Actively Recruiting

Phase 3
Age: 15Years - 64Years
All Genders
NCT05432466

Clinical Trial to Compare the Efficacy of Celiprolol to Placebo in Patients With Vascular Ehlers-Danlos Syndrome

Led by Acer Therapeutics Inc. · Updated on 2025-08-24

150

Participants Needed

1

Research Sites

333 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a prospective, Phase 3, randomized, double-blind, placebo-controlled efficacy study to evaluate celiprolol in patients genetically confirmed as COL3A1-positive vEDS using a decentralized clinical trial design.

CONDITIONS

Official Title

Clinical Trial to Compare the Efficacy of Celiprolol to Placebo in Patients With Vascular Ehlers-Danlos Syndrome

Who Can Participate

Age: 15Years - 64Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Willingness to obtain magnetic resonance angiogram (MRA) image at a local imaging facility
  • Genetic test confirming presence of a pathogenic COL3A1 variant classified as likely pathogenic or pathogenic
  • Age 15 years or older at the time of randomization
  • Able and willing to discontinue use of beta-blockers before randomization
Not Eligible

You will not qualify if you...

  • No confirmed COL3A1 pathogenic variant or presence of a COL3A1 haploinsufficiency variant
  • Arterial rupture, dissection, uterine rupture, or intestinal rupture within 6 months before screening
  • Unable to stop beta-blocker treatment before randomization
  • Unable or unwilling to complete study procedures
  • Breastfeeding, pregnancy, or planned pregnancy during the trial
  • Any medical condition posing safety risks or interfering with study participation as judged by the Investigator
  • Use of any prohibited medications

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Science 37

Culver City, California, United States, 90230

Actively Recruiting

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Research Team

S

Sheila Woodhouse, MD; Ph.D.

CONTACT

J

Jonathan Cotliar, MD; Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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