UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031832 |
|---|---|
| Receipt number | R000036354 |
| Scientific Title | Treatment Outcomes in Chronic Hepatitis B Patients on Sequential Therapy With Tenofovir Alafenamide (TAF) |
| Date of disclosure of the study information | 2018/03/22 |
| Last modified on | 2023/10/26 23:35:46 |
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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
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
amizuta@stanford.edu
Sponsor or person
Institute
Stanford University Medical Center
Institute
Department
Personal name
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
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
Completed
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 | 09 | Month | 07 | Day |
Date of closure to data entry
| 2021 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 22 | Day |
Last modified on
| 2023 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036354
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