Pulmonary TuberculosisPhase 2AIPH-TB-RCT-P2NCT07467252
AIPH-TB: AI-Optimised Pyrazinamide-Hydroxychloroquine vs Standard RIPE for Drug-Sensitive Pulmonary Tuberculosis - A Phase II RCT
A Phase 2 study testing Pyrazinamide and Hydroxychloroquine (AI-Optimised) and Standard RIPE Regimen (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol) in people with Pulmonary Tuberculosis, run by Ministry of Health, Saudi Arabia at 1 site in Saudi Arabia.
Trial summary
Tuberculosis (TB) kills 1.3 million people annually and remains the world's deadliest bacterial disease. The standard four-drug RIPE regimen achieves only 85% cure rates and causes drug-induced hepatotoxicity in 25-37% of patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pulmonary Tuberculosis
- What is being tested?
- Pyrazinamide and Hydroxychloroquine (AI-Optimised) and Standard RIPE Regimen (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Sep 2026to Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of drug-sensitive pulmonary tuberculosis (bacteriologically confirmed by positive sputum smear microscopy or GeneXpert MTB/RIF)
- Age 18 to 65 years
- Naive to anti-tuberculosis treatment (no previous TB treatment or less than 1 month of TB treatment in the past)
- Willing to provide written informed consent
- Able to comply with study visits and procedures
- HIV-negative or HIV-positive with CD4 count ≥200 cells/mm³ on stable antiretroviral therapy
Who cannot join
- Drug-resistant tuberculosis (confirmed resistance to Rifampicin or Isoniazid)
- Severe hepatic impairment (Child-Pugh Class C) or ALT/AST >3 times upper limit of normal
- Severe renal impairment (eGFR <30 mL/min/1.73m²)
- Known hypersensitivity to Pyrazinamide, Hydroxychloroquine, or any RIPE drugs
- Pregnancy or breastfeeding
- Retinal disease or known contraindications to Hydroxychloroquine
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- Concomitant use of medications with significant interactions with study drugs
- Extrapulmonary tuberculosis as the primary site
- Currently enrolled in another clinical trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site
Riyadh First Health Cluster, Ministry of Health
Riyadh, Riyadh Region, 11176
Amr Ahmed, MD, PhD, +966112010000, amr.ahmed@moh.gov.sa
About this study
Official title: A Phase II, Open-Label, Randomised, Parallel-Group, Active-Controlled Trial Evaluating the Efficacy, Safety, and Tolerability of AI-Optimised Pyrazinamide 1,500 mg / Hydroxychloroquine 200 mg Twice Daily (AIPH-TB Protocol) Versus Standard Four-Drug RIPE Regimen in Adults With Newly Diagnosed Drug-Sensitive Pulmonary Tuberculosis
Tuberculosis (TB) kills 1.3 million people annually and remains the world's deadliest bacterial disease. The standard four-drug RIPE regimen achieves only 85% cure rates and causes drug-induced hepatotoxicity in 25-37% of patients. Hydroxychloroquine (HCQ), an FDA-approved antimalarial, has been shown to synergise with pyrazinamide (PZA) by inhibiting the BCRP-1 efflux pump and raising phagolysosomal pH, increasing intracellular PZA concentrations (FICI 0.38 in vitro). The AIPH-TB computational framework (Artificial Intelligence Physicochemical Harmonisation for Tuberculosis) uses multi-objective reinforcement learning, Gaussian process regression, and a digital twin macrophage simulator to identify an AI-optimised dosing schedule that maximises this synergy (PZA 1,500 mg + HCQ 200 mg at 0800 and HCQ 200 mg at 2000), maintaining phagolysosomal pH within 5.2-5.8 for 18 of 24 hours. The computational model predicts FICI 0.28 (strongly synergistic), 9.4-fold increase in intracellular PZA concentration, 99.5% cure rate, and <1.5% hepatotoxicity. This Phase II randomised controlled trial will test whether the AI-optimised PYZ-HCQ protocol is superior to standard RIPE in 200 newly-diagnosed drug-sensitive pulmonary TB patients over 6 months of treatment with 6 months of follow-up.
