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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C, Chronic; Hepatitis C

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

Phase: N/A

Status: Terminated

Sponsored by: Merck Sharp & Dohme Corp.

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.

Clinical Details

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

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: Incidence of serious adverse events

Secondary outcome: Sustained virologic response (defined as undetectable viral load at 24 weeks post-treatment)

Eligibility

Minimum age: 3 Years. Maximum age: 17 Years. Gender(s): Both.

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)

Locations and Contacts

Additional Information

Starting date: June 2006
Last updated: April 7, 2015

Page last updated: August 23, 2015

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