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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03236584
Recruitment Status : Unknown
Verified July 2017 by Chang Wook Kim, Uijeongbu St. Mary Hospital.
Recruitment status was:  Active, not recruiting
First Posted : August 2, 2017
Last Update Posted : August 2, 2017
Information provided by (Responsible Party):
Chang Wook Kim, Uijeongbu St. Mary Hospital

Brief 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

Condition or disease Intervention/treatment Phase
Proportion of Patients With a Sustained Virological Response (Serum HBV DNA <20 IU/mL) at Week 48 Drug: lamivudine plus adefovir combination Drug: Tenofovir Disoproxil Fumarate Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 1, 2015
Estimated Primary Completion Date : March 30, 2018
Estimated Study Completion Date : March 30, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: lamivudine adefovir Drug: lamivudine plus adefovir combination
continuing lamivudine plus adefovir

Experimental: tenofovir Drug: Tenofovir Disoproxil Fumarate
switching to tenofovir

Primary Outcome Measures :
  1. SVR [ Time Frame: 48 WEEK ]
    Proportion of patients with a sustained virological response (serum HBV DNA <20 IU/mL) at week 48

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Responsible Party: Chang Wook Kim, C.W. Kim, Uijeongbu St. Mary Hospital Identifier: NCT03236584    
Other Study ID Numbers: UC15MISI0099
First Posted: August 2, 2017    Key Record Dates
Last Update Posted: August 2, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis, Chronic
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents