Reversing Vecuronium-Induced Neuromuscular Blockade in Patients Undergoing General Anesthesia SurgeryPhase 2NCT07595393
A Dose-Finding Study of Amogammadex Sodium for Reversing Vecuronium and Rocuronium-Induced Neuromuscular Blockade
A Phase 2 study testing Rocuronium (0.6mg/kg) and vecuronium bromide (0.1mg/kg) in people with Reversing Vecuronium-Induced Neuromuscular Blockade in Patients Undergoing General Anesthesia Surgery and Reversing Rocuronium-Induced Neuromuscular Blockade in Patients Undergoing General Anesthesia Surgery, run by Amckaus PTY LTD..
Trial summary
Background context: Amogammadex sodium has completed Phase I-III clinical studies in China for reversal of rocuronium-induced blockade. No clinical studies have yet been conducted for vecuronium-induced blockade. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Reversing Vecuronium-Induced Neuromuscular Blockade in Patients Undergoing General Anesthesia Surgery, Reversing Rocuronium-Induced Neuromuscular Blockade in Patients Undergoing General Anesthesia Surgery
- What is being tested?
- Rocuronium (0.6mg/kg) and vecuronium bromide (0.1mg/kg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 30 Dec 2027
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants should be willing to participate in the clinical study; the participants should fully understand and know this study and sign an informed consent form; the participants should be willing to follow and be able to complete all study procedures.
- Male or female, 18 ≤ age ≤ 60.
- Participant with the grade of American Society of Anaesthesiologists (ASA) physical status classification 1-2.
- Participants who are scheduled to undergo approximately 2-hour surgery under TIVA with endotracheal intubation, and for whom vecuronium or rocuronium bromide is planned as the sole neuromuscular blocking agent.
- Body mass index (BMI) between 18 and 32 kg/m2 (both exclusive), and weight ≥ 50 kg for males and ≥ 45 kg for females.
- Willingness to use adequate contraception (abstinence is acceptable if it aligns with lifestyle) and refrain from pregnancy, impregnating a partner, or donating sperm/ova from screening until 3 months after study completion. Females of nonchildbearing potential are exempt.
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- 1)For females of childbearing potential: an adequate method of contraception is defined as the use of a condom by the male partner combined with the use of a highly effective method of contraception, either be sexually inactive (abstinent) for 28 days prior to the first dose and throughout the study, or be using one of the following acceptable birth control methods:
- Intrauterine device in place for at least 3 months prior to dosing with a barrier method (condom or diaphragm) and spermicide (if available) throughout the study
- Double barrier methods (e.g., condom and diaphragm) with spermicide (if available) for at least 28 days prior to dosing and throughout the study
- Surgical sterilization of the partner (vasectomy for 6 months minimum) with a barrier method (e.g., condom or diaphragm) and spermicide (if available) throughout the study.
- Bilateral tubal occlusion (e.g. Essure-non-surgical sterility procedure and Bilateral tubal ligation), and/or a vasectomized partner with documented azoospermia 90 days after procedure, if that partner is the sole sexual partner.
- 2)For males: An adequate method of contraception is defined as use of a condom combined with the use of a highly effective method of contraception by the female partner of childbearing potential. Non-sterilized males with a female partner of childbearing potential must agree to use a double barrier method of birth control until five half-lives plus 90 days after the administration of the study drug.
- 7.Female participants must be non-pregnant (confirmed by a negative serum at screening and urine pregnancy test on Day -1), non-lactating, or be of nonchildbearing potential (females who have been postmenopausal [defined as 24 months of amenorrhea in the absence of other biological cause] or are surgically sterile [hysterectomy or bilateral oophorectomy or bilateral complete salpingectomy]).
Who cannot join
- Known or expected difficult intubation due to anatomical deformities
- Known or suspected neuromuscular diseases, anatomical abnormality or neurological injury history that may affect neuromuscular transmission.
- History or manifestation of disease that, in the opinion of the investigator, renders the participant unsuitable for the study, including but not limited to nervous system, cardiovascular, blood, lymphatic, immune, kidney, liver, gastrointestinal, respiratory, metabolic, and musculoskeletal disorders.
- Participants with abnormal blood pressure not satisfactorily controlled (systolic blood pressure >160 mmHg or < 90 mmHg, diastolic blood pressure > 100 mmHg or < 60 mmHg). For subjects with systolic blood pressure ≥ 140 mmHg and ≤ 160 mmHg or diastolic blood pressure ≥ 90 mmHg and ≤ 100 mmHg and a history of well-controlled blood pressure, and no definite discomfort symptoms, the determination of clinical significance will be made at investigator discretion.
- Known heart failure or other serious cardiovascular diseases with New York Heart Association (NYHA) functional class III or IV; with abnormal ECG, QTcF interval (using Fridericia's formula) male > 450 ms, female > 470 ms, which is judged to have clinical significance by the investigators; with resting heart rate < 60 bpm or > 100 bpm, which is judged to have clinical significance by the investigators.
- History of human immunodeficiency virus (HIV); or positive results at screening for HIV antibody/antigen (HIV Ab/Ag)
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- Hepatic insufficiency or known liver disease:
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.0 × upper limit of normal (ULN);
- Known liver disease, such as acute hepatitis, chronic hepatitis (HBsAg positive with liver function abnormalities meeting the above criterion a, anti-HCV positive), liver cirrhosis, etc., deemed by the investigator as inappropriate for study inclusion.
- kidney function impairment: Serum creatinine (Cr) >1.5 × ULN or having previously known severe kidney diseases or Estimated Glomerular Filtration Rate (eGFR) (CKD-EPI 2021 formula) < 60 ml/(min·1.73m²) or renal insufficiency.
- Participants who had hereditary haemorrhagic diseases, coagulation disease, or non-traumatic bleeding history (bleeding that requires treatment), and thromboembolism; and currently have a risk of haemorrhage (including coagulation disease, thrombocytopenia [platelet count < 100×109/L], thrombin original international standardized ratio > 1.5 or on a routine anticoagulation therapy).
- Participants known or suspected to have malignant hyperthermia or with family history; febrile illness defined as a body temperature above 37.5℃ within 7 days before administration.
- Systemic allergic reactions caused by any known reasons, including food allergy and allergy to animals; participants known or suspected to be allergic to cyclodextrin including sugammadex, anesthetics, muscle relaxants and other drugs used in general anesthesia; participants known to be allergic to gel electrodes.
- Participants who have taken fusidic acid and/or toremifene citrate within 24 hours prior to or scheduled within 24 hours after the study drug administration. Participants receiving drugs known to affect muscle relaxants within 24 hours before or during surgery (e.g., anticonvulsants, aminoglycoside antibiotics, magnesium salts [Mg2+]) except for supplements to maintain physiological levels.
- Participants with suspected alcohol or drug abuse;
- Participation in strenuous activity (e.g., heavy lifting, strenuous running, competitive sports such as basketball, football, and singles tennis, mountain climbing, rowing machine training, etc) within 48 hours prior to dosing (Day 1).
- Anatomical deformities on upper extremities that cannot perform monitoring mentioned in the protocol: non-invasive blood pressure monitor, ECG, pulse oximetry, end-tidal capnography and neuromuscular monitoring.
- Participants who participated in other clinical trials within 3 months before the administration.
- Female participants who are pregnant or breastfeeding, who have a positive serum or urine pregnancy test result, or who are unable or unwilling to take contraceptive or abstinence measures approved by the investigator during the study.
- Participants who are considered not suitable for participating in a clinical trial by the investigator or the surgeon.
About this study
Official title: A Multi-Centre, Open-Label, Phase II Study of Amogammadex Sodium as A Reversal Agent for Vecuronium Bromide or Rocuronium Bromide-Induced Moderate (at the Reappearance of T2) and Deep (PTC=1~2) Neuromuscular Blockade in Participants Undergoing ASA Grade 1-2 Elective Surgery
Background context: Amogammadex sodium has completed Phase I-III clinical studies in China for reversal of rocuronium-induced blockade. No clinical studies have yet been conducted for vecuronium-induced blockade. Therefore, this dose-finding study in an Australian population is intended to support further Phase III trials in European and American populations for reversal of both rocuronium- and vecuronium-induced neuromuscular blockade.
The goal of this clinical trial is to explore how well different doses of amogammadex sodium work to reverse neuromuscular blockade caused by rocuronium or vecuronium during surgery, and to learn about its safety. The main questions it aims to answer are:
Read more
- How quickly and effectively does amogammadex sodium restore muscle strength after moderate or deep neuromuscular blockade?
- What medical problems do participants have when receiving amogammadex sodium?
Researchers will compare different doses of amogammadex sodium to see which works best. All participants will receive amogammadex sodium, but at different dose levels depending on when they join the study.
Participants will:
- Undergo screening up to 28 days before surgery to confirm eligibility
- Receive amogammadex sodium at the end of surgery to reverse the effects of the muscle relaxant
- Stay in the study for follow-up visits up to 7 days after surgery.
- Conditions
- Reversing Vecuronium-Induced Neuromuscular Blockade in Patients Undergoing General Anesthesia Surgery, Reversing Rocuronium-Induced Neuromuscular Blockade in Patients Undergoing General Anesthesia Surgery
- Being tested
- Rocuronium (0.6mg/kg), vecuronium bromide (0.1mg/kg)
- Keywords
- Amogammadex sodium, neuromuscular blockade, Adamgammadex sodium, rocuronium bromide, vecuronium bromide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocuronium (0.6mg/kg)Drug
a single-dose intravenous bolus of 0.6 mg/kg rocuronium bromide，additional 0.1-0.2 mg/kg can be provided based on the required depth of neuromuscular blockade for surgery.
vecuronium bromide (0.1mg/kg)Drug
A single-dose intravenous bolus of 0.10 mg/kg vecuronium bromide， additional 0.015 mg/kg can be provided based on the required depth of neuromuscular blockade for surgery.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: 4mg/kg amogammadex sodium moderate antagonism | Experimental | Not described Receives: Drug: Rocuronium (0.6mg/kg) |
| Arm 2: 8mg/kg amogammadex sodium moderate antagonism | Experimental | Not described Receives: Drug: vecuronium bromide (0.1mg/kg) |
| Arm 3: 12mg/kg amogammadex sodium moderate antagonism | Experimental | Not described Receives: Drug: vecuronium bromide (0.1mg/kg) |
| Arm 4: 16mg/kg amogammadex sodium moderate antagonism | Experimental | Not described Receives: Drug: vecuronium bromide (0.1mg/kg) |
| Arm 5: 4mg/kg amogammadex sodium deep antagonism | Experimental | Not described Receives: Drug: Rocuronium (0.6mg/kg) |
| Arm 6: 8mg/kg amogammadex sodium deep antagonism | Experimental | Not described Receives: Drug: vecuronium bromide (0.1mg/kg) |
| Arm 7: 12mg/kg amogammadex sodium deep antagonism | Experimental | Not described Receives: Drug: vecuronium bromide (0.1mg/kg) |
| Arm 8: 16mg/kg amogammadex sodium deep antagonism | Experimental | Not described Receives: Drug: vecuronium bromide (0.1mg/kg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Evaluation: The time from the start of the administration of amogammadex sodium to the recovery of the TOFr to 0.9 on day 1.
The TOFr value was measured using the TetraGraph neuromuscular transmission monitor during muscle relaxation monitoring. If The TOFr value is ≥ 0.9 for three consecutive times, the first time is recorded as the time of TOFr recovery to 0.9.
Measured: Time from the start of the administration of IP to the recovery of the TOFr to 0.9 on day 1
Secondary outcomes (2)
The Time from the start of administration of amogammadex sodium to recovery of the TOFr to 0.8 on day 1.
The TOFr value was measured using the TetraGraph neuromuscular transmission monitor during muscle relaxation monitoring. If The TOFr value is ≥ 0.8 for three consecutive times, the first time is recorded as the time of TOFr recovery to 0.8.
Measured: Time from the start of administration of IP to recovery of the TOFr to 0.8 on day 1
The Time from the start of administration of amogammadex sodium to recovery of the TOFr to 0.7 on day 1.
The TOFr value was measured using the TetraGraph neuromuscular transmission monitor during muscle relaxation monitoring. If The TOFr value is ≥ 0.7 for three consecutive times, the first time is recorded as the time of TOFr recovery to 0.7.
Measured: Time from the start of administration of IP to recovery of the TOFr to 0.7 on day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reversing Vecuronium-Induced Neuromuscular Blockade in Patients Undergoing General Anesthesia SurgeryStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amckaus PTY LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07595393
- Sponsor's protocol ID
- Aom0498-ACT02-01
- Status last verified
- May 2026
- First submitted
- 20 Apr 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre, Open-Label, Phase II Study of Amogammadex Sodium as A Reversal Agent for Vecuronium Bromide or Rocuronium Bromide-Induced Moderate (at the Reappearance of T2) and Deep (PTC=1~2) Neuromuscular Blockade in Participants Undergoing ASA Grade 1-2 Elective Surgery
- ClinicalTrials.gov ID
- NCT07595393
- Acronym / sponsor ID
- Aom0498-ACT02-01
- Conditions
- Reversing Vecuronium-Induced Neuromuscular Blockade in Patients Undergoing General Anesthesia Surgery, Reversing Rocuronium-Induced Neuromuscular Blockade in Patients Undergoing General Anesthesia Surgery
- Keywords
- Amogammadex sodium, neuromuscular blockade, Adamgammadex sodium, rocuronium bromide, vecuronium bromide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Amckaus PTY LTD.Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 19 May 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.
Background context: Amogammadex sodium has completed Phase I-III clinical studies in China for reversal of rocuronium-induced blockade. No clinical studies have yet been conducted for vecuronium-induced blockade. Therefore, this dose-finding study in an Australian population is intended to support further Phase III trials in European and American populations for reversal of both rocuronium- and vecuronium-induced neuromuscular blockade.
The goal of this clinical trial is to explore how well different doses of amogammadex sodium work to reverse neuromuscular blockade caused by rocuronium or vecuronium during surgery, and to learn about its safety. The main questions it aims to answer are:
- How quickly and effectively does amogammadex sodium restore muscle strength after moderate or deep neuromuscular blockade?
- What medical problems do participants have when receiving amogammadex sodium?
Researchers will compare different doses of amogammadex sodium to see which works best. All participants will receive amogammadex sodium, but at different dose levels depending on when they join the study.
Participants will:
- Undergo screening up to 28 days before surgery to confirm eligibility
- Receive amogammadex sodium at the end of surgery to reverse the effects of the muscle relaxant
- Stay in the study for follow-up visits up to 7 days after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Arm 1: 4mg/kg amogammadex sodium moderate antagonism | Experimental | Drug: Rocuronium (0.6mg/kg) |
| Arm 2: 8mg/kg amogammadex sodium moderate antagonism | Experimental | Drug: vecuronium bromide (0.1mg/kg) |
| Arm 3: 12mg/kg amogammadex sodium moderate antagonism | Experimental | Drug: vecuronium bromide (0.1mg/kg) |
| Arm 4: 16mg/kg amogammadex sodium moderate antagonism | Experimental | Drug: vecuronium bromide (0.1mg/kg) |
| Arm 5: 4mg/kg amogammadex sodium deep antagonism | Experimental | Drug: Rocuronium (0.6mg/kg) |
| Arm 6: 8mg/kg amogammadex sodium deep antagonism | Experimental | Drug: vecuronium bromide (0.1mg/kg) |
| Arm 7: 12mg/kg amogammadex sodium deep antagonism | Experimental | Drug: vecuronium bromide (0.1mg/kg) |
| Arm 8: 16mg/kg amogammadex sodium deep antagonism | Experimental | Drug: vecuronium bromide (0.1mg/kg) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Participants should be willing to participate in the clinical study; the participants should fully understand and know this study and sign an informed consent form; the participants should be willing to follow and be able to complete all study procedures.
- Male or female, 18 ≤ age ≤ 60.
- Participant with the grade of American Society of Anaesthesiologists (ASA) physical status classification 1-2.
- Participants who are scheduled to undergo approximately 2-hour surgery under TIVA with endotracheal intubation, and for whom vecuronium or rocuronium bromide is planned as the sole neuromuscular blocking agent.
- Body mass index (BMI) between 18 and 32 kg/m2 (both exclusive), and weight ≥ 50 kg for males and ≥ 45 kg for females.
Key exclusion criteria (20 listed)
- Known or expected difficult intubation due to anatomical deformities
- Known or suspected neuromuscular diseases, anatomical abnormality or neurological injury history that may affect neuromuscular transmission.
- History or manifestation of disease that, in the opinion of the investigator, renders the participant unsuitable for the study, including but not limited to nervous system, cardiovascular, blood, lymphatic, immune, kidney, liver, gastrointestinal, respiratory, metabolic, and musculoskeletal disorders.
- Participants with abnormal blood pressure not satisfactorily controlled (systolic blood pressure >160 mmHg or < 90 mmHg, diastolic blood pressure > 100 mmHg or < 60 mmHg). For subjects with systolic blood pressure ≥ 140 mmHg and ≤ 160 mmHg or diastolic blood pressure ≥ 90 mmHg and ≤ 100 mmHg and a history of well-controlled blood pressure, and no definite discomfort symptoms, the determination of clinical significance will be made at investigator discretion.
- Known heart failure or other serious cardiovascular diseases with New York Heart Association (NYHA) functional class III or IV; with abnormal ECG, QTcF interval (using Fridericia's formula) male > 450 ms, female > 470 ms, which is judged to have clinical significance by the investigators; with resting heart rate < 60 bpm or > 100 bpm, which is judged to have clinical significance by the investigators.
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 |
|---|---|---|
| Rocuronium (0.6mg/kg)a single-dose intravenous bolus of 0.6 mg/kg rocuronium bromide，additional 0.1-0.2 mg/kg can be provided based on the required depth of neuromuscular blockade for surgery. | Drug | Arm 1: 4mg/kg amogammadex sodium moderate antagonism, Arm 5: 4mg/kg amogammadex sodium deep antagonism |
| vecuronium bromide (0.1mg/kg)A single-dose intravenous bolus of 0.10 mg/kg vecuronium bromide， additional 0.015 mg/kg can be provided based on the required depth of neuromuscular blockade for surgery. | Drug | Arm 2: 8mg/kg amogammadex sodium moderate antagonism, Arm 3: 12mg/kg amogammadex sodium moderate antagonism, Arm 4: 16mg/kg amogammadex sodium moderate antagonism, Arm 6: 8mg/kg amogammadex sodium deep antagonism, Arm 7: 12mg/kg amogammadex sodium deep antagonism, Arm 8: 16mg/kg amogammadex sodium deep antagonism |
Primary outcome
Efficacy Evaluation: The time from the start of the administration of amogammadex sodium to the recovery of the TOFr to 0.9 on day 1.
Time frame: Time from the start of the administration of IP to the recovery of the TOFr to 0.9 on day 1
The TOFr value was measured using the TetraGraph neuromuscular transmission monitor during muscle relaxation monitoring. If The TOFr value is ≥ 0.9 for three consecutive times, the first time is recorded as the time of TOFr recovery to 0.9.
2 secondary outcomes
The Time from the start of administration of amogammadex sodium to recovery of the TOFr to 0.8 on day 1.
Time frame: Time from the start of administration of IP to recovery of the TOFr to 0.8 on day 1
The Time from the start of administration of amogammadex sodium to recovery of the TOFr to 0.7 on day 1.
Time frame: Time from the start of administration of IP to recovery of the TOFr to 0.7 on day 1
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 19 May 2026.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rocuronium (0.6mg/kg) and vecuronium bromide (0.1mg/kg) in people with Reversing Vecuronium-Induced Neuromuscular Blockade in Patients Undergoing General Anesthesia Surgery and Reversing Rocuronium-Induced Neuromuscular Blockade in Patients Undergoing General Anesthesia Surgery, run by Amckaus PTY LTD..
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 13 inclusion and 20 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 19 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy Evaluation: The time from the start of the administration of amogammadex sodium to the recovery of the TOFr to 0.9 on day 1. (time frame: Time from the start of the administration of IP to the recovery of the TOFr to 0.9 on day 1). 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 19 May 2026.