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NCT05746611
Phase IV Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein
Phase 4 trial testing Recombinant Mycobacterium tuberculosis fusion protein for injection in Latent Tuberculosis Infection in 7,500 participants. Completed in 13 May 2024.
13 May 2024
Quick facts
| Lead sponsor | Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | diagnostic |
| Enrollment | 7,500 |
| Start date | 17 April 2023 |
| Primary completion | 13 May 2024 |
| Estimated completion | 13 May 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- Recombinant Mycobacterium tuberculosis fusion protein for injection — full drug profile →
- TB-PPD was injected — full drug profile →
Conditions studied
- Latent Tuberculosis Infection — all drugs for Latent Tuberculosis Infection →
Sponsor
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. — full company profile →
Who can join
6 Months and older, any sex, with Latent Tuberculosis Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Cohort 1 was a randomized, double-blind, controlled clinical trial with a planned enrollment of 500 patients. Cohort 2 is a non-randomized, open-label clinical trial with a planned enrollment of approximately 60000 patients. Cohort I was injected with EC and TB-PPD in both arms, and cohort II was injected with EC only
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Safety and Diagnostic Performance of Recombinant Fusion Protein ESAT6-CPF10 Skin Test in A Large Population: A Phase 4 Clinical Trial.
Chen J, Zhao L, Zhou X, Mo Y, et al · · 2025 · cited 1× · PMID 40560769 · DOI 10.1093/infdis/jiaf332
Verify or expand the search:
- PubMed search for NCT05746611
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Latent Tuberculosis Infection
Currently open trials in the same condition.
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- NCT05899179 — Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein for 65-year-olds and Above · Phase 3 · recruiting
- NCT05680415 — Clinical Trial of Mica · Phase 4 · active not recruiting
- NCT06874725 — Latent Tuberculosis in Type 2 Diabetes · Phase 4 · active not recruiting
Other Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. trials
Trials by the same sponsor.
- NCT06747455 — BCG for Therapeutic Use Phase Ⅲ Clinical Trial · Phase 3 · recruiting
- NCT06524947 — Clinical Trial of Protective Efficacy of Quadrivalent Recombinant Norovirus Vaccine (Pichia Pastoris) · Phase 3 · active not recruiting
- NCT06100653 — BCG for Therapeutic Use Phase I Clinical Trial · Phase 1 · completed
- NCT06025812 — Clinical Study of Omicron BA.4/5-Delta Strain Recombinant Novel Coronavirus Protein Vaccine (CHO Cells) · NA · unknown
- NCT05899179 — Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein for 65-year-olds and Above · Phase 3 · recruiting
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 NCT05746611 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Last refreshed: 19 September 2024
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/NCT05746611.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing