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

Merck Sharp & Dohme (MSD)

Status: Terminated

Conditions: Hepatitis C, Chronic; Hepatitis C

Treatments: Biological: IntronA (interferon alfa-2b; SCH 30500); Drug: Rebetol (ribavirin; SCH 18908)

Study type: Observational

Funder types: Industry

Identifiers

NCT00727077

P04397

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 3 to 17 years old

Volunteers: No Healthy Volunteers

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)

Trial design

3 participants in 1 patient group

IntronA/Rebetol

Description:

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

Treatment:

Drug: Rebetol (ribavirin; SCH 18908)

Biological: IntronA (interferon alfa-2b; SCH 30500)