Acute Pancreatitis (AP)Phase 4NCT07609771
Heparin to Prevent Organ Failure in Acute Pancreatitis
A Phase 4 study testing Unfractionated heparin and Standard supportive care in people with Acute Pancreatitis (AP), run by Allied Hospital Faisalabad at 1 site in Pakistan.
Trial summary
This clinical trial is designed to evaluate whether adding a standard blood-thinning medication, Unfractionated Heparin, to standard hospital care can help prevent severe organ failure in patients admitted with acute pancreatitis. Acute pancreatitis is a sudden and severe inflammation of the pancreas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis (AP)
- What is being tested?
- Unfractionated heparin and Standard supportive care
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- Jun 2026to Nov 2026
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older.
- Confirmed clinical diagnosis of acute pancreatitis based on meeting at least two of the following three revised Atlanta criteria: (1) acute onset of severe, persistent upper abdominal pain; (2) serum amylase or lipase levels elevated to at least three times the upper limit of normal; (3) characteristic findings of acute pancreatitis on cross-sectional abdominal imaging.
- Presentation to the hospital and initiation of the trial protocol within 24 hours of the onset of symptoms.
- Absence of systemic organ failure at the baseline assessment during initial hospital admission.
Who cannot join
- Baseline organ failure already present at the time of initial hospital admission (defined as a Modified Marshall Score of 2 or more in any organ system).
- Patients with a known history of chronic pancreatitis or recurrent episodes of pancreatitis.
- History of hypersensitivity, allergy, or known adverse reactions to heparin, low molecular weight heparins, or related anticoagulants.
- Active clinically significant bleeding, recent major hemorrhage, known bleeding diathesis, or severe thrombocytopenia (platelet count less than 100,000/mcL).
- Existing indication for therapeutic systemic anticoagulation (such as active deep vein thrombosis, pulmonary embolism, mechanical heart valves, or atrial fibrillation).
- Pregnant or lactating females.
- Refusal to provide informed consent to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Allied Hospital, Faisalabad
Faisalābad, Punjab Province, 38000
Muhammad Asad Parvez, MBBS, 00923217626547, asadparvez2@gmail.com
About this study
Official title: Unfractionated Heparin for Organ Failure Prevention in Acute Pancreatitis: A Randomized Trial
This clinical trial is designed to evaluate whether adding a standard blood-thinning medication, Unfractionated Heparin, to standard hospital care can help prevent severe organ failure in patients admitted with acute pancreatitis.
Acute pancreatitis is a sudden and severe inflammation of the pancreas. During this condition, intense inflammation can trigger a hypercoagulable state (excessive blood clotting) in the small blood vessels supplying vital organs. This microvascular clotting can block normal blood flow, starving tissues of oxygen and potentially leading to dangerous, life-threatening multi-organ failure involving the lungs, kidneys, or heart. Currently, standard medical care for acute pancreatitis is purely supportive-consisting of intensive intravenous fluid hydration, pain management, and nutritional support-without any specific targeted drug therapy to halt the disease's progression.
Read more
In this study, participating patients are randomly assigned into one of two balanced groups using a randomized lottery method upon their admission to the surgical unit:
- The Control Group: Receives standard supportive hospital medical care only.
- The Intervention Group: Receives the same standard supportive medical care plus a continuous, carefully monitored intravenous infusion of Unfractionated Heparin.
The primary objective of the study is to determine if early initiation of this standard anticoagulant therapy preserves blood flow, dampens the severe inflammatory cascade, and successfully prevents the development of new or worsening organ failure. The study will also evaluate secondary clinical endpoints, including the total duration of the patient's hospital stay and the general safety profile of the intervention by monitoring for any adverse bleeding complications.
Read the detailed description
This randomized controlled clinical trial is conducted to evaluate the clinical efficacy and safety of early, continuous intravenous administration of Unfractionated Heparin (UFH) as an adjunctive treatment to mitigate the development and progression of systemic multi-organ failure in patients presenting with acute pancreatitis.
