Safety and Tolerability of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin for the Treatment of Vietnamese Subjects With Chronic Hepatitis C Genotype 1 (P08599)

NCT01641666 | Withdrawn Phase 3

• 1 other identifier: P08599
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is designed to assess the safety and tolerability of boceprevir dosed 800 mg three times daily (TID) orally (PO) in combination with Peginterferon alfa-2b (PEG2b) 1.5 mcg/kg once a week (QW) administered subcutaneously (SC) plus ribavirin (RBV) (800 to 1400 mg/day) PO in Response Guided Therapy (RGT) in adult Vietnamese subjects with Chronic Hepatitis C, Genotype 1 (CHC GT1) who failed prior treatment with any interferon and ribavirin in Vietnam.

Conditions

Chronic Hepatitis C

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Achieving Sustained Virologic Response (SVR)

  Follow-Up Week 24

• Percentage of Participants Experiencing a Serious Adverse Event (SAE) During the Study Therapy Period

  Treatment Week 1 to Treatment Week 24

Study Arms (1)

Peg2b + Ribavirin + Boceprevir

EXPERIMENTAL

Peginterferon alpha-2b (Peg2b) plus ribavirin (RBV) starting on Day 1 and boceprevir starting on Week 5

Drug: Boceprevir; Drug: Peginterferon Alfa-2b 1.5 mcg/kg/week; Drug: Ribavirin

Interventions

Boceprevir DRUG

Boceprevir will be dosed orally at a dose of 800 mg three times daily (TID) for a total daily dose of 2400 mg.

Also known as: SCH 503034

Peg2b + Ribavirin + Boceprevir

Peginterferon Alfa-2b 1.5 mcg/kg/week DRUG

Peginterferon alpha-2b will be administered subcutaneously at a dose of 1.5 mcg/kg each week.

Also known as: Pegintron®, Rebetol®

Peg2b + Ribavirin + Boceprevir

Ribavirin DRUG

Ribavirin will be administered orally at a dose of 800 mg/day to 1400 mg/day in two divided daily doses (BID).

Also known as: Rebetol®, Pegintron®

Peg2b + Ribavirin + Boceprevir

Eligibility Criteria

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

You may qualify if:

• Weight ≥ 40 kg to ≤ 125 kg
• Sexually active male participants and female participants of child-bearing potential must agree to use a medically acceptable form of contraception
• Must have documented Chronic Hepatitis C Genotype 1 infection
• Must have failed prior treatment with interferon plus ribavirin
• Must have completed treatment with interferon plus ribavirin for at least 12 weeks
• Must have had a liver biopsy or Fibroscan to determine status as cirrhotic or non-cirrhotic
• Participants with cirrhosis must have had an ultrasound or imaging study within 6 months of the Screening visit

You may not qualify if:

• Known co-infection with the human immunodeficiency virus (HIV) or the hepatitis B virus
• Prior discontinuation of treatment with interferon or ribavirin due to the occurrence of an adverse event(s) considered by the investigator to be possibly or probably related to the treatment
• Treatment with ribavirin within 90 days and any interferon within 1 month of the Screening visit
• Treatment with any investigational drug within 30 days prior to the Screening visit
• Treatment with midazolam, pimozide, amiodarone, flecainide, propafenone, quinidine, or ergot derivatives within 2 weeks prior to the Day 1 visit
• Participation in any investigational trial within 30 days of the Screening visit
• Evidence of decompensated liver disease
• Child Pugh score \> 6 (Class B and C)
• Diabetic and/or hypertensive participants with clinically significant ocular examination findings
• Pre-existing psychiatric conditions
• Clinical diagnosis of substance abuse
• Active or suspected malignancy
• Pregnant or nursing

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hepatitis C, Chronic

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

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2012
• First Posted: July 17, 2012
• Study Start: May 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 9, 2015

Record last verified: 2015-09