Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00507507
Status:
COMPLETED
Last Update Posted:
2015-07-17
First Post:
2007-07-25
Brief Title:
A Study to Compare Tenofovir DF Versus the Combination of Emtricitabine Plus Tenofovir DF for the Treatment of Chronic Hepatitis B in Patients With Normal Alanine Aminotransferase ALT
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
A Randomized Double-Blind Study Evaluating Tenofovir Disoproxil Fumarate DF Monotherapy Versus the Combination of Emtricitabine and Tenofovir DF for the Treatment of Chronic Hepatitis B
Status:
COMPLETED
Status Verified Date:
2015-07
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 main objective of the study was to evaluate the antiviral activity of tenofovir disoproxil fumarate tenofovir DF monotherapy versus emtricitabine FTC plus tenofovir DF combination therapy for the treatment of chronic hepatitis B HBV in participants in the immune tolerant phase of HBV infection
The efficacy of tenofovir DF monotherapy versus FTC plus tenofovir DF combination therapy was evaluated for suppression of the virus decrease in HBV DNA serological response generation of antibodies to the virus biochemical response changes in liver enzymes and the development of drug-resistant mutations The safety and tolerability of both tenofovir DF monotherapy and FTC plus tenofovir DF were evaluated by routine monitoring for adverse events and changes in laboratory parameters
Participants were randomized in a 11 ratio to receive tenofovir DF monotherapy or FTC plus tenofovir DF All subjects were to continue on blinded study medication until the last subject reached Week 192 Participants who permanently discontinued study drug on or before Week 192 were followed for a 24-week treatment-free follow-up period or until initiation of alternative HBV therapy whichever occurred first Subjects who discontinued study drug on or after Week 48 because of hepatitis B surface antigen HBsAg loss or seroconversion to antibody to hepatitis B surface antigen anti-HBs however were to have returned for their regularly scheduled through Week 192 and every 16 weeks thereafter until the last subject reached Week 192
The efficacy of tenofovir DF monotherapy versus FTC plus tenofovir DF combination therapy was evaluated for suppression of the virus decrease in HBV DNA serological response generation of antibodies to the virus biochemical response changes in liver enzymes and the development of drug-resistant mutations The safety and tolerability of both tenofovir DF monotherapy and FTC plus tenofovir DF were evaluated by routine monitoring for adverse events and changes in laboratory parameters
Participants were randomized in a 11 ratio to receive tenofovir DF monotherapy or FTC plus tenofovir DF All subjects were to continue on blinded study medication until the last subject reached Week 192 Participants who permanently discontinued study drug on or before Week 192 were followed for a 24-week treatment-free follow-up period or until initiation of alternative HBV therapy whichever occurred first Subjects who discontinued study drug on or after Week 48 because of hepatitis B surface antigen HBsAg loss or seroconversion to antibody to hepatitis B surface antigen anti-HBs however were to have returned for their regularly scheduled through Week 192 and every 16 weeks thereafter until the last subject reached Week 192
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