RECRUITING

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

Talk to us

Conditions

Vascular Ehlers-Danlos Syndrome

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 clinical trial design.

Official Title

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

Quick Facts

Study Start:2022-11-07
Study Completion:2029-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05432466

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:15 Years to 64 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Willingness to obtain magnetic resonance angiogram (MRA) image at local imaging facility.
  2. 2. A genetic test confirming the presence of a pathogenic COL3A1 variant (classified as likely pathogenic or pathogenic according to ACMG/AMP Guidelines.
  3. 3. Patients must be ≥ 15 years of age at the time of randomization.
  4. 4. Able and willing to discontinue use of β-blockers prior to randomization.
  1. 1. 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.
  2. 2. Arterial rupture or dissection, uterine rupture, and/or intestinal rupture within 6 months prior to Screening.
  3. 3. Patients unable to discontinue β-blocker treatment prior to randomization.
  4. 4. Unable or unwilling to complete the study procedures.
  5. 5. Breastfeeding, pregnancy, or planned pregnancy during the trial.
  6. 6. 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.
  7. 7. Use of any prohibited medications

Contacts and Locations

Study Contact

Sheila Woodhouse, MD; Ph.D.
CONTACT
984-377-3737
sheila.woodhouse@science37.com
Jonathan Cotliar, MD; Ph.D.
CONTACT
984-377-3737
jonathan@science37.com

Study Locations (Sites)

Science 37
Culver City, California, 90230
United States

Collaborators and Investigators

Sponsor: Acer Therapeutics Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-07
Study Completion Date2029-04-01

Study Record Updates

Study Start Date2022-11-07
Study Completion Date2029-04-01

Terms related to this study

Additional Relevant MeSH Terms

  • Vascular Ehlers-Danlos Syndrome