Hereditary AngioedemaPhase 3NCT04656418
CSL312 (Garadacimab) in the Prevention of Hereditary Angioedema Attacks
A Phase 3 study testing CSL312 in people with Hereditary Angioedema, run by CSL Behring at 28 sites in 7 countries.
Trial summary
This is a multicenter, double-blind, randomized, placebo-controlled, parallel-arm study to investigate the efficacy and safety of subcutaneous administration of CSL312 (garadacimab) in the prophylactic treatment of hereditary angioedema. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Hereditary Angioedema
- What is being tested?
- CSL312
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 28 sitesin 7 countries
- Study dates
- 27 Jan 2021to 7 Jun 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female ≥ 12 years of age; diagnosed with clinically confirmed C1-INH hereditary angioedema; experience ≥ 3 attacks during the 3 months before screening.
- Note: For subjects taking any prophylactic HAE therapy during the 3 months before Screening, ≥ 3 HAE attacks may be documented over 3 consecutive months before commencing the prophylactic therapy.
Who cannot join
- Concomitant diagnosis of another form of angioedema such as idiopathic or acquired angioedema, recurrent angioedema associated with urticarial or hereditary angioedema type 3
Trial locations and contacts
28 sites in 7 countries.
28 sites in 7 countries
United States8 sites
Clinical Research Center of Alabama
Birmingham, Alabama, 35209
Institute of Asthma and Allergy
Chevy Chase, Maryland, 20815
Bernstein Clinical Research Center LLC
Cincinnati, Ohio, 45231
AARA Research Center
Dallas, Texas, 75231
Pennsylvania State University
Hershey, Pennsylvania, 17033
Raffi Tachdjian MD, Inc.
Santa Monica, California, 90404
Medical Research of Arizona
Scottsdale, Arizona, 85251
Allergy and Asthma Clinical Research
Walnut Creek, California, 94598
Japan8 sites
Juntendo University Hospital
Bunkyo, Tokyo, 113-8431
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551
St.Marianna University School of Medicine Hospital
Kawasaki-shi, Kanagawa, 216-8511
Kobe University Hospital
Kobe, Hyōgo, '650-0017
Saga University Hospital
Saga, Saga-shi, '849-8501
Saitama Medical Center
Saitama, Kawagoe-shi, 350-8550
Saiyu Soka Hospital
Saitama, 340-0041
Koga Community Hospital
Yaizu-shi, Shizuoka, 425-0088
Germany5 sites
Charité Universitätsmedizin Berlin
Berlin, 10117
Universitätsklinikum Frankfurt Goethe-Universität
Frankfurt am Main, Hesse, 60590
Universitätsklinikum Leipzig
Leipzig, 04103
CRC Clinical Research / Hautklinik und Poliklinik der Universitätsklinik Mainz
Mainz, 55131
HZRM Hämophilie Zentrum Rhein Main GmbH
Mörfelden-Walldorf, 64546
Canada4 sites
University of Alberta - Research Transition Facility
Edmonton, Alberta, T6G 2B7
Ottawa Allergy Research Corp
Ottawa, Ontario, K1H 1E4
Clinique specialisee en allergie de la Capitale
Québec, G1V 4W2
Gordon Sussman Clinical Research Inc.
Toronto, Ontario, M3B 3S6
About this study
Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-arm Study to Investigate the Efficacy and Safety of Subcutaneous Administration of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema
This is a multicenter, double-blind, randomized, placebo-controlled, parallel-arm study to investigate the efficacy and safety of subcutaneous administration of CSL312 (garadacimab) in the prophylactic treatment of hereditary angioedema.
- Conditions
- Hereditary Angioedema
- Being tested
- CSL312, Placebo
- Medical subject headings
- Angioedemas, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSL312Biological
Also called Factor XIIa inhibitor monoclonal antibody, garadacimab
Fully human immunoglobulin G subclass 4/lambda recombinant monoclonal antibody
PlaceboDrug
Buffer without active ingredient
| Study group | Role | What they receive |
|---|---|---|
| CSL312 | Experimental | Participants received a CSL312 loading dose of 400 mg as two 200 mg SC injections in Month 1 along with CSL312 of 200 mg subcutaneous (SC) injections, once monthly from Months 2 to 6. Receives: Biological: CSL312 |
| Placebo | Placebo comparator | Participants received a CSL312 matched loading dose of placebo as two SC injections in Month 1 along with CSL312 matched placebo SC injections, once monthly from Months 2 to 6. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-Normalized Number of Hereditary Angioedema (HAE) Attacks Per Month During Treatment Period
Time-normalized number of HAE attacks per month during treatment was calculated per participant as: [number of HAE attacks / length of participant treatment in days] * 30.4375.
Measured: First injection up to 6 months
Secondary outcomes (12)
Percentage Change in the Time-normalized Number of HAE Attacks Per Month During the Treatment Period Compared to the Run-in Period
Percentage change in the time-normalized number of HAE attacks was calculated within a participant as:
100 * [1 - (time-normalized number of HAE attacks per month during treatment period / time-normalized number of HAE attacks per month during run-in period)]. Time-normalized number of HAE attacks per month during treatment period was calculated per participant as: [number of HAE attacks / length of participant treatment in days] * 30.4375.
Measured: 6 months, first 3-months and second 3-months of treatment period
Time-Normalized Number of HAE Attacks Per Month Requiring On-Demand Treatment
Time-normalized number of HAE attacks per month requiring on-demand treatment was calculated per participant as: [number of HAE attacks requiring on-demand treatment / length of participant in days] * 30.4375.
Measured: 6 months, first 3-months and second 3-months of treatment period
Time-Normalized Number of Moderate or Severe HAE Attacks Per Month
Time-normalized number of moderate or severe HAE attacks per month during treatment period was calculated per participant as: [number of moderate or severe HAE attacks / length of participant treatment in days] * 30.4375.
Measured: 6 months, first 3-months and second 3-months of treatment period
Time-normalized Number of HAE Attacks Per Month in the First 3-months and Second 3-months of Treatment Period
Time-normalized number of HAE attacks per month during treatment was calculated per participant as: [number of HAE attacks / length of participant treatment in days] * 30.4375.
Measured: First 3-months and second 3-months of treatment period
Relative Difference in Means in the Time-Normalized Number of HAE Attacks Per Month Between CSL312 to Placebo
Relative difference in means in the time-normalized number of HAE attacks per month CSL312 to Placebo was calculated as: 100 * [(mean time-normalized number of HAE attacks for CSL312 - mean time-normalized number of HAE attacks for placebo) / mean time-normalized number of HAE attacks for placebo]. Time-normalized number of HAE attacks per month during treatment was calculated per participant as: [number of HAE attacks / length of participant treatment in days] * 30.4375.
Measured: 6 months, first 3-months and second 3-months of treatment period
Percentage of Participants With a Response to Subject's Global Assessment of Response to Therapy (SGART)
SGART is a self-assessment by the participant and measures the subject's overall treatment response to the investigational product using the following ratings: 0 (none: worse or no response at all, not acceptable), 1 (poor: very little response, not acceptable), 2 (fair: some response, acceptable but could be better), 3 (good: good response, acceptable), and 4 (excellent: excellent response, as good as can be imagined).
Measured: Up to 6 months
Number of Participants With at Least One Adverse Event (AE), Serious Adverse Event (SAE), and AEs of Special Interest (AESI)
AE is any untoward medical occurrence in a participant administered with an investigational product which does not necessarily have a causal relationship with treatment, can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of an investigational product, whether or not considered related to product. SAE is any untoward medical occurrence that results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect, or is a medically significant event. An AESI is an AE of scientific and medical concern specific to sponsor's product or program, for which ongoing monitoring and rapid communication by investigator to sponsor is appropriate.
Measured: From first dose of study drug up to 3 months after the last injection (approximately 8 months)
Number of Participants With CSL312-induced Anti-CSL312 Antibodies
Measured: Up to 8 months
Number of Participants With Clinically Significant Abnormalities in Laboratory Assessments Reported as Treatment Emergent Adverse Events (TEAEs)
Laboratory assessments included: Hematology, biochemistry, urinalysis, and coagulation parameters.
Measured: From first dose of study drug up to 3 months after the last injection (approximately 8 months)
Percentage of Participants With at Least One AE, SAE, and AESI
AE is any untoward medical occurrence in a participant administered with an investigational product which does not necessarily have a causal relationship with treatment, can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of an investigational product, whether or not considered related to product. SAE is any untoward medical occurrence that results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect, or is a medically significant event. An AESI is an AE of scientific and medical concern specific to sponsor's product or program, for which ongoing monitoring and rapid communication by investigator to sponsor is appropriate.
Measured: From first dose of study drug up to 3 months after the last injection (approximately 8 months)
Percentage of Participants With CSL312-induced Anti-CSL312 Antibodies
Measured: Up to 6 months
Percentage of Participants With Clinically Significant Abnormalities in Laboratory Assessments Reported as TEAEs
Laboratory assessments included: Hematology, biochemistry, urinalysis, and coagulation parameters.
Measured: From first dose of study drug up to 3 months after the last injection (approximately 8 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start27 Jan 2021
- Primary completion7 Jun 2022
- Study completion7 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hereditary AngioedemaStudies of the same condition, open and under way.
- More trials run by CSL BehringThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, CSL Behring LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656418
- Sponsor's protocol ID
- CSL312_3001
- Other IDs
- 2020-000570-25
- Status last verified
- Jun 2023
- First submitted
- 1 Dec 2020
- Last updated
- 29 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com. Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD. If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
Publications
Craig TJ, Guilarte M, Li HH, Anderson J, Martinez Saguer I, Jacobs JS, Tachdjian R, Farkas H, Yang WH, Ohsawa I, Hakl R, Pollen M, Pragst I, Lawo JP, Shetty H, Nenci C, Magerl M. Long-Term Integrated Safety and Efficacy of Garadacimab for Hereditary Angioedema Prophylaxis. Adv Ther. 2026 Jun 10. doi: 10.1007/s12325-026-03628-x. Online ahead of print.
PubMed 42268494Staubach P, Craig TJ, Fukuda T, Aygoren-Pursun E, Hakl R, Braverman J, Lawo JP, Pollen M, Nenci C, Li PH, Farkas H. Becoming attack-free further improves health-related quality of life in patients with hereditary angioedema receiving garadacimab. Allergy Asthma Proc. 2025 May 1;46(3):200-208. doi: 10.2500/aap.2025.46.250026.
PubMed 40380356Craig TJ, Reshef A, Li HH, Jacobs JS, Bernstein JA, Farkas H, Yang WH, Stroes ESG, Ohsawa I, Tachdjian R, Manning ME, Lumry WR, Saguer IM, Aygoren-Pursun E, Ritchie B, Sussman GL, Anderson J, Kawahata K, Suzuki Y, Staubach P, Treudler R, Feuersenger H, Glassman F, Jacobs I, Magerl M. Efficacy and safety of garadacimab, a factor XIIa inhibitor for hereditary angioedema prevention (VANGUARD): a global, multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023 Apr 1;401(10382):1079-1090. doi: 10.1016/S0140-6736(23)00350-1. Epub 2023 Feb 28.
PubMed 36868261Beard N, Frese M, Smertina E, Mere P, Katelaris C, Mills K. Interventions for the long-term prevention of hereditary angioedema attacks. Cochrane Database Syst Rev. 2022 Nov 3;11(11):CD013403. doi: 10.1002/14651858.CD013403.pub2.
PubMed 36326435
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-arm Study to Investigate the Efficacy and Safety of Subcutaneous Administration of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema
- ClinicalTrials.gov ID
- NCT04656418
- Acronym / sponsor ID
- CSL312_3001
- Conditions
- Hereditary Angioedema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 7 Jun 2022 (actual)
- Study completion
- 7 Jun 2022 (actual)
- First posted
- 7 Dec 2020 (actual)
- Results
- Posted 29 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, double-blind, randomized, placebo-controlled, parallel-arm study to investigate the efficacy and safety of subcutaneous administration of CSL312 (garadacimab) in the prophylactic treatment of hereditary angioedema.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSL312 | Experimental | Biological: CSL312Participants received a CSL312 loading dose of 400 mg as two 200 mg SC injections in Month 1 along with CSL312 of 200 mg subcutaneous (SC) injections, once monthly from Months 2 to 6. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received a CSL312 matched loading dose of placebo as two SC injections in Month 1 along with CSL312 matched placebo SC injections, once monthly from Months 2 to 6. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female ≥ 12 years of age; diagnosed with clinically confirmed C1-INH hereditary angioedema; experience ≥ 3 attacks during the 3 months before screening.
- Note: For subjects taking any prophylactic HAE therapy during the 3 months before Screening, ≥ 3 HAE attacks may be documented over 3 consecutive months before commencing the prophylactic therapy.
Key exclusion criteria (1 listed)
- Concomitant diagnosis of another form of angioedema such as idiopathic or acquired angioedema, recurrent angioedema associated with urticarial or hereditary angioedema type 3
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 |
|---|---|---|
| CSL312Also: Factor XIIa inhibitor monoclonal antibody, garadacimabFully human immunoglobulin G subclass 4/lambda recombinant monoclonal antibody | Biological | CSL312 |
| PlaceboBuffer without active ingredient | Drug | Placebo |
Primary outcome
Time-Normalized Number of Hereditary Angioedema (HAE) Attacks Per Month During Treatment Period
Time frame: First injection up to 6 months
Time-normalized number of HAE attacks per month during treatment was calculated per participant as: [number of HAE attacks / length of participant treatment in days] * 30.4375.
