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NCT06305104
Clinical Trial to Explore the Skin Test Dosage of EEC in People Aged 18 to 65 Years Old and the Safety and Preliminary Efficacy in People Aged 3 to 75 Years Old.
Phase 2 trial testing 2.5μg/ml EEC in Tuberculosis in 420 participants. Status unknown.
30 May 2024
Quick facts
| Lead sponsor | Chengdu CoenBiotech Co., Ltd |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | diagnostic |
| Enrollment | 420 |
| Start date | 18 July 2023 |
| Primary completion | 30 May 2024 |
| Estimated completion | 30 June 2024 |
| Sites | 6 locations across China |
Drugs / interventions tested
- 2.5μg/ml EEC — full drug profile →
- 5μg/ml EEC — full drug profile →
- 5 unit（U） EC — full drug profile →
Conditions studied
- Tuberculosis — all drugs for Tuberculosis →
Sponsor
Chengdu CoenBiotech Co., Ltd — full company profile →
Who can join
Adults 3 to 75, any sex, with Tuberculosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a randomized, blind, positive-controlled study to explore the skin test dosage of recombinant mycobacterium tuberculosis fusion protein ( EEC) in the population aged 18 to 65 years old , and to further evaluate the safety and preliminary efficacy of EEC in the population aged 3 to 75 years old. In the first stage,180 healthy subjects, 140 tuberculosis（TB）subjects and 40 non-TB subjects with lung diseases aged 18 to 65 years old are divided into different groups through a randomized, blind methods. Every group carry out a low-dose (2.5μg/ml) or high-dose (5μg/ml) study, with 180 subjects in each dose group .Every subject injects intradermally EEC and EC randomly in both arms of the same person. Evaluate the consistency of assay results of EEC, EC and Interferon-Gamma Release Assay（IGRA）.Evaluate the sensitivity, specificity and consistency of assay results of EEC, EC and IGRA in healthy people, TB patients and non-TB patients with lung diseases, and determine the optimal dose of EEC for clinical auxiliary diagnosis of tuberculosis. In the second stage, 60 healthy subjects and TB subjects aged 3-17 years and 66-75 years old are divided into different groups through a randomized, open, single-arm method with the target dose. Evaluate the safety, tolerance and preliminary efficacy of target dose of EEC in healthy people and TB patients aged 3 to 17 years old and 66 to 75 years old.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06305104
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Other Chengdu CoenBiotech Co., Ltd trials
Trials by the same sponsor.
- NCT07152639 — Clinical Trial to Evaluate the Efficacy and Safety of EEC for the Diagnosis of Mycobacterium Tuberculosis Infection in P · Phase 3 · recruiting
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- NCT06224608 — Phase I Clinical Trial to Evaluate the Safety of Recombinant Mycobacterium Tuberculosis Fusion Protein (EEC) in Healthy · Phase 1 · completed
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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 NCT06305104 (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 Chengdu CoenBiotech Co., Ltd
- Last refreshed: 12 March 2024
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