Autosomal Dominant Hypocalcemia (ADH)Phase 2NCT04581629
Safety, Tolerability, and Efficacy of Encaleret in Participants With Autosomal Dominant Hypocalcemia (ADH) Type 1
A Phase 2 study testing Encaleret in people with Autosomal Dominant Hypocalcemia (ADH) and Autosomal Dominant Hypocalcemia Type 1 (ADH1), run by Calcilytix Therapeutics, Inc., a BridgeBio company at 1 site in United States.
Trial summary
The primary purpose of this study is to evaluate the safety, tolerability and effectiveness of encaleret in participants with Autosomal Dominant Hypocalcemia Type 1 (ADH1). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Autosomal Dominant Hypocalcemia (ADH), Autosomal Dominant Hypocalcemia Type 1 (ADH1)
- What is being tested?
- Encaleret
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2020to 7 Sep 2023
- Phase
- Phase 2
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Be able to understand and sign a written informed consent or assent form, which must be obtained prior to initiation of study procedures.
- Postmenopausal women are allowed to participate in this study
- Body mass index (BMI) ≥ 18.5 to < 39 kilograms (kg)/square meter (m^2)
- Have an activating mutation of the Calcium-sensing receptor (CASR) gene
- Participants being treated with thiazide diuretics may be enrolled if they are willing and able to discontinue thiazides
- Participants being treated with strong Cytochrome P3A4 (CYP3A4) inhibitors should ideally, if clinically appropriate, discontinue these medications during the screening period
- Participants being treated with magnesium or potassium citrate supplements should discontinue such treatment starting on Day -1 during Period 1 and Period 2 and may be asked to discontinue treatment during Period 3
Who cannot join
- History of treatment with parathyroid hormone (PTH) 1-84 or 1-34 within the previous 3 months
- History of hypocalcemic seizure within the past 3 months
- Blood 25-OH Vitamin D level < 25 nanograms (ng)/milliliter (mL)
- Participants with hemoglobin (Hgb) < 13 grams (g)/deciliter (dL) for men and < 12 g/dL for women
- Estimated glomerular filtration rate (eGFR) < 25 mL/minute/1.73 m^2 using Chronic Kidney Disease Epidemiology Collaboration (for participants <18 years old the Schwartz equation will be calculated)
- 12-lead resting electrocardiogram (ECG) with clinically significant abnormalities
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- Participants with positive hepatitis B surface antigen (HBsAg), hepatitis A immunoglobulin M (IgM), or human immunodeficiency virus (HIV) viral serology test results at the Screening Visit
- Pregnant or nursing (lactating) women
- History of drug or alcohol dependency within 12 months preceding the Screening Visit
- History of thyroid or parathyroid surgery
- Current participation in other investigational drug studies
- Unwillingness to refrain from blood donation within 12 weeks prior to Screening Visit from the start of the study enrollment through one year after the last dose of the study drug
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health (NIH) Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: A Phase 2b, Open-label Dose-ranging Study Evaluating the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics, and Efficacy of CLTX-305 (Encaleret) in Autosomal Dominant Hypocalcemia (ADH) Type 1
The primary purpose of this study is to evaluate the safety, tolerability and effectiveness of encaleret in participants with Autosomal Dominant Hypocalcemia Type 1 (ADH1).
- Being tested
- Encaleret
- Medical subject headings
- Hypercalciuric Hypocalcemia, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EncaleretDrug
Also called CLTX-305
Tablets administered orally
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Ascending + Steady-State Dose | Experimental | Period 1: Participants will receive an ascending dose of encaleret once daily for the first 3 days. Participants will then receive an individualized dose of encaleret twice daily for 2 days.
Period 2: Participants will receive encaleret twice daily for 5 days at a single dose level based on responses from Period 1.
Period 3: After completion of Period 2, participants will be eligible to receive encaleret for an additional 24 weeks.
Long-Term Extension (LTE): At the end of the study, participants will also have an option to receive encaleret for up to an additional 2 years. Receives: Drug: Encaleret |
| Cohort 2: Steady-State Dose | Experimental | Participants will directly be enrolled into Period 2, and receive encaleret twice daily at a dose based on data and responses from Cohort 1 Period 1.
Period 2: Participants will receive encaleret twice daily for 5 days.
Period 3: After completion of Period 2, participants will be eligible to receive encaleret for an additional 24 weeks.
