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

Primary Purpose

Genotype 4 Chronic Hepatitis C Infection

Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Boceprevir
Peginterferon alfa-2b
ribavirin
Sponsored by
Theodor Bilharz Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Genotype 4 Chronic Hepatitis C Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • 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.

Sites / Locations

  • Theodor Bilharz Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Arm B

Control Arm

Arm Description

48 weeks of peginterferon alfa-2b and ribavirin Plus Boceprevir 800 mg

48 weeks of peginterferon alfa-2b and ribavirin

Outcomes

Primary Outcome Measures

Efficacy
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
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
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
To evaluate the effect of IL-28B polymorphism (CC,CT,TT) alleles on the viral kinetic response after the addition of Boceprevir

Full Information

First Posted
July 26, 2012
Last Updated
December 25, 2014
Sponsor
Theodor Bilharz Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01653236
Brief Title
Boceprevir With Peginterferon Alfa-2b and Ribavirin in the Treatment-naive Patients Infected With Genotype 4 Chronic Hepatitis C Infection
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 Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Theodor Bilharz Research Institute

4. Oversight

Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genotype 4 Chronic Hepatitis C Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Arm B
Arm Type
Experimental
Arm Description
48 weeks of peginterferon alfa-2b and ribavirin Plus Boceprevir 800 mg
Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
48 weeks of peginterferon alfa-2b and ribavirin
Intervention Type
Drug
Intervention Name(s)
Boceprevir
Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa-2b
Intervention Type
Drug
Intervention Name(s)
ribavirin
Primary Outcome Measure Information:
Title
Efficacy
Description
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
Time Frame
72 Weeks
Secondary Outcome Measure Information:
Title
Week 8 Response
Description
1. Assess the number of patients who achieved SVR after achieving undetectable or ≥2 log reduction of HCV RNA level at treatment week 8;
Time Frame
8 weeks
Title
12 Weeks response
Description
Assess the number of patients who achieved SVR after achieving undetectable or ≥2 log reduction of HCV RNA level at treatment week 12
Time Frame
12 weeks
Title
IL-28B polymorphism
Description
To evaluate the effect of IL-28B polymorphism (CC,CT,TT) alleles on the viral kinetic response after the addition of Boceprevir
Time Frame
72 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Theodor Bilharz Research Institute
City
Giza
ZIP/Postal Code
12311
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ibrahim Mostafa, PHD
Phone
00201222113466
Email
ibrahimmostafa@egyptgastrohep.com
First Name & Middle Initial & Last Name & Degree
Ibrahim Mostafa, PHD

12. IPD Sharing Statement

Citations:
PubMed Identifier
21449783
Citation
Poordad F, McCone J Jr, Bacon BR, Bruno S, Manns MP, Sulkowski MS, Jacobson IM, Reddy KR, Goodman ZD, Boparai N, DiNubile MJ, Sniukiene V, Brass CA, Albrecht JK, Bronowicki JP; SPRINT-2 Investigators. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med. 2011 Mar 31;364(13):1195-206. doi: 10.1056/NEJMoa1010494.
Results Reference
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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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