Refractory Ascites in Children With CirrhosisNCT05084534
Efficacy and Safety of Midodrine in Refractory or Recurrent Ascites in Children With Cirrhosis.
A study testing Midodrine and Standard medical treatment in people with Refractory Ascites in Children With Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Refractory ascites is seen in 17% of cirrhotic patients with the 1year mortality rate being high, upto 20-50% [1]. The pathogenesis of cirrhotic ascites includes release of vasodilatory molecules like nitric oxide, damage associated molecular pathogens (DAMPs) and pattern associated molecular pathogens (PAMPs)… Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Refractory Ascites in Children With Cirrhosis
- What is being tested?
- Midodrine and Standard medical treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIndia
- Study dates
- 1 Nov 2021to Mar 2023
- 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 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- • Children and Adolescents of age group upto 18 years with cirrhosis and refractory Ascites that cannot be mobilized by sodium - restricted diet (maximum upto 2mEq/kg/day- 88meq=2gm of salt) and high-dose diuretic treatment (6 mg/kg/day of spironolactone and 2 mg/kg/day of furosemide) or optimum doses of diuretics cannot be given due to development of diuretic-induced complications (Sodium <130mEq, AKI as per KDIGO, hypovolemia, hypokalemia (<3.5meq)/hyperkalemia (>5meq); new onset HE) or ascites that recurs within 4 weeks of mobilization) or recurrent ascites ( Ascites that has recurred 3 times within 12 months despite standard medical treatment) with stable renal function (age appropriate creatinine level in last 2 weeks) attending the Pediatric Hepatology Department, ILBS will be prospectively included in this study after informed consent.
Who cannot join
- GIT bleeding in last 1 month
- SBP in last 1 month
- HE grade 3 or higher
- Septic shock
- Hepatorenal syndrome
- Presence of PVT
- Renal or cardiovascular disease or arterial hypertension
- Presence of HCC
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Midodrine in Refractory or Recurrent Ascites in Children With Cirrhosis - A Randomized Controlled Trial
Refractory ascites is seen in 17% of cirrhotic patients with the 1year mortality rate being high, upto 20-50% [1]. The pathogenesis of cirrhotic ascites includes release of vasodilatory molecules like nitric oxide, damage associated molecular pathogens (DAMPs) and pattern associated molecular pathogens (PAMPs) secondary to bacterial translocation, which causes splanchnic bed vasodilation resulting in activation of renin-angiotensin and aldosterone axis causing sodium and water retention. The standard medical therapy for the treatment of ascites includes sodium restriction to 2mEq/kg/day with diuretics (Spirinolactone 3-6mg/kg/day and furosemide 0.5-2 mg/kg/day) and therapeutic paracentesis (>50ml/kg/day) with albumin replacement at 8g/L of ascitic fluid tapped. Refractory ascites is defined as ascites that cannot be mobilized by sodium - restricted diet (maximum upto 2mEq/kg/day- 88meq=2gm of salt) and high-dose diuretic treatment (6 mg/kg/day of spironolactone and 2 mg/kg/day of furosemide) or optimum doses of diuretics cannot be given due to development of diuretic-induced complications (Sodium <130mEq, AKI as per KDIGO, hypovolemia, hypo (<3.5meq)/hyperkalemia (>5meq); new onset HE) and recurrent ascites as ascites that has recurred within a 12 weeks period despite standard treatment. All the children and adolescents upto 18 years of age with refractory or recurrent ascites will be included in the study and randomized into 2 groups. One group will receive only standard medical therapy and other group will receive midodrine and standard medical therapy for 12 weeks. Mean arterial pressure will be monitored at every OPD visit. At the end of 12 weeks, plasma renin activity, number of therapeutic paracentesis done, change in serum sodium, estimated glomerular filtration rate and complications will be assessed.
If there is complete resolution of ascites, liver transplantation or death before 12 weeks, midodrine will be stopped.
