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

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 Lamivudine Plus Adefovir in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Lamivudine Plus Adefovir Combination Therapy - Multicenter Randomized Open-label Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03236584
• Other study ID #: UC15MISI0099
• Status: Active, not recruiting
• Phase: Phase 3
• First received: July 28, 2017
• Last updated: July 28, 2017
• Start date: September 1, 2015
• Est. completion date: March 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 lam-resistant chronic hepatitis B patients who achieved a complete virological response to lamivudine plus adefovir. This study was to investigate the efficacy of switching to tenofovir monotherapy for lamivudine -resistant chronic hepatitis B patients with undetectable hepatitis B virus DNA while on lamivudine plus adefovir combination therapy

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 76
• Est. completion date: March 30, 2019
• Est. primary completion date: March 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) currently receiving LAM plus ADV for more than 12 months HBV DNA levels <20 IU/ml on two consecutive tests of 3-month interval

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:
• lamivudine plus adefovir combination
continuing lamivudine plus adefovir
• Tenofovir Disoproxil Fumarate
switching to tenofovir

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Uijeongbu St. Mary Hospital

Outcome

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