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Entecavir to TAF Switch

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.
 
ClinicalTrials.gov Identifier: NCT03489239
Recruitment Status : Active, not recruiting
First Posted : April 5, 2018
Last Update Posted : June 25, 2020
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Thomas Jefferson University

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Hepatitis B Drug: Tenofovir Alafenamide Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Long-term Study to Observe Safety and Efficacy of TAF in Patients With Chronic Hepatitis B
Actual Study Start Date : November 16, 2017
Estimated Primary Completion Date : August 15, 2020
Estimated Study Completion Date : September 16, 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Single Arm
SingleArm: TAF 25 mg
 Drug: Tenofovir Alafenamide
subjects switching from Entecavir to single arm TAF 25mg
Other Name: TAF


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03489239


Locations
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United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Gilead Sciences
More Information
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Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03489239    
Other Study ID Numbers: 11729
First Posted: April 5, 2018    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020

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