Liver TransplantationPhase 2VITACTOHNCT05754242
Ascorbic Acid to Prevent Postreperfusion Syndrome in Liver Transplantation
A Phase 2 study testing Ascorbic acid and 0.9% Saline solution in people with Liver Transplantation and Postreperfusion Syndrome, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial summary
The goal of this clinical trial is to test the efficacy of intravenous ascorbic acid in preventing the postreperfusion syndrome in liver transplantation. The main questions it aims to answer are: Can intravenous ascorbic acid prevent postreperfusion syndrome in liver transplantation ? Can ascorbic acid decrease the… Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Liver Transplantation, Postreperfusion Syndrome, Ascorbic Acid
- What is being tested?
- Ascorbic acid and 0.9% Saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 17 Nov 2020to 30 Jul 2023
- Phase
- Phase 2
- 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 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing liver transplantation
Who cannot join
- Pregnancy
- Allergy to ascorbic acid
- Nephrolithiasis
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Hyperoxaluria
- Hyperuricemia
Show all 14Show fewer
- Haemochromatosis
- Sickle cell anemia
- Serum Creatinine > 1.2 mg/dl in women and 1.3 mg/dl in men
- Split liver graft
- Acute liver failure
- Living donor liver transplantation
- Controlled donor asystolia
- Treatment with: indinavir, Vitamin B12, Cyclosporine, iron, deferoxamine, disulfiram
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario RAmon y Cajal
Madrid, 28034
Luis Gajate, MD PhD, +34913368269, gajate.luis@gamil.com
Ines de la Hoz, MD, +34913368269, delahozpoloines@gmail.com
About this study
Official title: Intravenous Vitamin C for the Prevention of Postreperfusion Syndrome in Orthotopic Liver Transplantation From Deceased Donors
The goal of this clinical trial is to test the efficacy of intravenous ascorbic acid in preventing the postreperfusion syndrome in liver transplantation. The main questions it aims to answer are:
- Can intravenous ascorbic acid prevent postreperfusion syndrome in liver transplantation ?
- Can ascorbic acid decrease the incidence of liver graft dysfunction after liver transplantation?
- Can ascorbic acid decreased the incidence of postoperative complications after liver transplantation ?
Read more
Participants will receive 1.5 g of intravenous ascorbic acid diluted in 100 ml of saline or 100 ml of saline alone, during the anhepatic phase of liver transplantation before reperfusion of the new graft.
Researchers will compared the incidence of postreperfusion syndrome in both groups.
Read the detailed description
Researches will compared:
- Incidence of postreperfusion syndrome in liver transplantation
- Changes in interleukin values and other inflammatory markers before and after transplantation
- Incidence of liver graft dysfunction between groups
- Incidence of acute renal failure and other complications between groups
- Being tested
- Ascorbic acid, 0.9% Saline solution
- Keywords
- Postreperfusion syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascorbic acidDrug
Also called Vitamin C
1.5 gr of ascorbic acid
0.9% Saline solutionDrug
Also called Saline
100 ml of 0.9% saline solution
| Study group | Role | What they receive |
|---|---|---|
| Ascorbic acid | Experimental | 1.5 gr of ascorbic acid diluted in 100 ml of 0.9% saline solution will be administered intravenously during the anhepatic phase of liver transplantation Receives: Drug: Ascorbic acid |
| Saline solution | Placebo comparator | 100 ml of 0.9% saline solution will be administered during the anhepatic phase of liver transplantation Receives: Drug: 0.9% Saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postreperfusion syndrome
When mean arterial pressure decreases by more than 30% relative to the value at the end of the anhepatic phase and lasts for at least 1 min
Measured: Within the first 5 minutes after reperfusion of the grafted liver
Secondary outcomes (14)
Ascorbic acid serum levels
Quantification of ascorbic acid levels before and after liver transplantation
Measured: Immediately before induction of anesthesia and 12 hours after repercussion of the graft
Interleukin1beta (IL-1β) levels
Quantification of IL-1β before and after liver transplantation
Measured: Immediately before induction of anesthesia and 12 hours after repercussion of the graft
Tumor Necrosis Factor-alpha (TNFα) levels
Quantification of TNFα before and after liver transplantation
Measured: Immediately before induction of anesthesia and 12 hours after repercussion of the graft
Interleukin-6 levels (IL-6)
Quantification of IL-6 before and after liver transplantation
Measured: Immediately before induction of anesthesia and 12 hours after repercussion of the graft
Interleukin-8 (IL-8) levels
Quantification of IL-8 before and after liver transplantation
Measured: Immediately before induction of anesthesia and 12 hours after repercussion of the graft
Interferon gamma (IFNγ) levels
Quantification of IFNγ before and after liver transplantation
Measured: Immediately before induction of anesthesia and 12 hours after repercussion of the graft
Primary graft dysfunction
Incidence of primary graft nonfunction and early graft dysfunction. Graft nonfunction: lack of liver function leading to death if not retransplanted Early graft dysfunction: Olthoff's criteria
Measured: First postoperative week
Acute renal failure
Postoperative renal failure after liver transplantation as Kidney Disease Improving Global Outcomes (KDIGO) definition
Measured: First postoperative week
Mechanical ventilation
Duration of mechanical ventilation (hours) until extubation of the patient
Measured: Postoperative until day 30
Mortality
Mortality of any cause
Measured: Up to day 30
Length of hospitalization
Length of stay in hospital (days)
Measured: Through study completion (30 days)
Length of Intensive Care Unit (ICU) stay
Length of ICU stay
Measured: Through study completion (30 days)
Duration of vasopressor support after transplantation
Duration of vasopressor or inotropic support after transplantation
Measured: Postoperative until study completion (30 days)
Maximum dose of vasopressor support after transplantation
Maximum dose of vasopressor or inotropic support after transplantation
Measured: Postoperative until study completion (30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start17 Nov 2020
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantationStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Gajate Martín, Hospital Universitario Ramon y Cajal
- Investigators
- Luis Gajate, MD PhD, Principal investigator, Hospital Universitario Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05754242
- Sponsor's protocol ID
- EC 20/606
- Acronym
- VITACTOH
- Status last verified
- Mar 2023
- First submitted
- 15 Feb 2023
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data (IPD) that underlie results in a publication
Publications
Aggarwal S, Kang Y, Freeman JA, Fortunato FL, Pinsky MR. Postreperfusion syndrome: cardiovascular collapse following hepatic reperfusion during liver transplantation. Transplant Proc. 1987 Aug;19(4 Suppl 3):54-5. No abstract available.
PubMed 3303534Siniscalchi A, Dante A, Spedicato S, Riganello L, Zanoni A, Cimatti M, Pierucci E, Bernardi E, Miklosova Z, Moretti C, Faenza S. Hyperdynamic circulation in acute liver failure: reperfusion syndrome and outcome following liver transplantation. Transplant Proc. 2010 May;42(4):1197-9. doi: 10.1016/j.transproceed.2010.03.097.
PubMed 20534260Paugam-Burtz C, Kavafyan J, Merckx P, Dahmani S, Sommacale D, Ramsay M, Belghiti J, Mantz J. Postreperfusion syndrome during liver transplantation for cirrhosis: outcome and predictors. Liver Transpl. 2009 May;15(5):522-9. doi: 10.1002/lt.21730.
PubMed 19399736Blanot S, Gillon MC, Lopez I, Ecoffey C. Circulating endotoxins and postreperfusion syndrome during orthotopic liver transplantation. Transplantation. 1995 Jul 15;60(1):103-6. doi: 10.1097/00007890-199507150-00019. No abstract available.
PubMed 7624932Bezinover D, Kadry Z, McCullough P, McQuillan PM, Uemura T, Welker K, Mastro AM, Janicki PK. Release of cytokines and hemodynamic instability during the reperfusion of a liver graft. Liver Transpl. 2011 Mar;17(3):324-30. doi: 10.1002/lt.22227.
PubMed 21384515Blanot S, Gillon MC, Ecoffey C, Lopez I. Circulating endotoxins during orthotopic liver transplantation and post-reperfusion syndrome. Lancet. 1993 Oct 2;342(8875):859-60. doi: 10.1016/0140-6736(93)92715-6. No abstract available.
PubMed 8104281Ishine N, Yagi T, Ishikawa T, Sasaki H, Nakagawa K, Tanaka N. Hemodynamic analysis of post-reperfusion syndrome and the effect of preventing this syndrome using thromboxane A2 synthetase inhibitor (OKY-046) in swine liver transplantation. Transplant Proc. 1997 Feb-Mar;29(1-2):378-81. doi: 10.1016/s0041-1345(96)00127-3. No abstract available.
PubMed 9123045Girn HR, Ahilathirunayagam S, Mavor AI, Homer-Vanniasinkam S. Reperfusion syndrome: cellular mechanisms of microvascular dysfunction and potential therapeutic strategies. Vasc Endovascular Surg. 2007 Aug-Sep;41(4):277-93. doi: 10.1177/1538574407304510.
PubMed 17704330Wilson JX. Mechanism of action of vitamin C in sepsis: ascorbate modulates redox signaling in endothelium. Biofactors. 2009 Jan-Feb;35(1):5-13. doi: 10.1002/biof.7.
PubMed 19319840Tanaka H, Matsuda T, Miyagantani Y, Yukioka T, Matsuda H, Shimazaki S. Reduction of resuscitation fluid volumes in severely burned patients using ascorbic acid administration: a randomized, prospective study. Arch Surg. 2000 Mar;135(3):326-31. doi: 10.1001/archsurg.135.3.326.
PubMed 10722036Zabet MH, Mohammadi M, Ramezani M, Khalili H. Effect of high-dose Ascorbic acid on vasopressor's requirement in septic shock. J Res Pharm Pract. 2016 Apr-Jun;5(2):94-100. doi: 10.4103/2279-042X.179569.
PubMed 27162802Fowler AA 3rd, Syed AA, Knowlson S, Sculthorpe R, Farthing D, DeWilde C, Farthing CA, Larus TL, Martin E, Brophy DF, Gupta S; Medical Respiratory Intensive Care Unit Nursing; Fisher BJ, Natarajan R. Phase I safety trial of intravenous ascorbic acid in patients with severe sepsis. J Transl Med. 2014 Jan 31;12:32. doi: 10.1186/1479-5876-12-32.
PubMed 24484547Gajate Martin L, de la Hoz I, Martin M, Fernandez C, Martin Grande A, Parise D, Villahoz J, Gomez M, Espino M, Pastor O, Rodriguez Gandia MA, Nuno J. A randomized trial of ascorbic acid for the prevention of post-reperfusion syndrome during liver transplantation. Hepatol Commun. 2025 Jul 29;9(8):e0777. doi: 10.1097/HC9.0000000000000777. eCollection 2025 Aug 1.
PubMed 40719561Gajate L, de la Hoz I, Espino M, Martin Gonzalez MDC, Fernandez Martin C, Martin-Grande A, Parise Roux D, Pastor O, Villahoz J, Rodriguez-Gandia MA, Nuno Vazquez J. Intravenous Ascorbic Acid for the Prevention of Postreperfusion Syndrome in Orthotopic Liver Transplantation: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Dec 15;12:e50091. doi: 10.2196/50091.
PubMed 38100226
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Vitamin C for the Prevention of Postreperfusion Syndrome in Orthotopic Liver Transplantation From Deceased Donors
- ClinicalTrials.gov ID
- NCT05754242
- Acronym / sponsor ID
- VITACTOH / EC 20/606
- Keywords
- Postreperfusion syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 3 Mar 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 goal of this clinical trial is to test the efficacy of intravenous ascorbic acid in preventing the postreperfusion syndrome in liver transplantation. The main questions it aims to answer are:
- Can intravenous ascorbic acid prevent postreperfusion syndrome in liver transplantation ?
- Can ascorbic acid decrease the incidence of liver graft dysfunction after liver transplantation?
- Can ascorbic acid decreased the incidence of postoperative complications after liver transplantation ?
Participants will receive 1.5 g of intravenous ascorbic acid diluted in 100 ml of saline or 100 ml of saline alone, during the anhepatic phase of liver transplantation before reperfusion of the new graft.
Researchers will compared the incidence of postreperfusion syndrome in both groups.
Detailed description
Researches will compared:
- Incidence of postreperfusion syndrome in liver transplantation
- Changes in interleukin values and other inflammatory markers before and after transplantation
- Incidence of liver graft dysfunction between groups
- Incidence of acute renal failure and other complications between groups
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ascorbic acid | Experimental | Drug: Ascorbic acid1.5 gr of ascorbic acid diluted in 100 ml of 0.9% saline solution will be administered intravenously during the anhepatic phase of liver transplantation |
| Saline solution | Placebo comparator | Drug: 0.9% Saline solution100 ml of 0.9% saline solution will be administered during the anhepatic phase of liver transplantation |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing liver transplantation
Key exclusion criteria (14 listed)
- Pregnancy
- Allergy to ascorbic acid
- Nephrolithiasis
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Hyperoxaluria
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 |
|---|---|---|
| Ascorbic acidAlso: Vitamin C1.5 gr of ascorbic acid | Drug | Ascorbic acid |
| 0.9% Saline solutionAlso: Saline100 ml of 0.9% saline solution | Drug | Saline solution |
Primary outcome
Postreperfusion syndrome
Time frame: Within the first 5 minutes after reperfusion of the grafted liver
When mean arterial pressure decreases by more than 30% relative to the value at the end of the anhepatic phase and lasts for at least 1 min
14 secondary outcomes
Ascorbic acid serum levels
Time frame: Immediately before induction of anesthesia and 12 hours after repercussion of the graft
Interleukin1beta (IL-1β) levels
Time frame: Immediately before induction of anesthesia and 12 hours after repercussion of the graft
Tumor Necrosis Factor-alpha (TNFα) levels
Time frame: Immediately before induction of anesthesia and 12 hours after repercussion of the graft
Interleukin-6 levels (IL-6)
Time frame: Immediately before induction of anesthesia and 12 hours after repercussion of the graft
Interleukin-8 (IL-8) levels
Time frame: Immediately before induction of anesthesia and 12 hours after repercussion of the graft
Interferon gamma (IFNγ) levels
Time frame: Immediately before induction of anesthesia and 12 hours after repercussion of the graft
Primary graft dysfunction
Time frame: First postoperative week
Acute renal failure
Time frame: First postoperative week
Mechanical ventilation
Time frame: Postoperative until day 30
Mortality
Time frame: Up to day 30
Length of hospitalization
Time frame: Through study completion (30 days)
Length of Intensive Care Unit (ICU) stay
Time frame: Through study completion (30 days)
Duration of vasopressor support after transplantation
Time frame: Postoperative until study completion (30 days)
Maximum dose of vasopressor support after transplantation
Time frame: Postoperative until study completion (30 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Background: PubMed 3303534Aggarwal S, Kang Y, Freeman JA, Fortunato FL, Pinsky MR. Postreperfusion syndrome: cardiovascular collapse following hepatic reperfusion during liver transplantation. Transplant Proc. 1987 Aug;19(4 Suppl 3):54-5. No abstract available.
- Background: PubMed 20534260Siniscalchi A, Dante A, Spedicato S, Riganello L, Zanoni A, Cimatti M, Pierucci E, Bernardi E, Miklosova Z, Moretti C, Faenza S. Hyperdynamic circulation in acute liver failure: reperfusion syndrome and outcome following liver transplantation. Transplant Proc. 2010 May;42(4):1197-9. doi: 10.1016/j.transproceed.2010.03.097.