12 secondary outcomes
Percentage Change in the Time-normalized Number of HAE Attacks Per Month During the Treatment Period Compared to the Run-in Period
Time frame: 6 months, first 3-months and second 3-months of treatment period
Time-Normalized Number of HAE Attacks Per Month Requiring On-Demand Treatment
Time frame: 6 months, first 3-months and second 3-months of treatment period
Time-Normalized Number of Moderate or Severe HAE Attacks Per Month
Time frame: 6 months, first 3-months and second 3-months of treatment period
Time-normalized Number of HAE Attacks Per Month in the First 3-months and Second 3-months of Treatment Period
Time frame: First 3-months and second 3-months of treatment period
Relative Difference in Means in the Time-Normalized Number of HAE Attacks Per Month Between CSL312 to Placebo
Time frame: 6 months, first 3-months and second 3-months of treatment period
Percentage of Participants With a Response to Subject's Global Assessment of Response to Therapy (SGART)
Time frame: Up to 6 months
Number of Participants With at Least One Adverse Event (AE), Serious Adverse Event (SAE), and AEs of Special Interest (AESI)
Time frame: From first dose of study drug up to 3 months after the last injection (approximately 8 months)
Number of Participants With CSL312-induced Anti-CSL312 Antibodies
Time frame: Up to 8 months
Number of Participants With Clinically Significant Abnormalities in Laboratory Assessments Reported as Treatment Emergent Adverse Events (TEAEs)
Time frame: From first dose of study drug up to 3 months after the last injection (approximately 8 months)
Percentage of Participants With at Least One AE, SAE, and AESI
Time frame: From first dose of study drug up to 3 months after the last injection (approximately 8 months)
Percentage of Participants With CSL312-induced Anti-CSL312 Antibodies
Time frame: Up to 6 months
Percentage of Participants With Clinically Significant Abnormalities in Laboratory Assessments Reported as TEAEs
Time frame: From first dose of study drug up to 3 months after the last injection (approximately 8 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42268494Craig TJ, Guilarte M, Li HH, Anderson J, Martinez Saguer I, Jacobs JS, Tachdjian R, Farkas H, Yang WH, Ohsawa I, Hakl R, Pollen M, Pragst I, Lawo JP, Shetty H, Nenci C, Magerl M. Long-Term Integrated Safety and Efficacy of Garadacimab for Hereditary Angioedema Prophylaxis. Adv Ther. 2026 Jun 10. doi: 10.1007/s12325-026-03628-x. Online ahead of print.
- Derived from this study: PubMed 40380356Staubach P, Craig TJ, Fukuda T, Aygoren-Pursun E, Hakl R, Braverman J, Lawo JP, Pollen M, Nenci C, Li PH, Farkas H. Becoming attack-free further improves health-related quality of life in patients with hereditary angioedema receiving garadacimab. Allergy Asthma Proc. 2025 May 1;46(3):200-208. doi: 10.2500/aap.2025.46.250026.
- Derived from this study: PubMed 36868261Craig TJ, Reshef A, Li HH, Jacobs JS, Bernstein JA, Farkas H, Yang WH, Stroes ESG, Ohsawa I, Tachdjian R, Manning ME, Lumry WR, Saguer IM, Aygoren-Pursun E, Ritchie B, Sussman GL, Anderson J, Kawahata K, Suzuki Y, Staubach P, Treudler R, Feuersenger H, Glassman F, Jacobs I, Magerl M. Efficacy and safety of garadacimab, a factor XIIa inhibitor for hereditary angioedema prevention (VANGUARD): a global, multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023 Apr 1;401(10382):1079-1090. doi: 10.1016/S0140-6736(23)00350-1. Epub 2023 Feb 28.
- Derived from this study: PubMed 36326435Beard N, Frese M, Smertina E, Mere P, Katelaris C, Mills K. Interventions for the long-term prevention of hereditary angioedema attacks. Cochrane Database Syst Rev. 2022 Nov 3;11(11):CD013403. doi: 10.1002/14651858.CD013403.pub2.
- Individual participant dataSharing planned: Yes. CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com. Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD. If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
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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. This study is not recruiting at the moment.
Study Director study director
CSL Behring LLC
28 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CSL312 in people with Hereditary Angioedema, run by CSL Behring at 28 sites in 7 countries.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Japan, Germany, Canada, Hungary and 2 more countries. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time-Normalized Number of Hereditary Angioedema (HAE) Attacks Per Month During Treatment Period (time frame: First injection up to 6 months). 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 NCT04656418, which also lists 4 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 29 Jun 2023.