Sickle Cell AnemiaPhase 3NCT01179217
A Phase III Safety and Efficacy Study of L-Glutamine to Treat Sickle Cell Disease or Sickle βo-thalassemia
A Phase 3 study testing L-glutamine in people with Sickle Cell Anemia and Sickle ß0-Thalassemia, run by Emmaus Medical, Inc. at 31 sites in United States.
Trial summary
The purpose of this research is to evaluate the effects of L-glutamine as a therapy for Sickle Cell Anemia or Sickle ß0 Thalassemia as evaluated by the number of occurrences of sickle cell crises. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Sickle Cell Anemia, Sickle ß0-Thalassemia
- What is being tested?
- L-glutamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 31 sitesUnited States
- Study dates
- May 2010to Mar 2014
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient is at least five years of age.
- Patient has been diagnosed with sickle cell anemia or sickle ß°-thalassemia (documented by hemoglobin electrophoresis).
- Patient has had at least two documented episodes of sickle cell crises within 12 months of the screening visit.
- If the patient has been treated with an anti-sickling agent within three months of the screening visit, the therapy must have been continuous for at least three months with the intent to continue for the duration of the study.
- Patient or the patient's legally authorized representative has given written informed consent.
- If the patient is a female of child-bearing potential, she agrees to avoid pregnancy during the study and is willing and agrees to practice a recognized form of birth control during the course of the study (e.g. barrier, birth control pills, abstinence).
Who cannot join
- Patient has a significant medical condition that required hospitalization (other than sickle cell crisis) within two months of the screening visit.
- Patient has prothrombin time INR > 2.0.
- Patient has serum albumin < 3.0 g/dl.
- Patient has received any blood products within three weeks of the Screening Visit.
- Patient has uncontrolled liver disease or renal insufficiency.
- Patient is pregnant or lactating or has the intention of becoming pregnant during the study (if female and of child-bearing potential).
Show all 11Show fewer
- Patient is currently taking or has been treated with any form of glutamine supplement within 30 days of the screening visit.
- Patient has been treated with an experimental anti-sickling medication/ treatment within 30 days of the screening visit (with the exception of hydroxyurea in pediatric patients).
- Patient is currently taking or has been treated with an investigational drug within 30 days of the screening visit (with the exception of hydroxyurea in pediatric patients).
- Patient is currently enrolled in an investigational drug or device study and/or has participated in such a study within 30 days of the screening visit.
- There are factors that would, in the judgment of the investigator, make it difficult for the patient to comply with the requirements of the study.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Children's Healthcare of Atlanta at Egleston/Emory University
Atlanta, Georgia, 30322
University of Denver School of Medicine Sickle Cell Treatment & Research Center
Aurora, Colorado, 80045
Johns Hopkins University
Baltimore, Maryland, 21205
Boston University Medical Center
Boston, Massachusetts, 02118
The Brooklyn Hospital Center
Brooklyn, New York, 11201
SUNY - Downstate Medical Center
Brooklyn, New York, 11203
Brookdale University Hospital and Medical Center
Brooklyn, New York, 11212
New York Methodist Hospital - SC/Thalassemia Program
Brooklyn, New York, 11215
Interfaith Medical Center
Brooklyn, New York, 11238
Cooper University Hospital
Camden, New Jersey, 08103
Presbyterian Blume Pediatric Hematology-Oncology Clinic
Charlotte, North Carolina, 28204
University of Illinois at Chicago
Chicago, Illinois, 60612
Children's Hospital of Michigan
Detroit, Michigan, 48201
University of Florida
Gainesville, Florida, 32610-0296
Kaiser Permanente
Inglewood, California, 90301
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
Children's Specialty Center of Nevada
Las Vegas, Nevada, 89109
Comprehensive Cancer Center of Nevada
Las Vegas, Nevada, 89109
University of Louisville School of Medicine
Louisville, Kentucky, 40202
University of Tennessee Cancer Institute
Memphis, Tennessee, 38104
University of South Alabama Medical Center
Mobile, Alabama, 36617
Sickle Cell Center of S. Louisiana, Tulane University School of Medicine
New Orleans, Louisiana, 70112
Children's Hospital & Research Center at Oakland
Oakland, California, 94609
Children's Hospital of Orange County
Orange, California, 92868
Phoenix Children's Hospital Center for Cancer and Blood Disorders
Phoenix, Arizona, 85016
Virginia Commonwealth University
Richmond, Virginia, 23298-0306
All Children's Hospital
St. Petersburg, Florida, 33701
Bronx Lebanon Hospital
The Bronx, New York, 11203
Harbor-UCLA Medical Center
Torrance, California, 90509
Howard University Hospital & Howard University
Washington D.C., District of Columbia, 20060
About this study
Official title: A PHASE III, PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY OF L GLUTAMINE THERAPY FOR SICKLE CELL ANEMIA AND SICKLE ß0-THALASSEMIA
The purpose of this research is to evaluate the effects of L-glutamine as a therapy for Sickle Cell Anemia or Sickle ß0 Thalassemia as evaluated by the number of occurrences of sickle cell crises.
