Trial · NCT05324384
Different Doses of Sirolimus for the Maintenance Treatment of Kaposiform Hemangioendothelioma
NCT05324384, Phase 2, Unknown, West China Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Different Doses of Sirolimus for the Maintenance Treatment of Kaposiform Hemangioendothelioma. Trials, record NCT05324384. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05324384
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Different Doses of Sirolimus for the Maintenance Treatment of Kaposiform Hemangioendothelioma
- NCT number
- NCT05324384
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 30 participants, estimated
- Lead sponsor
- West China Hospital
- Conditions
- Hemangioendothelioma
- Interventions
- Sirolimus
- First posted
- 2022-04-12
- Last updated
- 2024-01-24
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The changes in KHE volume | 12 months. | Response to therapy was measured by volumetric magnetic resonance imaging (MRI) analyses were performed at baseline and 6 and 12 months after treatment and were independently assessed by 2 radiologists. Changes in KHE size were classified as further growth (increase of ≥10%), no change (\<10% increase and \<10% decrease), partial involution (decrease of ≥10% and \<75%), nearly complete involution (decrease of ≥75% and \<100%), or complete involution (100%). |
| Secondary | Quality of life (QOL) in patients | Baseline, 6 months, 12 months. | Pediatric Quality of Life Inventory (PedsQLTM) 4.0 Genetic Core Infant Scales (\<2 years) or Pediatric Quality of Life Inventory (PedsQLTM) 4.0 Genetic Core Scales (2-18 years) were used. |
| Secondary | Frequency of adverse events | Baseline, 6 months, 12 months. | Frequency of adverse events (e.g. gastrointestinal disorders, blood and lymphatic system disorders, metabolic disorders or other abnormal laboratory results, skin disorders and general disorders, etc.) collected by investigator and reported by parents. All adverse events were collected and graded according to Common Terminology Criteria for Adverse Events, version 4.0 (CTCAE v4.0). The causality of the adverse event was determined by the multidisciplinary staff and was classified as definitively not related, probably not related, possibly related, probably related, or definitively related. Any dose reductions, interruptions, or cessations enacted at the discretion of the investigators were recorded. |
| Secondary | The changes in the patient's musculoskeletal complication. | Baseline, 3 monthss, 6 months, 9 months, 12 months. | The severity of musculoskeletal complication was scored by using a 4-point scale: 1, asymptomatic or mild symptoms, clinical or diagnostic observations only; 2, moderate symptoms, limiting age-appropriate instrumental activities of daily living; 3, severe or medically significant symptoms, disabling or limiting self-care activities of daily living; and 4, life-threatening consequences, with urgent intervention indicated. |
| Secondary | The changes of platelet counts. | Baseline, 3 monthss, 6 months, 9 months, 12 months. | Platelet counts |
| Secondary | The changes of fibrinogen levels. | Baseline, 3 monthss, 6 months, 9 months, 12 months. | Fibrinogen levels |
| Secondary | The changes of D-dimer levels. | Baseline, 3 monthss, 6 months, 9 months, 12 months. | D-dimer levels |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05324384
GET https://conductscience.org/api/trials/v1/NCT05324384/registered