LTE: At the end of the study, participants will also have an option to receive encaleret for up to an additional 2 years. Receives: Drug: Encaleret |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periods 1, 2 and 3: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Adverse events (AEs) were defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. Treatment-emergence was defined as any AE(s) regardless of relationship to investigational medicinal product (IMP), that had an onset or worsened in severity on or after the first dose of IMP.
Measured: Day 1 up to 16 months
Period 3: Change From Baseline in Albumin-Corrected Blood Calcium Concentrations (cCa)
Measured: Baseline, Week 24
Period 3: Rate of Urinary Calcium Excretion
Measured: Week 24
Secondary outcomes (16)
Periods 1 and 2: Intact Parathyroid Hormone (iPTH) Concentrations in the Blood
Blood samples were taken for analysis of iPTH concentrations. iPTH concentrations were analyzed via an electrochemiluminescence immunoassay.
Measured: 15 minutes pre-dose on Day 5 of Periods 1 and 2 (Periods were 5 days)
Periods 1 and 2: Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of Encaleret
Measured: Periods 1 and 2: Day 5 (Periods were 5 days)
Periods 1, 2 and 3: Maximum Plasma Concentration (Cmax) of Encaleret
Measured: Periods 1 and 2: Day 5, Period 3: Week 24 (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3)
Periods 1, 2 and 3: Time to Maximum Plasma Concentration (Tmax) of Encaleret
Measured: Periods 1 and 2: Day 5; Period 3: Week 24 (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3)
Periods 2 and 3: Change From Baseline in Blood Calcium Concentration (cCa)
Data values presented are for the change from baseline for the average values at the specified timepoints/visits.
Measured: Period 2: Baseline, Day 5 (Period was 5 days), Period 3: Baseline, Week 24 (Period was 24 weeks)
Period 3: Urinary Calcium Clearance as Assessed by Fractional Excretion
Fractional Excretion of Calcium was derived as (Urine Calcium at the interval considered * Serum Creatinine at the end of the interval considered)/(Serum Calcium at the end of the interval considered * Urine Creatinine at the interval considered) and is presented as percentage.
Measured: Period 3: Week 24, 15 minutes pre-dose (Period was 24 weeks)
Periods 1, 2 and 3: Urinary Calcium Clearance as Assessed by 24-Hour Total Excretion
Measured: Periods 1 and 2: Day 5; Period 3, Week 24 (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3)
Periods 1, 2 and 3: Renal Function as Assessed by Estimated Glomerular Filtration Rate (eGFR)
eGFR was calculated using Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI) formula (mL/min/1.73m^2) = 141 x min (SCr/K, 1)^α x max(SCR /K,1)-1.209 x 0.993Age x 1.018 [if female] x 1.159 [if Black], where SCr is the serum creatinine (mg/dL), K = 0.7 for female and 0.9 for males, α is -0.329 for female and -0.411 for males.
Measured: Periods 1 and 2: Day 5 (15 minutes pre-dose), Period 3: Week 24 (15 minutes pre-dose) (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3)
Periods 1, 2 and 3: Serum Levels of 1,25-(OH)2 Vitamin D
Measured: Periods 1 and 2: Day 5 (15 minutes pre-dose), Period 3: Week 24 (15 minutes pre-dose); (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3)
Periods 1, 2 and 3: Magnesium, Phosphorus, and Creatinine Levels as Assessed by Blood Sample Examinations
Measured: Periods 1 and 2: Day 5 (15 minutes pre-dose), Period 3: Week 24 (15 minutes pre-dose); (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3)
Periods 1, 2 and 3: Creatinine, Phosphorus, Magnesium, and Citrate Total Excretion Levels as Assessed by Urine Sample Examinations
Measured: Periods 1 and 2: Day 5 (0-24h post-dose), Period 3: Week 24 (0-24h post-dose); (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3)
Periods 1, 2 and 3: pH as Assessed by Urine Sample Examinations
Measured: Periods 1 and 2: Day 5 (0-24 hours post-dose), Period 3: Week 24: (0-24 hours post-dose); (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3)
Periods 1, 2 and 3: Potassium and Sodium Total Excretion Levels as Assessed by Urine Sample Examinations
Measured: Periods 1 and 2: Day 5 (0-24h post-dose), Period 3: Week 24 (0-24h post-dose); (Period was 5 days for periods 1 and 2; 24 weeks for period 3)
Periods 1, 2 and 3: Cyclic Adenosine Monophosphate (cAMP) Total Excretion Levels as Assessed by Urine Sample Examinations
Measured: Periods 1 and 2: Day 5 (0-4h post-dose), Period 3: Week 24 (0-4h post dose); (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3)
Periods 1, 2 and 3: Bone Resorption Markers as Assessed by Collagen Cross-Linked C-Telopeptide (CTx)
Blood samples were taken for analysis of bone resorption markers (CTx).