Read the detailed description
Primary objective:
To evaluate the efficacy of oral L-glutamine as a therapy for sickle cell anemia and sickle ß0-thalassemia as evaluated by the number of occurrences of sickle cell crises.
Secondary objectives:
To assess the effect of oral L-glutamine on: (a) frequency of hospitalizations for sickle cell pain; (b) frequency of emergency room/medical facility visits for sickle cell pain; and (c) hematological parameters (hemoglobin, hematocrit, and reticulocyte count); and to assess the safety of L-glutamine as a therapy for sickle cell anemia as evaluated by adverse events, laboratory parameters, and vital signs.
Methodology:
This was a 2:1 randomized, double-blind, placebo-controlled, parallel-group, multicenter study in patients with sickle cell anemia and sickle ß0-thalassemia who were at least 5 years old. Informed consent was obtained up to four weeks prior to Week 0 (Baseline). Screening procedures were performed anytime between the date of consent and Week 0, as long as all eligibility criteria had been confirmed prior to Week 0. At Week 0, patients were randomized (to L-glutamine or placebo) and underwent 48 weeks of treatment (orally BID), with dose calculated according to patient weight. Patient clinic visits occurred every 4 weeks, and phone calls took place between visits to monitor compliance. After 48 weeks of treatment, the dose was tapered to 0 within 3 weeks. A final evaluation visit occurred 2 weeks after last dose for a total of 53 weeks on study.
- Conditions
- Sickle Cell Anemia, Sickle ß0-Thalassemia
- Being tested
- L-glutamine, Placebo
- Keywords
- Sickle Cell Anemia, Sickle Cell Pain Crises, Painful Crises, Sickle Cell Pain, Vaso-occlusive Crises
- Medical subject headings
- Anemia, Sickle Cell, Vaso-Occlusive Crises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-glutamineDrug
Also called oral L-glutamine
0.3 g/kg of L-glutamine will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration. Mixing L-glutamine with soda or highly acidic juices (such as grapefruit juice or lemonade) is not recommended.
PlaceboDrug
Also called Maltodextrin
0.3 g/kg of placebo (100% maltodextrin) will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration.
| Study group | Role | What they receive |
|---|---|---|
| L-glutamine | Experimental | Patients will be randomized to receive investigational product, L-Glutamine. Receives: Drug: L-glutamine |
| 100% maltodextrin | Placebo comparator | Patients will be randomized to receive Placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Occurrences of Sickle Cell Crises
The number of occurrences of protocol-defined sickle cell crises that occur from Week 0 to Week 48 will be used to evaluate the efficacy of oral L-glutamine as a treatment for sickle cell anemia and beta-0 thalassemia.
Measured: 48 weeks
Secondary outcomes (9)
The Number of Hospitalizations for Sickle Cell Pain
The number of hospitalizations that occur from Week 0 to Week 48, will be used to evaluate the efficacy of oral L-glutamine as a treatment for sickle cell anemia and beta-0 thalassemia.
Measured: 48 weeks
The Number of Emergency Room/Medical Facility Visits for Sickle Cell Pain
The number of emergency room visits or medical facility visits that occur from Week 0 to Week 48, will be used to evaluate the efficacy of oral L-glutamine as a treatment for sickle cell anemia and beta-0 thalassemia.
Measured: 48 weeks
The Effect of Oral -L-glutamine on Hematological Parameters
To assess the effect of oral L-glutamine on hematological parameters (hemoglobin), Change from Baseline will be reported at Weeks 4, 24 and 48.
Measured: Baseline, Week 4, 24 and 48
The Effect of Oral L-glutamine on Vital Signs
To assess the effect of oral L-glutamine on Vital signs (systolic and diastolic blood pressure). Change from Baseline will be reported at Weeks 4, 24, and 48.
Measured: Baseline, Week 4, 24, and 48
The Effect of Oral L-glutamine on Hematological Parameters
To assess the effect of oral L-glutamine on hematological parameters (hematocrit), Change from Baseline will be reported at Weeks 4, 24 and 48.
