UMIN-CTR Clinical Trial

Basic information
Public title	Treatment Outcomes in Chronic Hepatitis B Patients on Sequential Therapy With Tenofovir Alafenamide (TAF)
Acronym	Treatment Outcomes in Chronic Hepatitis B Patients on Sequential Therapy With Tenofovir Alafenamide (TAF)
Scientific Title	Treatment Outcomes in Chronic Hepatitis B Patients on Sequential Therapy With Tenofovir Alafenamide (TAF)
Scientific Title:Acronym	Treatment Outcomes in Chronic Hepatitis B Patients on Sequential Therapy With Tenofovir Alafenamide (TAF)
Region	Japan Asia(except Japan) North America

Condition
Condition	Chronic hepatitis B
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To describe rate of persistence and/or improvement of viral suppression with TAF as with previous anti-HBV (hepatitis B virus) treatment.
Basic objectives2	Others
Basic objectives -Others	Describe persistence of ALT (alanine aminotransferase) normalization and/or improvement of ALT levels with TAF as with previous anti-HBV treatment To describe trends in serum creatinine and calculated creatinine clearance as available by local labs. To describe trends in bone mass from baseline to 24 months after switch.
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase IV

Assessment
Primary outcomes	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
Key secondary outcomes	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 Creatinine Clearance Trends [ Time Frame: 24 months ] To describe trends in calculated creatinine clearance as available by local labs. Serum Creatinine Trends [ Time Frame: 24 months ] To describe trends in serum creatinine as available by local labs. Bone Mass Density Trends [ Time Frame: 24 months ] To describe trends in bone mass density from baseline to end of study.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	TAF, 25mg, 24 months
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1Male or female, age over18 years 2CHB (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 2year 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
Key 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 (below 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
Target sample size	251

Research contact person
Name of lead principal investigator	1st name Mindie Middle name H Last name Nguyen
Organization	Stanford University Medical Center
Division name	Division of Gasteroenterology and Hepatology
Zip code	94304
Address	750 Welch Road, #210
TEL	650-736-1371
Email	mindiehn@stanford.edu

Public contact
Name of contact person	1st name Akiko Middle name Last name Mizuta
Organization	Stanford University Medical Center
Division name	Division of Gasteroenterology and Hepatology
Zip code	94304
Address	750 Welch Road, #210, Palo Alto, CA 94304
TEL	650-736-1371
Homepage URL
Email	amizuta@stanford.edu

Sponsor
Institute	Stanford University Medical Center
Institute
Department

Funding Source
Organization	Gilead Sciences
Organization
Division
Category of Funding Organization	Outside Japan
Nationality of Funding Organization	USA

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Stanford University Reserch Conpliance Offfice
Address	3000 El Camino Real Five Palo Alto Square, 4th Floor Palo Alto, CA 94306
Tel	650-724-7141
Email	sam.doan@stanford.edu

Secondary IDs
Secondary IDs	YES
Study ID_1	NCT03471624
Org. issuing International ID_1	ClinicalTrials.gov identifier (NCT number)
Study ID_2	E 45054
Org. issuing International ID_2
IND to MHLW

Institutions

Institutions

Stanford University Medical Center(USA),San Jose Gastroenterology(USA),Kyushu University Hospital(Japan),Nagoya City University(Japan), Osaka City University(Japan), Saga University Hospital(Japan), Hanyang University Seoul Hospital(South Korea),Nowon Eulji Medical Center, Eulji University College of Medicine(South Korea), Sanggye Paik Hospital, Inje University College of Medicine(South Korea),Kaohsiung Medical University Hospital(Taiwan),E-Da Hospital(Taiwan), China Medical University Hospital(Taiwan)

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 22 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	270
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2018 Year 04 Month 01 Day
Date of IRB	2018 Year 03 Month 29 Day
Anticipated trial start date	2018 Year 04 Month 15 Day
Last follow-up date	2021 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2022 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date	2018 Year 03 Month 22 Day
Last modified on	2020 Year 09 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036354

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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