Acute on Chronic Liver FailureNCT06556472
Safety and Efficacy of Continuous Infusion of Terlipressin With Norepinephrine Versus Norepinephrine Alone in Improving Outcomes of Acute Kidney Injury in Acute on Chronic Liver Failure With Septic Shock
A study testing Terlipressin and Norephrine in people with Acute on Chronic Liver Failure, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
ACLF is defined differently in APASL,EASL and AASLD.APASL talks of reversibility in ACLF as per its definition and constitution of Homogenous population with ACLF.The definition of ACLF as per APASL is an acute hepatic insult manifesting as jaundice (serum bilirubin ≥ 5 mg/dL (85 micromol/L) and coagulopathy (INR ≥… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute on Chronic Liver Failure
- What is being tested?
- Terlipressin and Norephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteIndia
- Study dates
- 15 Aug 2024to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age>18 years and <60 yrs
- ACLF as per APASL
- AKI according to KDIGO Criteria
- septic shock requiring norepinephrine (<0.05mcg/kg/min).
Who cannot join
- Septic shock requiring 2 vasopressors (Norephinephrine reuirement > 0.05mcg/kg/min)
- Symptomatic cardiopulmonary disease
- Chronic kidney disease
- Peripheral vascular disease
- Hepatocellular carcinoma outside Milan criteria
- Prior use of terlipressin in last 48 hours
Show all 13Show fewer
- Patients with hypovolemic or hemorrhagic shock
- Patients already meeting criteria for dialysis or with history of dialysis in last 7 days
- Intrinsic kidney disease, Acute tubular necrosis with urinary output < 400 ml /day or obstructive uropathy
- History of immunosuppressive drugs
- Pregnancy
- Human immunodeficiency virus 1 and 2
- Portal vein thrombus
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, 110070
Dr Jitendra Kumar Singh, MD, 01146300000, jitendra2602kc@gmail.com
About this study
Official title: Safety and Efficacy of Continuous Infusion of Terlipressin With Norepinephrine Versus Norepinephrine Alone in Improving Outcomes of Acute Kidney Injury in Acute on Chronic Liver Failure With Septic Shock - A Randomised Controlled Trial
ACLF is defined differently in APASL,EASL and AASLD.APASL talks of reversibility in ACLF as per its definition and constitution of Homogenous population with ACLF.The definition of ACLF as per APASL is an acute hepatic insult manifesting as jaundice (serum bilirubin ≥ 5 mg/dL (85 micromol/L) and coagulopathy (INR ≥ 1.5 or prothrombin activity < 40%) complicated within 4 weeks by clinical ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease/cirrhosis, and is associated with a high 28-day mortality.
At the onset of septic shock there is initially an increased secretion of Arginine vasopressin. However, this initial rise is short lasting, and the vasopressin levels come back to normal or low serum levels with continued hypotension. However, even normal levels are too low for the degree of hypotension in septic shock. This causes a relative deficiency of vasopressin in septic shock. The exact time when this fall happens is not known and it is likely to be variable. Vasopressin was therefore tried as an agent in septic shock. Terlipressin is a synthetic analogue of vasopressin. It has a greater selectivity for the V1 receptor.
Read more
Currently, Norepinephrine is recommended as the first vasopressor to be started in general in septic shock population.(3) Catecholamines are the clinically used vasopressor agents of choice for supporting arterial blood pressure and ensuring adequate organ perfusion.
Development of adrenergic hyposensitivity with loss of catecholamine presser effects is seen in advanced stages of Vasodilatory Shock. Progressively increasing catecholamine therapy frequently enters into a vicious cycle of major adverse side effects resulting in continuous clinical deterioration necessitating further catecholamine excess.
Read the detailed description
- Aim: To study the safety and efficacy of low-dose continuous infusion of terlipressin with norepinephrine compared to norepinephrine alone in improving outcomes of Acute kidney injury occurring in the context of septic shock in patients with Acute on chronic liver failure.
