Acquired Antithrombin DeficiencyPhase 3NCT06096116
Phase 3 Study on the Efficacy and Safety of Human Plasma Derived Antithrombin (Atenativ) in Heparin-Resistant Patients Scheduled to Undergo Cardiac Surgery Necessitating Cardiopulmonary Bypass
A Phase 3 study testing Human plasma derived antithrombin in people with Acquired Antithrombin Deficiency, run by Octapharma at 27 sites in 10 countries.
Trial summary
The primary objective of this study is to evaluate the efficacy of two different doses of Atenativ, versus placebo, in restoring and maintaining heparin responsiveness in adult patients undergoing cardiac surgery necessitating cardiopulmonary bypass (CPB) Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acquired Antithrombin Deficiency
- What is being tested?
- Human plasma derived antithrombin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 27 sitesin 10 countries
- Study dates
- 21 Aug 2024to Mar 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned cardiac surgery with CPB
- Heparin-resistant patients (pre-CPB Hemochron ACT less than 480 s in the measurement taken between 2-5 minutes following intravenous administration of 500 U/kg UFH)
- Patients between 18 and 85 years of age, inclusive
- Freely given written or electronic informed consent
- In female patients of childbearing potential, a pre-existing negative pregnancy test within 14 days prior to surgery
Who cannot join
- Receiving, or have received within the timeframes specified, one or more of the following medications prior to the start of surgery:
- vitamin K antagonists (within 3 days)
- direct oral anticoagulants (within 2 days)
- thienopyridines (ticlopidine within 14 days, prasugrel within 7 days, or clopidogrel within 5 days), unless platelet function is satisfactory according to local standard of care assessment
- ticagrelor (within 5 days), unless platelet function is satisfactory according to local standard of care assessment
- glycoprotein IIb/IIIa antagonist (within 24 hours)
Show all 14Show fewer
- Pre-existing coagulopathy, a history of bleeding problems, or a laboratory-diagnosed bleeding disorder (e.g., von Willebrand disease, platelet disorder)
- Renal insufficiency, defined as serum creatinine level >2.0 mg/dL
- Thrombocytosis, defined as platelet count >400,000 per μL
- Known hypersensitivity or allergic reaction to antithrombin or any of the excipients in Atenativ, i.e., human albumin, sodium chloride, acetyl tryptophan, caprylic acid
- History of anaphylactic reaction(s) to blood or blood components
- Refusal to receive transfusion of blood or blood-derived products
- Current participation in another interventional clinical trial or previous participation in the current trial
- Treatment with any IMP within 30 days prior to screening visit
Trial locations and contacts
27 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
27 sites in 10 countries
United States9 sites, 9 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
- Recruiting
The Ohio State University
Columbus, Ohio, 43214
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710-1000
- Recruiting
University of Miami
Miami, Florida, 33136
- Recruiting
OU Health University of Oklahoma Medical Center
Oklahoma City, Oklahoma, 73104
- Recruiting
Stanford University School of Medicine
Stanford, California, 94305-5101
- Recruiting
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
Canada4 sites, 4 recruiting
- Recruiting
Kingston Health Sciences Centre
Kingston, Ontario, K7L2V7
- Recruiting
Montreal Heart Institute
Montreal, Quebec, H1T1C8
- Recruiting
Royal Columbian Hospital
New Westminster, British Columbia, V3L0A4
- Not yet recruiting
Toronto General Hospital
Toronto, Ontario, M5G2C4
United Kingdom3 sites, 3 recruiting
- Recruiting
Royal Papworth Hospital
Cambridge
- Recruiting
University Hospital Coventry and Warwickshire
Coventry
- Recruiting
The James Cook University Hospital
Middlesbrough
Austria2 sites, 2 recruiting
- Recruiting
University Hospital Innsbruck
Innsbruck
- Recruiting
Vienna General Hospital AKH, Medical University of Vienna
Vienna
Czechia2 sites, 1 recruiting
- Recruiting
Center of Cardiovascular and Transplant Surgery
Brno
- Terminated
Institute for Clinical and Experimental Medicine
Prague
France2 sites
- Terminated
CHU de Reims, Hôpital Robert Debré
Reims
- Withdrawn
CHU de Rennes
Rennes
Lithuania2 sites, 1 recruiting
- Terminated
Hospital of Lithuanian university of Health sciences Kauno Klinikos
Kaunas
- Recruiting
Vilnius University hospital Santaros Klinikos
Vilnius
Romania1 site, 1 recruiting
- Recruiting
Institute for Cardiovascular Diseases C.C. Iliescu
Bucharest
Serbia1 site, 1 recruiting
- Recruiting
Institute of Cardiovascular Diseases Vojvodina
Kamenitz
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Centre Ljubljana
Ljubljana
About this study