Clinical Workflow and Protocol:
- Patient Screening and Enrollment: Patients presenting to the emergency department or the surgical wards with a clinical diagnosis of acute pancreatitis are assessed immediately for eligibility based on pre-established clinical parameters. Acute pancreatitis is diagnosed using standard clinical criteria, requiring at least two of the following: characteristic severe abdominal pain, serum amylase or lipase levels elevated to at least three times the upper limit of normal, or characteristic cross-sectional abdominal imaging findings.
- Baseline Assessments: Upon securing formal written informed consent, enrolled patients undergo an immediate baseline clinical evaluation. Baseline laboratory parameters-including a complete blood count (CBC), serum electrolytes, renal function tests (serum creatinine and blood urea), liver function tests, serum amylase/lipase, and arterial blood gases (ABGs)-are drawn. Baseline physiological parameters are recorded to calculate initial disease severity and multi-organ function scores.
- Randomization and Group Allocation: Following baseline verification, patients are randomly allocated in a 1:1 ratio to either the Intervention Group (Group A) or the Control Group (Group B) utilizing a randomized lottery method managed through sequentially numbered, opaque, sealed envelopes to ensure allocation concealment.
- Therapeutic Interventions:
- Control Group (Group B): Patients receive standard institutional supportive medical therapy for acute pancreatitis. This includes aggressive tailored intravenous fluid resuscitation (primarily balanced crystalloids like Ringer's Lactate) titrated to clinical endpoints, standardized analgesia for pain management, close hemodynamic monitoring, and early targeted nutritional support.
- Intervention Group (Group A): Patients receive the identical standard institutional supportive medical therapy protocol provided to the control group. In addition, an active anticoagulant protocol is initiated within the first 24 hours of admission, consisting of Unfractionated Heparin administered via a continuous intravenous infusion pump.
- Safety Monitoring and Titration: To maximize patient safety and evaluate potential adverse events, patients receiving the intravenous UFH protocol undergo rigorous monitoring. Coagulation profiles, including Activated Partial Thromboplastin Time (aPTT), are checked regularly to guide safe administration. Patients in both groups are carefully monitored daily by the clinical team for any clinical signs of minor or major bleeding complications, such as hematemesis, melena, epistaxis, or an unexplained drop in hemoglobin levels.
- Outcome Evaluation:
All participating patients are evaluated daily throughout their acute hospital stay. The development of systemic complications is tracking objectively using the Modified Marshall Scoring System, which grades respiratory, cardiovascular, and renal organ function daily from admission through Day 14 or until official hospital discharge. Total duration of hospital stay and all-cause clinical outcomes are recorded at the time of discharge.
- Conditions
- Acute Pancreatitis (AP)
- Being tested
- Unfractionated heparin, Standard supportive care
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unfractionated heparinDrug
- Route: Continuous intravenous (IV) infusion via a calibrated pump or micro-drip controller to maintain stable serum drug levels.
- Timing: Initiated within the first 24 hours of hospital admission, immediately following the clinical diagnosis of acute pancreatitis on the surgical ward.
- Dosing: Administered as a continuous weight-adjusted maintenance infusion titrated per institutional safety guidelines for non-cardiac anticoagulation. No loading bolus is given.
- Duration: Maintained continuously for up to 7 days, or until clinical resolution of symptoms and transition to oral intake.
- Monitoring: Regular tracking of Activated Partial Thromboplastin Time (aPTT) and daily clinical screening for signs of bleeding (e.g., hematemesis, melena, epistaxis).
- Discontinuation: Immediate termination if a major bleeding event occurs or urgent surgical/radiological intervention is required.