Measured: Baseline, Week 4, 24 and 48
The Effect of Oral L-glutamine on Hematological Parameters
To assess the effect of oral L-glutamine on hematological parameters (reticulocyte count), Change from Baseline will be reported at Weeks 4, 24 and 48.
Measured: Baseline, Week 4, 24 and 48
The Effect of Oral L-glutamine on Vital Signs
To assess the effect of oral L-glutamine on Vital signs (pulse rate). Change from Baseline will be reported at Weeks 4, 24, and 48.
Measured: Baseline, Week 4, Week 24 and Week 48
Effect of Oral L-glutamine on Vital Signs
To assess the effect of oral L-glutamine on Vital signs (temperature). Change from Baseline will be reported at Weeks 4, 24, and 48.
Measured: Baseline, Week 4, Week 24 and Week 48
The Effect of Oral L-glutamine on Vital Signs
To assess the effect of oral L-glutamine on Vital signs (respiration). Change from Baseline will be reported at Weeks 4, 24, and 48.
Measured: Baseline, Week 4, Week 24 and Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2010 (estimated)
- Study startMay 2010
- Primary completionMar 2014
- Study completionMar 2014
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 (2)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell AnemiaStudies 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
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emmaus Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yutaka Niihara, MD, MPH, Study director, Chairman and CEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01179217
- Sponsor's protocol ID
- GLUSCC09-01
- Status last verified
- Jul 2017
- First submitted
- 21 May 2010
- Last updated
- 19 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bolarinwa AB, Oduwole O, Okebe J, Ogbenna AA, Otokiti OE, Olatinwo AT. Antioxidant supplementation for sickle cell disease. Cochrane Database Syst Rev. 2024 May 22;5(5):CD013590. doi: 10.1002/14651858.CD013590.pub2.
PubMed 38775255Niihara Y, Miller ST, Kanter J, Lanzkron S, Smith WR, Hsu LL, Gordeuk VR, Viswanathan K, Sarnaik S, Osunkwo I, Guillaume E, Sadanandan S, Sieger L, Lasky JL, Panosyan EH, Blake OA, New TN, Bellevue R, Tran LT, Razon RL, Stark CW, Neumayr LD, Vichinsky EP; Investigators of the Phase 3 Trial of l-Glutamine in Sickle Cell Disease. A Phase 3 Trial of l-Glutamine in Sickle Cell Disease. N Engl J Med. 2018 Jul 19;379(3):226-235. doi: 10.1056/NEJMoa1715971.
PubMed 30021096
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE III, PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY OF L GLUTAMINE THERAPY FOR SICKLE CELL ANEMIA AND SICKLE ß0-THALASSEMIA
- ClinicalTrials.gov ID
- NCT01179217
- Acronym / sponsor ID
- GLUSCC09-01
- Conditions
- Sickle Cell Anemia, Sickle ß0-Thalassemia
- Keywords
- Sickle Cell Anemia, Sickle Cell Pain Crises, Painful Crises, Sickle Cell Pain, Vaso-occlusive Crises
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Emmaus Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 11 Aug 2010 (estimated)
- Results
- Posted 10 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to evaluate the effects of L-glutamine as a therapy for Sickle Cell Anemia or Sickle ß0 Thalassemia as evaluated by the number of occurrences of sickle cell crises.
Detailed description
Primary objective:
To evaluate the efficacy of oral L-glutamine as a therapy for sickle cell anemia and sickle ß0-thalassemia as evaluated by the number of occurrences of sickle cell crises.
Secondary objectives:
To assess the effect of oral L-glutamine on: (a) frequency of hospitalizations for sickle cell pain; (b) frequency of emergency room/medical facility visits for sickle cell pain; and (c) hematological parameters (hemoglobin, hematocrit, and reticulocyte count); and to assess the safety of L-glutamine as a therapy for sickle cell anemia as evaluated by adverse events, laboratory parameters, and vital signs.
Methodology:
This was a 2:1 randomized, double-blind, placebo-controlled, parallel-group, multicenter study in patients with sickle cell anemia and sickle ß0-thalassemia who were at least 5 years old. Informed consent was obtained up to four weeks prior to Week 0 (Baseline). Screening procedures were performed anytime between the date of consent and Week 0, as long as all eligibility criteria had been confirmed prior to Week 0. At Week 0, patients were randomized (to L-glutamine or placebo) and underwent 48 weeks of treatment (orally BID), with dose calculated according to patient weight. Patient clinic visits occurred every 4 weeks, and phone calls took place between visits to monitor compliance. After 48 weeks of treatment, the dose was tapered to 0 within 3 weeks. A final evaluation visit occurred 2 weeks after last dose for a total of 53 weeks on study.
