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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)

NCT00727077 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 3

Last updated 2015-04-08

No results posted yet for this study

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.

Conditions

  • Hepatitis C, Chronic
  • Hepatitis C

Interventions

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

Sponsors & Collaborators

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2007-06-30
Completion
2007-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00727077 on ClinicalTrials.gov