RecruitingNCT02998710

Natural History Study of Homocystinuria Caused by Cystathionine Beta-Synthase Deficiency (ACAPPELLA)

A Multicenter, Observational, Prospective, Natural History Study of Homocystinuria Due to Cystathionine Beta-synthase Deficiency in Pediatric and Adult Patients (ACAPPELLA)


Sponsor

Travere Therapeutics, Inc.

Enrollment

150 participants

Start Date

Jan 1, 2017

Study Type

OBSERVATIONAL

Conditions

Summary

The purpose of the study is to characterize the clinical course of homocystinuria in pediatric and adult patients aged 1 to 65 years under current clinical management practices


Eligibility

Min Age: 1 YearMax Age: 65 Years

Inclusion Criteria4

  • Patients who are clinically diagnosed with homocystinuria
  • Male/female patients aged 1 to 65 years
  • Patients who consented and/or assented
  • Patients who are willing and able to comply with all study-related procedures.

Exclusion Criteria2

  • Medically significant postnatal complications or congenital anomalies that are not associated with homocystinuria
  • Received any experimental therapy for homocystinuria during the 6 months prior to enrollment or expected to receive any such therapy during duration of the study

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Locations(11)

Travere Investigational Site - Virtual Site

Culver City, California, United States

Travere Investigational Site (Enrolling 1 to <5 Year-olds Only)

Aurora, Colorado, United States

Travere Investigational Site (Enrolling 1 to <5 Year-olds Only)

Washington D.C., District of Columbia, United States

Travere Investigational Site

Atlanta, Georgia, United States

Travere Investigational Site

Indianapolis, Indiana, United States

Travere Investigational Site

Boston, Massachusetts, United States

Travere Investigational Site (Enrolling 1 to <5 Year-olds Only)

Philadelphia, Pennsylvania, United States

Travere Investigational Site

Dublin, Ireland

Travere Investigational Site

Doha, Qatar, Qatar

Travere Investigational Site

Doha, Qatar

Travere Investigational Site

Salford, Manchester, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT02998710