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: 14.1Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2010-023498-20-DE

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

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 48

Inclusion Criteria

Key Inclusion Criteria:
1) Subjects must be 17 to 3 years of age (inclusive) at screening.
2) Subjects 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) Subjects may be treatment naïve or have failed previous (peg)interferon/ribavirin 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) Subjects known to be co-infected with the human immunodeficiency virus (HIV) and hepatitis B virus (HBaAg positive).
2) Subjects must not have 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) Subjects must not have received previous treatment with a HCV protease inhibitor.

Key Laboratory Exclusion 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