Study population:
- septic shock with AKI in patients of ACLF Study design: Prospective open labelled randomised controlled study. The study will be conducted in Department of Hepatology ILBS- intensive care unit. At admission: Complete history and physical examination
- Recent Diuretics use
- Loose stools / Recurrent vomiting
- Fever, signs of sepsis (Systemic inflammatory response syndrome), shock, respiratory tract infection,spontaneous bacterial peritonitis
- Recent contrast use (< 7 days)/ nephrotoxins use including NSAIDs
- Prior renal dysfunction, chronic kudney disease, history of Hemodialysis
- History of Hypertension, Diabetes/ renal stones
- Baseline workup for Acute on chronic liver failure
- Severity of liver disease,AARC-ACLF, MELD score, CTP score (B) Intervention during 0-3 hours (Before randomization) - Pre-randomization interventions:
- Withdrawal of diuretics/ Withdrawal of lactulose (in patients with loose stools)
- IV hydration with 5 % albumin according to FRISC protocol
- Urine output monitoring (catheterize and monitor hourly) ,hourly MAP, Pulse rate
- Use of broad-spectrum IV antibiotics promptly within the first hour, in case of suspected/proven sepsis (Avoid nephrotoxic drugs as possible)
- Lung ultrasound and IVC (Inferior Vena Cava) measurements will be performed at baseline and hourly for 3 hours.
- Fluid boluses will be administered based on IVC measurements and lung ultrasound findings.
- Fluid bolus criteria include IVCCI(inferior vena cava collapsibility index) >40% and an A profile on lung ultrasound.
- The stopping rule for fluid boluses is IVCCI <40% or a B profile on lung ultrasound.
- Patients showing improvement within 3 hours will be excluded from further intervention Monitoring • Hemodynamic- MAP,HR, Urine output hourly
- Metabolic - lactate, blood sugar, electrolytes
- Microbiologic - urine -routine, microscopy and culture, ascitic fluid analysis along with gram stain and c/s in blood culture bottle, sputum or mini BAL -C/s Gram stain. Daily.
- Others - daily chest X-ray, Procalcitonin, Cardiac-ECG, 2D echo. Prognostic models: CTP, MELD SOFA daily Stopping Rule
- Requirement of Third Vasopressor (Need of Norepinephrine > 0.5 mcg/kg/min):
- If a patient requires norepinephrine at a dose exceeding 0.5 mcg/min, indicating the need for a third vasopressor, this criterion triggers specific actions as per the study protocol.
- Threshold (Stopping Rule) for Fluid Boluses:
- Fluid boluses will be administered based on IVC and lung ultrasound findings.
- The stopping rule for fluid boluses is activated if any of the following criteria are met:
- IVC >25
- IVCCI <40%
- B profile on lung ultrasound
- Severe Side Effects or Toxicities (CTAE Grade 4):
- If a patient experiences severe side effects or toxicities categorized as CTAE (Common Terminology Criteria for Adverse Events) Grade 4, including arrhythmia, AMI (Acute Myocardial Infarction), cardiomyopathy (as defined later), cyanosis, suspicion or confirmed bowel ischemia, or any other severe adverse event, specific actions or interventions may be required. Salvage group • Patient Unwilling for Further Hospital Stay: • Non responders or when patient in either arm failed
- Study will be stopped and management will be done accordingly to guidelines
- Adverse effects to terlipressin
- Further increase in MAP to be maintained by addition of other ( vasopressors--vasopressin, phenylephrine,steroids)
- If the target MAP is not achieved in arm A ,a third vasopressor along with hydrocortisone, Adrenaline and then phenylephrine
- If the target MAP is not achieved in arm B, vasopressin along with hydrocortisone, followed by adrenaline and phenylephrine, may be added as a fourth vasopressor.
- The indication for start of steroid
- Maximum dose of vasopressor in each arm and all patients in salvage arm
- Hydrocortisone 100-150mg bolus start followed by 50mg q6hrly and later tapering dose.
- Conditions
- Acute on Chronic Liver Failure
- Being tested
- Terlipressin, Norephrine
- Medical subject headings
- Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TerlipressinDrug
- Patients in this group will receive continuous terlipressin infusion (1 mg/24 hr on day 1, increasing to 1 mg in 24 hours if target MAP not achieved ,reaching maximum terlipressin dose of 4 mg/24 hr on day 4).If target MAP not achieved by terlipressin dose ,increase noradrenaline dose keeping terlipressin maximum 1 mg ,2 mg ,3mg ,4mg at Day 1,2,3,4 respectively.
