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

NCT03798119 | Unknown Phase 4

• 1 other identifier: KMUHIRB-F(II)-20180111
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Hepatitis B; Fibrosis and Cirrhosis of Liver

Keywords

Hepatitis B; advanced fibrosis; Cirrhosis; Switch; Tenofovir alafenamide

Outcome Measures

Primary Outcomes (1)

• Rate of virological response

  HBV DNA \<LLOQ

  at 48 weeks of TAF therapy.

Secondary Outcomes (6)

• Rate of virological response

  at 96 weeks of treatment

• Rate of ALT normalization

  at week 48 and 96

• Changes of serum creatinine

  at week 48 and 96

• Changes of calculated creatinine clearance (Cockcroft-Gault)

  at week 48 and 96

• Changes in bone mineral density

  at week 48 and 96

Study Arms (1)

Switch to TAF

EXPERIMENTAL

Subjects who meet the inclusion and exclusion criteria will switch prior NUCs to TAF 25 mg/day for 96 weeks

Drug: Tenofovir Alafenamide

Interventions

Tenofovir Alafenamide DRUG

Subjects in this group will switch prior nucleot(s)ide analogs to Tenofovir Alafenamide 25 mg/day for 96 weeks

Switch to TAF

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age ≥20 years
• 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.
• 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.
• 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.
• 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).
• Willing and able to provide informed consent
• Able to comply with dosing instructions for study drug administration and able to complete the study schedule of assessments

You may not qualify if:

• Pregnant women, women who are breast feeding or who believe they may wish to become pregnant during the course of the study
• Previous recipient of a liver transplant
• Co-infection with human immunodeficiency virus (HIV) or hepatitis C (HCV) or hepatitis D (HDV)
• Severe or uncontrolled comorbidities, determined by the Investigator.
• Known history of serum albumin level \<3 g/dL, or total bilirubin level \>3 mg/dL, or presence of ascites.
• Known history of hepatic encephalopathy, and/or variceal bleeding.
• 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).
• 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.
• Males and females of reproductive potential who are unwilling to use "effective" protocol-specified method(s) of contraception during the study.
• Current substance or alcohol abuse judged by the investigator to potentially interfere with subject compliance.
• 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

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University Hospital

Kaohsiung City, 807, Taiwan

RECRUITING

MeSH Terms

Conditions

Hepatitis B; Fibrosis

Interventions

tenofovir alafenamide

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ming-Lung Yu, Prof.

  Kaohsiung Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming-Lung Yu, Prof.

CONTACT

+88673121101; fish6069@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2018
• First Posted: January 9, 2019
• Study Start: February 25, 2019
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2021
• Last Updated: April 26, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)