Tenofovir Monotherapy in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Entecavir Plus Tenofovir

Proportion of Patients With a Sustained Virological Response (Serum HBV DNA <20 IU/mL) at Week 48 Clinical Trial

Official title:

Investigation of Efficacy of Tenofovir Monotherapy in Comparison With Entecavir Plus Tenofovir in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Entecavir Plus Tenofovir Combination Therapy-Multicenter Randomized Open-label Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03236610
• Other study ID #: XC15MIMI0100U
• Status: Recruiting
• Phase: Phase 3
• First received: July 28, 2017
• Last updated: July 28, 2017
• Start date: January 1, 2016
• Est. completion date: June 30, 2019

Study information

• Verified date: July 2017
• Source: Uijeongbu St. Mary Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Little is known about efficacy of switching to tenofovir monotherapy for multidrug-resistant chronic ehpatitis B patients who achieved a complete virological response to entecavir and tenofovir. This study aimed to investigate the efficacy of switching to tenofovir monotherapy for multidrug-resistant chronic hepatitis B patients with undetectable heaptitis B virus DNA while on tenofovir plus entecavir combination therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• HBsAg (+) for > 6 months age >19 years antiviral resistance to LAM(rtL180M and/or M204V/I) & ADV (rtA181V/T and/or rtN236T) or ETV (rtT184A/C/F/G/I/L/S, rtS202G, or rtM250L/V, in addition to rtM204V/I) HBV DNA levels <20 IU/ml on two consecutive tests of 3-month interval currently receiving TDF+ETV for more than 12 months

Exclusion Criteria:

• Cr =1.5 mg/dL Evidence of decompensated liver disease Malignant neoplasm Coinfection with HIV, HCV

Related Conditions & MeSH terms

• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic
• Proportion of Patients With a Sustained Virological Response (Serum HBV DNA <20 IU/mL) at Week 48

Intervention

Drug:
• tenofovir monotherapy
switching to tenofovir monotherapy
• tenofovir plus entecavir combination
continuing tenofovir plus entecavir

Locations

Country	Name	City	State
Korea, Republic of	Uijeongbu St. Mary Hospital	Uijongbu

Sponsors (1)

Lead Sponsor	Collaborator
Uijeongbu St. Mary Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SVR at week 48	Proportion of patients with a sustained virological response (serum HBV DNA <20 IU/mL) at week 48	48 week