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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000031832 |
Receipt No. | 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 | 2020/09/23 |
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 |
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Condition | ||
Condition | Chronic hepatitis B | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 251 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | No longer recruiting | ||||||
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Other | |
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Management information | |||||||
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Last modified on |
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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 |