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NCT03566030
Switching From Tenofovir Disoproxi Fumarate to Tenofovir Alafenamide in Chronic Hepatitis B Patients With Antiviral Resistance
trial testing Tenofovir disoproxil fumarate 300mg in Hepatitis B in 300 participants. Status unknown.
31 August 2019
Quick facts
| Lead sponsor | Yonsei University |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 300 |
| Start date | 1 September 2018 |
| Primary completion | 31 August 2019 |
| Estimated completion | 31 August 2020 |
Drugs / interventions tested
- Tenofovir disoproxil fumarate 300mg — full drug profile →
- Tenofovir Alafenamide 25 mg — full drug profile →
Conditions studied
- Hepatitis B — all drugs for Hepatitis B →
- Antiviral Drug Adverse Reaction — all drugs for Antiviral Drug Adverse Reaction →
Sponsor
Yonsei University
Who can join
20 and older, any sex, with Hepatitis B or Antiviral Drug Adverse Reaction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
* To evaluate the efficacy of switching to tenofovir alafenamide (TAF) 25 mg QD versus continued tenofovir disoproxil fumarate (TDF) 300 mg QD in CHB patients with antiviral resistance, as determined by the proportion of virologically suppressed patients at week 48 * To evaluate the safety and tolerability of switching to TAF 25 mg QD versus continuing TDF 300 mg QD in antiviral-resistant subjects with chronic HBV at week 48
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03566030
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT05282407 — A phase4 Clinical Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Disoproxil From Tenofovir Disoprox · Phase 4 · completed
- NCT03468907 — The Safety of Anti-viral Therapy in Preventing HBV MTCT in Pregnant Women After Discontinuation · Phase 4 · completed
Other recruiting trials for Hepatitis B
Currently open trials in the same condition.
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Other Yonsei University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03566030 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Yonsei University
- Last refreshed: 21 June 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03566030.
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