Blue Bell, Pennsylvania 19422


Purpose:

THRIVE is an observational study that will collect information on patients with UCDs. THRIVE will follow enrolled participants for up to 10 years. As an observational study, enrolled patients will not be required to make any additional office visits or take any medicine outside of normal care.


Study summary:

UCDs disproportionately affect children and females: depending on the severity of the defect, a UCD can manifest shortly after birth or later in life. This study will track long-term outcomes in UCD patients and effects of ammonia-scavenging agents on neuropsychological functions of UCD patients. This is a non-interventional, multi-center registry to be conducted in patients with UCDs. Investigators will prescribe treatments based on usual clinical practice, and there will be no restrictions on the use of commercially available medications. As an observational study, this study will not change the patient/ healthcare provider relationship, nor influence the healthcare provider's drug prescription or the therapeutic management of the patient. Patients with UCDs will be recruited and invited to attend a Baseline visit. After eligible patients are enrolled, retrospective and baseline data will be collected. Patients will be followed for up to 10 years, during which time they will be assessed by their healthcare provider. Patients and healthcare provider will be asked to report episodes of hyperammonemic crisis, available ammonia values, and other information.


Criteria:

Inclusion Criteria: - Confirmed or suspected diagnosis of UCD - Signed informed consent/Health Insurance Portability and Accountability Act (HIPAA) Authorization and medical records release Exclusion Criteria: - Any other reason that, in the Investigator's opinion, makes the patient unsuitable to participate in this study.


NCT ID:

NCT01948427


Primary Contact:

United Biosource Corporation
Phone: 855-UCD-2595
Email: thriveregistry@unitedbiosource.com


Backup Contact:

N/A


Location Contact:

Blue Bell, Pennsylvania 19422
United States

THRIVE Registry Team
Phone: 855-823-2595
Email: thriveregistry@unitedbiosource.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 20, 2017

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