NCT03489239Active, not recruitingPhase 3
Entecavir to TAF Switch
Long-term Study to Observe Safety and Efficacy of TAF in Patients With Chronic Hepatitis B
Source: ClinicalTrials.gov · Last updated 25 Jun 2020
Brief summary (registry, in English)
A research study to observe the safety, efficacy and tolerability of switching from Entecavir (ETV) to Tenofovir Alafenamide TAF in patients with chronic hepatitis B
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 27 (actual)
- First submitted
- 14 Mar 2018
- Start date
- 16 Nov 2017
- Primary completion date
- 15 Aug 2020
- Lead sponsor
- Thomas Jefferson University
- Diseases
- Hepatitis B
- NCT number
- NCT03489239
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 27
- From 16 Nov 2017 to the primary completion date, 15 Aug 2020
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Subjects with co-infection with HCV or HIV subjects with decompensated cirrhosis and HCC will be excluded to participate in the study.
Other
- Subjects with known poor or non-compliance
- Pregnant women and those who wish to become pregnant during the course of the study.
Who the study is looking for
- Subjects, adult male and female ≥18 years of age with chronic hepatitis B with or without compensated cirrhosis
- Maintained on Entecavir for a minimum of 48 weeks
- Viral suppression (HBV DNA \<20 IU/mL) for a minimum of 12 weeks prior to entry are eligible for this study.
- Estimated creatinine clearance ≥ 50 ml/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at the baseline evaluation.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Thomas Jefferson University Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.