Measured: Periods 1 and 2: Day 5 (15 minutes pre-dose), Period 3 Week 24 (15 minutes pre-dose); (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3)
Periods 1, 2 and 3: Bone Formation Markers as Assessed by Blood Procollagen Type 1 N-Propeptide (P1NP)
Blood samples were taken for analysis of bone formation markers (P1NP).
Measured: Periods 1 and 2: Day 5 (15 minutes pre-dose), Period 3 Week 24 (15 minutes pre-dose); (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start20 Sep 2020
- Primary completion7 Sep 2023
- Study completion7 Sep 2023
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.
- Other trials for Autosomal Dominant Hypocalcemia (ADH)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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calcilytix Therapeutics, Inc., a BridgeBio company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Calcilytix Medical Director, Study director, Calcilytix Therapeutics, Inc., a BridgeBio company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04581629
- Sponsor's protocol ID
- CLTX-305-201
- Status last verified
- Oct 2024
- First submitted
- 16 Sep 2020
- Last updated
- 19 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Open-label Dose-ranging Study Evaluating the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics, and Efficacy of CLTX-305 (Encaleret) in Autosomal Dominant Hypocalcemia (ADH) Type 1
- ClinicalTrials.gov ID
- NCT04581629
- Acronym / sponsor ID
- CLTX-305-201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Calcilytix Therapeutics, Inc., a BridgeBio companyIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2020 (actual)
- Primary completion
- 7 Sep 2023 (actual)
- Study completion
- 7 Sep 2023 (actual)
- First posted
- 9 Oct 2020 (actual)
- Results
- Posted 19 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to evaluate the safety, tolerability and effectiveness of encaleret in participants with Autosomal Dominant Hypocalcemia Type 1 (ADH1).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Ascending + Steady-State Dose | Experimental | Drug: EncaleretPeriod 1: Participants will receive an ascending dose of encaleret once daily for the first 3 days. Participants will then receive an individualized dose of encaleret twice daily for 2 days. Period 2: Participants will receive encaleret twice daily for 5 days at a single dose level based on responses from Period 1. Period 3: After completion of Period 2, participants will be eligible to receive encaleret for an additional 24 weeks. Long-Term Extension (LTE): At the end of the study, participants will also have an option to receive encaleret for up to an additional 2 years. |
| Cohort 2: Steady-State Dose | Experimental | Drug: EncaleretParticipants will directly be enrolled into Period 2, and receive encaleret twice daily at a dose based on data and responses from Cohort 1 Period 1. Period 2: Participants will receive encaleret twice daily for 5 days. Period 3: After completion of Period 2, participants will be eligible to receive encaleret for an additional 24 weeks. LTE: At the end of the study, participants will also have an option to receive encaleret for up to an additional 2 years. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Be able to understand and sign a written informed consent or assent form, which must be obtained prior to initiation of study procedures.
- Postmenopausal women are allowed to participate in this study
- Body mass index (BMI) ≥ 18.5 to < 39 kilograms (kg)/square meter (m^2)
- Have an activating mutation of the Calcium-sensing receptor (CASR) gene
- Participants being treated with thiazide diuretics may be enrolled if they are willing and able to discontinue thiazides
Key exclusion criteria (13 listed)
- History of treatment with parathyroid hormone (PTH) 1-84 or 1-34 within the previous 3 months
- History of hypocalcemic seizure within the past 3 months
- Blood 25-OH Vitamin D level < 25 nanograms (ng)/milliliter (mL)
- Participants with hemoglobin (Hgb) < 13 grams (g)/deciliter (dL) for men and < 12 g/dL for women
- Estimated glomerular filtration rate (eGFR) < 25 mL/minute/1.73 m^2 using Chronic Kidney Disease Epidemiology Collaboration (for participants <18 years old the Schwartz equation will be calculated)
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 |
|---|---|---|
| EncaleretAlso: CLTX-305Tablets administered orally | Drug | Cohort 1: Ascending + Steady-State Dose, Cohort 2: Steady-State Dose |
Primary outcome
Periods 1, 2 and 3: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 up to 16 months
Adverse events (AEs) were defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. Treatment-emergence was defined as any AE(s) regardless of relationship to investigational medicinal product (IMP), that had an onset or worsened in severity on or after the first dose of IMP.
