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NCT04861064 · ClinicalTrials.gov registry record · Phase 2

Weekly Sirolimus Therapy

A Phase 2 study of Lymphatic Malformation and Venous Malformation, sponsored by Medical University of South Carolina.

Recruiting
Registry status
Phase 2
Development phase
24
Enrollment target
1
Study location

NCT04861064: Recruiting Phase 2 study of Lymphatic Malformation and Venous Malformation, sponsored by Medical University of South Carolina.

NCT04861064 is a Phase 2 study of Lymphatic Malformation and Venous Malformation that is actively recruiting participants, run by Medical University of South Carolina. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04861064, a Phase 2 study of Lymphatic Malformation and Venous Malformation, is actively recruiting participants, sponsored by Medical University of South Carolina.

RECRUITING
Registry status
Phase 2
Development phase
24 participants
Enrollment target
1
Study location

Study Summary

In current practice, options for venous and lymphatic malformations remain limited. Recently an oral medication, sirolimus, has been found to benefit patients when taken once or twice a day for several months. Unfortunately there are many side effects associated with this medication, some of which can be severe including, neutropenia, oral ulcerations, and lab abnormalities. The purpose of this study is to determine if once weekly dosed sirolimus will be effective for the treatment of venous and lymphatic malformations. Additionally, the study will evaluate patient satisfaction and identify adverse effects. Participants will be on the medication for 6 months with an option to continue after this time period.

Primary Outcome

Will be measuring the size of the lesions (mm) at each patient visit

Interventions

  • DRUG Sirolimus

Study Locations (1)

South Carolina

  • Medical University of South Carolina - Charleston

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2022-01-18
Est. Completion 2027-12
Phase Phase 2

What NCT04861064 shows while recruiting

NCT04861064 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).

The record links to 2 conditions, with Lymphatic Malformation appearing as the primary indexed condition, and to 1 intervention - of which Sirolimus is the first listed.

NCT04861064 reports a single indexed study location in South Carolina.

Frequently Asked Questions

What is clinical trial NCT04861064 about?

NCT04861064 is a clinical study titled "Weekly Sirolimus Therapy". In current practice, options for venous and lymphatic malformations remain limited. Recently an oral medication, sirolimus, has been found to benefit patients when taken once or twice a day for several months. Unfortunately there are many side effects associated with this medication, some of which c...

What is the current status of trial NCT04861064?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2022-01-18. Estimated completion is 2027-12.

What conditions does trial NCT04861064 study?

This clinical trial studies the following conditions: Lymphatic Malformation, Venous Malformation.

What interventions are being tested in trial NCT04861064?

The interventions under investigation include: Sirolimus (DRUG).

Who is sponsoring clinical trial NCT04861064?

This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04861064 being conducted?

This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Lymphatic Malformation

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04861064's enrollment target sits among peer trials

24 1756th of 2000 higher than 218 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04861064, the US trial registry maintained by the National Library of Medicine. NCT04861064 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.