Status:
TERMINATED
Post-marketing Surveillance of Children With Chronic Hepatitis C Treated With Intron A (Vial or Pen) and Rebetol (Study P04397)(TERMINATED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis C, Chronic
Hepatitis C
Eligibility:
All Genders
3-17 years
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00727077
Start Date
June 1 2006
End Date
June 1 2007
Last Update
April 8 2015
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