Hereditary Angioedema (HAE)Phase 3NCT02586805
Efficacy and Safety Study of DX-2930 to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE
A Phase 3 study testing DX-2930 - 300mg/2wk, DX-2930 - 300mg/4wk and DX-2930 - 150mg/4wk in people with Hereditary Angioedema (HAE), run by Shire at 41 sites in 7 countries.
Trial summary
This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of DX-2930 in preventing acute angioedema attacks in patients with Type I and Type II HAE. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Hereditary Angioedema (HAE)
- What is being tested?
- DX-2930 - 300mg/2wk, DX-2930 - 300mg/4wk and DX-2930 - 150mg/4wk
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 41 sitesin 7 countries
- Study dates
- 3 Mar 2016to 13 Apr 2017
- 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
- Males and females 12 years of age or older at time of screening
- Documented diagnosis of HAE, Type I or II
- Baseline rate of at least 1 Investigator-confirmed HAE attack per 4 weeks
- Adult subjects and caregivers of subjects under the age of 18 are willing and able to read, understand, and sign an informed consent form. Subjects age 12 to 17, whose caregiver provides informed consent, are willing and able to read, understand an dsign an assent form.
- Males and femailes who are fertile and sexually active must adhere to contraception requirements.
Who cannot join
- Concomitant diagnosis of another form of chronic, recurrent angioedema, such as acquired angioedema, idiopathic angioedema, or recurrent angioedema associated with urticaria.
- Participation in a prior DX-2930 study
- Treatment with any other investigational drug or exposure to an investigational device within 4 weeks prior screening
- Exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing medications within 4 weeks prior to screening.
- Exposure to androgens within 2 weeks prior to entering the run-in period.
- Use of long-term prophylactic therapy for HAE within 2 weeks prior to entering the run-in period.
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- Use of short-term prophylaxis for HAE within 7 days prior to entering the run-in period.
- Any of the following liver function test abnormalities: alanine aminotransferase (ALT) > 3x upper limit of normal, or aspartate aminotransferase (AST) > 3x upper limit of normal, or total bilirubin > 2x upper limit of normal (unless the bilirubin elevation is a result of Gilbert's syndrome).
- Pregnancy or breastfeeding.
Trial locations and contacts
41 sites in 7 countries.
41 sites in 7 countries
United States31 sites
University of Michigan Hospital and Health System
Ann Arbor, Michigan, 48106
Austin Regional Clinic
Austin, Texas, 78731
Hudson-Essex Allergy, LLC
Belleville, New Jersey, 07109
Clinical Research Center of Alabama, LLC
Birmingham, Alabama, 35209
Massachusetts General Hospital
Boston, Massachusetts, 02421
IMMUNOe International Health & Research Centers
Centennial, Colorado, 80112
American Health Research
Charlotte, North Carolina, 28277
Institute of Asthma & Allergy, P.C.
Chevy Chase, Maryland, 20815
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, 45231
Asthma and Allergy Associates, P.C.
Colorado Springs, Colorado, 80907
Optimed Research, LTD
Columbus, Ohio, 43235
AARA Research Center
Dallas, Texas, 75231
Intermountain Clinical Research
Draper, Utah, 84020
Duke Asthma, Allergy and Airway Center
Durham, North Carolina, 27705
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
University of Kansas Medical Center
Kansas City, Kansas, 66160
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
Winthrop University Hospital
Mineola, New York, 11501
Allergy Associates of Utah
Murray, Utah, 84107
The Mount Sinai Medical Center
New York, New York, 10029
Atlantic Research Center, LLC
Ocean City, New Jersey, 07712
Midwest Immunology Clinic
Plymouth, Minnesota, 55446
Virginia Commonwealth University
Richmond, Virginia, 23219
UC San Diego School of Medicine
San Diego, California, 92122
AIRE Medical of Los Angeles
Santa Monica, California, 90404
Medical Research of Arizona
Scottsdale, Arizona, 85251
Marycliff Allergy Specialists
Spokane, Washington, 99202
Washington University School of Medicine
St Louis, Missouri, 63110
University of South Florida
Tampa, Florida, 33613
Toledo Institute of Clinical Research
Toledo, Ohio, 43617
Allergy & Asthma Clinical Research
Walnut Creek, California, 94598
Canada3 sites
Ottawa Allergy Research Corporation
Ottawa, Ontario, K1G 6C6
Clinique Specialisee en Allergie de la Capitale
Québec, Quebec, G1V 4M6
Gordon Sussman Clinical Research Inc.
Toronto, Ontario, M4V 1R2
Germany3 sites
Charité - University of Berlin
Berlin, 10117
Hautklinik und Poliklinik der Universitätsmedizin
Mainz, 55131
HZRM Hamophilie-Zentrum Rhein Main
Mörfelden-Walldorf, 64546
United Kingdom1 site
Barts Health NHS Trust Clinical Research Centre
London, E1 2ES
About this study
Official title: HELP Study: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate DX-2930 For Long-Term Prophylaxis Against Acute Attacks of Hereditary Angioedema (HAE)
This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of DX-2930 in preventing acute angioedema attacks in patients with Type I and Type II HAE.
- Conditions
- Hereditary Angioedema (HAE)
- Being tested
- DX-2930 - 300mg/2wk, DX-2930 - 300mg/4wk, DX-2930 - 150mg/4wk, Placebo
- Keywords
- DX-2930, Hereditary Angioedema, Dyax
- Medical subject headings
- Angioedemas, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DX-2930 - 300mg/2wkDrug
300 mg DX-2930 administered every 2 weeks by subcutaneous injection.
DX-2930 - 300mg/4wkDrug
300 mg DX-2930 administered every 4 weeks by subcutaneous injection. To maintain the study blind, subjects will be given placebo injections every other 2 weeks when they are not receiving drug.
DX-2930 - 150mg/4wkDrug
150 mg DX-2930 administered every 4 weeks by subcutaneous injection. To maintain the study blind, subjects will be given placebo injections every other 2 weeks when they are not receiving drug.
PlaceboDrug
Placebo administered every 2 weeks by subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| DX-2930 300 mg every 2 weeks | Experimental | 300 mg DX-2930 administered every 2 weeks by subcutaneous injection. Receives: Drug: DX-2930 - 300mg/2wk |
| DX-2930 300 mg every 4 weeks | Experimental | 300 mg DX-2930 administered every 4 weeks by subcutaneous injection Receives: Drug: DX-2930 - 300mg/4wk |
| DX-2930 150 mg every 4 weeks | Experimental | 150 mg DX-2930 administered every 4 weeks by subcutaneous injection Receives: Drug: DX-2930 - 150mg/4wk |
| Placebo | Placebo comparator | Placebo administered every 2 weeks by subcutaneous injection. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attacks During Treatment Period
HAE attack was defined as a discrete episode during which the participant progressed from no angioedema to symptoms of angioedema. Rate of investigator confirmed HAE attacks was analyzed using a generalized linear model (GLM) for count data assuming a poisson distribution with a log link function and Pearson chi-square scaling of standard errors to account for potential overdispersion. The logarithm of time in days each subject was observed during the treatment period was used as an offset variable in the model.
Measured: From Day 0 to Day 182
Secondary outcomes (3)
Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attack Requiring Acute Treatment
HAE attack was defined as a discrete episode during which the participant progressed from no angioedema to symptoms of angioedema. Rate of investigator confirmed HAE attack was analyzed using the GLM for count data assuming a poisson distribution with a log link function and Pearson chi-square scaling of standard errors to account for potential overdispersion. The logarithm of time in days each subject was observed during the treatment period was used as an offset variable in the model.
Measured: From Day 0 to Day 182
Rate of Moderate or Severe Investigator Confirmed Hereditary Angioedema (HAE) Attacks
HAE attack was defined as a discrete episode during which the participant progressed from no angioedema to symptoms of angioedema. Moderate and severe investigator-confirmed HAE attacks were the attacks that were moderate or severe as per the HAE attack assessment and reporting procedures (HAARP) defined severity. The overall severity of attack was determined by the investigator using following definitions: mild (transient or mild discomfort), moderate (mild to moderate limitation in activity), severe (marked limitation in activity). Rate of moderate or severe investigator confirmed HAE attack was analyzed using the GLM for count data assuming a poisson distribution with a log link function and Pearson chi-square scaling of standard errors to account for potential overdispersion. The logarithm of time in days each subject was observed during the treatment period was used as an offset variable in the model.
Measured: From Day 0 to Day 182
Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attacks During Day 14 Through Day 182
HAE attack was defined as a discrete episode during which the participant progressed from no angioedema to symptoms of angioedema. Rate of investigator confirmed HAE attacks during day 14 after study drug administration through day 182 was analyzed by the same poisson regression model as in the primary endpoint analysis.
Measured: From Day 14 to Day 182
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2015 (estimated)
- Study start3 Mar 2016
- Primary completion13 Apr 2017
- Study completion13 Apr 2017
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 Angioedema (HAE)Studies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dyax Corp.
- Responsible party
- Sponsor
- Investigators
- Shire Physician, Study director, Shire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586805
- Sponsor's protocol ID
- DX-2930-03
- Other IDs
- 2015-003943-20, 2015
- Status last verified
- May 2021
- First submitted
- 23 Oct 2015
- Last updated
- 2 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Publications
Lumry WR, Maurer M, Weller K, Riedl MA, Watt M, Yu M, Devercelli G, Meunier J, Banerji A; HELP OLE Study Group. Long-term lanadelumab treatment improves health-related quality of life in patients with hereditary angioedema. Ann Allergy Asthma Immunol. 2023 Jul;131(1):101-108.e3. doi: 10.1016/j.anai.2023.03.028. Epub 2023 Apr 5.
PubMed 37028510Beard 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 36326435Craig TJ, Zaragoza-Urdaz RH, Li HH, Yu M, Ren H, Juethner S, Anderson J; HELP and HELP OLE Study Investigators. Effectiveness and safety of lanadelumab in ethnic and racial minority subgroups of patients with hereditary angioedema: results from phase 3 studies. Allergy Asthma Clin Immunol. 2022 Sep 24;18(1):85. doi: 10.1186/s13223-022-00721-y.
PubMed 36153561Banerji A, Riedl MA, Bernstein JA, Cicardi M, Longhurst HJ, Zuraw BL, Busse PJ, Anderson J, Magerl M, Martinez-Saguer I, Davis-Lorton M, Zanichelli A, Li HH, Craig T, Jacobs J, Johnston DT, Shapiro R, Yang WH, Lumry WR, Manning ME, Schwartz LB, Shennak M, Soteres D, Zaragoza-Urdaz RH, Gierer S, Smith AM, Tachdjian R, Wedner HJ, Hebert J, Rehman SM, Staubach P, Schranz J, Baptista J, Nothaft W, Maurer M; HELP Investigators. Effect of Lanadelumab Compared With Placebo on Prevention of Hereditary Angioedema Attacks: A Randomized Clinical Trial. JAMA. 2018 Nov 27;320(20):2108-2121. doi: 10.1001/jama.2018.16773.
PubMed 30480729
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HELP Study: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate DX-2930 For Long-Term Prophylaxis Against Acute Attacks of Hereditary Angioedema (HAE)
- ClinicalTrials.gov ID
- NCT02586805
- Acronym / sponsor ID
- DX-2930-03
- Conditions
- Hereditary Angioedema (HAE)
- Keywords
- DX-2930, Hereditary Angioedema, Dyax
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Collaborators
- Dyax Corp.
- Study start
- 3 Mar 2016 (actual)
- Primary completion
- 13 Apr 2017 (actual)
- Study completion
- 13 Apr 2017 (actual)
- First posted
- 26 Oct 2015 (estimated)
- Results
- Posted 24 Apr 2018
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 phase 3, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of DX-2930 in preventing acute angioedema attacks in patients with Type I and Type II HAE.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DX-2930 300 mg every 2 weeks | Experimental | Drug: DX-2930 - 300mg/2wk300 mg DX-2930 administered every 2 weeks by subcutaneous injection. |
| DX-2930 300 mg every 4 weeks | Experimental | Drug: DX-2930 - 300mg/4wk300 mg DX-2930 administered every 4 weeks by subcutaneous injection |
| DX-2930 150 mg every 4 weeks | Experimental | Drug: DX-2930 - 150mg/4wk150 mg DX-2930 administered every 4 weeks by subcutaneous injection |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered every 2 weeks by subcutaneous injection. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females 12 years of age or older at time of screening
- Documented diagnosis of HAE, Type I or II
- Baseline rate of at least 1 Investigator-confirmed HAE attack per 4 weeks
- Adult subjects and caregivers of subjects under the age of 18 are willing and able to read, understand, and sign an informed consent form. Subjects age 12 to 17, whose caregiver provides informed consent, are willing and able to read, understand an dsign an assent form.
- Males and femailes who are fertile and sexually active must adhere to contraception requirements.
