Ignite Creation Date:
2024-05-05 @ 11:11 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01277601
Status:
COMPLETED
Last Update Posted:
2016-08-26
First Post:
2011-01-13
Brief Title:
Efficacy Safety of Tenofovir Disoproxil Fumarate TDF Plus Peginterferon α-2a Peg-IFN Versus TDF or Peg-IFN Monotherapy in Chronic Hepatitis B
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
A Phase 4 Randomized Open-label Active-Controlled Superiority Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate TDF in Combination With Peginterferon α-2a Pegasys Versus Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon α-2a Monotherapy for 48 Weeks in Non-Cirrhotic Subjects With HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B CHB
Status:
COMPLETED
Status Verified Date:
2016-07
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 primary objective of this study is to evaluate the efficacy of tenofovir disoproxil fumarate TDF plus peginterferon α-2a Peg-IFN combination therapy for 48 weeks versus standard of care TDF monotherapy or Peg-IFN monotherapy for 48 weeks in non-cirrhotic adults with chronic hepatitis B virus HBV as determined by loss of hepatitis B surface antigen HBsAg
The study will consist of 2 phases for participants in the TDFPeg-IFN 48 Weeks TDF 48 Weeks Peg-IFN 16 Weeks and Peg-IFN 48 Weeks groups Following an initial 48 weeks of treatment participants in these groups will be monitored for 24 weeks for signs of worsening HBV and those meeting TDF retreatment and flare management criteria will be eligible to receive TDF monotherapy during a retreatment phase up to Week 120
The study will consist of 2 phases for participants in the TDFPeg-IFN 48 Weeks TDF 48 Weeks Peg-IFN 16 Weeks and Peg-IFN 48 Weeks groups Following an initial 48 weeks of treatment participants in these groups will be monitored for 24 weeks for signs of worsening HBV and those meeting TDF retreatment and flare management criteria will be eligible to receive TDF monotherapy during a retreatment phase up to Week 120
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2010-024586-45 | EUDRACT_NUMBER | None | None |