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

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

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.

Study Overview

• Status: Terminated
• Conditions: Hepatitis C; Hepatitis C, Chronic
• Intervention / Treatment: Biological: IntronA (interferon alfa-2b; SCH 30500); Drug: Rebetol (ribavirin; SCH 18908)

• Study Type: Observational
• Enrollment (Actual): 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
IntronA/Rebetol; Children age 3 to 17, with chronic hepatitis C, treated in clinical practice at 10 German sites	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; Other Names: SCH 30500; Drug: Rebetol (ribavirin; SCH 18908); Rebetol (15 mg/kg/day) administered in accordance with the SPC and approved European labeling; Other Names: SCH 18908

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Sustained virologic response (defined as undetectable viral load at 24 weeks post-treatment)	Assessed at the end of treatment and 24 weeks post-treatment

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): June 1, 2007
• Study Completion (Actual): June 1, 2007

Study Registration Dates

• First Submitted: July 30, 2008
• First Submitted That Met QC Criteria: July 30, 2008
• First Posted (Estimate): August 1, 2008

Study Record Updates

• Last Update Posted (Estimate): April 8, 2015
• Last Update Submitted That Met QC Criteria: April 7, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Hepatitis; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Antineoplastic Agents; Immunologic Factors; Interferons; Interferon-alpha; Ribavirin; Interferon alpha-2
• Other Study ID Numbers: P04397