Read the detailed description
BACKGROUND AND RATIONALE:
Pyrazinamide (PZA) is the only first-line agent active against dormant intracellular MTB, making it irreplaceable for sterilising activity. Its clinical utility is limited by BCRP-1-mediated efflux - after entering the phagolysosome, PZA is rapidly expelled before it can be protonated to its active form, pyrazinoic acid (POA). Hydroxychloroquine (HCQ) inhibits BCRP-1 and raises phagolysosomal pH. The AIPH-TB AI framework identified that an oscillating HCQ schedule (0800/2000) maintains optimal pH 5.2-5.8 for 18 h/day - a 125% improvement over unoptimised dosing - and predicts a novel second mechanism: reduction of mycobacterial cell wall zeta potential from -18 mV to -8 mV, increasing membrane permeability to POA by 340%.
STUDY DESIGN OVERVIEW:
This is a Phase II, open-label, randomised, parallel-group, active-controlled superiority trial conducted at two tertiary TB treatment centres in Riyadh, Saudi Arabia. Participants will be randomised 1:1 to receive either the AIPH-TB protocol (Arm A) or standard RIPE therapy (Arm B) for 6 months, with 6 months post-treatment follow-up (total study duration per participant: 12 months).
RANDOMISATION:
Block randomisation (block size 4 and 6, randomly varied), stratified by site and HIV status. Centralised web-based randomisation via REDCap (MOH Research Directorate Biostatistics Unit).
BLINDING:
Open-label study. Laboratory personnel processing sputum cultures and liver enzyme results are blinded to treatment arm (assessor-blind for primary outcomes). The DSMB will conduct unblinded interim analyses.
SAMPLE SIZE:
Total 200 participants (100 per arm). Based on 80% sputum culture conversion at Week 8 for standard RIPE vs 95% for AIPH-TB (15 percentage point difference), alpha=0.05, power=80%, with 25% dropout inflation.
- Conditions
- Pulmonary Tuberculosis
- Being tested
- Pyrazinamide and Hydroxychloroquine (AI-Optimised), Standard RIPE Regimen (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol)
- Keywords
- Tuberculosis, Pyrazinamide, Hydroxychloroquine, Artificial Intelligence, Drug-Sensitive TB, AIPH-TB
- Medical subject headings
- Tuberculosis, Pulmonary, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyrazinamide and Hydroxychloroquine (AI-Optimised)Drug
AI-optimised combination drug regimen consisting of Pyrazinamide (PYZ) and Hydroxychloroquine (HCQ) for treating drug-sensitive pulmonary tuberculosis. Dosing is personalised using AI algorithms that analyse patient pharmacokinetic parameters, pharmacogenomic data, and real-time treatment response. The AI system adjusts doses to optimise bactericidal activity while minimising adverse effects. PYZ dose: 15-30 mg/kg/day; HCQ dose: 200-400 mg/day, duration adjusted per AI protocol over 6 months.
Standard RIPE Regimen (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol)Drug
Standard WHO first-line anti-tuberculosis treatment regimen: 2 months of Rifampicin (R) 10 mg/kg/day, Isoniazid (I) 5 mg/kg/day, Pyrazinamide (Z) 25 mg/kg/day, and Ethambutol (E) 15 mg/kg/day (intensive phase), followed by 4 months of Rifampicin and Isoniazid (continuation phase). Total treatment duration: 6 months.
| Study group | Role | What they receive |
|---|---|---|
| AI-Optimised PYZ-HCQ Arm | Experimental | Participants receive AI-optimised combination of Pyrazinamide (PYZ) and Hydroxychloroquine (HCQ) for drug-sensitive pulmonary tuberculosis. AI algorithms determine optimal dosing and duration based on patient pharmacokinetic and pharmacogenomic parameters over a 4-month intensive phase followed by 2-month continuation phase. Receives: Drug: Pyrazinamide and Hydroxychloroquine (AI-Optimised) |
| Standard RIPE Regimen Arm | Active comparator | Participants receive standard WHO-recommended RIPE regimen (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol) for drug-sensitive pulmonary tuberculosis. Standard 2-month intensive phase followed by 4-month continuation phase with Rifampicin and Isoniazid. Receives: Drug: Standard RIPE Regimen (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sputum Culture Conversion Rate at 2 Months
Proportion of participants achieving sputum culture negativity (conversion from positive to negative culture on Löwenstein-Jensen medium) at 2 months after treatment initiation, compared between AI-optimised PYZ-HCQ arm and standard RIPE arm.
Measured: 2 months after treatment initiation
Secondary outcomes (1)
Treatment Success Rate at 6 Months (End of Treatment)
Proportion of participants achieving treatment success (cure or treatment completion) as defined by WHO criteria at 6 months (end of treatment).
Measured: 6 months (end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulmonary TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Saudi Arabia
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Amr kamel khalil Ahmed, Ministry of Health, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467252
- Sponsor's protocol ID
- PYZ-HCQ-AIPH-001-Ph2
- Acronym
- AIPH-TB-RCT-P2
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to patient privacy and data protection regulations. Aggregate results will be published in peer-reviewed journals.
Publications
Crowle AJ, May MH. Inhibition of tubercle bacilli in cultured human macrophages by chloroquine used alone and in combination with streptomycin, isoniazid, pyrazinamide, and two metabolites of vitamin D3. Antimicrob Agents Chemother. 1990 Nov;34(11):2217-22. doi: 10.1128/AAC.34.11.2217.
PubMed 2127346Zhang Y, Shi W, Zhang W, Mitchison D. Mechanisms of Pyrazinamide Action and Resistance. Microbiol Spectr. 2014 Aug;2(4):MGM2-0023-2013. doi: 10.1128/microbiolspec.MGM2-0023-2013.
PubMed 26104205Zhang N, Savic RM, Boeree MJ, Peloquin CA, Weiner M, Heinrich N, Bliven-Sizemore E, Phillips PPJ, Hoelscher M, Whitworth W, Morlock G, Posey J, Stout JE, Mac Kenzie W, Aarnoutse R, Dooley KE; Tuberculosis Trials Consortium (TBTC) and Pan African Consortium for the Evaluation of Antituberculosis Antibiotics (PanACEA) Networks. Optimising pyrazinamide for the treatment of tuberculosis. Eur Respir J. 2021 Jul 20;58(1):2002013. doi: 10.1183/13993003.02013-2020. Print 2021 Jul.
PubMed 33542052
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-Label, Randomised, Parallel-Group, Active-Controlled Trial Evaluating the Efficacy, Safety, and Tolerability of AI-Optimised Pyrazinamide 1,500 mg / Hydroxychloroquine 200 mg Twice Daily (AIPH-TB Protocol) Versus Standard Four-Drug RIPE Regimen in Adults With Newly Diagnosed Drug-Sensitive Pulmonary Tuberculosis
- ClinicalTrials.gov ID
- NCT07467252
- Acronym / sponsor ID
- AIPH-TB-RCT-P2 / PYZ-HCQ-AIPH-001-Ph2
- Conditions
- Pulmonary Tuberculosis
- Keywords
- Tuberculosis, Pyrazinamide, Hydroxychloroquine, Artificial Intelligence, Drug-Sensitive TB, AIPH-TB
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ministry of Health, Saudi ArabiaOther government
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tuberculosis (TB) kills 1.3 million people annually and remains the world's deadliest bacterial disease. The standard four-drug RIPE regimen achieves only 85% cure rates and causes drug-induced hepatotoxicity in 25-37% of patients. Hydroxychloroquine (HCQ), an FDA-approved antimalarial, has been shown to synergise with pyrazinamide (PZA) by inhibiting the BCRP-1 efflux pump and raising phagolysosomal pH, increasing intracellular PZA concentrations (FICI 0.38 in vitro). The AIPH-TB computational framework (Artificial Intelligence Physicochemical Harmonisation for Tuberculosis) uses multi-objective reinforcement learning, Gaussian process regression, and a digital twin macrophage simulator to identify an AI-optimised dosing schedule that maximises this synergy (PZA 1,500 mg + HCQ 200 mg at 0800 and HCQ 200 mg at 2000), maintaining phagolysosomal pH within 5.2-5.8 for 18 of 24 hours. The computational model predicts FICI 0.28 (strongly synergistic), 9.4-fold increase in intracellular PZA concentration, 99.5% cure rate, and <1.5% hepatotoxicity. This Phase II randomised controlled trial will test whether the AI-optimised PYZ-HCQ protocol is superior to standard RIPE in 200 newly-diagnosed drug-sensitive pulmonary TB patients over 6 months of treatment with 6 months of follow-up.
Detailed description
BACKGROUND AND RATIONALE:
Pyrazinamide (PZA) is the only first-line agent active against dormant intracellular MTB, making it irreplaceable for sterilising activity. Its clinical utility is limited by BCRP-1-mediated efflux - after entering the phagolysosome, PZA is rapidly expelled before it can be protonated to its active form, pyrazinoic acid (POA). Hydroxychloroquine (HCQ) inhibits BCRP-1 and raises phagolysosomal pH. The AIPH-TB AI framework identified that an oscillating HCQ schedule (0800/2000) maintains optimal pH 5.2-5.8 for 18 h/day - a 125% improvement over unoptimised dosing - and predicts a novel second mechanism: reduction of mycobacterial cell wall zeta potential from -18 mV to -8 mV, increasing membrane permeability to POA by 340%.
STUDY DESIGN OVERVIEW:
This is a Phase II, open-label, randomised, parallel-group, active-controlled superiority trial conducted at two tertiary TB treatment centres in Riyadh, Saudi Arabia. Participants will be randomised 1:1 to receive either the AIPH-TB protocol (Arm A) or standard RIPE therapy (Arm B) for 6 months, with 6 months post-treatment follow-up (total study duration per participant: 12 months).
RANDOMISATION:
Block randomisation (block size 4 and 6, randomly varied), stratified by site and HIV status. Centralised web-based randomisation via REDCap (MOH Research Directorate Biostatistics Unit).
BLINDING:
Open-label study. Laboratory personnel processing sputum cultures and liver enzyme results are blinded to treatment arm (assessor-blind for primary outcomes). The DSMB will conduct unblinded interim analyses.
SAMPLE SIZE:
Total 200 participants (100 per arm). Based on 80% sputum culture conversion at Week 8 for standard RIPE vs 95% for AIPH-TB (15 percentage point difference), alpha=0.05, power=80%, with 25% dropout inflation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-Optimised PYZ-HCQ Arm | Experimental | Drug: Pyrazinamide and Hydroxychloroquine (AI-Optimised)Participants receive AI-optimised combination of Pyrazinamide (PYZ) and Hydroxychloroquine (HCQ) for drug-sensitive pulmonary tuberculosis. AI algorithms determine optimal dosing and duration based on patient pharmacokinetic and pharmacogenomic parameters over a 4-month intensive phase followed by 2-month continuation phase. |
| Standard RIPE Regimen Arm | Active comparator | Drug: Standard RIPE Regimen (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol)Participants receive standard WHO-recommended RIPE regimen (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol) for drug-sensitive pulmonary tuberculosis. Standard 2-month intensive phase followed by 4-month continuation phase with Rifampicin and Isoniazid. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Confirmed diagnosis of drug-sensitive pulmonary tuberculosis (bacteriologically confirmed by positive sputum smear microscopy or GeneXpert MTB/RIF)
- Age 18 to 65 years
- Naive to anti-tuberculosis treatment (no previous TB treatment or less than 1 month of TB treatment in the past)
- Willing to provide written informed consent
- Able to comply with study visits and procedures
Key exclusion criteria (9 listed)
- Drug-resistant tuberculosis (confirmed resistance to Rifampicin or Isoniazid)
- Severe hepatic impairment (Child-Pugh Class C) or ALT/AST >3 times upper limit of normal
- Severe renal impairment (eGFR <30 mL/min/1.73m²)
- Known hypersensitivity to Pyrazinamide, Hydroxychloroquine, or any RIPE drugs
- Pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pyrazinamide and Hydroxychloroquine (AI-Optimised)AI-optimised combination drug regimen consisting of Pyrazinamide (PYZ) and Hydroxychloroquine (HCQ) for treating drug-sensitive pulmonary tuberculosis. Dosing is personalised using AI algorithms that analyse patient pharmacokinetic parameters, pharmacogenomic data, and real-time treatment response. The AI system adjusts doses to optimise bactericidal activity while minimising adverse effects. PYZ dose: 15-30 mg/kg/day; HCQ dose: 200-400 mg/day, duration adjusted per AI protocol over 6 months. | Drug | AI-Optimised PYZ-HCQ Arm |
| Standard RIPE Regimen (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol)Standard WHO first-line anti-tuberculosis treatment regimen: 2 months of Rifampicin (R) 10 mg/kg/day, Isoniazid (I) 5 mg/kg/day, Pyrazinamide (Z) 25 mg/kg/day, and Ethambutol (E) 15 mg/kg/day (intensive phase), followed by 4 months of Rifampicin and Isoniazid (continuation phase). Total treatment duration: 6 months. | Drug | Standard RIPE Regimen Arm |
Primary outcome
Sputum Culture Conversion Rate at 2 Months
Time frame: 2 months after treatment initiation
Proportion of participants achieving sputum culture negativity (conversion from positive to negative culture on Löwenstein-Jensen medium) at 2 months after treatment initiation, compared between AI-optimised PYZ-HCQ arm and standard RIPE arm.
1 secondary outcome
Treatment Success Rate at 6 Months (End of Treatment)
Time frame: 6 months (end of treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Background: PubMed 2127346Crowle AJ, May MH. Inhibition of tubercle bacilli in cultured human macrophages by chloroquine used alone and in combination with streptomycin, isoniazid, pyrazinamide, and two metabolites of vitamin D3. Antimicrob Agents Chemother. 1990 Nov;34(11):2217-22. doi: 10.1128/AAC.34.11.2217.
- Background: PubMed 26104205Zhang Y, Shi W, Zhang W, Mitchison D. Mechanisms of Pyrazinamide Action and Resistance. Microbiol Spectr. 2014 Aug;2(4):MGM2-0023-2013. doi: 10.1128/microbiolspec.MGM2-0023-2013.
- Background: PubMed 33542052Zhang N, Savic RM, Boeree MJ, Peloquin CA, Weiner M, Heinrich N, Bliven-Sizemore E, Phillips PPJ, Hoelscher M, Whitworth W, Morlock G, Posey J, Stout JE, Mac Kenzie W, Aarnoutse R, Dooley KE; Tuberculosis Trials Consortium (TBTC) and Pan African Consortium for the Evaluation of Antituberculosis Antibiotics (PanACEA) Networks. Optimising pyrazinamide for the treatment of tuberculosis. Eur Respir J. 2021 Jul 20;58(1):2002013. doi: 10.1183/13993003.02013-2020. Print 2021 Jul.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to patient privacy and data protection regulations. Aggregate results will be published in peer-reviewed journals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pyrazinamide and Hydroxychloroquine (AI-Optimised) and Standard RIPE Regimen (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol) in people with Pulmonary Tuberculosis, run by Ministry of Health, Saudi Arabia at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact amr K.K. Ahmed, MD, MSc (00966597310032, drmedahmed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sputum Culture Conversion Rate at 2 Months (time frame: 2 months after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07467252, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.