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 |
|---|---|---|
| L-glutamine | Experimental | Drug: L-glutaminePatients will be randomized to receive investigational product, L-Glutamine. |
| 100% maltodextrin | Placebo comparator | Drug: PlaceboPatients will be randomized to receive Placebo. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patient is at least five years of age.
- Patient has been diagnosed with sickle cell anemia or sickle ß°-thalassemia (documented by hemoglobin electrophoresis).
- Patient has had at least two documented episodes of sickle cell crises within 12 months of the screening visit.
- If the patient has been treated with an anti-sickling agent within three months of the screening visit, the therapy must have been continuous for at least three months with the intent to continue for the duration of the study.
- Patient or the patient's legally authorized representative has given written informed consent.
Key exclusion criteria (11 listed)
- Patient has a significant medical condition that required hospitalization (other than sickle cell crisis) within two months of the screening visit.
- Patient has prothrombin time INR > 2.0.
- Patient has serum albumin < 3.0 g/dl.
- Patient has received any blood products within three weeks of the Screening Visit.
- Patient has uncontrolled liver disease or renal insufficiency.
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 |
|---|---|---|
| L-glutamineAlso: oral L-glutamine0.3 g/kg of L-glutamine will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration. Mixing L-glutamine with soda or highly acidic juices (such as grapefruit juice or lemonade) is not recommended. | Drug | L-glutamine |
| PlaceboAlso: Maltodextrin0.3 g/kg of placebo (100% maltodextrin) will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration. | Drug | 100% maltodextrin |
Primary outcome
The Number of Occurrences of Sickle Cell Crises
Time frame: 48 weeks
The number of occurrences of protocol-defined sickle cell crises that occur from Week 0 to Week 48 will be used to evaluate the efficacy of oral L-glutamine as a treatment for sickle cell anemia and beta-0 thalassemia.
9 secondary outcomes
The Number of Hospitalizations for Sickle Cell Pain
Time frame: 48 weeks
The Number of Emergency Room/Medical Facility Visits for Sickle Cell Pain
Time frame: 48 weeks
The Effect of Oral -L-glutamine on Hematological Parameters
Time frame: Baseline, Week 4, 24 and 48
The Effect of Oral L-glutamine on Vital Signs
Time frame: Baseline, Week 4, 24, and 48
The Effect of Oral L-glutamine on Hematological Parameters
Time frame: Baseline, Week 4, 24 and 48
The Effect of Oral L-glutamine on Hematological Parameters
Time frame: Baseline, Week 4, 24 and 48
The Effect of Oral L-glutamine on Vital Signs
Time frame: Baseline, Week 4, Week 24 and Week 48
Effect of Oral L-glutamine on Vital Signs
Time frame: Baseline, Week 4, Week 24 and Week 48
The Effect of Oral L-glutamine on Vital Signs
Time frame: Baseline, Week 4, Week 24 and Week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38775255Bolarinwa AB, Oduwole O, Okebe J, Ogbenna AA, Otokiti OE, Olatinwo AT. Antioxidant supplementation for sickle cell disease. Cochrane Database Syst Rev. 2024 May 22;5(5):CD013590. doi: 10.1002/14651858.CD013590.pub2.
- Derived from this study: PubMed 30021096Niihara Y, Miller ST, Kanter J, Lanzkron S, Smith WR, Hsu LL, Gordeuk VR, Viswanathan K, Sarnaik S, Osunkwo I, Guillaume E, Sadanandan S, Sieger L, Lasky JL, Panosyan EH, Blake OA, New TN, Bellevue R, Tran LT, Razon RL, Stark CW, Neumayr LD, Vichinsky EP; Investigators of the Phase 3 Trial of l-Glutamine in Sickle Cell Disease. A Phase 3 Trial of l-Glutamine in Sickle Cell Disease. N Engl J Med. 2018 Jul 19;379(3):226-235. doi: 10.1056/NEJMoa1715971.
- Individual participant dataSharing planned: No
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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.
Yutaka Niihara, MD, MPH study director
Chairman and CEO
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing L-glutamine in people with Sickle Cell Anemia and Sickle ß0-Thalassemia, run by Emmaus Medical, Inc. at 31 sites in United States.
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 6 inclusion and 11 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 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. 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 10 Aug 2017). 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?
The Number of Occurrences of Sickle Cell Crises (time frame: 48 weeks). 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 NCT01179217, which also lists 2 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 19 Aug 2020.