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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00727077
Recruitment Status : Terminated (Study halted due to low recruitment. The 3 participants at time of termination transferred into study P04538 (NCT00727077). See NCT00727077 for details/results.)
First Posted : August 1, 2008
Last Update Posted : April 8, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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 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.

Condition or disease Intervention/treatment
Hepatitis C, Chronic Hepatitis C Biological: IntronA (interferon alfa-2b; SCH 30500) Drug: Rebetol (ribavirin; SCH 18908)

Study Type : Observational
Actual Enrollment : 3 participants
Observational Model: Case-Only
Time Perspective: Prospective
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 Start Date : June 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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 Name: SCH 30500

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

Primary Outcome Measures :
  1. Incidence of serious adverse events [ Time Frame: 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 :
  1. Sustained virologic response (defined as undetectable viral load at 24 weeks post-treatment) [ Time Frame: Assessed at the end of treatment and 24 weeks post-treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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)

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00727077     History of Changes
Other Study ID Numbers: P04397
First Posted: August 1, 2008    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Hepatitis C
Hepatitis C, Chronic
Hepatitis A
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs