Trial · NCT02638389
Efficacy and Safety of Sirolimus in Vascular Anomalies That Are Refractory to Standard Care
NCT02638389, Phase 3, Recruiting, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Sirolimus in Vascular Anomalies That Are Refractory to Standard Care. Trials, record NCT02638389. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02638389
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Sirolimus in Vascular Anomalies That Are Refractory to Standard Care
- NCT number
- NCT02638389
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 250 participants, estimated
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Conditions
- Vascular Malformations
- Interventions
- Sirolimus
- First posted
- 2015-12-23
- Last updated
- 2023-02-24
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Self-assesment (or parent assesment), using visual anagogic scale (0-10) of efficacy of sirolimus | every 3 months, up to 2-year period. | * Global treatment efficacy * Pain * Local complications/symptoms (bleeding, skin tension, esthetic and functional impairment) |
| Secondary | Number of enrolled patients with treatment-related adverse events as assessed by CTCAE v4.0 | every month during the first three months and then every three months for a 2-year-treatment period | |
| Secondary | Self assessment of quality of life change induced by sirolimus | every 3 months, up to 2-year period. | Measured by quality of life questionnaire (adapted to MOS SF-36 survey). |
| Secondary | Volumetric changes of the malformation on sirolimus, based on magnetic resonance imaging (MRI) 12 months after sirolimus onset. | At 12 month | Relative change of volume of the vascular malformation between the baseline MRI (before sirolimus onset) and the 12-month MRI (during sirolimus treatment) |
| Secondary | Efficacy of sirolimus | every three months, up to 2-year period | Change in plasma levels fibrinogen and/ or D-dimers, reflecting improvement in an abnormal intravascular coagulation consumption |
| Secondary | Efficacy of sirolimus measured on digital photographs | every three months, up to 2-year period | Qualitative assessment of efficacy on 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.
Papers3
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/NCT02638389
GET https://conductscience.org/api/trials/v1/NCT02638389/registered