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Active, Not Recruiting

NCT Number: NCT03489239

Entecavir to TAF Switch

A research study to observe the safety, efficacy and tolerability of switching from Entecavir (ETV) to Tenofovir Alafenamide TAF in patients with chronic hepatitis B

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects, adult male and female ≥18 years of age with chronic hepatitis B with or without compensated cirrhosis
  • Maintained on Entecavir for a minimum of 48 weeks
  • Viral suppression (HBV DNA <20 IU/mL) for a minimum of 12 weeks prior to entry are eligible for this study.
  • Estimated creatinine clearance ≥ 50 ml/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at the baseline evaluation.

Exclusion criteria

  • Subjects with known poor or non-compliance
  • Subjects with co-infection with HCV or HIV subjects with decompensated cirrhosis and HCC will be excluded to participate in the study.
  • Pregnant women and those who wish to become pregnant during the course of the study.

Treatment and study plan

Tenofovir alafenamide

Drug

subjects switching from Entecavir to single arm TAF 25mg

Other names: TAF

Primary outcomes

  1. Results of viral Hepatitis B DNA to be <20 IU/mL

    Time frame: 48 weeks

    The proportion of subjects with plasma HBV DNA levels below 20 IU/mL at week 48.

Secondary outcomes

  1. Complete viral suppression at study completion

    Time frame: 96 Weeks

    The proportion of subjects with complete viral suppression, i.e., plasma HBV DNA level below 20 IU/mL at Week 96.

  2. Positive eGFR changes at study completion compared to Baseline visit

    Time frame: 96 weeks

    Change in eGFR from baseline to Week 96

  3. Improved Bone Mass Density at study completion

    Time frame: 96 weeks

    % change from baseline in BMD at the hip and lumbar spine at Week 96.

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Collaborators

  • Gilead Sciences

Registry information

Official study title

Long-term Study to Observe Safety and Efficacy of TAF in Patients With Chronic Hepatitis B

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Apr 5, 2018
Registry last updated
Jun 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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