Ignite Creation Date:
2024-05-05 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 9:53 AM
Study NCT ID:
NCT00727077
Status:
TERMINATED
Last Update Posted:
2015-04-08
First Post:
2008-07-30
Brief Title:
Post-marketing Surveillance of Children With Chronic Hepatitis C Treated With Intron A Vial or Pen and Rebetol Study P04397TERMINATED
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
Treatment of Chronic Hepatitis C in Children With Intron Vial or Pen and Rebetol According to German Law 67 Abs 6 AMG
Status:
TERMINATED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study halted due to low recruitment The 3 participants at time of termination transferred into study P04538 NCT00727077 See NCT00727077 for detailsresults
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of the study is to assess the safety and efficacy of Intron A 3 Mio IEm2 3 times per week and Rebetol 15 mgkgday 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None