Chronic Hepatitis C in pediatric patients. MedDRA version: 14.1 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: PEGINTRON*SC 1FL 100MCG+1F
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Peginterferon alfa-2b
CAS Number: 215647-85-1
Concentration unit: µg micr
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety, efficacy and tolerability of the combination of PEG-Intron 60 µg/m2 once weekly (QW) plus REBETOL 15 mg/kg/day in pediatric subjects with chronic hepatitis C.;Secondary Objective: To measure the multiple-dose pharmacokinetics of PEG-Intron and REBETOL in pediatric subjects with chronic hepatitis C.;Primary end point(s): The primary endpoint(s) are the safety and efficacy (efficacy defined as the proportion of subjects in each group that exhibits SVR at 24 weeks of follow-up) of PEG-Intron and REBETOL.;Timepoint(s) of evaluation of this end point: 24 settimana di follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Countries
Argentina, Italy, Puerto Rico, Spain, United States
Contacts
Public ContactDivisione Ricerca Clinica
MSD Italia s.r.l.
Outcome results
None listed