Read the detailed description
Aim: To determine the efficacy of midodrine in combination with standard medical therapy in reduction of refractory or recurrent ascites in children with cirrhosis
Primary objective:
- To compare the proportion of patients who will achieve partial or complete control of ascites at 12 weeks after therapy between the two groups
Secondary Objectives:
- Comparison of total number of therapeutic paracentesis (>50ml/kg) procedures between the groups by the end of 12 weeks
- Frequency of complete response (elimination of ascites) by 12 weeks
- Time taken to achieve complete response
- Frequency of partial response (persistent ascites not requiring therapeutic paracentesis) by 12 weeks
- To compare change in plasma renin activity from baseline to 12 weeks
- Change in serum sodium from baseline to 4 weeks and 12 weeks
- Change in eGFR from baseline to 4 weeks
- Change in MAP at 1 week, 4 weeks and 12 weeks from baseline
- Comparison of proportion of patients with transplant free survival at 12 weeks between the 2 groups
- Frequency of worsening HE by 12 weeks
- Frequency of development of HRS by 12 weeks
- Proportion of patients developing hypertension at 12 weeks
- Frequency of development of adverse effects by 12 weeks
Methodology:
- Study population : Children and Adolescents with cirrhosis and refractory or recurrent ascites with stable renal function (age appropriate creatinine level in last 2 weeks) attending the Pediatric Hepatology Department
- Study design:
Open label RCT (computer based randomization - block randomization with block size of 4)
- Study period:12 weeks for each patient; The study will be conducted between September 2021 and December 2022
- Sample size: Pilot study - 10 patients in each group
- Intervention:
- Standard Medical Treatment will be continued in all, which includes,
- To continue restriction of sodium to < 2meq/kg/day
- To continue maximum tolerable dose of diuretics
- Repeat LVP with infusion of albumin (8 g/L) performed for tense, symptomatic ascites
- Albumin infusion for serum albumin <2.5g/dl - dose 1g/kg/day (maximum 20g/day)
- Midodrine starting at 0.25mg/kg/day in divided doses, increased to 0.5mg/kg/day after 7 days if MAP does not increase by >10% (maximum dose - 15mg/day)
- Midodrine dosage will be decreased by 25% in case of arterial hypertension (>95th centile BP for the age)
Monitoring and assessment :
- Abdominal girth, Blood pressure (MAP) , HE - every visit (1-2 weekly)
- Haemogram, INR, Liver function test, Kidney function test- every 2 weekly
- Bedside Ultrasound - every visit (1-2 weekly)
- Plasma renin activity at baseline and 12 weeks
- Need for therapeutic paracentesis (tense ascites causing respiratory embarrassment) at every visit (1-2 weekly)
Adverse effects: Hypertension , Bradycardia, Piloerection, Pruritus, Dysuria
Stopping rule of the study:
- Complete resolution of ascites or 12 weeks of midodrine therapy whichever is earlier
- Liver transplantation
- Death without transplantation
- TIPSS
- Being tested
- Midodrine, Standard medical treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidodrineDrug
Midodrine starting at 0.25mg/kg/day in divided doses, increased to 0.5mg/kg/day after 7 days if MAP does not increase by >10% (maximum dose - 15mg/day)
- Midodrine dosage will be decreased by 25% in case of arterial hypertension (>95th centile BP for the age)
Standard medical treatmentOther
Standard Medical Treatment will be continued in all, which includes,
- To continue restriction of sodium to < 2meq/kg/day
- To continue maximum tolerable dose of diuretics
- Repeat LVP with infusion of albumin (8 g/L) performed for tense, symptomatic ascites
- Albumin infusion for serum albumin <2.5g/dl - dose 1g/kg/day (maximum 20g/day)
| Study group | Role | What they receive |
|---|---|---|
| Midodrine hydrochloride plus standard medical treatment | Experimental | * Standard Medical Treatment will be continued in all, which includes,
* To continue restriction of sodium to < 2meq/kg/day
* To continue maximum tolerable dose of diuretics
* Repeat LVP with infusion of albumin (8 g/L) performed for tense, symptomatic ascites
* Albumin infusion for serum albumin <2.5g/dl - dose 1g/kg/day (maximum 20g/day)
* Midodrine starting at 0.25mg/kg/day in divided doses, increased to 0.5mg/kg/day after 7 days if MAP does not increase by >10% (maximum dose - 15mg/day)
* Midodrine dosage will be decreased by 25% in case of arterial hypertension (>95th centile BP for the age) Receives: Drug: Midodrine; Other: Standard medical treatment |
| Standard medical treatment | Other | * Standard Medical Treatment will be continued in all, which includes,
* To continue restriction of sodium to < 2meq/kg/day
* To continue maximum tolerable dose of diuretics
* Repeat LVP with infusion of albumin (8 g/L) performed for tense, symptomatic ascites
* Albumin infusion for serum albumin <2.5g/dl - dose 1g/kg/day (maximum 20g/day) Receives: Other: Standard medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
• To compare the proportion of patients who will achieve partial or complete control of ascites at 12 weeks after therapy between the two groups
Measured: 12 weeks
Secondary outcomes (13)
• Comparison of total number of therapeutic paracentesis (>50ml/kg) procedures between the groups by the end of 12 weeks
Measured: 12 weeks
• Frequency of complete response (elimination of ascites) by 12 weeks
Measured: 12 weeks
• Time taken to achieve complete response
Measured: 12 weeks
• Frequency of partial response (persistent ascites not requiring therapeutic paracentesis) by 12 weeks
Measured: 12 weeks
• To compare change in plasma renin activity from baseline to 12 weeks
Measured: 12 weeks
• Change in serum sodium from baseline to 4 weeks and 12 weeks
Measured: 12 weeks
• Change in eGFR from baseline to 4 weeks
Measured: 4 weeks
• Change in MAP at 1 week, 4 weeks and 12 weeks from baseline
Measured: 12 weeks
• Comparison of proportion of patients with transplant free survival at 12 weeks between the 2 groups
Measured: 12 weeks
• Frequency of worsening HE by 12 weeks
Measured: 12 weeks
• Frequency of development of HRS by 12 weeks
Measured: 12 weeks
• Proportion of patients developing hypertension at 12 weeks
Measured: 12 weeks
• Frequency of development of adverse effects by 12 weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start1 Nov 2021
- Primary completionFeb 2023 (estimated)
- Study completionMar 2023 (estimated)
Why it stopped: No cases of refractory ascites presented to hospital in one year
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Ascites in Children With CirrhosisStudies 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
- 0 participants (actual)
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
- NCT05084534
- Sponsor's protocol ID
- ILBS-Cirrhosis-47
- Status last verified
- Oct 2021
- First submitted
- 18 Oct 2021
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Midodrine in Refractory or Recurrent Ascites in Children With Cirrhosis - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05084534
- Acronym / sponsor ID
- ILBS-Cirrhosis-47
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No cases of refractory ascites presented to hospital in one year
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 19 Oct 2021 (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.
Refractory ascites is seen in 17% of cirrhotic patients with the 1year mortality rate being high, upto 20-50% [1]. The pathogenesis of cirrhotic ascites includes release of vasodilatory molecules like nitric oxide, damage associated molecular pathogens (DAMPs) and pattern associated molecular pathogens (PAMPs) secondary to bacterial translocation, which causes splanchnic bed vasodilation resulting in activation of renin-angiotensin and aldosterone axis causing sodium and water retention. The standard medical therapy for the treatment of ascites includes sodium restriction to 2mEq/kg/day with diuretics (Spirinolactone 3-6mg/kg/day and furosemide 0.5-2 mg/kg/day) and therapeutic paracentesis (>50ml/kg/day) with albumin replacement at 8g/L of ascitic fluid tapped. Refractory ascites is defined as ascites that cannot be mobilized by sodium - restricted diet (maximum upto 2mEq/kg/day- 88meq=2gm of salt) and high-dose diuretic treatment (6 mg/kg/day of spironolactone and 2 mg/kg/day of furosemide) or optimum doses of diuretics cannot be given due to development of diuretic-induced complications (Sodium <130mEq, AKI as per KDIGO, hypovolemia, hypo (<3.5meq)/hyperkalemia (>5meq); new onset HE) and recurrent ascites as ascites that has recurred within a 12 weeks period despite standard treatment. All the children and adolescents upto 18 years of age with refractory or recurrent ascites will be included in the study and randomized into 2 groups. One group will receive only standard medical therapy and other group will receive midodrine and standard medical therapy for 12 weeks. Mean arterial pressure will be monitored at every OPD visit. At the end of 12 weeks, plasma renin activity, number of therapeutic paracentesis done, change in serum sodium, estimated glomerular filtration rate and complications will be assessed.
If there is complete resolution of ascites, liver transplantation or death before 12 weeks, midodrine will be stopped.
Detailed description
Aim: To determine the efficacy of midodrine in combination with standard medical therapy in reduction of refractory or recurrent ascites in children with cirrhosis
Primary objective:
- To compare the proportion of patients who will achieve partial or complete control of ascites at 12 weeks after therapy between the two groups
Secondary Objectives:
- Comparison of total number of therapeutic paracentesis (>50ml/kg) procedures between the groups by the end of 12 weeks
- Frequency of complete response (elimination of ascites) by 12 weeks
- Time taken to achieve complete response
- Frequency of partial response (persistent ascites not requiring therapeutic paracentesis) by 12 weeks
- To compare change in plasma renin activity from baseline to 12 weeks
- Change in serum sodium from baseline to 4 weeks and 12 weeks
- Change in eGFR from baseline to 4 weeks
- Change in MAP at 1 week, 4 weeks and 12 weeks from baseline
- Comparison of proportion of patients with transplant free survival at 12 weeks between the 2 groups
- Frequency of worsening HE by 12 weeks
- Frequency of development of HRS by 12 weeks
- Proportion of patients developing hypertension at 12 weeks
- Frequency of development of adverse effects by 12 weeks
Methodology:
- Study population : Children and Adolescents with cirrhosis and refractory or recurrent ascites with stable renal function (age appropriate creatinine level in last 2 weeks) attending the Pediatric Hepatology Department
- Study design:
Open label RCT (computer based randomization - block randomization with block size of 4)
- Study period:12 weeks for each patient; The study will be conducted between September 2021 and December 2022
- Sample size: Pilot study - 10 patients in each group
- Intervention:
- Standard Medical Treatment will be continued in all, which includes,
- To continue restriction of sodium to < 2meq/kg/day
- To continue maximum tolerable dose of diuretics
- Repeat LVP with infusion of albumin (8 g/L) performed for tense, symptomatic ascites
- Albumin infusion for serum albumin <2.5g/dl - dose 1g/kg/day (maximum 20g/day)
- Midodrine starting at 0.25mg/kg/day in divided doses, increased to 0.5mg/kg/day after 7 days if MAP does not increase by >10% (maximum dose - 15mg/day)
- Midodrine dosage will be decreased by 25% in case of arterial hypertension (>95th centile BP for the age)
Monitoring and assessment :
- Abdominal girth, Blood pressure (MAP) , HE - every visit (1-2 weekly)
- Haemogram, INR, Liver function test, Kidney function test- every 2 weekly
- Bedside Ultrasound - every visit (1-2 weekly)
- Plasma renin activity at baseline and 12 weeks
- Need for therapeutic paracentesis (tense ascites causing respiratory embarrassment) at every visit (1-2 weekly)
Adverse effects: Hypertension , Bradycardia, Piloerection, Pruritus, Dysuria
Stopping rule of the study:
- Complete resolution of ascites or 12 weeks of midodrine therapy whichever is earlier
- Liver transplantation
- Death without transplantation
- TIPSS
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midodrine hydrochloride plus standard medical treatment | Experimental | Drug: Midodrine, Other: Standard medical treatment* Standard Medical Treatment will be continued in all, which includes, * To continue restriction of sodium to < 2meq/kg/day * To continue maximum tolerable dose of diuretics * Repeat LVP with infusion of albumin (8 g/L) performed for tense, symptomatic ascites * Albumin infusion for serum albumin <2.5g/dl - dose 1g/kg/day (maximum 20g/day) * Midodrine starting at 0.25mg/kg/day in divided doses, increased to 0.5mg/kg/day after 7 days if MAP does not increase by >10% (maximum dose - 15mg/day) * Midodrine dosage will be decreased by 25% in case of arterial hypertension (>95th centile BP for the age) |
| Standard medical treatment | Other | Other: Standard medical treatment* Standard Medical Treatment will be continued in all, which includes, * To continue restriction of sodium to < 2meq/kg/day * To continue maximum tolerable dose of diuretics * Repeat LVP with infusion of albumin (8 g/L) performed for tense, symptomatic ascites * Albumin infusion for serum albumin <2.5g/dl - dose 1g/kg/day (maximum 20g/day) |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- • Children and Adolescents of age group upto 18 years with cirrhosis and refractory Ascites that cannot be mobilized by sodium - restricted diet (maximum upto 2mEq/kg/day- 88meq=2gm of salt) and high-dose diuretic treatment (6 mg/kg/day of spironolactone and 2 mg/kg/day of furosemide) or optimum doses of diuretics cannot be given due to development of diuretic-induced complications (Sodium <130mEq, AKI as per KDIGO, hypovolemia, hypokalemia (<3.5meq)/hyperkalemia (>5meq); new onset HE) or ascites that recurs within 4 weeks of mobilization) or recurrent ascites ( Ascites that has recurred 3 times within 12 months despite standard medical treatment) with stable renal function (age appropriate creatinine level in last 2 weeks) attending the Pediatric Hepatology Department, ILBS will be prospectively included in this study after informed consent.
Key exclusion criteria (8 listed)
- GIT bleeding in last 1 month
- SBP in last 1 month
- HE grade 3 or higher
- Septic shock
- Hepatorenal syndrome
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 |
|---|---|---|
| MidodrineMidodrine starting at 0.25mg/kg/day in divided doses, increased to 0.5mg/kg/day after 7 days if MAP does not increase by >10% (maximum dose - 15mg/day) • Midodrine dosage will be decreased by 25% in case of arterial hypertension (>95th centile BP for the age) | Drug | Midodrine hydrochloride plus standard medical treatment |
| Standard medical treatmentStandard Medical Treatment will be continued in all, which includes, * To continue restriction of sodium to < 2meq/kg/day * To continue maximum tolerable dose of diuretics * Repeat LVP with infusion of albumin (8 g/L) performed for tense, symptomatic ascites * Albumin infusion for serum albumin <2.5g/dl - dose 1g/kg/day (maximum 20g/day) | Other | Midodrine hydrochloride plus standard medical treatment, Standard medical treatment |
Primary outcome
• To compare the proportion of patients who will achieve partial or complete control of ascites at 12 weeks after therapy between the two groups
Time frame: 12 weeks
13 secondary outcomes
• Comparison of total number of therapeutic paracentesis (>50ml/kg) procedures between the groups by the end of 12 weeks
Time frame: 12 weeks
• Frequency of complete response (elimination of ascites) by 12 weeks
Time frame: 12 weeks
• Time taken to achieve complete response
Time frame: 12 weeks
• Frequency of partial response (persistent ascites not requiring therapeutic paracentesis) by 12 weeks
Time frame: 12 weeks
• To compare change in plasma renin activity from baseline to 12 weeks
Time frame: 12 weeks
• Change in serum sodium from baseline to 4 weeks and 12 weeks
Time frame: 12 weeks
• Change in eGFR from baseline to 4 weeks
Time frame: 4 weeks
• Change in MAP at 1 week, 4 weeks and 12 weeks from baseline
Time frame: 12 weeks
• Comparison of proportion of patients with transplant free survival at 12 weeks between the 2 groups
Time frame: 12 weeks
• Frequency of worsening HE by 12 weeks
Time frame: 12 weeks
• Frequency of development of HRS by 12 weeks
Time frame: 12 weeks
• Proportion of patients developing hypertension at 12 weeks
Time frame: 12 weeks
• Frequency of development of adverse effects by 12 weeks
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midodrine and Standard medical treatment in people with Refractory Ascites in Children With Cirrhosis, 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 1 inclusion and 8 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: withdrawn, as of the sponsor's last update on 7 May 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
• To compare the proportion of patients who will achieve partial or complete control of ascites at 12 weeks after therapy between the two groups (time frame: 12 weeks). 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 7 May 2024.