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.
Verified July 2012 by Theodor Bilharz Research Institute
Sponsor:
Theodor Bilharz Research Institute
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
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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
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:
|
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 Ribavirin Peginterferon alfa-2b Interferon-alpha Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013