NCT01320943

Stopping TDF Treatment After Long Term Virologic Suppression in HBeAg-negative CHB

FINITE CHB - First Investigation in Stopping Tenofovir Disoproxil Fumarate (TDF) Treatment After Long Term Virologic Suppression in HBeAg-negative Chronic Hepatitis B

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	TDF	Tenofovir disoproxil fumarate (TDF) 300 mg tablet administered orally once daily
OTHER	Stop TDF	Participants will stop TDF therapy

Timeline

• Start date: 2011-04-26
• Primary completion: 2016-07-28
• Completion: 2016-08-23
• First posted: 2011-03-23
• Last updated: 2017-08-29
• Results posted: 2017-08-29

Locations

13 sites across 1 country: Germany

Regulatory

• FDA-regulated drug study