NorephrineDrug
- Patients in this group will receive norepinephrine only, with a dose range of 0.05 mcg/kg/min to 0.5 mcg/kg/min to maintain a MAP > 65 to 75 mm Hg.
| Study group | Role | What they receive |
|---|---|---|
| Continuous terlipressin infusion + Norepinephrine | Experimental | 1. Patients in this group will receive continuous terlipressin infusion (1 mg/24 hr on day 1, increasing to 1 mg in 24 hours if target MAP not achieved ,reaching maximum terlipressin dose of 4 mg/24 hr on day 4).If target MAP not achieved by terlipressin dose ,increase noradrenaline dose keeping terlipressin maximum 1 mg ,2 mg ,3mg ,4mg at Day 1,2,3,4 respectively.
2. Norepinephrine will be initiated @0.05mcg/kg/min and titrated upto 0.5 mcg/kg/min to maintain a MAP > 65 to 75 mm Hg.
3. IV albumin as per volume status to maintain target MAP .
4. If the target MAP is not achieved, a third vasopressor along with hydrocortisone, Adrenaline and then phenylephrine. Receives: Drug: Terlipressin; Drug: Norephrine |
| Norepinephrine | Active comparator | 1. Patients in this group will receive norepinephrine only, with a dose range of 0.05 mcg/kg/min to 0.5 mcg/kg/min to maintain a MAP > 65 to 75 mm Hg.
2. IV albumin as per volume status to maintain target MAP .
3. If the target MAP is not achieved, vasopressin along with hydrocortisone, followed by adrenaline and phenylephrine, may be added as a fourth vasopressor. Receives: Drug: Norephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients developing 1 stage improvement in Acute kidney injury stage with resolution of shock at day 4 in both groups
Measured: Day 4
Secondary outcomes (5)
Outcome of acute kidney injury at day 4,7
Outcome in terms of resolution, persistence or progreession
Measured: Day 4 and 7
Incidence of adverse events in both groups
Measured: 1 year
Need of renal replacement therapy at day 7
Measured: Day 7
Duration of ICU and hospital stay
Measured: 1 year
Mortality
Measured: Day 7 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start15 Aug 2024 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute on Chronic Liver FailureStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556472
- Sponsor's protocol ID
- ILBS-ACLF-19
- Status last verified
- Jul 2024
- First submitted
- 30 Jul 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Continuous Infusion of Terlipressin With Norepinephrine Versus Norepinephrine Alone in Improving Outcomes of Acute Kidney Injury in Acute on Chronic Liver Failure With Septic Shock - A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06556472
- Acronym / sponsor ID
- ILBS-ACLF-19
- Conditions
- Acute on Chronic Liver Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 15 Aug 2024 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 16 Aug 2024 (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.
ACLF is defined differently in APASL,EASL and AASLD.APASL talks of reversibility in ACLF as per its definition and constitution of Homogenous population with ACLF.The definition of ACLF as per APASL is an acute hepatic insult manifesting as jaundice (serum bilirubin ≥ 5 mg/dL (85 micromol/L) and coagulopathy (INR ≥ 1.5 or prothrombin activity < 40%) complicated within 4 weeks by clinical ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease/cirrhosis, and is associated with a high 28-day mortality.
At the onset of septic shock there is initially an increased secretion of Arginine vasopressin. However, this initial rise is short lasting, and the vasopressin levels come back to normal or low serum levels with continued hypotension. However, even normal levels are too low for the degree of hypotension in septic shock. This causes a relative deficiency of vasopressin in septic shock. The exact time when this fall happens is not known and it is likely to be variable. Vasopressin was therefore tried as an agent in septic shock. Terlipressin is a synthetic analogue of vasopressin. It has a greater selectivity for the V1 receptor.
Currently, Norepinephrine is recommended as the first vasopressor to be started in general in septic shock population.(3) Catecholamines are the clinically used vasopressor agents of choice for supporting arterial blood pressure and ensuring adequate organ perfusion.
Development of adrenergic hyposensitivity with loss of catecholamine presser effects is seen in advanced stages of Vasodilatory Shock. Progressively increasing catecholamine therapy frequently enters into a vicious cycle of major adverse side effects resulting in continuous clinical deterioration necessitating further catecholamine excess.
Detailed description
- Aim: To study the safety and efficacy of low-dose continuous infusion of terlipressin with norepinephrine compared to norepinephrine alone in improving outcomes of Acute kidney injury occurring in the context of septic shock in patients with Acute on chronic liver failure.
Study population:
- septic shock with AKI in patients of ACLF Study design: Prospective open labelled randomised controlled study. The study will be conducted in Department of Hepatology ILBS- intensive care unit. At admission: Complete history and physical examination
- Recent Diuretics use
- Loose stools / Recurrent vomiting
- Fever, signs of sepsis (Systemic inflammatory response syndrome), shock, respiratory tract infection,spontaneous bacterial peritonitis
- Recent contrast use (< 7 days)/ nephrotoxins use including NSAIDs
- Prior renal dysfunction, chronic kudney disease, history of Hemodialysis
- History of Hypertension, Diabetes/ renal stones
- Baseline workup for Acute on chronic liver failure
- Severity of liver disease,AARC-ACLF, MELD score, CTP score (B) Intervention during 0-3 hours (Before randomization) - Pre-randomization interventions:
- Withdrawal of diuretics/ Withdrawal of lactulose (in patients with loose stools)
- IV hydration with 5 % albumin according to FRISC protocol
- Urine output monitoring (catheterize and monitor hourly) ,hourly MAP, Pulse rate
- Use of broad-spectrum IV antibiotics promptly within the first hour, in case of suspected/proven sepsis (Avoid nephrotoxic drugs as possible)
- Lung ultrasound and IVC (Inferior Vena Cava) measurements will be performed at baseline and hourly for 3 hours.
- Fluid boluses will be administered based on IVC measurements and lung ultrasound findings.
- Fluid bolus criteria include IVCCI(inferior vena cava collapsibility index) >40% and an A profile on lung ultrasound.
- The stopping rule for fluid boluses is IVCCI <40% or a B profile on lung ultrasound.
- Patients showing improvement within 3 hours will be excluded from further intervention Monitoring • Hemodynamic- MAP,HR, Urine output hourly
- Metabolic - lactate, blood sugar, electrolytes
- Microbiologic - urine -routine, microscopy and culture, ascitic fluid analysis along with gram stain and c/s in blood culture bottle, sputum or mini BAL -C/s Gram stain. Daily.
- Others - daily chest X-ray, Procalcitonin, Cardiac-ECG, 2D echo. Prognostic models: CTP, MELD SOFA daily Stopping Rule
- Requirement of Third Vasopressor (Need of Norepinephrine > 0.5 mcg/kg/min):
- If a patient requires norepinephrine at a dose exceeding 0.5 mcg/min, indicating the need for a third vasopressor, this criterion triggers specific actions as per the study protocol.
- Threshold (Stopping Rule) for Fluid Boluses:
- Fluid boluses will be administered based on IVC and lung ultrasound findings.
- The stopping rule for fluid boluses is activated if any of the following criteria are met:
- IVC >25
- IVCCI <40%
- B profile on lung ultrasound
- Severe Side Effects or Toxicities (CTAE Grade 4):
- If a patient experiences severe side effects or toxicities categorized as CTAE (Common Terminology Criteria for Adverse Events) Grade 4, including arrhythmia, AMI (Acute Myocardial Infarction), cardiomyopathy (as defined later), cyanosis, suspicion or confirmed bowel ischemia, or any other severe adverse event, specific actions or interventions may be required. Salvage group • Patient Unwilling for Further Hospital Stay: • Non responders or when patient in either arm failed
- Study will be stopped and management will be done accordingly to guidelines
- Adverse effects to terlipressin
- Further increase in MAP to be maintained by addition of other ( vasopressors--vasopressin, phenylephrine,steroids)
- If the target MAP is not achieved in arm A ,a third vasopressor along with hydrocortisone, Adrenaline and then phenylephrine
- If the target MAP is not achieved in arm B, vasopressin along with hydrocortisone, followed by adrenaline and phenylephrine, may be added as a fourth vasopressor.
- The indication for start of steroid
- Maximum dose of vasopressor in each arm and all patients in salvage arm
- Hydrocortisone 100-150mg bolus start followed by 50mg q6hrly and later tapering dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous terlipressin infusion + Norepinephrine | Experimental | Drug: Terlipressin, Drug: Norephrine1. Patients in this group will receive continuous terlipressin infusion (1 mg/24 hr on day 1, increasing to 1 mg in 24 hours if target MAP not achieved ,reaching maximum terlipressin dose of 4 mg/24 hr on day 4).If target MAP not achieved by terlipressin dose ,increase noradrenaline dose keeping terlipressin maximum 1 mg ,2 mg ,3mg ,4mg at Day 1,2,3,4 respectively. 2. Norepinephrine will be initiated @0.05mcg/kg/min and titrated upto 0.5 mcg/kg/min to maintain a MAP > 65 to 75 mm Hg. 3. IV albumin as per volume status to maintain target MAP . 4. If the target MAP is not achieved, a third vasopressor along with hydrocortisone, Adrenaline and then phenylephrine. |
| Norepinephrine | Active comparator | Drug: Norephrine1. Patients in this group will receive norepinephrine only, with a dose range of 0.05 mcg/kg/min to 0.5 mcg/kg/min to maintain a MAP > 65 to 75 mm Hg. 2. IV albumin as per volume status to maintain target MAP . 3. If the target MAP is not achieved, vasopressin along with hydrocortisone, followed by adrenaline and phenylephrine, may be added as a fourth vasopressor. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age>18 years and <60 yrs
- ACLF as per APASL
- AKI according to KDIGO Criteria
- septic shock requiring norepinephrine (<0.05mcg/kg/min).
Key exclusion criteria (13 listed)
- Septic shock requiring 2 vasopressors (Norephinephrine reuirement > 0.05mcg/kg/min)
- Symptomatic cardiopulmonary disease
- Chronic kidney disease
- Peripheral vascular disease
- Hepatocellular carcinoma outside Milan criteria
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 |
|---|---|---|
| Terlipressin1. Patients in this group will receive continuous terlipressin infusion (1 mg/24 hr on day 1, increasing to 1 mg in 24 hours if target MAP not achieved ,reaching maximum terlipressin dose of 4 mg/24 hr on day 4).If target MAP not achieved by terlipressin dose ,increase noradrenaline dose keeping terlipressin maximum 1 mg ,2 mg ,3mg ,4mg at Day 1,2,3,4 respectively. | Drug | Continuous terlipressin infusion + Norepinephrine |
| Norephrine1. Patients in this group will receive norepinephrine only, with a dose range of 0.05 mcg/kg/min to 0.5 mcg/kg/min to maintain a MAP > 65 to 75 mm Hg. | Drug | Continuous terlipressin infusion + Norepinephrine, Norepinephrine |
Primary outcome
Proportion of patients developing 1 stage improvement in Acute kidney injury stage with resolution of shock at day 4 in both groups
Time frame: Day 4
5 secondary outcomes
Outcome of acute kidney injury at day 4,7
Time frame: Day 4 and 7
Incidence of adverse events in both groups
Time frame: 1 year
Need of renal replacement therapy at day 7
Time frame: Day 7
Duration of ICU and hospital stay
Time frame: 1 year
Mortality
Time frame: Day 7 and 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Terlipressin and Norephrine in people with Acute on Chronic Liver Failure, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
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 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: status not confirmed, as of the sponsor's last update on 16 Aug 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 India. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Jitendra Kumar Singh, MD (01146300000, jitendra2602kc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients developing 1 stage improvement in Acute kidney injury stage with resolution of shock at day 4 in both groups (time frame: Day 4). 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 16 Aug 2024.