Chronic Hepatitis C Infection
Drug: Boceprevir
Drug: Peginterferon alfa-2b
Drug: ribavirin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study to Determine the Efficacy and Safety of Combining Boceprevir With Peginterferon Alfa-2b and Ribavirin in the Treatment-naive Patients Infected With Genotype 4 Chronic Hepatitis C Infection

Resource links provided by NLM:


Further study details as provided by Theodor Bilharz Research Institute:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 72 Weeks ] [ Designated as safety issue: Yes ]
    The primary efficacy objective of this study is to assess the efficacy of Boceprevir in combination with PEG 1.5 μg/kg QW SC plus WBD of RBV (800 to 1400 mg/day) compared to the efficacy of SOC (therapy with PEG+RBV WBD) in the Control Arm in previously untreated adult subjects with CHC genotype 4 infection


Secondary Outcome Measures:
  • Week 8 Response [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    1. Assess the number of patients who achieved SVR after achieving undetectable or ≥2 log reduction of HCV RNA level at treatment week 8;

  • 12 Weeks response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Assess the number of patients who achieved SVR after achieving undetectable or ≥2 log reduction of HCV RNA level at treatment week 12

  • IL-28B polymorphism [ Time Frame: 72 Weeks ] [ Designated as safety issue: No ]
    To evaluate the effect of IL-28B polymorphism (CC,CT,TT) alleles on the viral kinetic response after the addition of Boceprevir


Estimated Enrollment: 40
Study Start Date: September 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Arm B
48 weeks of peginterferon alfa-2b and ribavirin Plus Boceprevir 800 mg
Drug: Boceprevir Drug: Peginterferon alfa-2b Drug: ribavirin
Active Comparator: Control Arm
48 weeks of peginterferon alfa-2b and ribavirin
Drug: Peginterferon alfa-2b Drug: ribavirin

Detailed Description:

Objectives:

The primary objective of this study is to assess the efficacy and safety of Boceprevir 800 mg three times per day (TID) orally (PO) (hereafter called Boceprevir) in combination with peginterferon alfa-2b 1.5 μg/kg once per week (QW) subcutaneously (SC) plus weight-based dosing (WBD) of ribavirin (800 to 1400 mg/day) compared to standard of care (SOC) (therapy with peginterferon alfa-2b (PEG)+ribavirin (RBV) WBD) in previously untreated adult subjects with chronic hepatitis C (CHC) genotype 4 infection.

Primary Trial Objectives:

- The primary efficacy objective of this study is to assess the efficacy of Boceprevir in combination with PEG 1.5 μg/kg QW SC plus WBD of RBV (800 to 1400 mg/day) compared to the efficacy of SOC (therapy with PEG+RBV WBD) in the Control Arm in previously untreated adult subjects with CHC genotype 4 infection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Ages Eligible for Study: 18 Years and older
  • Genders Eligible for Study: Both

Inclusion Criteria:

  • Subject must be more than 18 years of age.
  • Subject's weight must be more than 40 kg and less than 125 kg.
  • Subject and subject's partner must each agree to use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study medication, or longer if dictated by local regulations.
  • Subjects must be willing to give written informed consent for the trial and for the pharmacogenetic testing.
  • Subjects who are unwilling to provide written informed consent for pharmacogenetic testing may be included in the trial; however, pharmacogenetic samples must not be obtained.
  • Subject must have previously documented CHC genotype 4 infection.
  • Subjects with other or mixed genotypes are not eligible. The HCV-RNA result obtained from the central laboratory at the screening visit must confirm genotype 4 infection and be more10,000 IU per mL Previously untreated patients with Pegylated interferon
  • Subject must have a liver biopsy or fibrotest and fibroscan with histology consistent with CHC and no other etiology.

Exclusion Criteria:

  • Subject who is coinfected with the human immunodeficiency virus (HIV) or hepatitis B virus.
  • Prior treatment with interferon, ribavirin and/or investigational agent for hepatitis C.
  • Prior treatments with herbal remedies with known hepatotoxicity are exclusionary.
  • All herbal remedies used for hepatitis C treatment must be discontinued before Day 1.
  • Treatment with any investigational drug within 30 days of the screening visit in this trial.
  • Subject who received any of the following medication(s) within 2 weeks prior to the Day 1 visit that are highly dependent on CYP3A4.5 for clearance, and for which elevated plasma concentrations are associated with serious and or life-threatening events such as: orally administered midazolam, pimozide, amiodarone, flecainide, propafenone, quinidine and ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine).
  • Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.
  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: NCT01653236

Locations
Egypt
Theodor Bilharz Research Institute Not yet recruiting
Giza, Egypt, 12311
Contact: Ibrahim Mostafa, PHD    00201222113466    ibrahimmostafa@egyptgastrohep.com   
Principal Investigator: Ibrahim Mostafa, PHD         
Sponsors and Collaborators
Theodor Bilharz Research Institute
  More Information

Publications:
Responsible Party: Ibrahim Mostafa, Vice President, Theodor Bilharz Research Institute
ClinicalTrials.gov Identifier: NCT01653236     History of Changes
Other Study ID Numbers: 3034-108
Study First Received: July 26, 2012
Last Updated: July 30, 2012
Health Authority: Egypt: Ministry of Health (MOH)

Additional relevant MeSH terms:
Communicable Diseases
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Infection
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferon-alpha
Peginterferon alfa-2b
Ribavirin
Anti-Infective Agents
Antimetabolites
Antiviral Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014