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

July 26, 2012
July 30, 2012
September 2012
June 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01653236 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Study of Combining Boceprevir With Peginterferon Alfa-2b and Ribavirin in the Treatment-naive Patients Infected With Genotype 4 Chronic Hepatitis C Infection
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

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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Genotype 4 Chronic Hepatitis C Infection
  • Drug: Boceprevir
  • Drug: Peginterferon alfa-2b
  • Drug: ribavirin
  • Experimental: Experimental Arm B
    48 weeks of peginterferon alfa-2b and ribavirin Plus Boceprevir 800 mg
    Interventions:
    • Drug: Boceprevir
    • Drug: Peginterferon alfa-2b
    • Drug: ribavirin
  • Active Comparator: Control Arm
    48 weeks of peginterferon alfa-2b and ribavirin
    Interventions:
    • Drug: Peginterferon alfa-2b
    • Drug: ribavirin
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
40
December 2014
June 2014   (final data collection date for primary outcome measure)
  • 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.
Both
18 Years and older
No
Egypt
 
NCT01653236
3034-108
No
Ibrahim Mostafa, Theodor Bilharz Research Institute
Theodor Bilharz Research Institute
Not Provided
Not Provided
Theodor Bilharz Research Institute
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP