Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00507689
Status:
COMPLETED
Last Update Posted:
2014-03-14
First Post:
2007-07-25
Brief Title:
Truvada Versus Truvada Plus Hepatitis B Immunoglobulin HBIg in Prevention of Chronic Hepatitis B Recurrence Post Liver Transplant
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
A Phase 2 Open-Label Randomized Study to Evaluate the Efficacy and Safety of the Combination Product EmtricitabineTenofovir Disoproxil Fumarate in the Presence or Absence of Hepatitis B Immunoglobulin HBIg in Preventing Recurrence of Chronic Hepatitis B CHB Post-Orthotopic Liver Transplant OLT
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this 96-week study was to evaluate the safety and antiviral efficacy of emtricitabinetenofovir disoproxil fumarate FTCTDF coformulated Truvada with or without hepatitis B immunoglobulin HBIg in preventing the recurrence of chronic hepatitis B following liver transplantation in participants who were chronically infected with hepatitis B prior to transplantation
Prior to enrollment participants were required to have received at least 12 weeks of HBIg therapy following liver transplantation Enrolled participants then received FTCTDF plus HBIg for an initial 24-week pre-randomization treatment period Participants who completed the pre-randomization period and who achieved sustained viral suppression were randomized to continue treatment with FTCTDF with or without HBIg for an additional 72 weeks randomized period The antiviral efficacy of treatment was assessed by measuring hepatitis B virus levels in the blood HBV DNA Safety and tolerability was monitored by assessing adverse events and various laboratory parameters
Prior to enrollment participants were required to have received at least 12 weeks of HBIg therapy following liver transplantation Enrolled participants then received FTCTDF plus HBIg for an initial 24-week pre-randomization treatment period Participants who completed the pre-randomization period and who achieved sustained viral suppression were randomized to continue treatment with FTCTDF with or without HBIg for an additional 72 weeks randomized period The antiviral efficacy of treatment was assessed by measuring hepatitis B virus levels in the blood HBV DNA Safety and tolerability was monitored by assessing adverse events and various laboratory parameters
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