Standard supportive careOther
Standard institutional supportive medical therapy for acute pancreatitis, including intravenous fluid resuscitation (Ringer's Lactate), standardized analgesia for pain management, close clinical monitoring, and early nutritional support. No anticoagulant infusions will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Heparin Group | Experimental | Patients in this arm will receive an adjunctive anticoagulant protocol consisting of Unfractionated Heparin (UFH) administered via a continuous intravenous infusion pump. The UFH therapy will be initiated within the first 24 hours of hospital admission. In addition to this active pharmacological intervention, all patients in this group will concurrently receive standard institutional supportive medical care for acute pancreatitis, which includes aggressive intravenous fluid resuscitation, standardized analgesia for pain management, close hemodynamic monitoring, and early nutritional support. Receives: Drug: Unfractionated heparin |
| Standard Care Group | Active comparator | Patients in this arm will receive standard institutional supportive medical therapy for acute pancreatitis as per ward protocols. This standard care regimen consists of aggressive, tailored intravenous fluid resuscitation (primarily balanced crystalloids such as Ringer's Lactate) titrated closely to clinical endpoints, standardized analgesia for pain management, regular vital signs and urine output monitoring, and early targeted nutritional support. Patients in this group will not receive any active adjunctive anticoagulant therapy or continuous heparin infusions during their study participation. Receives: Other: Standard supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of New-Onset Organ Failure
This outcome tracks the proportion of patients who develop new-onset systemic organ failure during their hospital stay among individuals who had no baseline organ failure at the time of admission. Organ failure will be objectively assessed using the Modified Marshall Scoring System, evaluating three main organ systems: respiratory (PaO2/FiO2 ratio), renal (serum creatinine), and cardiovascular (systolic blood pressure). A score of 2 or more in any of these systems indicates the development of organ failure.
Measured: Daily from Day 1 (after baseline assessment at hospital admission) up to Day 7 of hospitalization or until official hospital discharge, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study startJun 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Pancreatitis (AP)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allied Hospital Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Asad Parvez, Allied Hospital Faisalabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07609771
- Sponsor's protocol ID
- 48.ERC/FMU/2024-25/208
- Status last verified
- Jul 2026
- First submitted
- 20 May 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly to maintain absolute patient confidentiality and protect sensitive clinical information in accordance with local institutional ethical board guidelines. The aggregated statistical results, final data tables, and study conclusions will be fully disseminated through peer-reviewed publication and academic presentation upon completion of the trial.
Publications
Tozlu M, Kayar Y, Ince AT, Baysal B, Senturk H. Low molecular weight heparin treatment of acute moderate and severe pancreatitis: A randomized, controlled,open-label study. Turk J Gastroenterol. 2019 Jan;30(1):81-87. doi: 10.5152/tjg.2018.18583.
PubMed 30289392
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unfractionated Heparin for Organ Failure Prevention in Acute Pancreatitis: A Randomized Trial
- ClinicalTrials.gov ID
- NCT07609771
- Acronym / sponsor ID
- 48.ERC/FMU/2024-25/208
- Conditions
- Acute Pancreatitis (AP)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Allied Hospital FaisalabadUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 27 May 2026 (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.
This clinical trial is designed to evaluate whether adding a standard blood-thinning medication, Unfractionated Heparin, to standard hospital care can help prevent severe organ failure in patients admitted with acute pancreatitis.
Acute pancreatitis is a sudden and severe inflammation of the pancreas. During this condition, intense inflammation can trigger a hypercoagulable state (excessive blood clotting) in the small blood vessels supplying vital organs. This microvascular clotting can block normal blood flow, starving tissues of oxygen and potentially leading to dangerous, life-threatening multi-organ failure involving the lungs, kidneys, or heart. Currently, standard medical care for acute pancreatitis is purely supportive-consisting of intensive intravenous fluid hydration, pain management, and nutritional support-without any specific targeted drug therapy to halt the disease's progression.
In this study, participating patients are randomly assigned into one of two balanced groups using a randomized lottery method upon their admission to the surgical unit:
- The Control Group: Receives standard supportive hospital medical care only.
- The Intervention Group: Receives the same standard supportive medical care plus a continuous, carefully monitored intravenous infusion of Unfractionated Heparin.
The primary objective of the study is to determine if early initiation of this standard anticoagulant therapy preserves blood flow, dampens the severe inflammatory cascade, and successfully prevents the development of new or worsening organ failure. The study will also evaluate secondary clinical endpoints, including the total duration of the patient's hospital stay and the general safety profile of the intervention by monitoring for any adverse bleeding complications.
Detailed description
This randomized controlled clinical trial is conducted to evaluate the clinical efficacy and safety of early, continuous intravenous administration of Unfractionated Heparin (UFH) as an adjunctive treatment to mitigate the development and progression of systemic multi-organ failure in patients presenting with acute pancreatitis.
Clinical Workflow and Protocol:
- Patient Screening and Enrollment: Patients presenting to the emergency department or the surgical wards with a clinical diagnosis of acute pancreatitis are assessed immediately for eligibility based on pre-established clinical parameters. Acute pancreatitis is diagnosed using standard clinical criteria, requiring at least two of the following: characteristic severe abdominal pain, serum amylase or lipase levels elevated to at least three times the upper limit of normal, or characteristic cross-sectional abdominal imaging findings.
- Baseline Assessments: Upon securing formal written informed consent, enrolled patients undergo an immediate baseline clinical evaluation. Baseline laboratory parameters-including a complete blood count (CBC), serum electrolytes, renal function tests (serum creatinine and blood urea), liver function tests, serum amylase/lipase, and arterial blood gases (ABGs)-are drawn. Baseline physiological parameters are recorded to calculate initial disease severity and multi-organ function scores.
- Randomization and Group Allocation: Following baseline verification, patients are randomly allocated in a 1:1 ratio to either the Intervention Group (Group A) or the Control Group (Group B) utilizing a randomized lottery method managed through sequentially numbered, opaque, sealed envelopes to ensure allocation concealment.
- Therapeutic Interventions:
- Control Group (Group B): Patients receive standard institutional supportive medical therapy for acute pancreatitis. This includes aggressive tailored intravenous fluid resuscitation (primarily balanced crystalloids like Ringer's Lactate) titrated to clinical endpoints, standardized analgesia for pain management, close hemodynamic monitoring, and early targeted nutritional support.
- Intervention Group (Group A): Patients receive the identical standard institutional supportive medical therapy protocol provided to the control group. In addition, an active anticoagulant protocol is initiated within the first 24 hours of admission, consisting of Unfractionated Heparin administered via a continuous intravenous infusion pump.
- Safety Monitoring and Titration: To maximize patient safety and evaluate potential adverse events, patients receiving the intravenous UFH protocol undergo rigorous monitoring. Coagulation profiles, including Activated Partial Thromboplastin Time (aPTT), are checked regularly to guide safe administration. Patients in both groups are carefully monitored daily by the clinical team for any clinical signs of minor or major bleeding complications, such as hematemesis, melena, epistaxis, or an unexplained drop in hemoglobin levels.
- Outcome Evaluation:
All participating patients are evaluated daily throughout their acute hospital stay. The development of systemic complications is tracking objectively using the Modified Marshall Scoring System, which grades respiratory, cardiovascular, and renal organ function daily from admission through Day 14 or until official hospital discharge. Total duration of hospital stay and all-cause clinical outcomes are recorded at the time of discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Heparin Group | Experimental | Drug: Unfractionated heparinPatients in this arm will receive an adjunctive anticoagulant protocol consisting of Unfractionated Heparin (UFH) administered via a continuous intravenous infusion pump. The UFH therapy will be initiated within the first 24 hours of hospital admission. In addition to this active pharmacological intervention, all patients in this group will concurrently receive standard institutional supportive medical care for acute pancreatitis, which includes aggressive intravenous fluid resuscitation, standardized analgesia for pain management, close hemodynamic monitoring, and early nutritional support. |
| Standard Care Group | Active comparator | Other: Standard supportive carePatients in this arm will receive standard institutional supportive medical therapy for acute pancreatitis as per ward protocols. This standard care regimen consists of aggressive, tailored intravenous fluid resuscitation (primarily balanced crystalloids such as Ringer's Lactate) titrated closely to clinical endpoints, standardized analgesia for pain management, regular vital signs and urine output monitoring, and early targeted nutritional support. Patients in this group will not receive any active adjunctive anticoagulant therapy or continuous heparin infusions during their study participation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 years or older.
- Confirmed clinical diagnosis of acute pancreatitis based on meeting at least two of the following three revised Atlanta criteria: (1) acute onset of severe, persistent upper abdominal pain; (2) serum amylase or lipase levels elevated to at least three times the upper limit of normal; (3) characteristic findings of acute pancreatitis on cross-sectional abdominal imaging.
- Presentation to the hospital and initiation of the trial protocol within 24 hours of the onset of symptoms.
- Absence of systemic organ failure at the baseline assessment during initial hospital admission.
Key exclusion criteria (7 listed)
- Baseline organ failure already present at the time of initial hospital admission (defined as a Modified Marshall Score of 2 or more in any organ system).
- Patients with a known history of chronic pancreatitis or recurrent episodes of pancreatitis.
- History of hypersensitivity, allergy, or known adverse reactions to heparin, low molecular weight heparins, or related anticoagulants.
- Active clinically significant bleeding, recent major hemorrhage, known bleeding diathesis, or severe thrombocytopenia (platelet count less than 100,000/mcL).
- Existing indication for therapeutic systemic anticoagulation (such as active deep vein thrombosis, pulmonary embolism, mechanical heart valves, or atrial fibrillation).
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 |
|---|---|---|
| Unfractionated heparin* Route: Continuous intravenous (IV) infusion via a calibrated pump or micro-drip controller to maintain stable serum drug levels. * Timing: Initiated within the first 24 hours of hospital admission, immediately following the clinical diagnosis of acute pancreatitis on the surgical ward. * Dosing: Administered as a continuous weight-adjusted maintenance infusion titrated per institutional safety guidelines for non-cardiac anticoagulation. No loading bolus is given. * Duration: Maintained continuously for up to 7 days, or until clinical resolution of symptoms and transition to oral intake. * Monitoring: Regular tracking of Activated Partial Thromboplastin Time (aPTT) and daily clinical screening for signs of bleeding (e.g., hematemesis, melena, epistaxis). * Discontinuation: Immediate termination if a major bleeding event occurs or urgent surgical/radiological intervention is required. | Drug | Experimental: Heparin Group |
| Standard supportive careStandard institutional supportive medical therapy for acute pancreatitis, including intravenous fluid resuscitation (Ringer's Lactate), standardized analgesia for pain management, close clinical monitoring, and early nutritional support. No anticoagulant infusions will be administered. | Other | Standard Care Group |
Primary outcome
Incidence of New-Onset Organ Failure
Time frame: Daily from Day 1 (after baseline assessment at hospital admission) up to Day 7 of hospitalization or until official hospital discharge, whichever occurs first.
This outcome tracks the proportion of patients who develop new-onset systemic organ failure during their hospital stay among individuals who had no baseline organ failure at the time of admission. Organ failure will be objectively assessed using the Modified Marshall Scoring System, evaluating three main organ systems: respiratory (PaO2/FiO2 ratio), renal (serum creatinine), and cardiovascular (systolic blood pressure). A score of 2 or more in any of these systems indicates the development of organ failure.
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 3 Aug 2026.
- Background: PubMed 30289392Tozlu M, Kayar Y, Ince AT, Baysal B, Senturk H. Low molecular weight heparin treatment of acute moderate and severe pancreatitis: A randomized, controlled,open-label study. Turk J Gastroenterol. 2019 Jan;30(1):81-87. doi: 10.5152/tjg.2018.18583.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly to maintain absolute patient confidentiality and protect sensitive clinical information in accordance with local institutional ethical board guidelines. The aggregated statistical results, final data tables, and study conclusions will be fully disseminated through peer-reviewed publication and academic presentation upon completion of the trial.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Unfractionated heparin and Standard supportive care in people with Acute Pancreatitis (AP), run by Allied Hospital Faisalabad at 1 site in Pakistan.
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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 3 Aug 2026. 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 Pakistan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Muhammad Asad Parvez, MBBS (+923217626547, asadparvez2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of New-Onset Organ Failure (time frame: Daily from Day 1 (after baseline assessment at hospital admission) up to Day 7 of hospitalization or until official hospital discharge, whichever occurs first.). 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 NCT07609771, which also lists 1 linked publication.
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 3 Aug 2026.