Period 3: Change From Baseline in Albumin-Corrected Blood Calcium Concentrations (cCa)
Time frame: Baseline, Week 24
Period 3: Rate of Urinary Calcium Excretion
Time frame: Week 24
16 secondary outcomes
Periods 1 and 2: Intact Parathyroid Hormone (iPTH) Concentrations in the Blood
Time frame: 15 minutes pre-dose on Day 5 of Periods 1 and 2 (Periods were 5 days)
Periods 1 and 2: Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of Encaleret
Time frame: Periods 1 and 2: Day 5 (Periods were 5 days)
Periods 1, 2 and 3: Maximum Plasma Concentration (Cmax) of Encaleret
Time frame: Periods 1 and 2: Day 5, Period 3: Week 24 (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3)
Periods 1, 2 and 3: Time to Maximum Plasma Concentration (Tmax) of Encaleret
Time frame: Periods 1 and 2: Day 5; Period 3: Week 24 (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3)
Periods 2 and 3: Change From Baseline in Blood Calcium Concentration (cCa)
Time frame: Period 2: Baseline, Day 5 (Period was 5 days), Period 3: Baseline, Week 24 (Period was 24 weeks)
Period 3: Urinary Calcium Clearance as Assessed by Fractional Excretion
Time frame: Period 3: Week 24, 15 minutes pre-dose (Period was 24 weeks)
Periods 1, 2 and 3: Urinary Calcium Clearance as Assessed by 24-Hour Total Excretion
Time frame: Periods 1 and 2: Day 5; Period 3, Week 24 (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3)
Periods 1, 2 and 3: Renal Function as Assessed by Estimated Glomerular Filtration Rate (eGFR)
Time frame: Periods 1 and 2: Day 5 (15 minutes pre-dose), Period 3: Week 24 (15 minutes pre-dose) (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3)
Periods 1, 2 and 3: Serum Levels of 1,25-(OH)2 Vitamin D
Time frame: Periods 1 and 2: Day 5 (15 minutes pre-dose), Period 3: Week 24 (15 minutes pre-dose); (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3)
Periods 1, 2 and 3: Magnesium, Phosphorus, and Creatinine Levels as Assessed by Blood Sample Examinations
Time frame: Periods 1 and 2: Day 5 (15 minutes pre-dose), Period 3: Week 24 (15 minutes pre-dose); (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3)
Periods 1, 2 and 3: Creatinine, Phosphorus, Magnesium, and Citrate Total Excretion Levels as Assessed by Urine Sample Examinations
Time frame: Periods 1 and 2: Day 5 (0-24h post-dose), Period 3: Week 24 (0-24h post-dose); (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3)
Periods 1, 2 and 3: pH as Assessed by Urine Sample Examinations
Time frame: Periods 1 and 2: Day 5 (0-24 hours post-dose), Period 3: Week 24: (0-24 hours post-dose); (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3)
Periods 1, 2 and 3: Potassium and Sodium Total Excretion Levels as Assessed by Urine Sample Examinations
Time frame: Periods 1 and 2: Day 5 (0-24h post-dose), Period 3: Week 24 (0-24h post-dose); (Period was 5 days for periods 1 and 2; 24 weeks for period 3)
Periods 1, 2 and 3: Cyclic Adenosine Monophosphate (cAMP) Total Excretion Levels as Assessed by Urine Sample Examinations
Time frame: Periods 1 and 2: Day 5 (0-4h post-dose), Period 3: Week 24 (0-4h post dose); (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3)
Periods 1, 2 and 3: Bone Resorption Markers as Assessed by Collagen Cross-Linked C-Telopeptide (CTx)
Time frame: Periods 1 and 2: Day 5 (15 minutes pre-dose), Period 3 Week 24 (15 minutes pre-dose); (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3)
Periods 1, 2 and 3: Bone Formation Markers as Assessed by Blood Procollagen Type 1 N-Propeptide (P1NP)
Time frame: Periods 1 and 2: Day 5 (15 minutes pre-dose), Period 3 Week 24 (15 minutes pre-dose); (Period was 5 days for Periods 1 and 2; 24 weeks for Period 3)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Calcilytix Medical Director study director
Calcilytix Therapeutics, Inc., a BridgeBio company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Encaleret in people with Autosomal Dominant Hypocalcemia (ADH) and Autosomal Dominant Hypocalcemia Type 1 (ADH1), run by Calcilytix Therapeutics, Inc., a BridgeBio company at 1 site 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 7 inclusion and 13 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 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Nov 2024). 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?
Periods 1, 2 and 3: Number of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: Day 1 up to 16 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.