Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00228592
Status:
TERMINATED
Last Update Posted:
2007-02-13
First Post:
2005-09-27
Brief Title:
HepeX-B in Post Hepatic Allografts for Treatment of End Stage Liver Disease Due to Hepatitis B Infection
Sponsor:
Cubist Pharmaceuticals LLC a subsidiary of Merck Co Inc Rahway New Jersey USA
Organization:
Cubist Pharmaceuticals LLC a subsidiary of Merck Co Inc Rahway New Jersey USA
Study Overview
Official Title:
A Phase II Multicenter Randomized Open-Label Dose-Ranging Parallel Group Study to Compare the Anti-Viral Effects Pharmacokinetics and Safety of HepeX-Bä a Mixture of Two Monoclonal Antibodies as Compared to Hepatitis B Immune Globulin in Patients Who Have Received Hepatic Allografts for Treatment of End-Stage Liver Disease Due to Hepatitis B Virus Infection
Status:
TERMINATED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare the use of HepeX-B versus HBIg two anti-viral drugs in patients who have received liver transplants due to liver failure caused by Hepatitis B infection Patients will be evaluated over a 6 month to 15 year period to evaluate whether or not the drugs prevent the Hepatitis B virus from infecting the new liver
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