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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000031903 |
Receipt No. | R000036427 |
Scientific Title | Switching to tenofovir alafenamide on efficacy, safety, and tolerability for nucleos(t)ide analogue-experienced patients with chronic hepatitis B |
Date of disclosure of the study information | 2018/03/26 |
Last modified on | 2018/03/26 |
Basic information | ||
Public title | Switching to tenofovir alafenamide on efficacy, safety, and tolerability for nucleos(t)ide analogue-experienced patients with chronic hepatitis B | |
Acronym | Effectiveness for switiching to tenofovir alafenamide | |
Scientific Title | Switching to tenofovir alafenamide on efficacy, safety, and tolerability for nucleos(t)ide analogue-experienced patients with chronic hepatitis B | |
Scientific Title:Acronym | Effectiveness for switiching to tenofovir alafenamide | |
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 investigate efficacy, safety, and tolerability after switching from other nucleos(t)ide analogues to TAF for nucleos(t)ide analogue-experienced Japanese patients with chronic hepatitis B |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Proportion of patients with virological response (HBV DNA level <2.1 log copies/mL) at weeks 24, 48, 96, 120 and 144 after switching from other nucleos(t)ide analogues to TAF |
Key secondary outcomes | 1.Changes from the baseline in hepatitis surface antigen levels 2.Changes from the baseline in serum alanine aminotransferase 3.Changes from the baseline in estimated glomerular filtration rate and urine beta-2 microglobulinuria 4.Changes from the baseline in albuminuria 5.Changes in spine-and hip-bone mineral density |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
No. of arms | |
Purpose of intervention | |
Type of intervention | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1.Patients with chronic hepatitis B and under treatment by nucleos(t)ide analogue(s) (lamivudine (LMV), adefovir dipivoxil (ADV), entecavir (ETV), and tenofovir disoproxil fumarate (TDF)), including compensated cirrhosis. 2.Patients with stable and well controlled hypertension, diabetes mellitus, heart diseases, CKD or risk of CKD (eGFR <60), and other patients whom Dr. consider appropriate to switch. |
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Key exclusion criteria | 1.Patients with decompensated cirrhosis 2.Patients with co-infection of hepatitis C virus 3.Patients with co-infection of human immunodeficiency virus 4.Patients with stable estimated glomerular filtration rate <15 mL/min/1.73 m2 5.Patients with albumin <30 g/L and platelets <30,000 6.Patients with autoimmune hepatitis 7.Constant heavy alcohol drinkers (converted to ethanol over 60 g/day) 8.Patients who are pregnant females, or females who may become pregnant, or females who are breastfeeding 9.Patients judged (by the physician in charge of research) to be inappropriate as subjects for the study for any other reasons |
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Target sample size | 400 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kyushu University Hospital | ||||||
Division name | Kyushu University Liver Disease Study (KULDS) | ||||||
Zip code | |||||||
Address | 3-1-1, Maidashi, Higashi-ku, Fukuoka | ||||||
TEL | 092-642-5909 | ||||||
furusyo@gim.med.kyushu-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Kyushu University Hospital | ||||||
Division name | Department of General Internal Medicine | ||||||
Zip code | |||||||
Address | 3-1-1, Maidashi, Higashi-ku, Fukuoka | ||||||
TEL | 092-642-5909 | ||||||
Homepage URL | |||||||
eogawa@gim.med.kyushu-u.ac.jp |
Sponsor | |
Institute | Kyushu University |
Institute | |
Department |
Funding Source | |
Organization | Gilead Sciences K.K. |
Organization | |
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Category of Funding Organization | Profit organization |
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IRB Contact (For public release) | |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Number of participants that the trial has enrolled | |
Results | |
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Baseline Characteristics | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Open public recruiting | ||||||
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Date analysis concluded |
Other | |
Other related information | None |
Management information | |||||||
Registered date |
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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=R000036427 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |