Hereditary AngioedemaPhase 3NCT00912093
A Study of Icatibant in Patients With Acute Attacks of Hereditary Angioedema (FAST-3)
A Phase 3 study testing Icatibant in people with Hereditary Angioedema, run by Shire at 64 sites in 9 countries.
Trial summary
This study is being conducted to evaluate the efficacy and safety of icatibant compared to placebo in patients experiencing acute attacks of hereditary angioedema (HAE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hereditary Angioedema
- What is being tested?
- Icatibant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 64 sitesin 9 countries
- Study dates
- 16 Jul 2009to 1 Oct 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Each patient must meet the following criteria to be enrolled in this study.
- The patient is ≥18 years old at the time of informed consent.
- The patient has a documented diagnosis of HAE type I or II. The diagnosis will be confirmed either by documented decreased C4 levels and/or immunogenic or functional C1-INH deficiency results (<50% of normal levels) consistent with HAE types I and II or by medical history.
- The current HAE attack must be in the cutaneous, abdominal and/or laryngeal (inclusive of laryngeal and pharyngeal) areas.
- Cutaneous or abdominal HAE attacks must be moderate to very severe as determined by investigator global assessment at pre-treatment assessments
- The patient must report at least 1 VAS score ≥ 30mm
- The patient commences treatment within 6 hours of the attack becoming at least mild (laryngeal) or moderate (non-laryngeal) in severity, but not more than 12 hours after the onset of the attack.
- Women of childbearing potential must have a negative urine pregnancy test and must use appropriate methods to prevent pregnancy during their participation in the study.
Who cannot join
- Patients who meet any of the following criteria will be excluded from the study.
- The patient has a diagnosis of angioedema other than HAE type I or II.
- The patient has received previous treatment with icatibant.
- The patient has participated in a clinical trial and has received treatment with another investigational medicinal product within the past 30 days.
- The patient has received treatment with any pain medication since the onset of the current angioedema attack.
- The patient has received replacement therapy (fresh frozen plasma [FFP], C1-INH products) less than 5 days (120 hours) from the onset of the current angioedema attack.
Show all 10Show fewer
- The patient is receiving treatment with angiotensin converting enzyme (ACE) inhibitors.
- Evidence of coronary artery disease based on medical history or screening examination in particular unstable angina pectoris or severe coronary heart disease;
- The patient has a serious concomitant illness or condition that, in the opinion of the Investigator, would be a contraindication for participation in the trial.
- The patient is pregnant or breastfeeding.
Trial locations and contacts
64 sites in 9 countries.
64 sites in 9 countries
United States39 sites
Primary Care Associates of Alabaster
Alabaster, Alabama, 35007
Allergy Partners of Western North Carolina
Asheville, North Carolina, 28801
Family Allergy and Asthma Center, PC
Atlanta, Georgia, 30342
Valley Clinical Research Center
Bethlehem, Pennsylvania, 18020
UAB Lung Health Center
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
Institute for Asthman & Allergy, P.C.
Chevy Chase, Maryland, 20815-6901
Rush University Medical Center
Chicago, Illinois, 60612
University of Cincinnati Division of Immunology/Allergy
Cincinnati, Ohio, 45267
Asthma & Allergy Associates, PC
Colorado Springs, Colorado, 80907
Optimed Research, LTD
Columbus, Ohio, 43235
AARA Research Center
Dallas, Texas, 75231
Duke University Medical Center
Durham, North Carolina, 27710
STARx Research Center, LLC
Edison, New Jersey, 08820
Research Institute of Deaconess Clinic
Evansville, Indiana, 47713
University of Texas Medical Branch (UTMB)
Galveston, Texas, 77555-0561
Allergy and Asthma Insititute of the Valley
Granada Hills, California, 91344
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
Texas A&M Health Science Center College of Medicine
Houston, Texas, 77030
University of Iowa Asthma Center/ Hospitals & Clinics
Iowa City, Iowa, 52242
University of California San Diego
La Jolla, California, 92093
Baker Allergy, Asthma & Dermatology Research Center LLC
Lake Oswego, Oregon, 97035
Little Rock Allergy & Asthma Clinic, PA
Little Rock, Arkansas, 72205
UCLA - Clinical Immunology & Allergy
Los Angeles, California, 90095
Medical Associates of Brevard
Melbourne, Florida, 32935
Winthrop University Hospital Clinical Trials Center
Mineola, New York, 11501
Mount Sinai School of Medicine
New York, New York, 10029
Children's Hospital of Pittsburgh (of UMPC)
Pittsburgh, Pennsylvania, 15224
University of Reno Nevada School of Medicine
Reno, Nevada, 89503
University of Utah
Salt Lake City, Utah, 84132
Allergy and Asthma Research Center, P.A.
San Antonio, Texas, 78229
Medical Research of AZ A Division of Allergy & Immunology Assoc
Scottsdale, Arizona, 85251
LSUHSC Allergy & Immunology
Shreveport, Louisiana, 71130
The Asthma Center
St Louis, Missouri, 63141
Speciality Medical Clinic & Research Center
Stanford, California, 27330
Standford University
Stanford, California, 94305
University of South Florida Division of Allergy and Immunology
Tampa, Florida, 33613
Montefiore Medical Center/Albert Einstein College of Medicine
The Bronx, New York, 10461
Tulsa Allergy Clinic
Tulsa, Oklahoma, 74133
Russia7 sites
State Healthcare Institution of City of Moscow
Moscow, 115446
State Enterprise State Scientific Centre
Moscow, 115478
State Educational Institution of Additional Profess. Edu. Moscow
Moscow, 123182
Medical Academy of Postgraduate Education
Saint Petersburg, Sankt-Peterburg, 194291
Autonomous Non Commercial Organization
Saint Petersburg, Sankt-Peterburg, 198216
Municipal Medical & Preventive Treatment Institution
Smolensk, 214001
Regional Clinical Center of Specialized Medical Treatment
Vladivostok, 690091
Ukraine5 sites
Ivano-Frankivsk national Medical University
Ivano-Frankivsk, 76018
National Medical Academy for Postgraduate Education
Kyiv, 01133
Institute of Otolaryngology
Kyiv, 03680
Ukranian Medical Stomatological Academy Dept of Int Diseases
Poltava, 36039
Vinnitsa Medical Academy Chair of Internal Disease
Vinnitsa, 21029
Australia4 sites
Royal Adelaide Hospital
Adelaide
Dept of Medicine Immunology & Allergy Campbelltown Hospital
Campbelltown, New South Wales, 2560
Canberra Hospital Department of Immunology
Garran, Australian Capital Territory
Royal Melbourne Hospital Department of Immunology
Parkville, Victoria, 3050
Canada3 sites
NACTRC
Edmonton, Alberta, T6G 2H7
Allergy & Asthma Research Centre
Ottawa, Ontario, K1Y 4G2
Centre de recherché Appliquée en allergie de Québec
Québec, Quebec, G1V 5M6
Israel3 sites
Bnai-Zion Medical Center Division of Immunology & Allergy
Haifa, 31048
Tel Aviv Medical Center
Tel Aviv, 64239
The Chaim Sheba Medical Center
Tel HaShomer, 52621
Hungary1 site
3rd Department of Internal Medicine Semmelweis University
Budapest, 1125
Romania1 site
Spitalul Clinic Judetean Mures Sectia Medicina Interna
Târgu Mureş, Transylvania, 540103
South Africa1 site
Allergy Diagnostic and Clinical Research Unit (ADCRU)
Cape Town, Mowbray, 7700
About this study
Official title: A Phase III Randomized, Double-Blind,Placebo-Controlled, Multicenter Study of Icatibant for Subcutaneous Injection in Patients With Acute Attacks of Hereditary Angioedema (HAE)
This study is being conducted to evaluate the efficacy and safety of icatibant compared to placebo in patients experiencing acute attacks of hereditary angioedema (HAE).
Read the detailed description
This Phase III study consisted of two parts: A controlled phase and an open label extension (OLE) phase.
The controlled phase describes the double blind part of the study and was intended to evaluate the efficacy and safety of icatibant compared with placebo for the first treated cutaneous and/or abdominal attack.
Patients with moderate to severe abdominal or cutaneous attacks were randomized to receive a single, blinded, subcutaneous injection of icatibant (30 mg) or placebo. After a protocol amendment, patients with mild to moderate laryngeal HAE attacks were also randomized to receive a single, blinded subcutaneous injection of icatibant (30 mg) or placebo in order to obtain blinded, controlled efficacy and safety data for this subset of subjects. Patients experiencing severe laryngeal attacks (post-amendment) or mild to severe laryngeal attacks (pre-amendment) were to receive open-label icatibant.
After treatment of the first attack in the controlled phase, patients were eligible to enter the OLE phase. In the OLE phase, patients who experienced angioedema attacks severe enough to warrant treatment were to be treated with s.c. icatibant as appropriate until the study was discontinued or the product was commercially available.
- Conditions
- Hereditary Angioedema
- Being tested
- Icatibant, Placebo
- Keywords
- HAE, Type I HAE, Type II HAE
- Medical subject headings
- Angioedemas, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IcatibantDrug
Also called Firazyr
Single subcutaneous injection of icatibant, 30 mg
PlaceboDrug
Single subcutaneous injection of matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Single subcutaneous injection of matching placebo Receives: Drug: Placebo |
| Icatibant | Experimental | Single subcutaneous injection of icatibant, 30 mg Receives: Drug: Icatibant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Onset of Symptom Relief for an Acute Attack, as Assessed by the Patient
Time to onset of symptom relief was calculated from study drug administration to onset of symptom relief, where onset of symptom relief was defined as the earliest of 3 consecutive measurements in which there was a 50% reduction from pretreatment in composite VAS score. Composite VAS score comprised 3 symptoms, including skin swelling, skin pain, and abdominal pain, for cutaneous and abdominal attacks and 5 symptoms, including skin swelling, skin pain, abdominal pain, difficulty swallowing, and voice change, for laryngeal attacks. Subjects who did not achieve symptom relief within the observation period were censored at the last observation time.
Measured: Up to 120 hours post-dose
Secondary outcomes (4)
Time to Onset of Primary Symptom Relief
Time to primary symptom relief was calculated from the time of study drug administration to the onset of primary symptom relief, where onset of primary symptom relief was determined using the subject-assessed VAS score for a single primary symptom (determined by edema location) and defined as the earliest of 3 consecutive non-missing measurements in which a pre-specified reduction from the pretreatment value was met. Subjects who did not achieve primary symptom relief within the observation period were censored at the last observation time.
Measured: Up to 120 hours post-dose
Time to Almost Complete Symptom Relief
Time to almost complete symptom relief was calculated from the time of study drug administration to almost complete symptom relief, where almost complete symptom relief was defined as the earliest of 3 consecutive non-missing measurements in which all VAS scores <10 mm. Subjects who did not achieve almost complete symptom relief within the observation period were censored at the last observation time.
Measured: Up to 120 Hours post treatment
Time to Subject-Assessed Initial Symptom Improvement
Time to initial symptom improvement was calculated from the time of study drug administration to initial symptom improvement as determined by the subject as the time they felt symptoms were starting to improve. Subjects who did not achieve initial symptom improvement within the observation period were censored at the last observation time.
Measured: Up to 120 hours post-dose
Time to Investigator-Assessed Initial Symptom Improvement
Time to initial symptom improvement was calculated from the time of study drug administration to initial symptom improvement as determined by the investigator as the time they felt symptoms were starting to improve. Subjects who did not achieve initial symptom improvement within the observation period were censored at the last observation time.
Measured: Up to 120 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study start16 Jul 2009
- Primary completion1 Oct 2010
- Study completion1 Oct 2010
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00912093
- Sponsor's protocol ID
- HGT-FIR-054
- Other IDs
- 2009-015606-19, 2009
- Status last verified
- Jun 2021
- First submitted
- 2 Jun 2009
- Last updated
- 11 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Lumry WR, Farkas H, Moldovan D, Toubi E, Baptista J, Craig T, Riedl M. Icatibant for Multiple Hereditary Angioedema Attacks across the Controlled and Open-Label Extension Phases of FAST-3. Int Arch Allergy Immunol. 2015;168(1):44-55. doi: 10.1159/000441060. Epub 2015 Nov 11.
PubMed 26556097Maurer M, Longhurst HJ, Fabien V, Li HH, Lumry WR. Treatment of hereditary angioedema with icatibant: efficacy in clinical trials versus effectiveness in the real-world setting. Allergy Asthma Proc. 2014 Sep-Oct;35(5):377-81. doi: 10.2500/aap.2014.35.3780. Epub 2014 Aug 6.
PubMed 25198193Bas M. Clinical efficacy of icatibant in the treatment of acute hereditary angioedema during the FAST-3 trial. Expert Rev Clin Immunol. 2012 Nov;8(8):707-17. doi: 10.1586/eci.12.67.
PubMed 23167682Lumry WR, Li HH, Levy RJ, Potter PC, Farkas H, Moldovan D, Riedl M, Li H, Craig T, Bloom BJ, Reshef A. Randomized placebo-controlled trial of the bradykinin B(2) receptor antagonist icatibant for the treatment of acute attacks of hereditary angioedema: the FAST-3 trial. Ann Allergy Asthma Immunol. 2011 Dec;107(6):529-37. doi: 10.1016/j.anai.2011.08.015. Epub 2011 Oct 5.
PubMed 22123383
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized, Double-Blind,Placebo-Controlled, Multicenter Study of Icatibant for Subcutaneous Injection in Patients With Acute Attacks of Hereditary Angioedema (HAE)
- ClinicalTrials.gov ID
- NCT00912093
- Acronym / sponsor ID
- HGT-FIR-054
- Conditions
- Hereditary Angioedema
- Keywords
- HAE, Type I HAE, Type II HAE
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2009 (actual)
- Primary completion
- 1 Oct 2010 (actual)
- Study completion
- 1 Oct 2010 (actual)
- First posted
- 3 Jun 2009 (estimated)
- Results
- Posted 6 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to evaluate the efficacy and safety of icatibant compared to placebo in patients experiencing acute attacks of hereditary angioedema (HAE).
Detailed description
This Phase III study consisted of two parts: A controlled phase and an open label extension (OLE) phase.
The controlled phase describes the double blind part of the study and was intended to evaluate the efficacy and safety of icatibant compared with placebo for the first treated cutaneous and/or abdominal attack.
Patients with moderate to severe abdominal or cutaneous attacks were randomized to receive a single, blinded, subcutaneous injection of icatibant (30 mg) or placebo. After a protocol amendment, patients with mild to moderate laryngeal HAE attacks were also randomized to receive a single, blinded subcutaneous injection of icatibant (30 mg) or placebo in order to obtain blinded, controlled efficacy and safety data for this subset of subjects. Patients experiencing severe laryngeal attacks (post-amendment) or mild to severe laryngeal attacks (pre-amendment) were to receive open-label icatibant.
After treatment of the first attack in the controlled phase, patients were eligible to enter the OLE phase. In the OLE phase, patients who experienced angioedema attacks severe enough to warrant treatment were to be treated with s.c. icatibant as appropriate until the study was discontinued or the product was commercially available.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboSingle subcutaneous injection of matching placebo |
| Icatibant | Experimental | Drug: IcatibantSingle subcutaneous injection of icatibant, 30 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Each patient must meet the following criteria to be enrolled in this study.
- The patient is ≥18 years old at the time of informed consent.
- The patient has a documented diagnosis of HAE type I or II. The diagnosis will be confirmed either by documented decreased C4 levels and/or immunogenic or functional C1-INH deficiency results (<50% of normal levels) consistent with HAE types I and II or by medical history.
- The current HAE attack must be in the cutaneous, abdominal and/or laryngeal (inclusive of laryngeal and pharyngeal) areas.
- Cutaneous or abdominal HAE attacks must be moderate to very severe as determined by investigator global assessment at pre-treatment assessments
Key exclusion criteria (10 listed)
- Patients who meet any of the following criteria will be excluded from the study.
- The patient has a diagnosis of angioedema other than HAE type I or II.
- The patient has received previous treatment with icatibant.
- The patient has participated in a clinical trial and has received treatment with another investigational medicinal product within the past 30 days.
- The patient has received treatment with any pain medication since the onset of the current angioedema attack.
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 |
|---|---|---|
| IcatibantAlso: FirazyrSingle subcutaneous injection of icatibant, 30 mg | Drug | Icatibant |
| PlaceboSingle subcutaneous injection of matching placebo | Drug | Placebo |
Primary outcome
Time to Onset of Symptom Relief for an Acute Attack, as Assessed by the Patient
Time frame: Up to 120 hours post-dose
Time to onset of symptom relief was calculated from study drug administration to onset of symptom relief, where onset of symptom relief was defined as the earliest of 3 consecutive measurements in which there was a 50% reduction from pretreatment in composite VAS score. Composite VAS score comprised 3 symptoms, including skin swelling, skin pain, and abdominal pain, for cutaneous and abdominal attacks and 5 symptoms, including skin swelling, skin pain, abdominal pain, difficulty swallowing, and voice change, for laryngeal attacks. Subjects who did not achieve symptom relief within the observation period were censored at the last observation time.
4 secondary outcomes
Time to Onset of Primary Symptom Relief
Time frame: Up to 120 hours post-dose
Time to Almost Complete Symptom Relief
Time frame: Up to 120 Hours post treatment
Time to Subject-Assessed Initial Symptom Improvement
Time frame: Up to 120 hours post-dose
Time to Investigator-Assessed Initial Symptom Improvement
Time frame: Up to 120 hours post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26556097Lumry WR, Farkas H, Moldovan D, Toubi E, Baptista J, Craig T, Riedl M. Icatibant for Multiple Hereditary Angioedema Attacks across the Controlled and Open-Label Extension Phases of FAST-3. Int Arch Allergy Immunol. 2015;168(1):44-55. doi: 10.1159/000441060. Epub 2015 Nov 11.
- Derived from this study: PubMed 25198193Maurer M, Longhurst HJ, Fabien V, Li HH, Lumry WR. Treatment of hereditary angioedema with icatibant: efficacy in clinical trials versus effectiveness in the real-world setting. Allergy Asthma Proc. 2014 Sep-Oct;35(5):377-81. doi: 10.2500/aap.2014.35.3780. Epub 2014 Aug 6.
- Derived from this study: PubMed 23167682Bas M. Clinical efficacy of icatibant in the treatment of acute hereditary angioedema during the FAST-3 trial. Expert Rev Clin Immunol. 2012 Nov;8(8):707-17. doi: 10.1586/eci.12.67.
- Derived from this study: PubMed 22123383Lumry WR, Li HH, Levy RJ, Potter PC, Farkas H, Moldovan D, Riedl M, Li H, Craig T, Bloom BJ, Reshef A. Randomized placebo-controlled trial of the bradykinin B(2) receptor antagonist icatibant for the treatment of acute attacks of hereditary angioedema: the FAST-3 trial. Ann Allergy Asthma Immunol. 2011 Dec;107(6):529-37. doi: 10.1016/j.anai.2011.08.015. Epub 2011 Oct 5.
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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
Takeda
64 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Icatibant in people with Hereditary Angioedema, run by Shire at 64 sites in 9 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 8 inclusion and 10 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 11 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 64 sites in United States, Russia, Ukraine, Australia, Canada and 4 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 6 Aug 2014). 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 to Onset of Symptom Relief for an Acute Attack, as Assessed by the Patient (time frame: Up to 120 hours post-dose). 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 NCT00912093, 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 11 Jun 2021.