Official title: Phase 3, Double-blind, Placebo-controlled, Multicentre Study on the Efficacy and Safety of Human Plasma Derived Antithrombin (Atenativ) in Heparin-Resistant Patients Scheduled to Undergo Cardiac Surgery Necessitating Cardiopulmonary Bypass
The primary objective of this study is to evaluate the efficacy of two different doses of Atenativ, versus placebo, in restoring and maintaining heparin responsiveness in adult patients undergoing cardiac surgery necessitating cardiopulmonary bypass (CPB)
- Conditions
- Acquired Antithrombin Deficiency
- Being tested
- Human plasma derived antithrombin, Placebo
- Keywords
- heparin resistance, antithrombin deficiency, cardiopulmonary bypass, cardiac surgery
- Medical subject headings
- Antithrombin III Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human plasma derived antithrombinDrug
A solvent/detergent and heat-treated antithrombin concentrate derived from human plasma
PlaceboDrug
Half of the patients in the placebo group will be randomised to receive a volume of placebo corresponding to the low dose of Atenativ and the other half to receive a volume of placebo corresponding to a high dose of Atenativ
| Study group | Role | What they receive |
|---|---|---|
| Low-dose Atenativ | Experimental | Patients will receive a single bolus of 30 international units (IU)/kg body weight (BW) Atenativ. Receives: Drug: Human plasma derived antithrombin |
| High-dose Atenativ | Experimental | Patients will receive a single bolus of 60 international units (IU)/kg body weight (BW) Atenativ. Receives: Drug: Human plasma derived antithrombin |
| Placebo | Placebo comparator | Patients will receive a saline bolus dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restoring heparin responsiveness
The percentage of patients in each group in whom no further therapy containing antithrombin (i.e. frozen plasma or other antithrombin concentrates) is needed for restoring pre-CPB heparin responsiveness after administration of Atenativ or placebo, and for maintaining it during CPB
Measured: During surgery (from the time of the first surgical incision to the time at which the final suture or staple is placed)
Secondary outcomes (20)
Amounts of further therapy for restoring heparin responsiveness
The comparison between the amounts of further therapy containing antithrombin (i.e., FP or antithrombin concentrates) needed for restoring pre-CPB heparin responsiveness, after administration of Atenativ or placebo, and for maintaining it during CPB
Measured: During surgery (from the time of the first surgical incision to the time at which the final suture or staple is placed)
Change in activated clotting time (ACT) values
The comparison between the change in ACT values following infusion of each of the Atenativ doses and placebo
Measured: Within 5 minutes following intravenous administration of 500 U/kg unfractionated heparin (UFH) and between 2-10 minutes after IMP infusion
Change in antithrombin plasma levels
The comparison between the change in antithrombin plasma levels following infusion of each of the Atenativ doses and placebo
Measured: Within 10 minutes before IMP infusion and between 2 and 10 minutes after IMP infusion, within 10 minutes after the end of CPB, at the end of surgery, and at 24 hours after the start of IMP infusion
Change in heparin usage
The comparison between heparin usage following the infusion of each of the Atenativ doses and infusion of placebo
Measured: From end of IMP infusion to the end of surgery
FP unit use
The comparison between the number of units of FP transfused for reasons other than restoring or maintaining heparin responsiveness, both intraoperatively (from the start of Atenativ or placebo infusion until the start of CPB, during CPB, and from the end of CPB until the end of surgery) and postoperatively (from the end of surgery until 24 hours after the start of Atenativ or placebo infusion and until discharge or 7 days after surgery, whichever comes first), as well as cumulatively
Measured: From the start of IMP infusion until 24 hours following IMP infusion, and until discharge or 7 days after surgery, whichever comes first
Amounts of further antithrombin concentrate for maintaining heparin responsiveness
The comparison between postoperative use of antithrombin concentrates for reasons other than restoring heparin responsiveness (from the end of surgery until 24 hours after the start of Atenativ or placebo infusion and until discharge or 7 days after surgery, whichever comes first)
Measured: From placement of the final suture or staple until 24 hours following IMP infusion, to discharge or 7 days after surgery, whichever comes first
Transfusion of allogenic blood products
