Septic ShockPhase 3ARISSNCT03869385
Albumin Replacement Therapy in Septic Shock
A Phase 3 study testing Albutein® 200 g/L or Plasbumin® 20 in people with Septic Shock, run by Jena University Hospital at 27 sites in Germany.
Trial summary
Albumin is a key regulator of fluid distribution within the extracellular space and possesses several properties beyond its oncotic activity, including binding and transport of several endogenous molecules, anti-inflammatory and anti-oxidant actions, nitric oxide modulation, and buffer function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Albutein® 200 g/L or Plasbumin® 20
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 27 sitesGermany
- Study dates
- 21 Oct 2019to 13 Jun 2023
- 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
- The presence of septic shock meeting all of the following criteria:
- Clinically possible or probable or microbiologically confirmed infection taking into account the definitions of the "International Sepsis Forum (ISF)"
- Despite adequate volume therapy, vasopressors are required to maintain mean arterial pressure (MAP) ≥ 65 mm Hg for at least 1 hour
- Serum lactate level > 2 mmol/l (18 mg/dl) despite adequate volume therapy
- Start of septic shock less than 24 hours prior to inclusion, so that the start dose of the trial drug in the albumin group will be possible within 6-24 hours after the start of the septic shock
- Age: ≥ 18 years
- Written informed consent of the patient or his/her legal representative or confirmation of the urgency of participation in the clinical trial and possible benefit to the patient by an independent consultant or the implementation of other established procedures according to the local regulations of the contributing centre to include patients who are unable to provide informed consent in whom subsequent consent may be obtained retrospectively.
- Patients of childbearing age: negative pregnancy test
Who cannot join
- Moribund conditions with life expectancy less than 28 days because of comorbid conditions or advanced malignant disease and palliative situations with life expectancy less than 6 months
- Presence of an "end of life" decision prior to obtaining informed consent: "Do Not Resuscitate (DNR)" and "Withhold/Withdraw Life-Sustaining measures"
- Previous participation in this study
- Participation in another interventional clinical trial within the past 3 months
- Shock states that can be explained by other causes, e.g. cardiogenic shock, anaphylactic shock, neurogenic shock
- History of hypersensitivity to albumin or any other component of the trial drug, e.g., B., sodium caprylate, sodium N-acetyltryptophanate
Show all 9Show fewer
- Diseases in which albumin administration may be deleterious, e.g., decompensated heart failure or traumatic brain injury
- Clinical conditions where albumin administration is indicated, e.g., hepatorenal syndrome, nephrosis, burns, intestinal malabsorption syndrome
- Lactation
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
Germany27 sites
Klinikum Augsburg, Klinik für Anästhesiologie und Operative Intensivmedizin
Augsburg, 86156
Helios Klinikum Bad Saarow, Klinik für Intensivmedizin
Bad Saarow, 15526
Vivantes Humboldt Klinikum, Klinik für Innere Medizin, Kardiologie und konservative Intensivmedizin
Berlin, 13509
Universitätsklinikum Bonn, Klinik für Anästesiologie und Operative Intensivmedizin
Bonn, 53105
St. Elisabeth Krankenhaus, Klinik für Anästhesiologie, Operative Intensivmedizin und Schmerztherapie
Cologne, 50935
Universitätsklinikum Erlangen, Anästesiologische Klinik
Erlangen, 91054
Universitätsklinikum Freiburg, Klinik für Allgemein- und Viszeralchirurgie, Chir. Intensivstation
Freiburg im Breisgau, 79106
Universitätsmedizin Göttingen, Klinik für Anästhesiologie, Rettungs- und Intensivmedizin
Göttingen, 37075
Universitätsmedizin Greifswald, Klinik für Anästhesiologie, Intensiv-, Notfall- und Schmerzmedizin
Greifswald, 17475
Universitätsklinikum Hamburg-Eppendorf, Klinik für Intensivmedizin
Hamburg, 20246
Universitätsklinikum Heidelberg, Klinik für Anästhesiologie
Heidelberg, 69120
Klinikum Herford, Medizinische Klinik III, Kardiologie
Herford, 32049
Marien Hospital Herne, Universitätsklinikum der Ruhr-Universität Bochum, Klinik für Anästhesiologie, Operative Intensivmedizin, Schmerztherapie, Palliativmedizin
Herne, 44625
Universitätsklinikum des Saarlandes, Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie
Homburg, 66421
