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NCT04598204

Efficacy and Safety of Rapamycin to Complex Vascular Anomalies in Pediatric Patients

Status unknown Phase 2, PHASE3 Last updated 10 November 2021
What this trial tests

Phase 2, PHASE3 trial testing Treatment with oral rapmycin in Vascular Anomalies in 30 participants. Status unknown.

Timeline
1 December 2017
Primary endpoint
1 December 2022
1 December 2022

Quick facts

Lead sponsorZhujiang Hospital
PhasePhase 2, PHASE3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment30
Start date1 December 2017
Primary completion1 December 2022
Estimated completion1 December 2022
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Zhujiang Hospital

Who can join

Adults 1 Month to 14, any sex, with Vascular Anomalies. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

KHE and TA are rare tumors and some of the cases may lead to life-threatening complications including Kasabach-Merritt Phenomenon. Typically treated with steroids and vincristine, a majority of the cases do not have good prognosis. Complex vascular malformations are always managed by surgery,sclerotherapy and embolization therapy. While many of the cases still lead to complications such as disfigurement, chronic pain, recurrent infections, coagulopathies. Different medical centers are exploring new therapy for these tough problems. This study is plotted to determine the efficacy and safety of rapamycin monotherapy in KHE/TA and complex vascular malformations in pediatric patients.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A review of mechanisms of disease across PIK3CA-related disorders with vascular manifestations.
    Canaud G, Hammill AM, Adams D, Vikkula M, et al · · 2021 · cited 122× · PMID 34238334 · DOI 10.1186/s13023-021-01929-8

Verify or expand the search:

Other recruiting trials for Vascular Anomalies

Currently open trials in the same condition.

Other Zhujiang Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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