Stopping TDF Treatment After Long Term Virologic Suppression in HBeAg-negative CHB (FINITE CHB)
|ClinicalTrials.gov Identifier: NCT01320943|
Recruitment Status : Completed
First Posted : March 23, 2011
Results First Posted : August 29, 2017
Last Update Posted : August 29, 2017
The primary objective of this study is to evaluate hepatitis B surface antigen (HBsAg) loss and seroconversion in participants who stop tenofovir disoproxil fumarate (TDF) (Stop TDF arm) compared to participants who continue TDF (Continue TDF arm).
Only participants who already are on treatment with TDF monotherapy or TDF in combination with lamivudine or emtricitabine for at least 4 years and who achieved and maintained virologic suppression (< 400 copies/mL) for 3.5 or more years will be included in this study. One treatment arm will stop the TDF therapy while the other treatment arm will continue the TDF therapy. Participants in the Stop TDF arm will be monitored very closely with special focus on biochemical flares (especially alanine aminotransferase (ALT) increases) and virological relapses (Hepatitis B viral load increases). If any participant in the Stop TDF arm exceeds one or more predefined limits for such flares or relapses, TDF treatment will be reinstituted.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis B||Drug: TDF Other: Stop TDF||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||FINITE CHB - First Investigation in Stopping Tenofovir Disoproxil Fumarate (TDF) Treatment After Long Term Virologic Suppression in HBeAg-negative Chronic Hepatitis B|
|Actual Study Start Date :||April 26, 2011|
|Actual Primary Completion Date :||July 28, 2016|
|Actual Study Completion Date :||August 23, 2016|
Experimental: Stop TDF
Participants randomized to this arm will stop TDF therapy at baseline.
Other: Stop TDF
Participants will stop TDF therapy
Active Comparator: Continue TDF
Participants randomized to this arm will continue TDF therapy.
Tenofovir disoproxil fumarate (TDF) 300 mg tablet administered orally once daily
Other Name: Viread®
- Proportion of Participants With HBsAg Loss at Week 144 in Both Study Arms [ Time Frame: Week 144 ]HBsAg loss is defined as qualitative HBsAg result changing from positive at baseline (BL) to negative at any post-baseline visit. Proportions are based on a Kaplan-Meier estimate.
- Proportion of Participants With HBsAg Seroconversion in Both Study Arms at Weeks 96 and 144 [ Time Frame: Weeks 96 and 144 ]HBsAg seroconversion is defined as qualitative HBsAb result changing from negative at baseline to positive at any postbaseline visit. Proportions are based on the Kaplan-Meier estimate.
- Change From Baseline in Quantitative HBsAg (IU/mL) in Both Study Arms [ Time Frame: Baseline to Week 144 ]
- The analyses were summarized by 3 treatment subgroups: Stop TDF (TDF-Free), Restart TDF, and Continue TDF
- When participant randomized in the Stop TDF group restarted TDF therapy, that participant was considered part of the Restart TDF group from that point forward. For Restart TDF group, baseline is defined as the last available record on or prior to the restart date of TDF.
- Proportion of Participants Who Restart TDF Therapy in the Stop TDF Arm [ Time Frame: Weeks 48, 96, and 144 ]
- Percentage of Participants With Viral Suppression in the Stop TDF Arm (TDF-Free and Re-Start TDF Groups) [ Time Frame: Baseline to Week 144 ]Viral suppression is defined as 2 consecutive assessments of HBV DNA < 400 copies/mL (69 IU/mL) through Week 144.
- Percentage of Participants With Alanine Aminotransferase (ALT) > Upper Limit of the Normal Range in the Stop TDF Arm (TDF-Free and Restart TDF) [ Time Frame: Baseline to Week 144 ]
- Proportion of Participants With HBsAg Loss at Week 96 in Both Study Arms [ Time Frame: Week 96 ]HBsAg loss is defined as qualitative HBsAg result changing from positive at baseline (BL) to negative at any post-baseline visit. Proportions are based on a Kaplan-Meier estimate.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01320943
|Leberzentrum am Checkpoint|
|Berlin, Germany, 10969|
|Berlin, Germany, 13353|
|Zentrum für HIV und Hepatitis|
|Duesseldorf, Germany, 40237|
|J.W. Goethe Universitaetsklinikum|
|Frankfurt, Germany, 60590|
|ifi Studien und Projekte GmbH|
|Hamburg, Germany, 20099|
|Universitaetsklinikum Hamburg Eppendorf|
|Hamburg, Germany, 20246|
|Medizinische Hochschule Hannover|
|Hannover, Germany, 30625|
|Heidelberg, Germany, 69120|
|Herne, Germany, 44623|
|Leipzig, Germany, 04103|
|Leverkusen, Germany, 51375|
|Klinikum der LMU Grosshadern|
|Muenchen, Germany, 81377|
|Ulm, Germany, 89081|
|Study Director:||Gilead Study Director||Gilead Sciences|