Trial · NCT07350174
Phase 2a Trial of Alpibectir Plus Ethionamide for Tuberculosis Meningitis
NCT07350174, Phase 2, Not yet recruiting, BioVersys AG
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 2a Trial of Alpibectir Plus Ethionamide for Tuberculosis Meningitis. Trials, record NCT07350174. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07350174
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2a Trial of Alpibectir Plus Ethionamide for Tuberculosis Meningitis
- NCT number
- NCT07350174
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 64 participants, estimated
- Lead sponsor
- BioVersys AG
- Conditions
- Tuberculosis Meningitis
- Interventions
- HRZE, HRZE plus Alpe375, HRZE plus AlpE500, HRZE plus AlpE625
- First posted
- 2026-01-20
- Last updated
- 2026-03-03
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To describe the pharmacokinetics (PK) of AlpE in plasma and cerebrospinal fluid (CSF) in patients with newly diagnosed Tuberculosis Meningitis (TBM) | 15 days | CSF/plasma ratio of alpibectir, ethionamide and the metabolite ethionamide sulfoxide |
| Secondary | To assess the safety and tolerability of alpibectir and ethionamide (Eto) in patients with TBM | 56 days | Incidence of adverse events (AEs), including AEs ≥ grade 3, serious adverse events (SAEs), and AEs leading to AlpE discontinuation between D1 and D56 |
| Other | To assess the effect of AlpE on the plasma PK of isoniazid (H), rifampicin (R), pyrazinamide (Z), ethambutol (E) (HRZE). | Day 15 | CSF/plasma ratio of HRZE |
| Other | To assess the Mycobacterium tuberculosis (Mtb) culture conversion rate | 15 days | To estimate the Mycobacterium tuberculosis (Mtb) culture conversion rate and time to detection (by MGIT), and cycle threshold (GeneXpert MTB/RIF Ultra) on the CSF and respiratory samples at screening, D3, and D15. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07350174
GET https://conductscience.org/api/trials/v1/NCT07350174/registered