The comparison between transfusion of other allogeneic blood products (e.g., red blood cells [RBCs], platelets, cryoprecipitate, whole blood, albumin, other transfusion), both intraoperatively (from the start of Atenativ or placebo infusion until the start of CPB, during CPB, and from the end of CPB until the end of surgery) and postoperatively (from the end of surgery until 24 hours after the start of Atenativ or placebo infusion and until discharge or 7 days after surgery, whichever comes first), as well as cumulatively
Measured: From the start of IMP infusion until 24 hours after the start of Atenativ or placebo infusion and until discharge or 7 days after surgery, whichever comes first
Administration of coagulation factor concentrates
The comparison between administration of coagulation factor concentrates (fibrinogen concentrate, factor XIII concentrate, recombinant activated factor VII, other therapy)", both intraoperatively (from the start of Atenativ or placebo infusion until the start of CPB, during CPB, and from the end of CPB until the end of surgery) and postoperatively (from the end of surgery until 24 hours after the start of Atenativ or placebo infusion and until discharge or 7 days after surgery, whichever comes first), as well as cumulatively
Measured: From the start of IMP infusion until 24 hours after the start of Atenativ or placebo infusion and until discharge or 7 days after surgery, whichever comes first
Administration of other haemostatic-relevant therapies
The comparison between administration of other haemostatic-relevant therapies (i.e., tranexamic acid, aminocaproic acid, protamine, other therapies), both intraoperatively (from the start of Atenativ or placebo infusion until the start of CPB, during CPB, and from the end of CPB until the end of surgery) and postoperatively (from the end of surgery until 24 hours after the start of Atenativ or placebo infusion and until discharge or 7 days after surgery, whichever comes first), as well as cumulatively
Measured: From the start of IMP infusion until 24 hours after the start of Atenativ or placebo infusion and until discharge or 7 days after surgery, whichever comes first
Postoperative chest tube drainage
The comparison between postoperative chest tube drainage volume at 24 hours after the start of Atenativ or placebo infusion, and the comparison between total chest tube drainage volume until discharge or 7 days after surgery, whichever comes first
Measured: From the start of IMP infusion to 24 hours after infusion and until discharge or 7 days after surgery, whichever comes first
Need for reoperation due to bleeding
Comparison of the need for reoperation for bleeding, including description of the cause of bleeding (surgical vs. non-surgical)
Measured: 24 hours after the start of IMP infusion
Cell saver volume
The comparison between cell saver volume until the end of surgery
Measured: During surgery (from the time of the first surgical incision to the time at which the final suture or staple is placed)
Adverse events
Incidence of adverse events, including all related and non-related, non-serious adverse events
Measured: From the start of IMP infusion until hospital discharge or 7 days after IMP administration, whichever comes first
Serious adverse events
Incidence of serious adverse events
Measured: From the start of IMP infusion until 28 days after IMP administration
Survival status
Number of patients surviving in all three cohorts
Measured: At hospital discharge or 7 days after IMP administration (whichever comes first) and at 28 days (+ 4 days) after IMP administration
Red Blood Cell count
Standard haematological parameter
Measured: Within 10 minutes before IMP infusion, between 2-10 minutes after IMP infusion, within 10 minutes after the end of CPB, at the end of surgery, and at 24 hours after infusion
White Blood Cell count
Standard haematological parameter
Measured: Within 10 minutes before IMP infusion, between 2-10 minutes after IMP infusion, within 10 minutes after the end of CPB, at the end of surgery, and at 24 hours after infusion
Haemoglobin levels
Standard haematological parameter
Measured: Within 10 minutes before IMP infusion, between 2-10 minutes after IMP infusion, within 10 minutes after the end of CPB, at the end of surgery, and at 24 hours after infusion
Haematocrit
Standard haematological parameter
Measured: Within 10 minutes before IMP infusion, between 2-10 minutes after IMP infusion, within 10 minutes after weaning from CPB, at the end of surgery, and at 24 hours after infusion
Platelet count
Standard haematological parameter
Measured: Within 10 minutes before IMP infusion, between 2-10 minutes after IMP infusion, within 10 minutes after weaning from CPB, at the end of surgery, and at 24 hours after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start21 Aug 2024
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Antithrombin DeficiencyStudies of the same condition, open and under way.
- More trials run by OctapharmaThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Octapharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096116
- Sponsor's protocol ID
- ATN-108
- Status last verified
- Sep 2026
- First submitted
- 17 Oct 2023
- Last updated
- 28 Sep 2026
- Results posted
- No
- 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 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Double-blind, Placebo-controlled, Multicentre Study on the Efficacy and Safety of Human Plasma Derived Antithrombin (Atenativ) in Heparin-Resistant Patients Scheduled to Undergo Cardiac Surgery Necessitating Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT06096116
- Acronym / sponsor ID
- ATN-108
- Conditions
- Acquired Antithrombin Deficiency
- Keywords
- heparin resistance, antithrombin deficiency, cardiopulmonary bypass, cardiac surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- OctapharmaIndustry (pharma, biotech, devices)
- Study start
- 21 Aug 2024 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the efficacy of two different doses of Atenativ, versus placebo, in restoring and maintaining heparin responsiveness in adult patients undergoing cardiac surgery necessitating cardiopulmonary bypass (CPB)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-dose Atenativ | Experimental | Drug: Human plasma derived antithrombinPatients will receive a single bolus of 30 international units (IU)/kg body weight (BW) Atenativ. |
| High-dose Atenativ | Experimental | Drug: Human plasma derived antithrombinPatients will receive a single bolus of 60 international units (IU)/kg body weight (BW) Atenativ. |
| Placebo | Placebo comparator | Drug: PlaceboPatients will receive a saline bolus dose |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Planned cardiac surgery with CPB
- Heparin-resistant patients (pre-CPB Hemochron ACT less than 480 s in the measurement taken between 2-5 minutes following intravenous administration of 500 U/kg UFH)
- Patients between 18 and 85 years of age, inclusive
- Freely given written or electronic informed consent
- In female patients of childbearing potential, a pre-existing negative pregnancy test within 14 days prior to surgery
Key exclusion criteria (14 listed)
- Receiving, or have received within the timeframes specified, one or more of the following medications prior to the start of surgery:
- Pre-existing coagulopathy, a history of bleeding problems, or a laboratory-diagnosed bleeding disorder (e.g., von Willebrand disease, platelet disorder)
- Renal insufficiency, defined as serum creatinine level >2.0 mg/dL
- Thrombocytosis, defined as platelet count >400,000 per μL
- Known hypersensitivity or allergic reaction to antithrombin or any of the excipients in Atenativ, i.e., human albumin, sodium chloride, acetyl tryptophan, caprylic acid
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 |
|---|---|---|
| Human plasma derived antithrombinA solvent/detergent and heat-treated antithrombin concentrate derived from human plasma | Drug | High-dose Atenativ, Low-dose Atenativ |
| PlaceboHalf of the patients in the placebo group will be randomised to receive a volume of placebo corresponding to the low dose of Atenativ and the other half to receive a volume of placebo corresponding to a high dose of Atenativ | Drug | Placebo |
Primary outcome
Restoring heparin responsiveness
Time frame: During surgery (from the time of the first surgical incision to the time at which the final suture or staple is placed)
The percentage of patients in each group in whom no further therapy containing antithrombin (i.e. frozen plasma or other antithrombin concentrates) is needed for restoring pre-CPB heparin responsiveness after administration of Atenativ or placebo, and for maintaining it during CPB
20 secondary outcomes
Amounts of further therapy for restoring heparin responsiveness
Time frame: During surgery (from the time of the first surgical incision to the time at which the final suture or staple is placed)
Change in activated clotting time (ACT) values
Time frame: Within 5 minutes following intravenous administration of 500 U/kg unfractionated heparin (UFH) and between 2-10 minutes after IMP infusion
