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Observational Study That Will Collect Information on Patients With Urea Cycle Disorders (UCDs)

Information source: Horizon Pharma Ireland, Ltd., Dublin Ireland
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Urea Cycle Disorder

Phase: N/A

Status: Recruiting

Sponsored by: Horizon Pharma Ireland, Ltd., Dublin Ireland

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

Summary

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.

Clinical Details

Official title: Long-Term Registry of Patients With Urea Cycle Disorders (UCDs)

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Assessment of UCD specific disease characteristics

Detailed description: 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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

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

United BioSource Corporation, Blue Bell, Pennsylvania 19422, United States; Recruiting
THRIVE Registry Team, Phone: 855-823-2595, Email: thriveregistry@unitedbiosource.com
Additional Information

THRIVE Registry Website

Starting date: September 2013
Last updated: June 8, 2015

Page last updated: August 23, 2015

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