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

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ClinicalTrials.gov Identifier: NCT01653236
Recruitment Status : Unknown
Verified December 2014 by Mostafa Ibrahim, Theodor Bilharz Research Institute.
Recruitment status was:  Recruiting
First Posted : July 30, 2012
Last Update Posted : December 30, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Genotype 4 Chronic Hepatitis C Infection Drug: Boceprevir Drug: Peginterferon alfa-2b Drug: ribavirin Phase 3

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


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Efficacy [ Time Frame: 72 Weeks ]
    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 :
  1. Week 8 Response [ Time Frame: 8 weeks ]
    1. Assess the number of patients who achieved SVR after achieving undetectable or ≥2 log reduction of HCV RNA level at treatment week 8;

  2. 12 Weeks response [ Time Frame: 12 weeks ]
    Assess the number of patients who achieved SVR after achieving undetectable or ≥2 log reduction of HCV RNA level at treatment week 12

  3. IL-28B polymorphism [ Time Frame: 72 Weeks ]
    To evaluate the effect of IL-28B polymorphism (CC,CT,TT) alleles on the viral kinetic response after the addition of Boceprevir


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01653236


Locations
Egypt
Theodor Bilharz Research Institute 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: Mostafa Ibrahim, Vice President, Theodor Bilharz Research Institute
ClinicalTrials.gov Identifier: NCT01653236     History of Changes
Other Study ID Numbers: 3034-108
First Posted: July 30, 2012    Key Record Dates
Last Update Posted: December 30, 2014
Last Verified: December 2014

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