Clinical Trial Details
| Trial ID: | L1533 |
| Source ID: | NCT02862548 |
| Associated Drug: | Taf |
| Title: | Efficacy and Safety of Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF)-Containing Regimens in Participants With Chronic Hepatitis B Virus (HBV) Infection and Stage 2 or Greater Chronic Kidney Disease Who Have Received a Liver Transplant |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT02862548/results |
| Conditions: | Chronic Hepatitis B |
| Interventions: | DRUG: TAF|DRUG: TDF|DRUG: Other approved antivirals |
| Outcome Measures: | Primary: Change From Baseline in Serum Estimated Glomerular Filtration Rate (eGFR) at Week 24 Using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation, Baseline, Week 24|Percentage of Participants With HBV DNA < 20 IU/mL at Week 24, Week 24 | Secondary: Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 24, Baseline, Week 24|Percent Change From Baseline in Hip BMD at Week 48, Baseline, Week 48|Percent Change From Baseline in Spine BMD at Week 24, Baseline, Week 24|Percent Change From Baseline in Spine BMD at Week 48, Baseline, Week 48|Change From Baseline in Serum Creatinine at Week 24, Baseline, Week 24|Change From Baseline in Serum Creatinine at Week 48, Baseline, Week 48|Change From Baseline in Serum eGFR_CKD-EPI at Week 48, Baseline, Week 48|Percentage of Participants With HBV DNA < 20 IU/mL at Week 48, Week 48 |
| Sponsor/Collaborators: | Sponsor: Gilead Sciences |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 51 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2016-09-16 |
| Completion Date: | 2021-05-05 |
| Results First Posted: | 2019-02-26 |
| Last Update Posted: | 2022-06-08 |
| Locations: | Auckland City Hospital, Auckland, New Zealand |
| URL: | https://clinicaltrials.gov/show/NCT02862548 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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