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

Hepatitis C Clinical Trial

Official title:

Treatment of Chronic Hepatitis C in Children With Intron Vial or Pen and Rebetol According to German Law (§ 67 Abs 6 AMG)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00727077
• Other study ID #: P04397
• Status: Terminated
• Phase: N/A
• First received: July 30, 2008
• Last updated: April 7, 2015
• Start date: June 2006
• Est. completion date: June 2007

Study information

• Verified date: April 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 17 Years

Eligibility

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)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Biological:
• 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

Drug:
• Rebetol (ribavirin; SCH 18908)
Rebetol (15 mg/kg/day) administered in accordance with the SPC and approved European labeling

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of serious adverse events		After the inclusion of the subject in the study (defined as the time when the subject signs the informed consent) and up to 30 days after the subject completed or discontinued the study	Yes
Secondary	Sustained virologic response (defined as undetectable viral load at 24 weeks post-treatment)		Assessed at the end of treatment and 24 weeks post-treatment	No