Universitätsklinikum Jena, Innere Medizin I, Kardiologie
Jena, 07747
Universitätsklinikum Jena, Klinik für Innere Medizin I, Kardiologie
Jena, 07747
Universitätsklinikum Schleswig-Holstein, Klinik für Operative Intensivmedizin
Kiel, 24105
Universitätsklinikum Leipzig, Interdisziplinäre Internistische Intensivmedizin
Leipzig, 04103
Universitätsklinikum Leipzig, Klinik für Anästhesiologie u. Intensivtherapie
Leipzig, 04103
Universitätsklinikum Leipzig, Klinik und Poliklinik für Neurologie
Leipzig, 04103
Universitätsklinikum Magdeburg, Klinik für Innere Medizin, Kardiologie und Angiologie
Magdeburg, 39120
Universitätsklinikum Magdeburg, Klinik für Anästhesiologie und Intensivmedizin
Magdeburg
Universitätsklinikum der Johannes-Gutenberg-Universität Mainz, Klinik für Anästhesiologie
Mainz, 55131
Klinikum der LMU München, Klinik für Anästhesiologie
München, 81377
Klinikum rechts der Isar der TU München, Klinik für Anästhesiologie und Intensivmedizin
München, 81675
Universitätsklinikum Münster, Klinik für Anästesiologie, operative Intensivmedizin und Schmerztherapie
Münster, 48149
Universitätsklinikum Regensburg, Klinik und Poliklinik für Chirurgie
Regensburg, 93053
About this study
Official title: Randomised Controlled Multicentre Study of Albumin Replacement Therapy in Septic Shock
Albumin is a key regulator of fluid distribution within the extracellular space and possesses several properties beyond its oncotic activity, including binding and transport of several endogenous molecules, anti-inflammatory and anti-oxidant actions, nitric oxide modulation, and buffer function. The accumulating evidence suggests that supplementation of albumin may provide survival advantages only when the insult is severe as in patients with septic shock. Prospective randomized trials on the possible impact of albumin replacement in these patients with septic shock are lacking. The aim of the study is to investigate whether the replacement with albumin and the maintenance of its serum levels at least at 30 g/l for 28 days improve survival in patients with septic shock compared to resuscitation and volume maintenance without albumin. In this prospective, multicenter, randomised trial, adult patients (≥18 years) with septic shock will be randomly assigned within a maximum of 24 hours after the onset of septic shock after obtaining informed consents to treatment or control groups. Patients assigned to the treatment group will receive a 60 g loading dose of human albumin 20% over 2-3 hours. Serum albumin levels will be maintained at least at 30 g/l in the ICU for a maximum of 28 days following randomization using 40-80 g human albumin 20% infusion. The control group will be treated according to the usual practice with crystalloids as the first choice for the resuscitation and maintenance phase of septic shock. The primary end point is 90 days mortality and secondary end points include 28-day, 60-day, ICU, and in-hospital mortality, organ dysfunction/failure, and length of ICU and hospital stay. In total 1412 patients need to be analyzed, 706 per group. Assuming a dropout rate of 15%, a total of 1662 patients need to be allocated.
Read the detailed description
This is a prospective, multicentre, randomised, controlled, parallel-grouped, open-label, interventional clinical trial in which 1662 patients are planned to be allocated. Subjects will be randomized in a 1:1 ratio to receive either Albumin or routine treatment with crystalloids. Treatment will be continued at maximum for 28 days or until the patient leaves the ICU. Primary endpoint measurement will be carried out 90 days after randomisation
- Conditions
- Septic Shock
- Being tested
- Albutein® 200 g/L or Plasbumin® 20
- Keywords
- Human albumin, Sepsis
- Medical subject headings
- Shock, Septic, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albutein® 200 g/L or Plasbumin® 20Drug
Also called Human Albumin 20%
The initial dose of the trial drug must be started within 6 to 24 hours after the beginning of the septic shock. Starting dose: 60 g human albumin 20% (Albutein® 200 g/L, infusion solution) over 2-3 h Daily administration of the trial drug will be based on the serum albumin concentration measured each day. Dose adjustment will follow a predetermined schedule with the aim of maintaining a serum albumin concentration of at least 30 g/l. Administration of the trial drug will continue for a maximum of 28 study days after randomisation and only as long as the participant is being treated in the ICU.
