Trial · NCT04598204
Efficacy and Safety of Rapamycin to Complex Vascular Anomalies in Pediatric Patients
NCT04598204, Phase 2, Phase 3, Unknown, Zhujiang Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Rapamycin to Complex Vascular Anomalies in Pediatric Patients. Trials, record NCT04598204. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04598204
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Rapamycin to Complex Vascular Anomalies in Pediatric Patients
- NCT number
- NCT04598204
- Status
- Unknown
- Phases
- Phase 2, Phase 3
- Enrollment
- 30 participants, estimated
- Lead sponsor
- Zhujiang Hospital
- Conditions
- Vascular Anomalies
- Interventions
- Treatment with oral rapmycin
- First posted
- 2020-10-22
- Last updated
- 2021-11-10
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Volumetric changes in complicated vascular anomalies after rapamycin treatment | Baseline,and every 6 months until half a year after the finish of rapamycin treatment | Response to rapamycin treatment was measured by volumetric magnetic resonance imaging (MRI) and/or ultrasonography analyses. Changes in size of vascular anomalies were classified as further growth (increase of ≥20%), no change (\<20% increase and \<20% decrease),and involution (decrease of ≥20%). |
| Primary | Time of clinical lab indexes to be improved and stable | at least weekly before a improved and stable state is reached,assessed up to 8 weeks | For cases complicated with Kasabach-Merritt Phenomenon, clinical lab indexes including blood platelet and fibrinogen are followed up at least weekly before a improved and stable state is reached. Time (days) from the onset of treatment till these indexes to be improved and stable is calculated. Improved hematologic parameters are defined as a platelet count greater than 50,000/uL (or a 2 times increase in platelet count compared to baseline) and a fibrinogen level greater than 100mg/dl. |
| Primary | Occurrence of adverse reactions | From the date of trial until the date of first documented progression or date of lost to follow-up,till half a year after finish of treatment. | Record the time, degree and outcome of adverse reactions according to Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0. |
| Secondary | Trough concentration of rapamycin in plasma | 5 days after the onset of rapamycin or after the adjustment of drug doses;every 3 three months during the therapy if the concentration result is in the optimal target range during the treatment,assessed up to 100 months. | Trough concentration of rapamycin in plasma is monitored and according to which the dosage is adjusted，thus is part of the efficacy evaluation. |
| Secondary | Evolution of clinical situation and the quality of life | Baselin,3,6,12months,and till half an year after finish of treatment | Evolution of clinical situation and the quality of life is judged by the proxies of patients by describing clinical symptoms and by recording and viewing standardized digital photographs. |
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23796341 | RESULT |
Source PubMed
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/NCT04598204
GET https://conductscience.org/api/trials/v1/NCT04598204/registered