A Study in Children with Hepatitis C to Study the Effects and Safety of Boceprevir and Peginterferon alfa-2b Plus Ribaviri

Phase 1

• Conditions: Chronic Hepatitis C; MedDRA version: 20.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2010-024260-17-GB
• Lead Sponsor: Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-06-07
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 190

Inclusion Criteria

1. Subject must have chronic hepatitis C genotype 1 infection with HCV RNA levels of =10,000 IU/ml at the screening visit. Subjects with other or mixed genotypes are not eligible.
2. Part A: Treatment naïve, non-cirrhotic paediatric subject with CHC genotype 1.
3. Part B: Paediatric subject with CHC genotype 1 (mixed genotypes are not eligible) who:
a) failed previous (peg)interferon/RBV treatment (null responder, partial responder, relapser, or other”) and is non-cirrhotic,
OR
b) is cirrhotic regardless of whether treatment naïve or a treatment failure.
4. Part C: Subject must have completed the required post treatment follow-up in Part A or Part B.
5. Age =3 years and <18 years on the day of initiation of treatment (Day 1).
6. Weight =10 kg and =125 kg.
7. Body surface area (BSA) =0.46 m2 and =2.5 m2.
8. Each subject must have a liver biopsy with histology consistent with CHC and no other aetiology within 2 years of the screening visit. The liver biopsy may be obtained during the screening period. The pathology report must be available at the study site. Cirrhotic patients may use any historic liver biopsy demonstrating cirrhosis.
9. Subject and subject's partner(s) must each agree to use acceptable methods of contraception for 2 weeks prior to day 1 until at least 6 months after stopping study medication.
10. Subject and/or legal guardian must provide written informed consent.
Are the trial subjects under 18? yes
Number of subjects for this age range: 190
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Subject is known to be co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus (HBsAg positive).
2. Part A: Subject received any prior hepatitis C treatment, including herbal remedies with known hepatotoxicity. but excluding study treatment received in the boceprevir pediatric Phase 1 PK study (P07614).
3. Part B: Subject received treatment with RBV within 90 days or any (peg)interferon within 30 days prior to screening .
4. Part B: Subject received previous treatment with a HCV protease inhibitor (but excluding study treatment received in the boceprevir paediatric Phase 1 PK study P07614).
5. Part B: Subject required discontinuation of previous (peg)interferon/RBV therapy for an AE considered by the investigator to be related to (peg)interferon and/or RBV.
6. Part B: Subject is currently taking any antiviral/immunomodulatory treatment for HCV.
7. Subject received any of the following medications(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. The following medications are also exclusionary if taken within 2 weeks prior to the Day 1 visit: alfuzosin, cisapride, triazolam, sildenafil and tadalafil (the latter 2 medications only if they are used for the indication of chronic obstructive pulmonary disease (COPD).
9. Subject is participating in any other clinical trial within 30 days of enrolment or intends to participate in another clinical trial during participation in the study, except study P07614.
10. Subject exhibits evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.
11. Subject has a Child Pugh score of >6 (class B and C).
12. Subject has pre-existing clinically significant psychiatric condition(s) including but not limited to moderate to severe depression, psychotic disorders or history of suicidal ideation or attempt.
13. Subject with a history of drug abuse will only be permitted to participate if it is in the opinion of the Principal Investigator (PI) that the subject can be compliant with all study requirements and has been free of abuse of a sufficient length of time for the PI to make this determination.
14. Subject has any known pre-existing medical condition that could interfere with the subject's participation in and completion of the study.
14. The female subject is pregnant, nursing or intending to become pregnant during the study period. The male subject with partner(s) who is pregnant, nursing, or intending to become pregnant during the study period.

Laboratory Exclusion Criteria
1. Haemoglobin is not within normal limits of the laboratory reference range for the
subject's age.
2. Neutrophils <1500/mm3
3. Platelets <100,000/mm3
4. Direct bilirubin >1.5 x upper limit of normal (ULN) of the laboratory reference
range. Total bilirubin >1.6 mg/dL, unless the subject has a history of Gilbert’s

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified