SnakebitePhase 2TOCSINSNCT07500233
Trial of Oral Community SVMP INhibitors for Snakebite
A Phase 2 study testing 2,3-dimercapto-1-propanesulfonic acid, marimastat and Antivenom Snakes in people with Snakebite, run by Liverpool School of Tropical Medicine.
Trial summary
Bites by venomous snakes can cause disability and can be life-threatening. We are doing research in adult patients to try and find medications that can be administered orally and can help to reduce disability and death due to snakebite. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Snakebite
- What is being tested?
- 2,3-dimercapto-1-propanesulfonic acid, marimastat and Antivenom Snakes
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 504 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Snakebite in the preceding 12 hours (Stage A \& B)
- Aged ≥18-years (Stage A \& B)
- Residing in the Amazonas region of Brazil or the Upper West region of Ghana (Stage A \& B)
- Capable of giving informed consent (Stage A \& B)
- Are eligible for antivenom treatment according to local guidelines (Stage B only)
Who cannot join
- individual with severe envenoming (defined in the protocol) (Stage A \& B)
- concomitant anticoagulation (heparins, coumarin anticoagulants such as warfarin, or direct oral anticoagulants such as apixaban) (Stage A \& B)
- pregnant or breastfeeding (Stage A \& B)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 2 Randomised Placebo-controlled Platform Trial of Snake Venom Metalloproteinase Inhibitors for Snakebite Envenoming in Brazil and Ghana
Bites by venomous snakes can cause disability and can be life-threatening. We are doing research in adult patients to try and find medications that can be administered orally and can help to reduce disability and death due to snakebite. We do not know whether the drugs in this study work in humans and we aim to discover this.
In Stage A, we will provide a new drug or placebo (inactive medication) in community locations, such as rural health clinics, in Brazil and Ghana. Neither the patient nor the clinical team will know which treatment option has been allocated. If a drug were to show signs of working as a treatment during Stage A, it will progress to Stage B. In Stage B, we will provide the drug or antivenom (the current approved treatment for snakebite) in a hospital setting. During Stage B, the patient and the clinician will know which treatment has been received. The purpose of Stage B is to discover whether the drug might hold promise as an alternative treatment to antivenom in the future. Participants will be monitored closely during Stage B and 'rescue antivenom' will be given if they become unwell.
Read more
The medications being considered were developed for other health conditions, like cancer, so have been given to patients across the world before. The medications may prove effective at inhibiting the damaging effects of snake venom. Each of the trial drugs could be taken by mouth (oral) in community clinics and ambulances, much sooner than the current treatment for snakebite injuries (antivenom), which is only given within hospitals. They may have other advantages too, like reduced cost and less chance of side effects, including severe allergic reaction. Before a medication is included in the trial it will be reviewed and approved by a group of experts. Before a medication is included in Stage B of the trial it will be reviewed for whether it is safe and effective enough (from Stage A results) to be compared against antivenom.
Stage A Participants will be recruited in the field when they attend a community clinic or ambulance. They will be randomly assigned to receive either a study drug or a placebo. When they arrive at hospital, all participants will receive standard of care antivenom. Participants will continue to take study medication (or matching placebo) for 24 hours, and have frequent blood samples collected during their treatment. Once 20 participants have received the drug and twenty have received the placebo, recruitment for this drug will cease. The difference in the improvement in blood clotting studies (how long it takes to clot) will be compared between the participants receiving the drug and the placebo. If the drug shows an improvement in the clotting studies, then it will proceed to Stage B. If the drug fails to improve the clotting studies, or if it is found to cause unsafe side effects, then it will be rejected from progressing to Stage B.
Stage B Participants will be recruited upon arrival at the hospital site and randomly assigned to receive either a study drug shown to be effective in Stage A or standard-of-care antivenom. Study drugs will be administered for 24 hours, during which all participants will undergo frequent blood sampling. Recruitment for each study drug will stop once 48 participants have received the drug and 48 have received antivenom. The primary comparison will be the improvement in blood clotting parameters between the intervention and control groups. If the study drug is safe and achieves a similar improvement to antivenom - allowing for up to a three-hour delay in effect due to oral absorption compared with intravenous antivenom - it will be considered a promising alternative therapy.
Following a planned 3-day stay in hospital, all participants from Stage A and B will be followed up at 2 and 6 weeks. These follow-up visits can be conducted by telephone, outpatient hospital visit, or home visit, depending on what is most suitable for that individual. The end of study visit will take place at the 6-week visit.
- Conditions
- Snakebite
- Being tested
- 2,3-dimercapto-1-propanesulfonic acid, marimastat, Oral placebo capsules, Antivenom Snakes
- Keywords
- envenoming
- Medical subject headings
- Snake Bites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2,3-dimercapto-1-propanesulfonic acidDrug
Also called unithiol, DMPS
Oral administration
marimastatDrug
oral administration
Oral placebo capsulesDrug
Oral placebo
Antivenom SnakesDrug
Standard of care IV antivenom recommended in country
| Study group | Role | What they receive |
|---|---|---|
| Oral Placebo Stage A | Placebo comparator | Not described Receives: Drug: Oral placebo capsules |
| Stage B IV Antivenom | Active comparator | Not described Receives: Drug: Antivenom Snakes |
| Stage A & B Oral DMPS | Experimental | Not described Receives: Drug: 2,3-dimercapto-1-propanesulfonic acid |
| Stage A & B Oral Marimastat | Experimental | Not described Receives: Drug: marimastat |
| Stage B IV Marimastat | Experimental | Not described Receives: Drug: marimastat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean time until lab INR is less than 50% of the baseline value (efficacy)
Stage A and B - The mean time until the lab INR is <50% of the baseline value (or less than 1.4 if the baseline value is <2.8) on two consecutive measurements per treatment arm. Time is measured starting from randomisation. Time is measured until the first of the two consecutive measurements being <50% or <1.4. Baseline INR sample is defined as blood collected day 0 post-consent and prior to treatment administration.
Measured: From randomisation until end of admission
Incidence (cumulative) of safety events (safety)
Stage A and B- Incidence (cumulative) of any AE, non-serious AE, SAE, SAR, SUSAR. Cumulative incidence is calculated as the number (%) of participants who experience at least one AE in the pre-specified groups.
Measured: From informed consent until 42 days after randomisation
Secondary outcomes (13)
Stage A- Assess the effect of pre-hospital treatment on INR improvement based on travel time to hospital.
Stage A- Assess the effect of pre-hospital treatment on INR improvement based on travel time to hospital. Amongst participants with baseline INR ≥1.4, the log change in INR, from pre-hospital baseline to hospital arrival, will be analysed using a linear regression model with treatment group, travel time, and their interaction
Measured: Day 0 clinic and hospital
Stage A- Assess the effect of pre-hospital treatment on fibrinogen improvement based on travel time to hospital.
Stage A- Assess the effect of pre-hospital treatment on fibrinogen improvement based on travel time to hospital. Amongst participants with baseline INR ≥1.4, the log change in fibrinogen from pre-hospital baseline to 12 hours after randomisation, will be analysed using a linear regression model with treatment group, travel time, and their interaction.
Measured: Day 0 clinic and hospital
Stage A and B- To determine the acceptability of the intervention between treatment arms in terms of quality of life.
Stage A and B- to determine the acceptability of the intervention between treatment arms as a patient-reported outcome of functioning. Assessed using the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0), a 12-item validated scale measuring disability across six life domains (cognition, mobility, self-care, interpersonal interaction, life activities, and participation). Scores range from 0 to 48, where higher scores indicate greater disability.
Unit of Measure: Units on a scale (0-48)
Measured: Day 14, Day 42 (Stage A and B)
Stage A and B- To determine the acceptability of the intervention between treatment arms as patient-reported outcomes of functioning.
Assessed using the Patient Specific Functional Scale (PSFS), in which participants rate their ability to perform up to three self-nominated activities on a numerical scale from 0 to 10, where 0 indicates inability to perform the activity and 10 indicates full pre-injury ability. Higher scores indicate better function. Unit of Measure: Units on a scale (0-10).
Measured: Day 14 and Day 42 post-randomisation (Stage A and B)
Stage A and B- To evaluate the reach of the intervention (Participant refusal rate)
Stage A and B- To evaluate the reach of the intervention. Monitor enrolment data based on % refusal.
Measurement: Percentage of eligible patients who decline participation Unit of measure: Percentage (%)
Measured: Day 0 clinic (Stage A) or hospital (Stage B)
Stage A and B- To evaluate the reach of the intervention (Exclusion rate)
Stage A and B- To evaluate the reach of the intervention. Monitor enrolment data based on % exclusion.
Measurement: Percentage of screened patients excluded due to protocol-defined exclusion criteria.
Unit of measure: Percentage (%)
Measured: Day 0 clinic (Stage A) or hospital (Stage B)
Stage A and B- To evaluate the reach of the intervention (Time between bite and treatment received)
Stage A and B- To evaluate the reach of the intervention. Monitor enrolment data based on time between bite and treatment received.
Measurement: Time elapsed between reported snakebite and receipt of study treatment.
Unit of measure: Hours
Measured: Day 0 clinic (Stage A) or hospital (Stage B)
Stage A and B-To evaluate the reach of the intervention based on recruitment rate across the study catchment area (Recruitment rate)
Stage A and B- To evaluate the reach of the intervention. Monitor enrolment data based recruitment rate across the study catchment area.
Measurement: Rate of participant enrolment across the study catchment area. Unit of measure: Participants per site per month
Measured: Day 0 clinic (Stage A) or hospital (Stage B)
Stage A and B- Identify benefits of and barriers for future implementation of the intervention.
Stage A and B- Identify benefits of and barriers for future implementation of the intervention. Mixed-methods following the Consolidated Framework Implementation Research interviewing participants and health care providers
Measured: Day 42
Stage A- To determine differences in resolution of clinically relevant non-serious bleeding events.
Stage A- To determine differences in resolution of clinically relevant non-serious bleeding events. Amongst all participants with non-major bleeding (epistaxis, gingival bleeding, or bleeding from a venepuncture site for >5 min) at randomisation, proportion with cessation of bleeding on arrival to the hospital site per treatment arm.
Measured: Day 0 clinic and hospital
Stage B- Assess the effect of time to treatment on INR improvement (based on estimated time from bite until administration of the treatment).
Stage B- Assess the effect of time to treatment on INR improvement (based on estimated time from bite until administration of the treatment). Amongst participants with baseline INR ≥1.4, change in INR from baseline to 6 hours, analysed using a linear regression model with treatment group, estimated time from bite to treatment, and their interaction
Measured: Day 0 hospital
Stage B- Assess the effect of time to treatment on fibrinogen improvement (based on estimated time from bite until administration of the treatment).
Stage B- Assess the effect of time to treatment on fibrinogen improvement (based on estimated time from bite until administration of the treatment). Amongst participants with baseline INR ≥1.4, change in fibrinogen from baseline to 12 hours, analysed using a linear regression model with treatment group, estimated time from bite to treatment, and their interaction
Measured: Day 0 hospital
Stage B- To determine differences in resolution of clinically relevant non-serious bleeding events.
Stage B- To determine differences in resolution of clinically relevant non-serious bleeding events. Amongst all participants with non-major bleeding (epistaxis, gingival bleeding, or bleeding from a venepuncture site for >5 min) at randomisation, proportion with cessation of bleeding at 3 hours after randomisation per treatment arm.
Measured: Day 0 hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study startJan 2027 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SnakebiteStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 504 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool School of Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Coefficient Giving, Kumasi Centre for Collaborative Research (KCCR), Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500233
- Sponsor's protocol ID
- 25-033-310
- Acronym
- TOCSINS
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified IPD and related documents will be shared via a trial repository.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomised Placebo-controlled Platform Trial of Snake Venom Metalloproteinase Inhibitors for Snakebite Envenoming in Brazil and Ghana
- ClinicalTrials.gov ID
- NCT07500233
- Acronym / sponsor ID
- TOCSINS / 25-033-310
- Conditions
- Snakebite
- Keywords
- envenoming
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 504 participants (estimated)
- Lead sponsor
- Liverpool School of Tropical MedicineUniversity, hospital or other
- Collaborators
- Coefficient Giving, Kumasi Centre for Collaborative Research (KCCR), Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
- Study start
- Jan 2027 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 30 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.
Bites by venomous snakes can cause disability and can be life-threatening. We are doing research in adult patients to try and find medications that can be administered orally and can help to reduce disability and death due to snakebite. We do not know whether the drugs in this study work in humans and we aim to discover this.
In Stage A, we will provide a new drug or placebo (inactive medication) in community locations, such as rural health clinics, in Brazil and Ghana. Neither the patient nor the clinical team will know which treatment option has been allocated. If a drug were to show signs of working as a treatment during Stage A, it will progress to Stage B. In Stage B, we will provide the drug or antivenom (the current approved treatment for snakebite) in a hospital setting. During Stage B, the patient and the clinician will know which treatment has been received. The purpose of Stage B is to discover whether the drug might hold promise as an alternative treatment to antivenom in the future. Participants will be monitored closely during Stage B and 'rescue antivenom' will be given if they become unwell.
The medications being considered were developed for other health conditions, like cancer, so have been given to patients across the world before. The medications may prove effective at inhibiting the damaging effects of snake venom. Each of the trial drugs could be taken by mouth (oral) in community clinics and ambulances, much sooner than the current treatment for snakebite injuries (antivenom), which is only given within hospitals. They may have other advantages too, like reduced cost and less chance of side effects, including severe allergic reaction. Before a medication is included in the trial it will be reviewed and approved by a group of experts. Before a medication is included in Stage B of the trial it will be reviewed for whether it is safe and effective enough (from Stage A results) to be compared against antivenom.
Stage A Participants will be recruited in the field when they attend a community clinic or ambulance. They will be randomly assigned to receive either a study drug or a placebo. When they arrive at hospital, all participants will receive standard of care antivenom. Participants will continue to take study medication (or matching placebo) for 24 hours, and have frequent blood samples collected during their treatment. Once 20 participants have received the drug and twenty have received the placebo, recruitment for this drug will cease. The difference in the improvement in blood clotting studies (how long it takes to clot) will be compared between the participants receiving the drug and the placebo. If the drug shows an improvement in the clotting studies, then it will proceed to Stage B. If the drug fails to improve the clotting studies, or if it is found to cause unsafe side effects, then it will be rejected from progressing to Stage B.
Stage B Participants will be recruited upon arrival at the hospital site and randomly assigned to receive either a study drug shown to be effective in Stage A or standard-of-care antivenom. Study drugs will be administered for 24 hours, during which all participants will undergo frequent blood sampling. Recruitment for each study drug will stop once 48 participants have received the drug and 48 have received antivenom. The primary comparison will be the improvement in blood clotting parameters between the intervention and control groups. If the study drug is safe and achieves a similar improvement to antivenom - allowing for up to a three-hour delay in effect due to oral absorption compared with intravenous antivenom - it will be considered a promising alternative therapy.
Following a planned 3-day stay in hospital, all participants from Stage A and B will be followed up at 2 and 6 weeks. These follow-up visits can be conducted by telephone, outpatient hospital visit, or home visit, depending on what is most suitable for that individual. The end of study visit will take place at the 6-week visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Oral Placebo Stage A | Placebo comparator | Drug: Oral placebo capsules |
| Stage B IV Antivenom | Active comparator | Drug: Antivenom Snakes |
| Stage A & B Oral DMPS | Experimental | Drug: 2,3-dimercapto-1-propanesulfonic acid |
| Stage A & B Oral Marimastat | Experimental | Drug: marimastat |
| Stage B IV Marimastat | Experimental | Drug: marimastat |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Snakebite in the preceding 12 hours (Stage A \& B)
- Aged ≥18-years (Stage A \& B)
- Residing in the Amazonas region of Brazil or the Upper West region of Ghana (Stage A \& B)
- Capable of giving informed consent (Stage A \& B)
- Are eligible for antivenom treatment according to local guidelines (Stage B only)
Key exclusion criteria (3 listed)
- individual with severe envenoming (defined in the protocol) (Stage A \& B)
- concomitant anticoagulation (heparins, coumarin anticoagulants such as warfarin, or direct oral anticoagulants such as apixaban) (Stage A \& B)
- pregnant or breastfeeding (Stage A \& B)
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 |
|---|---|---|
| 2,3-dimercapto-1-propanesulfonic acidAlso: unithiol, DMPSOral administration | Drug | Stage A & B Oral DMPS |
| marimastatoral administration | Drug | Stage A & B Oral Marimastat, Stage B IV Marimastat |
| Oral placebo capsulesOral placebo | Drug | Oral Placebo Stage A |
| Antivenom SnakesStandard of care IV antivenom recommended in country | Drug | Stage B IV Antivenom |
Primary outcome
Mean time until lab INR is less than 50% of the baseline value (efficacy)
Time frame: From randomisation until end of admission
Stage A and B - The mean time until the lab INR is <50% of the baseline value (or less than 1.4 if the baseline value is <2.8) on two consecutive measurements per treatment arm. Time is measured starting from randomisation. Time is measured until the first of the two consecutive measurements being <50% or <1.4. Baseline INR sample is defined as blood collected day 0 post-consent and prior to treatment administration.
Incidence (cumulative) of safety events (safety)
Time frame: From informed consent until 42 days after randomisation
Stage A and B- Incidence (cumulative) of any AE, non-serious AE, SAE, SAR, SUSAR. Cumulative incidence is calculated as the number (%) of participants who experience at least one AE in the pre-specified groups.
13 secondary outcomes
Stage A- Assess the effect of pre-hospital treatment on INR improvement based on travel time to hospital.
Time frame: Day 0 clinic and hospital
Stage A- Assess the effect of pre-hospital treatment on fibrinogen improvement based on travel time to hospital.
Time frame: Day 0 clinic and hospital
Stage A and B- To determine the acceptability of the intervention between treatment arms in terms of quality of life.
Time frame: Day 14, Day 42 (Stage A and B)
Stage A and B- To determine the acceptability of the intervention between treatment arms as patient-reported outcomes of functioning.
Time frame: Day 14 and Day 42 post-randomisation (Stage A and B)
Stage A and B- To evaluate the reach of the intervention (Participant refusal rate)
Time frame: Day 0 clinic (Stage A) or hospital (Stage B)
Stage A and B- To evaluate the reach of the intervention (Exclusion rate)
Time frame: Day 0 clinic (Stage A) or hospital (Stage B)
Stage A and B- To evaluate the reach of the intervention (Time between bite and treatment received)
Time frame: Day 0 clinic (Stage A) or hospital (Stage B)
Stage A and B-To evaluate the reach of the intervention based on recruitment rate across the study catchment area (Recruitment rate)
Time frame: Day 0 clinic (Stage A) or hospital (Stage B)
Stage A and B- Identify benefits of and barriers for future implementation of the intervention.
Time frame: Day 42
Stage A- To determine differences in resolution of clinically relevant non-serious bleeding events.
Time frame: Day 0 clinic and hospital
Stage B- Assess the effect of time to treatment on INR improvement (based on estimated time from bite until administration of the treatment).
Time frame: Day 0 hospital
Stage B- Assess the effect of time to treatment on fibrinogen improvement (based on estimated time from bite until administration of the treatment).
Time frame: Day 0 hospital
Stage B- To determine differences in resolution of clinically relevant non-serious bleeding events.
Time frame: Day 0 hospital
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 May 2026.
- Individual participant dataSharing planned: Yes. Deidentified IPD and related documents will be shared via a trial repository.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 2,3-dimercapto-1-propanesulfonic acid, marimastat and Antivenom Snakes in people with Snakebite, run by Liverpool School of Tropical Medicine.
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 5 inclusion and 3 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 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 TOCSINS Trial Management (+44(0)1517053100, tocsins@lstmed.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean time until lab INR is less than 50% of the baseline value (efficacy) (time frame: From randomisation until end of admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2026.