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

This study has been terminated.
(Study halted due to low recruitment. The 3 participants at time of termination transferred into study P04538 (NCT00727077). See NCT00727077 for details/results.)
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00727077
First received: July 30, 2008
Last updated: August 28, 2009
Last verified: August 2009
History of Changes
  Purpose

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

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: June 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 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

  Eligibility

Ages Eligible for Study:   3 Years to 17 Years
Genders Eligible for Study:   Both
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

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)
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00727077     History of Changes
Other Study ID Numbers: P04397
Study First Received: July 30, 2008
Last Updated: August 28, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferon-alpha
Interferon Alfa-2a
 Interferon Alfa-2b
Interferons
Ribavirin
Reaferon
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 16, 2013