RecruitingPhase 3NCT05432466
Clinical Trial to Compare the Efficacy of Celiprolol to Placebo in Patients With Vascular Ehlers-Danlos Syndrome
A Phase 3 Randomized, Double-Blind, Decentralized Clinical Trial to Compare the Efficacy of Celiprolol to Placebo in the Treatment of Patients With COL3A1-Positive Vascular Ehlers-Danlos Syndrome
Sponsor
Acer Therapeutics Inc.
Enrollment
150 participants
Start Date
Nov 7, 2022
Study Type
INTERVENTIONAL
Conditions
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 clinical trial design.
Eligibility
Min Age: 15 YearsMax Age: 64 Years
Inclusion Criteria4
- 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 Criteria7
- 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
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Interventions
DRUGACER-002 (celiprolol) 200 mg BID
ACER-002 (celiprolol) 200 mg BID
DRUGPlacebo BID
placebo for ACER-002
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05432466