- Background: PubMed 19399736Paugam-Burtz C, Kavafyan J, Merckx P, Dahmani S, Sommacale D, Ramsay M, Belghiti J, Mantz J. Postreperfusion syndrome during liver transplantation for cirrhosis: outcome and predictors. Liver Transpl. 2009 May;15(5):522-9. doi: 10.1002/lt.21730.
- Background: PubMed 7624932Blanot S, Gillon MC, Lopez I, Ecoffey C. Circulating endotoxins and postreperfusion syndrome during orthotopic liver transplantation. Transplantation. 1995 Jul 15;60(1):103-6. doi: 10.1097/00007890-199507150-00019. No abstract available.
- Background: PubMed 21384515Bezinover D, Kadry Z, McCullough P, McQuillan PM, Uemura T, Welker K, Mastro AM, Janicki PK. Release of cytokines and hemodynamic instability during the reperfusion of a liver graft. Liver Transpl. 2011 Mar;17(3):324-30. doi: 10.1002/lt.22227.
- Background: PubMed 8104281Blanot S, Gillon MC, Ecoffey C, Lopez I. Circulating endotoxins during orthotopic liver transplantation and post-reperfusion syndrome. Lancet. 1993 Oct 2;342(8875):859-60. doi: 10.1016/0140-6736(93)92715-6. No abstract available.
- Background: PubMed 9123045Ishine N, Yagi T, Ishikawa T, Sasaki H, Nakagawa K, Tanaka N. Hemodynamic analysis of post-reperfusion syndrome and the effect of preventing this syndrome using thromboxane A2 synthetase inhibitor (OKY-046) in swine liver transplantation. Transplant Proc. 1997 Feb-Mar;29(1-2):378-81. doi: 10.1016/s0041-1345(96)00127-3. No abstract available.
- Background: PubMed 17704330Girn HR, Ahilathirunayagam S, Mavor AI, Homer-Vanniasinkam S. Reperfusion syndrome: cellular mechanisms of microvascular dysfunction and potential therapeutic strategies. Vasc Endovascular Surg. 2007 Aug-Sep;41(4):277-93. doi: 10.1177/1538574407304510.
- Background: PubMed 19319840Wilson JX. Mechanism of action of vitamin C in sepsis: ascorbate modulates redox signaling in endothelium. Biofactors. 2009 Jan-Feb;35(1):5-13. doi: 10.1002/biof.7.
- Background: PubMed 10722036Tanaka H, Matsuda T, Miyagantani Y, Yukioka T, Matsuda H, Shimazaki S. Reduction of resuscitation fluid volumes in severely burned patients using ascorbic acid administration: a randomized, prospective study. Arch Surg. 2000 Mar;135(3):326-31. doi: 10.1001/archsurg.135.3.326.
- Background: PubMed 27162802Zabet MH, Mohammadi M, Ramezani M, Khalili H. Effect of high-dose Ascorbic acid on vasopressor's requirement in septic shock. J Res Pharm Pract. 2016 Apr-Jun;5(2):94-100. doi: 10.4103/2279-042X.179569.
- Background: PubMed 24484547Fowler AA 3rd, Syed AA, Knowlson S, Sculthorpe R, Farthing D, DeWilde C, Farthing CA, Larus TL, Martin E, Brophy DF, Gupta S; Medical Respiratory Intensive Care Unit Nursing; Fisher BJ, Natarajan R. Phase I safety trial of intravenous ascorbic acid in patients with severe sepsis. J Transl Med. 2014 Jan 31;12:32. doi: 10.1186/1479-5876-12-32.
- Individual participant dataSharing planned: Yes. All individual participant data (IPD) that underlie results in a publication
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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.
Luis Gajate, MD PhD principal investigator
Hospital Universitario Ramon y Cajal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ascorbic acid and 0.9% Saline solution in people with Liver Transplantation and Postreperfusion Syndrome, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
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 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: status not confirmed, as of the sponsor's last update on 3 Mar 2023. 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 Spain. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Luis Gajate, MD PhD (+34913368269, gajate.luis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postreperfusion syndrome (time frame: Within the first 5 minutes after reperfusion of the grafted liver). 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 NCT05754242, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.