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

NCT01653236 | Unknown Phase 3

• 1 other identifier: 3034-108
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Genotype 4 Chronic Hepatitis C Infection

Outcome Measures

Primary Outcomes (1)

• 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

  72 Weeks

Secondary Outcomes (3)

• Week 8 Response

  8 weeks

• 12 Weeks response

  12 weeks

• IL-28B polymorphism

  72 Weeks

Study Arms (2)

Experimental Arm B

EXPERIMENTAL

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

Drug: Boceprevir; Drug: Peginterferon alfa-2b; Drug: ribavirin

Control Arm

ACTIVE COMPARATOR

48 weeks of peginterferon alfa-2b and ribavirin

Drug: Peginterferon alfa-2b; Drug: ribavirin

Interventions

Boceprevir DRUG

Experimental Arm B

Peginterferon alfa-2b DRUG

Control Arm; Experimental Arm B

ribavirin DRUG

Control Arm; Experimental Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Theodor Bilharz Research Institute: lead

Study Sites (1)

Theodor Bilharz Research Institute

Giza, 12311, Egypt

RECRUITING

Related Publications (1)

• 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.

  PMID: 21449783 BACKGROUND

MeSH Terms

Interventions

N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide; peginterferon alfa-2b; Ribavirin

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President

Study Record Dates

• First Submitted: July 26, 2012
• First Posted: July 30, 2012
• Study Start: December 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 30, 2014

Record last verified: 2014-12

Locations

EG (1)