Change in antithrombin plasma levels
Time frame: Within 10 minutes before IMP infusion and between 2 and 10 minutes after IMP infusion, within 10 minutes after the end of CPB, at the end of surgery, and at 24 hours after the start of IMP infusion
Change in heparin usage
Time frame: From end of IMP infusion to the end of surgery
FP unit use
Time frame: From the start of IMP infusion until 24 hours following IMP infusion, and until discharge or 7 days after surgery, whichever comes first
Amounts of further antithrombin concentrate for maintaining heparin responsiveness
Time frame: From placement of the final suture or staple until 24 hours following IMP infusion, to discharge or 7 days after surgery, whichever comes first
Transfusion of allogenic blood products
Time frame: From the start of IMP infusion until 24 hours after the start of Atenativ or placebo infusion and until discharge or 7 days after surgery, whichever comes first
Administration of coagulation factor concentrates
Time frame: From the start of IMP infusion until 24 hours after the start of Atenativ or placebo infusion and until discharge or 7 days after surgery, whichever comes first
Administration of other haemostatic-relevant therapies
Time frame: From the start of IMP infusion until 24 hours after the start of Atenativ or placebo infusion and until discharge or 7 days after surgery, whichever comes first
Postoperative chest tube drainage
Time frame: From the start of IMP infusion to 24 hours after infusion and until discharge or 7 days after surgery, whichever comes first
Need for reoperation due to bleeding
Time frame: 24 hours after the start of IMP infusion
Cell saver volume
Time frame: During surgery (from the time of the first surgical incision to the time at which the final suture or staple is placed)
Adverse events
Time frame: From the start of IMP infusion until hospital discharge or 7 days after IMP administration, whichever comes first
Serious adverse events
Time frame: From the start of IMP infusion until 28 days after IMP administration
Survival status
Time frame: At hospital discharge or 7 days after IMP administration (whichever comes first) and at 28 days (+ 4 days) after IMP administration
Red Blood Cell count
Time frame: Within 10 minutes before IMP infusion, between 2-10 minutes after IMP infusion, within 10 minutes after the end of CPB, at the end of surgery, and at 24 hours after infusion
White Blood Cell count
Time frame: Within 10 minutes before IMP infusion, between 2-10 minutes after IMP infusion, within 10 minutes after the end of CPB, at the end of surgery, and at 24 hours after infusion
Haemoglobin levels
Time frame: Within 10 minutes before IMP infusion, between 2-10 minutes after IMP infusion, within 10 minutes after the end of CPB, at the end of surgery, and at 24 hours after infusion
Haematocrit
Time frame: Within 10 minutes before IMP infusion, between 2-10 minutes after IMP infusion, within 10 minutes after weaning from CPB, at the end of surgery, and at 24 hours after infusion
Platelet count
Time frame: Within 10 minutes before IMP infusion, between 2-10 minutes after IMP infusion, within 10 minutes after weaning from CPB, at the end of surgery, and at 24 hours after infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
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.
27 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Human plasma derived antithrombin in people with Acquired Antithrombin Deficiency, run by Octapharma at 27 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 28 Sep 2026. 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 United States, Canada, United Kingdom, Austria, Czechia and 5 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cristina Solomon, MD (+41 79 585 90 42, Cristina.Solomon@octapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Restoring heparin responsiveness (time frame: During surgery (from the time of the first surgical incision to the time at which the final suture or staple is placed)). 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 28 Sep 2026.