Assessment of the safety, efficacy, tolerability and pharmacokinetics of PegIntron plus Rebetol in pediatric patients with chronic hepatitis C.

• Conditions: Chronic Hepatitis C in pediatric patients.; MedDRA version: 14.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2004-000558-22-IT
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-26
• Last Update Posted: 10 December 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Informed consent must be obtained from subject’s parent or legal guardian prior to any study-related procedures and the subject must be able to adhere to the dose and visit schedule. According to local laws and/or IRB/IEC requirements, subjects may also need to provide written assent. 2. History of chronic hepatitis C as documented either by anti-HCV or HCV RNA positivity at least 6 months prior to Screening 1. 3. Subjects 3 through 17 years of age (inclusive) at time of Screening 2, of either gender. 4. Body weight =90 kg at the Screening 2 visit. In addition, subjects undergoing pharmacokinetic sampling must weigh =13 kg at the Screening 2 visit. 5. Plasma positive for HCV RNA by quantitative RT-PCR, as measured by the sponsor`s assay, during Screening 1 visit. 6. Results of a liver biopsy performed prior to entry to the study are required
Are the trial subjects under 18? yes
Number of subjects for this age range: 10
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

1. Serum ALT level >10 times the upper limit of normal within the 6 months prior to Screening 1 visit. 2. Any other cause for liver disease other than chronic hepatitis C. 3.Evidence of decompensated liver disease such as history or presence of ascites, bleeding varices or hepatic encephalopathy. 4. The most recent liver biopsy is normal, as determined by the local pathology report. 5. Prior treatment for chronic hepatitis C, including but not limited to antiviral or immunomodulatory product, any interferon product, or ribavirin, either as monotherapy or in combination. 6. Suspected hypersensitivity to any interferon product or ribavirin. 7. Known coinfection with either HIV or HBV. 8. Known immunodeficiency disorders requiring immunoglobulin therapy. 9. Known coagulopathies, including hemophilia, or anticoagulant use. 10. Known hemoglobinopathies. 11. Known G6PD deficiency. 12. Evidence of active or suspected malignancy, or a history of malignancy within the last 5 years. 13. Subjects with organ transplants.

Study & Design

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