| Study group | Role | What they receive |
|---|---|---|
| Albumin group | Experimental | Patients assigned to the Albumin group will receive a 60 g loading dose of human albumin 20% over 2-3 hours. Serum albumin levels will be maintained at least at 30 g/l in the ICU for a maximum of 28 days following randomization using 40-80 g human albumin 20% infusion. Receives: Drug: Albutein® 200 g/L or Plasbumin® 20 |
| Control group without albumin: | No intervention | The control group will be treated according to the usual practice with crystalloids as the first choice for the resuscitation and maintenance phase of septic shock. |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day All Cause Mortality
Mortality within 90 days after randomisation
Measured: 90 days
Secondary outcomes (9)
28-day Mortality
Mortality within 28 days after randomisation
Measured: 28 days
60-day Mortality
Mortality within 60 days after randomisation
Measured: 60 days
Organ Failure
Organ failure defined as increase in the daily recorded Sequential organ Failure Assessement (SOFA) subscores; cardiovascular, respiratory, hematologic, hepatic, renal, neurologic (range 0-4 points each) from a value <2 to a value ≥ 2
Measured: 28 days
Sequential Organ Failure Assessement (SOFA) Score
The overall degree of organ dysfunction/failure assessed daily by the total Sequential Organ Failure Score (SOFA score: range 0-24 points), with higher scores indicating higher degree of overall organ dysfunction/failure).
Measured: 28 days
ICU Length of Stay
Intensive Care unit stay of first hospitalization after randomisation within 90 days
Measured: 90 days
Hospital Length of Stay
Hospital stay of first hospitalization after randomisation within 90 days
Measured: 90 days
Ventilation-free Days
Ventilation-free days within 28 days after randomisation
Measured: 28 days
Vasopressor-free Days
Vasopressor-free days within 28 days after randomisation
Measured: 28 days
Total Amount of Fluid of Fluid Administration and Total Fluid Balance in the ICU.
Total amount of fluid of fluid administration and total fluid balance in the ICU within 28 days after randomisation
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start21 Oct 2019
- Primary completion27 Jul 2022
- Study completion13 Jun 2023
Why it stopped: Sustained low inclusion rates.
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 Septic ShockStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jena University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation, Instituto Grifols, S.A., University Hospital Goettingen, SepNet - Critical Care Trials Group, Center for Sepsis Control and Care, Germany
- Responsible party
- Principal investigator, Yasser Sakr, Jena University Hospital
- Investigators
- Yasser Sakr, MD, PhD, Principal investigator, Jena University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869385
- Sponsor's protocol ID
- ZKSJ0112_ARISS
- Other IDs
- 2018-001874-89, SA 2167/3-1, Nr: 328809707, ZKSJ0112, 2018
- Acronym
- ARISS
- Status last verified
- Oct 2024
- First submitted
- 8 Mar 2019
- Last updated
- 28 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sakr Y, Nierhaus A, Schumacher U, Utzolino S, Jaschinski U, Petros S, Fichtner F, Eimer C, Putensen C, Tanev I, Kreienbuhl L, Kluge S, Kousoulas L, Kuhn SO, Jarczak D, Quintel M, Bauer M; SepNet Critical Care Trials Group and Albumin Replacement Therapy in Septic Shock (ARISS) investigators. Albumin Replacement Therapy in Septic Shock: A Randomized Clinical Trial. JAMA Netw Open. 2026 Feb 2;9(2):e2559297. doi: 10.1001/jamanetworkopen.2025.59297.
PubMed 41712212Sakr Y, Bauer M, Nierhaus A, Kluge S, Schumacher U, Putensen C, Fichtner F, Petros S, Scheer C, Jaschinski U, Tanev I, Jacob D, Weiler N, Schulze PC, Fiedler F, Kapfer B, Brunkhorst F, Lautenschlaeger I, Wartenberg K, Utzolino S, Briegel J, Moerer O, Bischoff P, Zarbock A, Quintel M, Gattinoni L; SepNet - Critical Care Trials Group. Randomized controlled multicentre study of albumin replacement therapy in septic shock (ARISS): protocol for a randomized controlled trial. Trials. 2020 Dec 7;21(1):1002. doi: 10.1186/s13063-020-04921-y.
PubMed 33287911
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Multicentre Study of Albumin Replacement Therapy in Septic Shock
- ClinicalTrials.gov ID
- NCT03869385
- Acronym / sponsor ID
- ARISS / ZKSJ0112_ARISS
- Conditions
- Septic Shock
- Keywords
- Human albumin, Sepsis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sustained low inclusion rates.
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Jena University HospitalUniversity, hospital or other
- Collaborators
- German Research Foundation, Instituto Grifols, S.A., University Hospital Goettingen, SepNet - Critical Care Trials Group, Center for Sepsis Control and Care, Germany
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 27 Jul 2022 (actual)
- Study completion
- 13 Jun 2023 (actual)
- First posted
- 11 Mar 2019 (actual)
- Results
- Posted 28 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Albumin is a key regulator of fluid distribution within the extracellular space and possesses several properties beyond its oncotic activity, including binding and transport of several endogenous molecules, anti-inflammatory and anti-oxidant actions, nitric oxide modulation, and buffer function. The accumulating evidence suggests that supplementation of albumin may provide survival advantages only when the insult is severe as in patients with septic shock. Prospective randomized trials on the possible impact of albumin replacement in these patients with septic shock are lacking. The aim of the study is to investigate whether the replacement with albumin and the maintenance of its serum levels at least at 30 g/l for 28 days improve survival in patients with septic shock compared to resuscitation and volume maintenance without albumin. In this prospective, multicenter, randomised trial, adult patients (≥18 years) with septic shock will be randomly assigned within a maximum of 24 hours after the onset of septic shock after obtaining informed consents to treatment or control groups. Patients assigned to the treatment group will receive a 60 g loading dose of human albumin 20% over 2-3 hours. Serum albumin levels will be maintained at least at 30 g/l in the ICU for a maximum of 28 days following randomization using 40-80 g human albumin 20% infusion. The control group will be treated according to the usual practice with crystalloids as the first choice for the resuscitation and maintenance phase of septic shock. The primary end point is 90 days mortality and secondary end points include 28-day, 60-day, ICU, and in-hospital mortality, organ dysfunction/failure, and length of ICU and hospital stay. In total 1412 patients need to be analyzed, 706 per group. Assuming a dropout rate of 15%, a total of 1662 patients need to be allocated.
Detailed description
This is a prospective, multicentre, randomised, controlled, parallel-grouped, open-label, interventional clinical trial in which 1662 patients are planned to be allocated. Subjects will be randomized in a 1:1 ratio to receive either Albumin or routine treatment with crystalloids. Treatment will be continued at maximum for 28 days or until the patient leaves the ICU. Primary endpoint measurement will be carried out 90 days after randomisation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Albumin group | Experimental | Drug: Albutein® 200 g/L or Plasbumin® 20Patients assigned to the Albumin group will receive a 60 g loading dose of human albumin 20% over 2-3 hours. Serum albumin levels will be maintained at least at 30 g/l in the ICU for a maximum of 28 days following randomization using 40-80 g human albumin 20% infusion. |
| Control group without albumin: | No intervention | –The control group will be treated according to the usual practice with crystalloids as the first choice for the resuscitation and maintenance phase of septic shock. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The presence of septic shock meeting all of the following criteria:
- Start of septic shock less than 24 hours prior to inclusion, so that the start dose of the trial drug in the albumin group will be possible within 6-24 hours after the start of the septic shock
- Age: ≥ 18 years
- Written informed consent of the patient or his/her legal representative or confirmation of the urgency of participation in the clinical trial and possible benefit to the patient by an independent consultant or the implementation of other established procedures according to the local regulations of the contributing centre to include patients who are unable to provide informed consent in whom subsequent consent may be obtained retrospectively.
