Loading clinical trials...

Efficacy and Safety of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P08034) | Clinical Trials | Clareo Health

WITHDRAWNPHASE3

Efficacy and Safety of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P08034)

A Phase 3 Study to Assess the Efficacy and Safety of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin in Pediatric Subjects With Chronic Hepatitis C Genotype 1

NCT01590225•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

This is a three-part (Part A, Part B, and Part C), open-label, multicenter study of boceprevir in pediatric participants with chronic hepatitis C (CHC) genotype 1 (GT1). In Part A and Part B, efficacy and safety will be evaluated in participants with CHC GT1 who are non-cirrhotic, treatment naïves (Part A) or who are non-cirrhotic, treatment failures to (peg)interferon/ribavirin or who are cirrhotics (whether treatment naïve or treatment failure) (Part B). Part C is long-term follow up and no study treatment will be administered during this period, but participants who do not achieve viral clearance will be allowed to receive other treatments for CHC.

Eligibility

Age

3 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•CHC GT1 infection for at least 6 months with with HCV-RNA ≥10,000 IU/mL.
•Treatment naive, non-cirrhotic participants will be eligible for inclusion in Study Part A
•Non-cirrhotic subjects who failed previous (peg)interferon/ribavirin treatment for CHC and cirrhotics, whether treatment naive or treatment failure, will be eligible for inclusion in Study Part B
•To participate in Study Part C, participants must have completed the required post-treatment follow-up in Study Part A or Part B
•Weight ≥ 10 kg to ≤ 125 kg
•Body surface area (BSA) ≥0.46 m\^2 and ≤2.5 m\^2
•Previous liver biopsy with histology consistent with chronic hepatitis C and no other etiology within 2 years of the screening visit
•Participants with bridging fibrosis or cirrhosis must have an ultrasound within 6 months of the screening visit or between the screening visit and Day 1 with no findings suspicious for hepatocellular carcinoma
•Participant must be able to adhere to dose and visit schedules

Exclusion Criteria

•Known co-infection with the the human immunodeficiency virus (HIV) or hepatitis B virus (HBsAg positive)
•For Study Part A, participant received any prior hepatitis C treatment, including herbal remedies, with known hepatotoxicity
•For Study Part B, participant received treatment with ribavirin within 90 days or any interferon alpha within 30 days prior to screening
•For Study Part B, participant received previous treatment with a hepatitis C virus protease inhibitor (excepting participants in study P07614, Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1)
•For Study Part B, participant required discontinuation of previous (peg)interferon/ribavirin therapy for an adverse event considered by the investigator to be related to (peg)interferon and/or ribavirin
•For Study Part B, participant is currently taking any antiviral/immunomodulatory treatment for hepatitis C
•Participant has taken any investigational drugs, except boceprevir
•Participant has received any of the following medication(s) within 2 weeks prior to the Day 1 visit: midazolam, pimozide, amiodarone, flecainide,
•propafenone, quinidine, and ergot derivatives (dihydroergotamine, ergonovine,
•ergotamine, methylergonovine)
+13 more criteria

Key Dates

Start Date

January 28, 2013

Primary Completion Date

August 18, 2021

Completion Date

August 18, 2021

Last Updated

January 29, 2021

Conditions

Chronic Hepatitis C

Interventions

Boceprevir

DRUG

Peginterferon alpha-2b

DRUG

Ribavirin

DRUG

Boceprevir

DRUG

Peginterferon alfa-2b

DRUG

Ribavirin

DRUG

Study of the Pharmacokinetic Action of Amantadine and Ribavirin in Chronic Hepatitis C. CINAM

NCT00199719

Chronic Hepatitis C

View study

COMPLETEDPHASE4

Study of the Efficacy and Safety of Pegnano Plus Barivir (Ribavirin) in Treatment-naïve Patients With Chronic Hepatitis C at KienGiang General Hospital

NCT06922643

Chronic Hepatitis C

View study

COMPLETEDNA

Changes in Liver Fibrosis, Lipid Profile and Insulin Resistance in HCV Patients Who Received Antiviral Therapy

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 29, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Efficacy and Safety of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P08034)

Inclusion Criteria

Exclusion Criteria

Study of the Pharmacokinetic Action of Amantadine and Ribavirin in Chronic Hepatitis C. CINAM

Study of the Efficacy and Safety of Pegnano Plus Barivir (Ribavirin) in Treatment-naïve Patients With Chronic Hepatitis C at KienGiang General Hospital

Changes in Liver Fibrosis, Lipid Profile and Insulin Resistance in HCV Patients Who Received Antiviral Therapy

Efficacy and Safety Study of Pegylated Interferon Lambda-1a With Ribavirin and Daclatasvir, to Treat naïve Subjects With Chronic HCV Genotypes 1, 2, 3, and 4 Who Are Co-infected With HIV

Treatment of HCV-Infected Recent Injection Drug Users in U.S. Liver Clinics

A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection