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Treatment Outcomes in Chronic Hepatitis B Patients on Sequential Therapy With Tenofovir Alafenamide (TAF)

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: NCT03471624
Recruitment Status : Active, not recruiting
First Posted : March 20, 2018
Last Update Posted : October 20, 2022
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Mindie H. Nguyen, Stanford University

Study Description
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Brief Summary:

Primary Objective:

To describe rate of persistence and/or improvement of viral suppression with TAF as with previous anti-HBV (hepatitis B virus) treatment


Condition or disease Intervention/treatment Phase
Hepatitis B, Chronic Drug: Tenofovir Alafenamide Phase 4

Detailed Description:

Secondary Objective(s):

  1. Describe persistence of ALT (alanine aminotransferase) normalization and/or improvement of ALT levels with TAF as with previous anti-HBV treatment
  2. To describe trends in serum creatinine and calculated creatinine clearance as available by local labs.
  3. To describe trends in bone mass from baseline to 24 months after switch.

https://med.stanford.edu/nguyenlab/clinical-trials.html

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 266 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment Outcomes in Chronic Hepatitis B Patients on Sequential Therapy With Tenofovir Alafenamide (TAF)
Actual Study Start Date : May 1, 2018
Actual Primary Completion Date : March 30, 2022
Estimated Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Tenofovir Alafenamide for 24 months
Subjects on any antiviral treatment for chronic HBV who plan to be switched by their physician to be treated with TAF 25 mg for 24 months.
 Drug: Tenofovir Alafenamide
Tenofovir alafenamide (TAF) is a new formulation of tenofovir with higher intracellular active drug concentration allowing for dosing of only 25 mg once daily and thus can potentially lower the already low risk of renal toxicity and bone loss with tenofovir disoproxil fumarate (TDF).
Other Name: Vemlidy


Outcome Measures
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Primary Outcome Measures :
  1. Improvement and/or Persistence of Viral Suppresion [ Time Frame: 24 months ]
    To describe rate of persistence and/or improvement of viral suppression with TAF as with previous anti-HBV treatment


Secondary Outcome Measures :
  1. ALT Normalization and/or Improvement [ Time Frame: 24 months ]
    To describe persistence of ALT normalization and/or improvement of ALT levels with TAF as with previous anti-HBV treatment

  2. Creatinine Clearance Trends [ Time Frame: 24 months ]
    To describe trends in calculated creatinine clearance as available by local labs.

  3. Serum Creatinine Trends [ Time Frame: 24 months ]
    To describe trends in serum creatinine as available by local labs.

  4. Bone Mass Density Trends [ Time Frame: 24 months ]
    To describe trends in bone mass density from baseline to end of study.


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:

  1. Male or female, age ≥18 years
  2. CHB (chronic hepatitis B) diagnosis confirmed by positive HBsAg or HBV DNA or HBeAg or documented history of CHB in physician note
  3. Currently maintained on antiviral therapy for at least 48 weeks with any HBV DNA value at Screening/Baseline and planned to be switched to TAF by their physician
  4. Routinely monitored for serum HBV DNA PCR (polymerase chain reaction), liver chemistry including AST (aspartate aminotransferase )/ALT/total bilirubin, renal chemistry including BUN (blood urea nitrogen)/Cr/CO2 (carbon dioxide) by their physicians every 3-6 months and a bone density scan at least every 2 years as per routine clinical care (one at baseline and one 2 years after switch).
  5. Estimated creatinine clearance > 15 ml/min (using the Cockcroft-Gault method) at Screening/Baseline Visit. (Note: multiply estimated rate by 0.85 for women).
  6. Willing and able to provide informed consent
  7. Able to comply with dosing instructions for study drug administration and able to complete the study schedule of assessments

Exclusion criteria:

  1. Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study
  2. Previous recipient of a liver transplant
  3. Co-infection with human immunodeficiency virus (HIV) or hepatitis C (HCV) or hepatitis D (HDV)
  4. Severe or uncontrolled comorbidities
  5. Current or known hepatic decompensation (≤2 years) (e.g ascites, encephalopathy, or variceal hemorrhage) with a Child-Pugh score of B or C
  6. Malignancy including liver cancer within 5 years except cancers curable by surgical resection (e.g. basal cell skin cancer and squamous cell cancer)
  7. On any of the disallowed concomitant medications listed in the prior and concomitant medications list (pg. 11). Subjects on prohibited medications who are otherwise eligible will need a wash out period of at least 30 days prior to the Screening/Baseline visit.
  8. Males and females of reproductive potential who are unwilling to use "effective" protocol-specified method(s) of contraception during the study.
  9. Current substance or alcohol abuse judged by the investigator to potentially interfere with subject compliance.
  10. Any other clinical conditions that, in the opinion of the Investigator, would make the subject unsuitable or unable to comply with any of the study procedures
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): NCT03471624


Locations
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United States, California
Stanford University Medical Center
Palo Alto, California, United States, 94304
San Jose Gastroenterology
San Jose, California, United States, 95128
Japan
Kyushu University Hospital
Fukuoka, Japan, 812-8582
Nagoya City University
Nagoya, Japan, 467-8601
Osaka City University
Osaka, Japan, 545-8585
Saga University Hospital
Saga, Japan, 849-8501
Korea, Republic of
Hanyang University Seoul Hospital
Seoul, Korea, Republic of, 04736
Nowon Eulji Medical Center, Eulji University College of Medicine,
Seoul, Korea, Republic of
Sanggye Paik Hospital, Inje University College of Medicine
Seoul, Korea, Republic of
Taiwan
Kaohsiung Medical University Hospital
Kaohsiung, Taiwan, 807
E-Da Hospital
Kaohsiung, Taiwan, 82445
China Medical University Hospital
Taichung, Taiwan
Sponsors and Collaborators
Stanford University
Gilead Sciences
Investigators
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Principal Investigator: Mindie H Nguyen, MD,MAS Stanford University
More Information
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Additional Information:

Publications:

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Responsible Party: Mindie H. Nguyen, Profesor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT03471624    
Other Study ID Numbers: 45054
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: October 20, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Mindie H. Nguyen, Stanford University:
Tenofovir alafenamide (TAF)
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
 Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic
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