- Patients of childbearing age: negative pregnancy test
Key exclusion criteria (9 listed)
- Moribund conditions with life expectancy less than 28 days because of comorbid conditions or advanced malignant disease and palliative situations with life expectancy less than 6 months
- Presence of an "end of life" decision prior to obtaining informed consent: "Do Not Resuscitate (DNR)" and "Withhold/Withdraw Life-Sustaining measures"
- Previous participation in this study
- Participation in another interventional clinical trial within the past 3 months
- Shock states that can be explained by other causes, e.g. cardiogenic shock, anaphylactic shock, neurogenic shock
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 |
|---|---|---|
| Albutein® 200 g/L or Plasbumin® 20Also: Human Albumin 20%The initial dose of the trial drug must be started within 6 to 24 hours after the beginning of the septic shock. Starting dose: 60 g human albumin 20% (Albutein® 200 g/L, infusion solution) over 2-3 h Daily administration of the trial drug will be based on the serum albumin concentration measured each day. Dose adjustment will follow a predetermined schedule with the aim of maintaining a serum albumin concentration of at least 30 g/l. Administration of the trial drug will continue for a maximum of 28 study days after randomisation and only as long as the participant is being treated in the ICU. | Drug | Albumin group |
Primary outcome
90-day All Cause Mortality
Time frame: 90 days
Mortality within 90 days after randomisation
9 secondary outcomes
28-day Mortality
Time frame: 28 days
60-day Mortality
Time frame: 60 days
Organ Failure
Time frame: 28 days
Sequential Organ Failure Assessement (SOFA) Score
Time frame: 28 days
ICU Length of Stay
Time frame: 90 days
Hospital Length of Stay
Time frame: 90 days
Ventilation-free Days
Time frame: 28 days
Vasopressor-free Days
Time frame: 28 days
Total Amount of Fluid of Fluid Administration and Total Fluid Balance in the ICU.
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41712212Sakr Y, Nierhaus A, Schumacher U, Utzolino S, Jaschinski U, Petros S, Fichtner F, Eimer C, Putensen C, Tanev I, Kreienbuhl L, Kluge S, Kousoulas L, Kuhn SO, Jarczak D, Quintel M, Bauer M; SepNet Critical Care Trials Group and Albumin Replacement Therapy in Septic Shock (ARISS) investigators. Albumin Replacement Therapy in Septic Shock: A Randomized Clinical Trial. JAMA Netw Open. 2026 Feb 2;9(2):e2559297. doi: 10.1001/jamanetworkopen.2025.59297.
- Derived from this study: PubMed 33287911Sakr Y, Bauer M, Nierhaus A, Kluge S, Schumacher U, Putensen C, Fichtner F, Petros S, Scheer C, Jaschinski U, Tanev I, Jacob D, Weiler N, Schulze PC, Fiedler F, Kapfer B, Brunkhorst F, Lautenschlaeger I, Wartenberg K, Utzolino S, Briegel J, Moerer O, Bischoff P, Zarbock A, Quintel M, Gattinoni L; SepNet - Critical Care Trials Group. Randomized controlled multicentre study of albumin replacement therapy in septic shock (ARISS): protocol for a randomized controlled trial. Trials. 2020 Dec 7;21(1):1002. doi: 10.1186/s13063-020-04921-y.
- 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.
Yasser Sakr, MD, PhD principal investigator
Jena University Hospital
27 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 Albutein® 200 g/L or Plasbumin® 20 in people with Septic Shock, run by Jena University Hospital at 27 sites in Germany.
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 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: stopped early, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Germany. 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 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 28 Oct 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?
90-day All Cause Mortality (time frame: 90 days). 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 NCT03869385, 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 28 Oct 2024.