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TAF Switch in F3/4 CHB pt With Partial Response to NUC (ESTAB-AFPVR)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03798119
Recruitment Status : Recruiting
First Posted : January 9, 2019
Last Update Posted : April 26, 2019
Information provided by (Responsible Party):
Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary:
A total of 80 adult chronic hepatitis B patients with advanced liver fibrosis (including fibrosis stage 3 and cirrhosis), who are currently on nucleot(s)ide analogs (except tenofovir alafenamide) therapy with detectable HBV DNA after 52 weeks of therapy will switch prior NUCs to TAF 25 mg/day for 96 weeks

Condition or disease Intervention/treatment Phase
Hepatitis B Fibrosis and Cirrhosis of Liver Drug: Tenofovir Alafenamide Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Switching to Tenofovir Alafenamide for Chronic Hepatitis B Patients With Advanced Fibrosis and Partial Virologic Responses to Oral Nucleos(t)Ide Analogues
Actual Study Start Date : February 25, 2019
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2021

Arm Intervention/treatment
Experimental: Switch to TAF
Subjects who meet the inclusion and exclusion criteria will switch prior NUCs to TAF 25 mg/day for 96 weeks
Drug: Tenofovir Alafenamide
Subjects in this group will switch prior nucleot(s)ide analogs to Tenofovir Alafenamide 25 mg/day for 96 weeks

Primary Outcome Measures :
  1. Rate of virological response [ Time Frame: at 48 weeks of TAF therapy. ]

Secondary Outcome Measures :
  1. Rate of virological response [ Time Frame: at 96 weeks of treatment ]

  2. Rate of ALT normalization [ Time Frame: at week 48 and 96 ]
    by local (<40 U/L), and AASLD (male ≤35, female ≤25 U/L) criteria

  3. Changes of serum creatinine [ Time Frame: at week 48 and 96 ]
  4. Changes of calculated creatinine clearance (Cockcroft-Gault) [ Time Frame: at week 48 and 96 ]
  5. Changes in bone mineral density [ Time Frame: at week 48 and 96 ]
  6. Changes in liver fibrosis [ Time Frame: at week 48 and 96 ]
    determined by Fibroscan

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or female, age ≥20 years
  2. CHB diagnosis confirmed by positive HBsAg or HBV DNA for more than 6 months, or documented history of CHB in medical record before initiation of NUC therapy.
  3. Currently maintained on nucleot(s)ide analogues (except TAF) therapy for more than one year, with detectable HBV DNA after 52 weeks of therapy, detectable HBV DNA within 3-6 months prior to screening, and remains detectable HBV DNA at screening.
  4. Patients with liver fibrosis stage 3 (defined as Metavir fibrosis stage 3 by liver biopsy, or fibrosis-4 score 3.25 ~ 6.49, or ARFI 1.80 ~ 1.99 m/s, or Fibroscan 9.5~12.4 kPa), or cirrhosis (defined as Metavir fibrosis stage 4 by liver biopsy, or APRI >2, or fibrosis-4 score ≥ 6.5, or ARFI ≥ 2.0 m/s, or Fibroscan ≥12.5 kPa, or image diagnosis with splenomegaly or esophageal/gastric varices) at the initiation of prior NUC therapy or during the prior NUC therapy. The liver biopsy should be within 5 years, or during the prior NUC therapy and other non-invasive assessments should be within 6 months at the initiation of NUC therapy or during the prior NUC therapy.
  5. Estimated creatinine clearance > 15 ml/min (using the Cockcroft-Gault method) within 6 months prior to screening. (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 breast feeding 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, determined by the Investigator.
  5. Known history of serum albumin level <3 g/dL, or total bilirubin level >3 mg/dL, or presence of ascites.
  6. Known history of hepatic encephalopathy, and/or variceal bleeding.
  7. Malignancy history including hepatocellular carcinoma, except cancers curable by surgical resection (e.g. basal cell skin cancer and squamous cell cancer within 5 yrs of screening).
  8. 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.
  9. Males and females of reproductive potential who are unwilling to use "effective" protocol-specified method(s) of contraception during the study.
  10. Current substance or alcohol abuse judged by the investigator to potentially interfere with subject compliance.
  11. 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

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 identifier (NCT number): NCT03798119

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Contact: Ming-Lung Yu, Prof. +88673121101 ext 7475

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Kaohsiung Medical University Hospital Recruiting
Kaohsiung, Taiwan, 807
Contact: Ming-Lung Yu, DR    +88673121101 ext 7475   
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
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Principal Investigator: Ming-Lung Yu, Prof. Kaohsiung Medical University

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Responsible Party: Kaohsiung Medical University Chung-Ho Memorial Hospital Identifier: NCT03798119     History of Changes
Other Study ID Numbers: KMUHIRB-F(II)-20180111
First Posted: January 9, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: December 2018
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
Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
Hepatitis B
advanced fibrosis
Tenofovir alafenamide
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis A
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Pathologic Processes
Hepadnaviridae Infections
DNA Virus Infections
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