Kaposiform HemangioendotheliomasPhase 2NCT00975819
Safety and Efficacy Study of Sirolimus in Complicated Vascular Anomalies
A Phase 2 study testing sirolimus in people with Kaposiform Hemangioendotheliomas and Tufted Angioma, run by Denise Martin Adams at 2 sites in United States.
Trial summary
The purpose of this study is to determine if the use of sirolimus in the treatment of children and young adults with complicated vascular anomalies will prove to be safe and provide objective response resulting in improved clinical status and quality of life. Read more about this study
- Who is it for?
- Ages Up to 31 years
- Conditions the study is for
- Kaposiform Hemangioendotheliomas, Tufted Angioma, Capillary Venous Lymphatic Malformation
- What is being tested?
- sirolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2009to Oct 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 31 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Inclusion will be strictly limited to children and young adults with vascular anomalies with complications that require systemic therapy for control.
- Diagnosis: All patients must have one of the following vascular anomalies as determined by clinical, radiographic and histologic criteria (when possible):
- Kaposiform Hemangioendotheliomas with Kasabach-Merritt Phenomenon
- Kaposiform Hemangioendotheliomas without Kasabach-Merritt Phenomenon
- Tufted Angioma with Kasabach-Merritt Phenomenon
- Tufted Angioma without Kasabach-Merritt Phenomenon
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- Capillary Lymphatico-Venous Malformation (CLVM)
- Venous Lymphatic Malformation (VLM)
- Microcystic Lymphatic Malformation (MLM)
- Multifocal Lymphangiomatosis and Thrombocytopenia (MLT)/Cutaneovisceral Angiomatosis and Thrombocytopenia (CAT)
- Capillary Lymphatic Arterial Venous Malformations (CLAVM)
- PTEN Overgrowth syndrome with vascular anomaly
- Lymphangiectasia Syndromes
- If archived tissue is available, histological diagnosis will be confirmed by the pathology lab at the enrolling site.
- Complications: Patients must have vascular anomalies that have potential to cause significant morbidity. In addition to the above diagnosis, one or more of the following criteria needs to be met:
- Coagulopathy
- Chronic pain
- Recurrent cellulitis (>3 episodes/year)
- Ulceration
- Visceral and/or bone involvement
- Cardiac dysfunction
- Age: Patients must be 0 - 31 years of age at the time of study entry. Enrollment includes patients of both genders and all ethnic groups.
- Organ function requirements:
- Adequate liver function defined as:
- Total bilirubin (sum of conjugated and unconjugated) ≤1.5 x ULN for age, and
- SGPT (ALT) <5 x ULN for age, and
- Serum albumin > or = 2 g/dL.
- Fasting LDL and cholesterol:
- Fasting LDL cholesterol of <160 mg/dL
- Patients taking a cholesterol lowering agent must be on a single medication and on a stable dose for at least 4 weeks
- Adequate Bone Marrow Function defined as:
- Peripheral absolute neutrophil count (ANC) > or = 1000/microL
- Hemoglobin > or = 8.0 gm/dL (may receive RBC transfusions)
- Platelet count > or = 50,000/microL (transfusion independent defined as not receiving a platelet transfusion within a 7 day period prior to enrollment)
- Note: There is NO platelet requirement for patients with Kasabach-Merritt Phenomenon
- Adequate Renal Function Defined as:
- A serum creatinine based on age as follows:
- ≤ 5 years of age maximum serum creatinine (mg/dL) of 0.8
- 6 < age ≤ 10 years of age maximum serum creatinine (mg/dL) of 1.0
- 11 < age ≤ 15 years of age maximum serum creatinine (mg/dL) of 1.2
- > 15 years of age maximum serum creatinine (mg/dL) of 1.5
- AND cystatin C equal to or less than the upper limit of normal for the patient. If cystatin C does not initially meet this criterion, it may be repeated or a more sensitive screening by nuclear GFR must be ≥ 70 ml/min.
- Urine protein to creatinine ratio (UPC) < 0.3 g/l
- Performance Status: Karnofsky > or = 50 (>10 years of age) and Lansky > or = 50 for patients < or = 10 years of age
- Prior therapy requirements:
- Patients who have undergone surgical resection or interventional radiology procedures for disease control are eligible if they meet all inclusion criteria after surgery/procedure
- Surgery: At least 2 weeks since undergoing any major surgery
- Steroids: Patients with endocrine deficiencies are allowed to receive physiologic or stress doses of steroids if necessary. Other patients, such as vascular tumor patients, need to be on a weaning dose of steroids (steroid use defined as intravenous or oral steroids required for more than one day).
- Myelosuppressive chemotherapy: Must not have received within 4 weeks of entry onto this study.
- Hematopoietic GFs: At least 7 days since the completion of therapy with a GF that supports platelet, red or white cell number or function.
- Biologic (anti-neoplastic agent): At least 14 days since the completion of therapy with a biologic agent. For agents that have known AEs occurring beyond 14 days after administration, this period must be extended beyond the time during which AEs are known to occur. These patients must be discussed with the Study Chair on a case-by-case basis.
- Patients diagnosed with Kaposiform Hemangioendotheliomas or Tufted Angiomas will not require a washout period prior to enrollment, but will be required to discontinue the use of prohibited concomitant medications upon enrollment in the study following the guidelines of the protocol.
- Investigational Drugs: Patients must not have received any non-FDA approved drug within 4 weeks.
- XRT: > or = 6 months from involved field radiation to vascular tumor.
- CYP3A4 inhibitors: Patients may not be currently receiving strong inhibitors of CYP3A4, and may not have received these medications within 1 week of entry. (See Appendix II). These include:
- Macrolide Antibiotics: clarithromycin, telithromycin, erythromycin, troleandomycin.
- Gastrointestinal prokinetic agents: cisapride, metoclopramide.
- Antifungals: itraconazole, ketoconazole, fluconazole (doses > 200 mg/day), voriconazole, clotrimazole
- Calcium channel blockers: verapamil, diltiazem, nicardipine
- Other drugs: rifampin, bromocriptine, cimetidine (Tagamet®), danazol, cyclosporine oral solution, lansoprazole (Prevacid®).
- Grapefruit juice.
- CYP3A4 inducers: Patients must also avoid strong inducers of CYP3A4, and may not have received these medications within 1 week of entry. These include:
- Anticonvulsants: carbamazepine, phenobarbital, phenytoin
- Antibiotics: rifabutin, rifapentine.
- Herbal preparations: St. John's Wort (Hypericum perforatum, hypericine).
- Enzyme inducing anticonvulsants: Patients may not be taking enzyme-inducing anticonvulsants, and may not have received these medications within 1 week of entry, as these patients may experience different drug disposition. These medications include:
- Carbamazepine (Tegretol®)
- Felbamate (Felbtol®)
- Phenobarbitol
- Phenytoin (Dilantinl®)
- Primidone (Mysoline®)
- Oxcarbazepine (Trileptal®)
Who cannot join
- Dental braces or prosthesis only if it interferes with radiologic analysis of vascular anomaly.
- Concurrent severe and/or uncontrolled medical disease which could compromise participation in the study (e.g. uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, chronic liver or renal disease, active upper GI tract ulceration).
- Chronic treatment with systemic steroids or another immunosuppressive agent. Patients with endocrine deficiencies are allowed to receive physiologic or stress doses of steroids if necessary. Patients with the diagnosis of a vascular tumor (KHE, TA) can be on a weaning dose of steroids.
- Patients who require medications that inhibit/induce CYP3A4 enzyme activity to control concurrent medical conditions.
- Known history of HIV seropositivity or known immunodeficiency. Testing is not required unless a condition is suspected.
- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of sirolimus (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection). A gastric tube or nasogastric tube is allowed.
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- Women who are pregnant or breast feeding.
- Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method during the period they are receiving the study drug and for 3 months thereafter. Abstinence is an acceptable method of birth control. Women of childbearing potential will be given a pregnancy test within 7 days prior to administration of sirolimus and must have a negative urine or serum pregnancy test.
- Patients who have received prior treatment with an mTOR inhibitor.
- Patients unwilling or unable to comply with the protocol, or who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.
- Patients who currently have an uncontrolled infection, defined as receiving intravenous antibiotics.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital Boston
Boston, Massachusetts, 02115
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: A Phase 2 Study - Clinical Trial Assessing Efficacy and Safety of the mTOR Inhibitor Sirolimus in the Treatment of Complicated Vascular Anomalies
The purpose of this study is to determine if the use of sirolimus in the treatment of children and young adults with complicated vascular anomalies will prove to be safe and provide objective response resulting in improved clinical status and quality of life.
Funding Source - FDA OOPD (Food and Drug Administration - Office of Orphan Products Development)
Read the detailed description
Patients with vascular anomalies (VA) have a spectrum of diseases that can be broadly classified into vascular tumors and malformations. Complicated vascular anomalies can cause disfigurement, chronic pain, and organ dysfunction with significant morbidity and mortality. Despite the severity of potential complications, we lack uniform guidelines for the treatment and response to treatment of children and young adults with these diseases. There are pre-clinical and clinical data supporting the essential regulatory function of the PI3K/Akt/mTOR pathway in vascular growth and organization, and suggest a therapeutic target for patients with complicated vascular anomalies. The overall goal of this trial is to objectively determine the effectiveness and safety of the mTOR inhibitor Rapamycin* in the treatment of children and young adults diagnosed with complicated vascular anomalies. We propose a Phase 2 trial with the diagnostic, therapeutic and response criteria experimentally determined in this study used as a framework for future Phase 3 clinical trials.
- Conditions
- Kaposiform Hemangioendotheliomas, Tufted Angioma, Capillary Venous Lymphatic Malformation, Venous Lymphatic Malformation, Microcystic Lymphatic Malformation, Mucocutaneous Lymphangiomatosis and Thrombocytopenia
- Being tested
- sirolimus
- Medical subject headings
- Tufted angioma, Lymphangioma, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sirolimusDrug
Also called Rapamune, rapamycin
liquid dosing based on trough levels
| Study group | Role | What they receive |
|---|---|---|
| Sirolimus | Experimental | Single arm using Sirolimus 0.8 mg/m2 per dose twice daily, Liquid form (1mg/ml) Length: 12 cycles of 28 day cycles Receives: Drug: sirolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response by Radiologic Evaluation, Quality of Life Assessment, and Functional Impairment Score
Measures were determined by 3 distinct methods: radiologic evaluation, functional impairment score (clinical measurement of disease), and health-related quality of life. (HRQOL). The most common radiologic evaluation was MRI but other studies including CT and X-rays were included. HRQOL was assessed using the Pediatric Quality of Life Inventory 4.0 (3-18 years) ad infant Scales (< or = to 2 years) and the Functional Assessment of Chronic Illness System (> 18 years). Third method was the functional impairment score which was adopted from the measure of organ function that have been validated in the quantification of adverse even results from medical therapies and procedures. Patients needed to have complete response, normalization in quality of life and functional impairment score to have a complete response. In order to have a partial response they needed to have improvement in all three areas of assessment and not worsening of any others.
Measured: 6 months
Overall Response by Radiologic Evaluation, Quality of Life Assessment, and Functional Impairment Score
Measures were determined by 3 distinct methods: radiologic evaluation, functional impairment score (clinical measurement of disease), and health-related quality of life. (HRQOL). The most common radiologic evaluation was MRI but other studies including CT and X-rays were included. HRQOL was assessed using the Pediatric Quality of Life Inventory 4.0 (3-18 years) ad infant Scales (< or = to 2 years) and the Functional Assessment of Chronic Illness System (> 18 years). Third method was the functional impairment score which was adopted from the measure of organ function that have been validated in the quantification of adverse even results from medical therapies and procedures. Patients needed to have complete response, normalization in quality of life and functional impairment score to have a complete response. In order to have a partial response they needed to have improvement in all three areas of assessment and not worsening of any others.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionMar 2014
- Study completionOct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kaposiform HemangioendotheliomasStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denise Martin Adams
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati
- Responsible party
- Sponsor-investigator, Denise Martin Adams, Boston Children's Hospital
- Investigators
- Denise M Adams, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00975819
- Sponsor's protocol ID
- SIR-DA-0901
- Other IDs
- 5R01FD003712-04
- Status last verified
- Dec 2025
- First submitted
- 10 Sep 2009
- Last updated
- 6 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ricci KW, Hammill AM, Mobberley-Schuman P, Nelson SC, Blatt J, Bender JLG, McCuaig CC, Synakiewicz A, Frieden IJ, Adams DM. Efficacy of systemic sirolimus in the treatment of generalized lymphatic anomaly and Gorham-Stout disease. Pediatr Blood Cancer. 2019 May;66(5):e27614. doi: 10.1002/pbc.27614. Epub 2019 Jan 22.
PubMed 30672136
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study - Clinical Trial Assessing Efficacy and Safety of the mTOR Inhibitor Sirolimus in the Treatment of Complicated Vascular Anomalies
- ClinicalTrials.gov ID
- NCT00975819
- Acronym / sponsor ID
- SIR-DA-0901
- Conditions
- Kaposiform Hemangioendotheliomas, Tufted Angioma, Capillary Venous Lymphatic Malformation, Venous Lymphatic Malformation, Microcystic Lymphatic Malformation, Mucocutaneous Lymphangiomatosis and Thrombocytopenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Denise Martin AdamsUniversity, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati
- Study start
- Oct 2009
- Primary completion
- Mar 2014 (actual)
- Study completion
- Oct 2020 (actual)
- First posted
- 11 Sep 2009 (estimated)
- Results
- Posted 6 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if the use of sirolimus in the treatment of children and young adults with complicated vascular anomalies will prove to be safe and provide objective response resulting in improved clinical status and quality of life.
Funding Source - FDA OOPD (Food and Drug Administration - Office of Orphan Products Development)
Detailed description
Patients with vascular anomalies (VA) have a spectrum of diseases that can be broadly classified into vascular tumors and malformations. Complicated vascular anomalies can cause disfigurement, chronic pain, and organ dysfunction with significant morbidity and mortality. Despite the severity of potential complications, we lack uniform guidelines for the treatment and response to treatment of children and young adults with these diseases. There are pre-clinical and clinical data supporting the essential regulatory function of the PI3K/Akt/mTOR pathway in vascular growth and organization, and suggest a therapeutic target for patients with complicated vascular anomalies. The overall goal of this trial is to objectively determine the effectiveness and safety of the mTOR inhibitor Rapamycin* in the treatment of children and young adults diagnosed with complicated vascular anomalies. We propose a Phase 2 trial with the diagnostic, therapeutic and response criteria experimentally determined in this study used as a framework for future Phase 3 clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sirolimus | Experimental | Drug: sirolimusSingle arm using Sirolimus 0.8 mg/m2 per dose twice daily, Liquid form (1mg/ml) Length: 12 cycles of 28 day cycles |
Who may qualify
- Ages
- Up to 31 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (72 listed)
- Inclusion will be strictly limited to children and young adults with vascular anomalies with complications that require systemic therapy for control.
- Diagnosis: All patients must have one of the following vascular anomalies as determined by clinical, radiographic and histologic criteria (when possible):
- Kaposiform Hemangioendotheliomas with Kasabach-Merritt Phenomenon
- Kaposiform Hemangioendotheliomas without Kasabach-Merritt Phenomenon
- Tufted Angioma with Kasabach-Merritt Phenomenon
Key exclusion criteria (11 listed)
- Dental braces or prosthesis only if it interferes with radiologic analysis of vascular anomaly.
- Concurrent severe and/or uncontrolled medical disease which could compromise participation in the study (e.g. uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, chronic liver or renal disease, active upper GI tract ulceration).
- Chronic treatment with systemic steroids or another immunosuppressive agent. Patients with endocrine deficiencies are allowed to receive physiologic or stress doses of steroids if necessary. Patients with the diagnosis of a vascular tumor (KHE, TA) can be on a weaning dose of steroids.
- Patients who require medications that inhibit/induce CYP3A4 enzyme activity to control concurrent medical conditions.
- Known history of HIV seropositivity or known immunodeficiency. Testing is not required unless a condition is suspected.
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 |
|---|---|---|
| sirolimusAlso: Rapamune, rapamycinliquid dosing based on trough levels | Drug | Sirolimus |
Primary outcome
Overall Response by Radiologic Evaluation, Quality of Life Assessment, and Functional Impairment Score
Time frame: 6 months
Measures were determined by 3 distinct methods: radiologic evaluation, functional impairment score (clinical measurement of disease), and health-related quality of life. (HRQOL). The most common radiologic evaluation was MRI but other studies including CT and X-rays were included. HRQOL was assessed using the Pediatric Quality of Life Inventory 4.0 (3-18 years) ad infant Scales (< or = to 2 years) and the Functional Assessment of Chronic Illness System (> 18 years). Third method was the functional impairment score which was adopted from the measure of organ function that have been validated in the quantification of adverse even results from medical therapies and procedures. Patients needed to have complete response, normalization in quality of life and functional impairment score to have a complete response. In order to have a partial response they needed to have improvement in all three areas of assessment and not worsening of any others.
Overall Response by Radiologic Evaluation, Quality of Life Assessment, and Functional Impairment Score
Time frame: 12 months
Measures were determined by 3 distinct methods: radiologic evaluation, functional impairment score (clinical measurement of disease), and health-related quality of life. (HRQOL). The most common radiologic evaluation was MRI but other studies including CT and X-rays were included. HRQOL was assessed using the Pediatric Quality of Life Inventory 4.0 (3-18 years) ad infant Scales (< or = to 2 years) and the Functional Assessment of Chronic Illness System (> 18 years). Third method was the functional impairment score which was adopted from the measure of organ function that have been validated in the quantification of adverse even results from medical therapies and procedures. Patients needed to have complete response, normalization in quality of life and functional impairment score to have a complete response. In order to have a partial response they needed to have improvement in all three areas of assessment and not worsening of any others.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30672136Ricci KW, Hammill AM, Mobberley-Schuman P, Nelson SC, Blatt J, Bender JLG, McCuaig CC, Synakiewicz A, Frieden IJ, Adams DM. Efficacy of systemic sirolimus in the treatment of generalized lymphatic anomaly and Gorham-Stout disease. Pediatr Blood Cancer. 2019 May;66(5):e27614. doi: 10.1002/pbc.27614. Epub 2019 Jan 22.
- National Organization of Vascular AnomaliesLink provided by the sponsor.
- Lymphangiomatosis \& Gorham's Disease AllianceLink provided by the sponsor.
Related trials for Kaposiform Hemangioendotheliomas
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RecruitingPhase 2/3
Low- vs High-Dose Sirolimus With Prednisolone for KHE and KMP
Kaposiform Hemangioendothelioma (KHE), Kasabach Merritt Phenomenon
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The Effect of Sirolimus on Immunizations During the Treatment of Kaposiform Hemangioendothelioma
Kaposiform Hemangioendothelioma
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Identification of Biomarkers for Patients with Vascular Anomalies
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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.
Denise M Adams, MD principal investigator
Children's Hospital Medical Center, Cincinnati
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sirolimus in people with Kaposiform Hemangioendotheliomas and Tufted Angioma, run by Denise Martin Adams at 2 sites in United States.
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 72 inclusion and 11 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: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 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?
Yes. Results are posted in the registry (first posted 6 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Response by Radiologic Evaluation, Quality of Life Assessment, and Functional Impairment Score (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT00975819, 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 6 Jan 2026.