Key exclusion criteria (9 listed)
- Concomitant diagnosis of another form of chronic, recurrent angioedema, such as acquired angioedema, idiopathic angioedema, or recurrent angioedema associated with urticaria.
- Participation in a prior DX-2930 study
- Treatment with any other investigational drug or exposure to an investigational device within 4 weeks prior screening
- Exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing medications within 4 weeks prior to screening.
- Exposure to androgens within 2 weeks prior to entering the run-in period.
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 |
|---|---|---|
| DX-2930 - 300mg/2wk300 mg DX-2930 administered every 2 weeks by subcutaneous injection. | Drug | DX-2930 300 mg every 2 weeks |
| DX-2930 - 300mg/4wk300 mg DX-2930 administered every 4 weeks by subcutaneous injection. To maintain the study blind, subjects will be given placebo injections every other 2 weeks when they are not receiving drug. | Drug | DX-2930 300 mg every 4 weeks |
| DX-2930 - 150mg/4wk150 mg DX-2930 administered every 4 weeks by subcutaneous injection. To maintain the study blind, subjects will be given placebo injections every other 2 weeks when they are not receiving drug. | Drug | DX-2930 150 mg every 4 weeks |
| PlaceboPlacebo administered every 2 weeks by subcutaneous injection. | Drug | Placebo |
Primary outcome
Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attacks During Treatment Period
Time frame: From Day 0 to Day 182
HAE attack was defined as a discrete episode during which the participant progressed from no angioedema to symptoms of angioedema. Rate of investigator confirmed HAE attacks was analyzed using a generalized linear model (GLM) for count data assuming a poisson distribution with a log link function and Pearson chi-square scaling of standard errors to account for potential overdispersion. The logarithm of time in days each subject was observed during the treatment period was used as an offset variable in the model.
3 secondary outcomes
Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attack Requiring Acute Treatment
Time frame: From Day 0 to Day 182
Rate of Moderate or Severe Investigator Confirmed Hereditary Angioedema (HAE) Attacks
Time frame: From Day 0 to Day 182
Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attacks During Day 14 Through Day 182
Time frame: From Day 14 to Day 182
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37028510Lumry WR, Maurer M, Weller K, Riedl MA, Watt M, Yu M, Devercelli G, Meunier J, Banerji A; HELP OLE Study Group. Long-term lanadelumab treatment improves health-related quality of life in patients with hereditary angioedema. Ann Allergy Asthma Immunol. 2023 Jul;131(1):101-108.e3. doi: 10.1016/j.anai.2023.03.028. Epub 2023 Apr 5.
- 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.
- Derived from this study: PubMed 36153561Craig TJ, Zaragoza-Urdaz RH, Li HH, Yu M, Ren H, Juethner S, Anderson J; HELP and HELP OLE Study Investigators. Effectiveness and safety of lanadelumab in ethnic and racial minority subgroups of patients with hereditary angioedema: results from phase 3 studies. Allergy Asthma Clin Immunol. 2022 Sep 24;18(1):85. doi: 10.1186/s13223-022-00721-y.
- Derived from this study: PubMed 30480729Banerji A, Riedl MA, Bernstein JA, Cicardi M, Longhurst HJ, Zuraw BL, Busse PJ, Anderson J, Magerl M, Martinez-Saguer I, Davis-Lorton M, Zanichelli A, Li HH, Craig T, Jacobs J, Johnston DT, Shapiro R, Yang WH, Lumry WR, Manning ME, Schwartz LB, Shennak M, Soteres D, Zaragoza-Urdaz RH, Gierer S, Smith AM, Tachdjian R, Wedner HJ, Hebert J, Rehman SM, Staubach P, Schranz J, Baptista J, Nothaft W, Maurer M; HELP Investigators. Effect of Lanadelumab Compared With Placebo on Prevention of Hereditary Angioedema Attacks: A Randomized Clinical Trial. JAMA. 2018 Nov 27;320(20):2108-2121. doi: 10.1001/jama.2018.16773.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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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.
Shire Physician study director
Shire
41 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 DX-2930 - 300mg/2wk, DX-2930 - 300mg/4wk and DX-2930 - 150mg/4wk in people with Hereditary Angioedema (HAE), run by Shire at 41 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 5 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: finished, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Canada, Germany, Italy, Jordan 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 24 Apr 2018). 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?
Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attacks During Treatment Period (time frame: From Day 0 to Day 182). 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 NCT02586805, 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 2 Jun 2021.