Status:
RECRUITING
Clinical Trial to Compare the Efficacy of Celiprolol to Placebo in Patients With Vascular Ehlers-Danlos Syndrome
Lead Sponsor:
Acer Therapeutics Inc.
Conditions:
Vascular Ehlers-Danlos Syndrome
Eligibility:
All Genders
15-64 years
Phase:
PHASE3
Brief Summary
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 clini...
Detailed Description
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 clini...
Eligibility Criteria
Inclusion
- Willingness to obtain magnetic resonance angiogram (MRA) image at local imaging facility.
- A genetic test confirming the presence of a pathogenic COL3A1 variant (classified as likely pathogenic or pathogenic according to ACMG/AMP Guidelines.
- Patients must be ≥ 15 years of age at the time of randomization.
- Able and willing to discontinue use of β-blockers prior to randomization.
Exclusion
- Lack of a COL3A1-positive test at screening (e.g., COL3A1 benign, likely benign, variant of unknown significance \[VUS\] or no variant) or presence of a COL3A1 variant but demonstration of a COL3A1 variant reported to be a haploinsufficiency variant.
- Arterial rupture or dissection, uterine rupture, and/or intestinal rupture within 6 months prior to Screening.
- Patients unable to discontinue β-blocker treatment prior to randomization.
- Unable or unwilling to complete the study procedures.
- Breastfeeding, pregnancy, or planned pregnancy during the trial.
- Any medical condition that in the opinion of the Investigator may pose a safety risk to the patient in this study, which may confound efficacy or safety assessment, or may interfere with study participation.
- Use of any prohibited medications
Key Trial Info
Start Date :
November 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2029
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05432466
Start Date
November 7 2022
End Date
April 1 2029
Last Update
August 24 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Science 37
Culver City, California, United States, 90230