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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04683341




Registration number
NCT04683341
Ethics application status
Date submitted
12/11/2020
Date registered
24/12/2020

Titles & IDs
Public title
Tenofovir Alafenamide in HBV Related Decompensated Liver
Scientific title
Safety and Efficacy of Tenofovir Alafenamide for Chronic Hepatitis B Patients With Decompensated Liver Disease
Secondary ID [1] 0 0
TAF-Deliver
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HBV 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tenofovir Alafenamide Tablets

Experimental: Arm A - initial TAF treatment group - cirrhotic or non-cirrhotic CHB patients with hepatic decompensation and HBV NUC treatment naïve or experienced (except prior TAF) will receive initial treatment (Arm A) with TAF 25 mg/day.

Experimental: Arm B - switch to TAF treatment group - cirrhotic or non-cirrhotic CHB patients with hepatic decompensation and currently under HBV NUC treatment (except TAF) with HBV DNA \< 20 IU/mL within 6 months prior screening will switch (Arm B) to TAF 25 mg/day


Treatment: Drugs: Tenofovir Alafenamide Tablets
Approximately 100 adults, cirrhotic or non-cirrhotic (capped at 50), CHB patients with hepatic decompensation, will receive initial treatment (Arm A) with or switch (Arm B) to TAF 25 mg/day for 144 weeks. For Initiation Arm (Arm A), CHB patients with hepatic decompensation, who are currently not under HBV antiviral treatment will be enrolled. For Switch Arm (Arm B), CHB patients who are currently with hepatic decompensation and virally suppressed under HBV NUC treatment (HBV DNA \< 20 IU/mL) will be enrolled.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Complete virological suppression
Timepoint [1] 0 0
week 48
Secondary outcome [1] 0 0
Rate of adverse events
Timepoint [1] 0 0
week 48
Secondary outcome [2] 0 0
Rate of recovery from hepatic decompensation
Timepoint [2] 0 0
week 48, 96, and 144
Secondary outcome [3] 0 0
Liver transplant-free survival
Timepoint [3] 0 0
week 48, 96, and 144
Secondary outcome [4] 0 0
Rate of virological response
Timepoint [4] 0 0
week 96, and 144
Secondary outcome [5] 0 0
Rate of ALT normalization
Timepoint [5] 0 0
week 48, 96, and 144
Secondary outcome [6] 0 0
Rate of HBeAg loss/seroconversion, HBsAg loss/seroconversion
Timepoint [6] 0 0
week 48, 96, and 144
Secondary outcome [7] 0 0
Changes of serum creatinine
Timepoint [7] 0 0
week 48, 96, and 144
Secondary outcome [8] 0 0
Changes of calculated creatinine clearance
Timepoint [8] 0 0
week 48, 96, and 144
Secondary outcome [9] 0 0
Changes in bone mineral density
Timepoint [9] 0 0
week 144
Secondary outcome [10] 0 0
Changes in value of transient elastography
Timepoint [10] 0 0
week 144
Secondary outcome [11] 0 0
Changes in body mass index
Timepoint [11] 0 0
week 48, 96, and 144
Secondary outcome [12] 0 0
Changes in blood lipid profile
Timepoint [12] 0 0
week 48, 96, and 144
Secondary outcome [13] 0 0
Changes in blood glucose
Timepoint [13] 0 0
week 48, 96, and 144

Eligibility
Key inclusion criteria
* Male or non-pregnant female, age =20 years
* Chronic HBV infection with positive hepatitis B surface antigen (HBsAg) for at least 6 months at screening.
* Hepatic decompensation, defined as Child-Turcotte-Pugh (CTP) score =7, or the presence of portal hypertension related complications including ascites, hepatic encephalopathy (<grade 2) at screening.
* HBV NUC treatment naïve or experienced (except prior TAF) for Arm A or currently under HBV NUC treatment (except TAF) with HBV DNA < 20 IU/mL within 6 months prior screening for Arm B.
* Patients with either liver cirrhosis or non-cirrhosis (defined by histology, non-invasive assessments, or imaging/clinical based diagnosis).
* Estimated creatinine clearance =30 ml/min (using the Cockcroft-Gault method) at 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
Minimum age
20 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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 solid organ (including liver), or bone marrow transplant.
* Severe or uncontrolled comorbidities determined by the Investigator.
* Currently =grade 2 hepatic encephalopathy, currently or history (within 60 days) of variceal bleeding, hepatorenal syndrome, refractory ascites or spontaneous bacterial peritonitis; cytopenia of absolute neutrophil count < 750/mm3, or hemoglobin < 8 g/dL, or platelet <30000/mm3; or MELD score =30 at screening.
* Malignancy history including hepatocellular carcinoma, except basal cell skin cancer without recurrence for more than 5 years.
* Acute exacerbation of HBV, defined as an elevation of alanine aminotransferase (ALT) activity to more than 10 times the upper limit of normal and more than twice the baseline value.
* On any of the disallowed concomitant medications listed in the prior and concomitant medications list (pg. 16). 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Taiwan
State/province [1] 0 0
Kaohsiung

Funding & Sponsors
Primary sponsor type
Other
Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ming-Lung Yu, Professor
Address 0 0
Hepatobiliary Division, Kaohsiung Medical University Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ming-Lung Yu, Professor
Address 0 0
Country 0 0
Phone 0 0
886-7-3121101
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04683341