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NCT03236610
Tenofovir Monotherapy in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Entecavir Plus Tenofovir
Phase 3 trial testing tenofovir monotherapy in Proportion of Patients With a Sustained Virological Response (Serum HBV DNA <20 IU/mL) at Week 48 in 112 participants. Status unknown.
30 June 2018
Quick facts
| Lead sponsor | Uijeongbu St. Mary Hospital |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 112 |
| Start date | 1 January 2016 |
| Primary completion | 30 June 2018 |
| Estimated completion | 30 June 2019 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- tenofovir monotherapy — full drug profile →
- tenofovir plus entecavir combination — full drug profile →
Conditions studied
- Proportion of Patients With a Sustained Virological Response (Serum HBV DNA <20 IU/mL) at Week 48 — all drugs for Proportion of Patients With a Sustained Virological Response (Serum HBV DNA <20 IU/mL) at Week 48 →
Sponsor
Uijeongbu St. Mary Hospital
Who can join
19 and older, any sex, with Proportion of Patients With a Sustained Virological Response (Serum HBV DNA <20 IU/mL) at Week 48. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Little is known about efficacy of switching to tenofovir monotherapy for multidrug-resistant chronic ehpatitis B patients who achieved a complete virological response to entecavir and tenofovir. This study aimed to investigate the efficacy of switching to tenofovir monotherapy for multidrug-resistant chronic hepatitis B patients with undetectable heaptitis B virus DNA while on tenofovir plus entecavir combination therapy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03236610
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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- NCT03236584 — Tenofovir Monotherapy in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Lamiv · Phase 3 · unknown
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 NCT03236610 (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 Uijeongbu St. Mary Hospital
- Last refreshed: 2 August 2017
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/NCT03236610.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing