A single dose study of boceprevir in children and adolescents to determine the therapeutic dose.

Conditions: Hepatitis type C (genotype I) virus infection
MedDRA version: 16.0Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 16.0Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2010-023498-20-PL

Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 48

Inclusion Criteria

1. Subject must be 17 to 3 years of age (inclusive) at screening.
2. Each subject must have previously documented CHC genotype 1 infection.
Subjects with other or mixed genotypes are not eligible. The HCV-RNA result at the Screening visit must confirm genotype 1 infection.
3. Subject may be treatment naïve, or failed previous (peg)interferon/RBV treatment and may be cirrhotic or non-cirrhotic.
Are the trial subjects under 18? yes
Number of subjects for this age range: 48
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Key Clinical Exclusion Criteria:
1. Subject known to be co-infected with the human immunodeficiency virus (HIV) and hepatitis B virus (HBsAg positive).
2. Subject received treatment with RBV within 90 days or any interferon-alpha
within 30 days prior to screening, or currently be receiving antiviral / immunomodulatory treatment for hepatitis C.
3. Subject must not have received previous treatment with a HCV protease inhibitor.

Key Clinical Laboratory Criteria:
• Hematologic criteria (growth factors may not be used to achieve study entry requirements):
o Hemoglobin < lower limit of normal range (LLN)
o Neutrophils <1500/mm3
o Platelets <100,000/mm3
• Serum albumin < lower limit of normal (LLN) of laboratory reference range.
• Thyroid-stimulating hormone (TSH) >1.2 x ULN or <0.8 x LLN of laboratory reference range with the following exceptions:
o The subject may be enrolled if clinically euthyroid, AND
o The euthyroid function is confirmed by thyroxine/triiodothyronine (T4/T3) testing
• Serum creatinine > ULN of laboratory reference range

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to determine weight based doses of boceprevir for children 17 to 3 years of age.;Secondary Objective: to evaluate the safety and tolerability of a single dose of boceprevir in children 17 to 3 years of age.;Primary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A

Secondary Outcome Measures