Post-marketing Surveillance of Children With Chronic Hepatitis C Treated With Intron A (Vial or Pen) and Rebetol (Study P04397)(TERMINATED)

NCT ID: NCT00727077

Last Updated: 2015-04-08

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 3 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2007-06-30

Brief Summary

The objective of the study is to assess the safety and efficacy of Intron A (3 Mio I.E./m2, 3 times per week) and Rebetol (15 mg/kg/day) in children aged 3 to 17, treated in common medical practice at 10 sites in Germany. The primary objective is to determine if there are any new severe adverse events observed with this recently approved dosing regimen. The study will also evaluate the rates of eradication of the HCV virus.

This study was terminated due to low enrollment. At the time of termination, 3 participants had enrolled. Therefore, these 3 participants transferred into study P04538 (NCT00727077) and will be included in the P04538 (NCT00727077) data reporting.

Conditions

Hepatitis C, Chronic; Hepatitis C

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

IntronA/Rebetol

Children age 3 to 17, with chronic hepatitis C, treated in clinical practice at 10 German sites

IntronA (interferon alfa-2b; SCH 30500)

Intervention Type: BIOLOGICAL

IntronA (3 Mio I.E./m2, 3 times per week) administered in accordance with the SPC and approved European labeling

Rebetol (ribavirin; SCH 18908)

Intervention Type: DRUG

Rebetol (15 mg/kg/day) administered in accordance with the SPC and approved European labeling

Interventions

IntronA (interferon alfa-2b; SCH 30500)

IntronA (3 Mio I.E./m2, 3 times per week) administered in accordance with the SPC and approved European labeling

Intervention Type: BIOLOGICAL

Rebetol (ribavirin; SCH 18908)

Rebetol (15 mg/kg/day) administered in accordance with the SPC and approved European labeling

Intervention Type: DRUG

Other Intervention Names

SCH 30500; SCH 18908

Eligibility Criteria

Inclusion Criteria

• Patients with chronic hepatitis C (serum HCV-RNA-positive)
• Age 3 to 17 years
• Treatment-naïve
• Platelets >= 100,000/mm^3
• Neutrophil counts >= 1,500/ mm^3
• TSH must be within normal limits
• Hemoglobin >=12 g/dL (females); >=13 g/dL (males)
• Women of childbearing potential must have a routine pregnancy test performed monthly during treatment and for 7 months thereafter. Sexually active female subjects of childbearing potential must be practicing adequate contraception (intrauterine device, oral contraceptives, implanted contraceptives, surgical sterilization, barrier method, or monogamous relationship with a male partner who has had a vasectomy or is using a condom (+ spermicide) during the treatment period and for 7 months after stopping treatment.
• Sexually active male subjects must be practicing acceptable methods of contraception (vasectomy, use of condom + spermicide, monogamous relationship with a female partner who practices an acceptable method of contraception) during the treatment period and for 7 months after stopping treatment.

Exclusion Criteria

• Contraindications according to the SPC and European approval
• Pretreatment of chronic hepatitis C
• Liver decompensation
• Hypersensitivity to the active substance or to any interferons or to any of the excipients
• Pregnant woman
• Woman who are breast feeding
• Existence of or history of psychiatric condition, in particular depression, suicidal ideation or suicide attempt
• A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months
• Severe debilitating medical conditions, including patients with chronic renal failure or creatinine clearance < 50 mlLmin
• Autoimmune hepatitis or history of autoimmune disease
• Severe hepatic dysfunction or decompensated cirrhosis of the liver
• Pre- existing thyroid disease unless it can be controlled with conventional therapy
• Epilepsy and/or compromised central nervous system function
• Individual decision of physician if patient suitable for treatment (e.g., disturbance of growth)

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P04397

Identifier Type: -

Identifier Source: org_study_id