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NCT05001672
The Efficacy of Prophylactic TAF for HBsAg-positive Patients Receiving bDMARDs
Phase 4 trial testing Tenofovir alafenamide in HBV in 108 participants. Status unknown.
30 June 2025
Quick facts
| Lead sponsor | Taipei Veterans General Hospital, Taiwan |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 108 |
| Start date | 15 August 2021 |
| Primary completion | 30 June 2025 |
| Estimated completion | 31 December 2025 |
Drugs / interventions tested
- Tenofovir alafenamide (TENOFOVIR ALAFENAMIDE) — full drug profile →
Conditions studied
- HBV — all drugs for HBV →
- Inflammatory Arthritis — all drugs for Inflammatory Arthritis →
Sponsor
Taipei Veterans General Hospital, Taiwan
Who can join
20 and older, any sex, with HBV or Inflammatory Arthritis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Hepatitis B virus reactivation (HBVr) is an emerging issue and a potentially life-threatening complication to patients with history of Hepatitis B virus (HBV) infection whose immune system is deficient or suppressed. It is estimated that the risk of HBVr ranges 20%-50% in hepatitis B surface antigen (HBsAg)-positive patients undergoing chemotherapy or immunosuppressive therapy. Not only HBsAg-positive patients but also HBsAg-negative/antibody to hepatitis B core antigen (anti-HBc)-positive patients (resolved hepatitis B) have the risk of HBVr. Recent studies also reported that the risk of HBVr associated with TNF-α inhibitor treatment widely ranged from 12.3% to 62.5%. Antiviral prophylaxis by nucleos(t)ide analogues (NUCs) is recommended for patients with high risk of HBVr according to 2018 AASLD guidance. Phase 3 studies reported that tenofovir alafenamide (Vemlidy, TAF) can effectively suppress HBV in both HBeAg-positive and HBeAg-negative chronic hepatitis B patients, and TAF is superior to TDF in safety profiles and ALT normalization. However, the evidence of TAF in prevention HBV reactivation for patients with HBsAg-positive and imflammatory arthritis, who need bDMARDs are still missing.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05001672
- Europe PMC full search
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- bioRxiv preprints
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Other Taipei Veterans General Hospital, Taiwan trials
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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 NCT05001672 (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 Taipei Veterans General Hospital, Taiwan
- Last refreshed: 12 August 2021
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/NCT05001672.
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