TerminatedNot Applicable

Oxidative Stress, Inflammation and Acute Decompensation in Urea Cycle Disorders

Stopped: DSMB suggested closure due to low enrollment

United States10 participantsStarted 2012-02

Plain-language summary

The primary purpose of the proposed study is to characterize the oxidative stress and inflammatory cytokine status in UCD during baseline and decompensated states.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Confirmed or highly-likely diagnosis of one of the eight UCDs as established for the Longitudinal Study (5101) (See section 4.2 Inclusion Criteria, Table 4 for diagnostic criteria for patients with UCD) * Enrolled in Longitudinal Study of Urea Cycle Disorders (RDCRN UCDC #5101) Exclusion Criteria: * UCD patients who have undergone orthotopic liver transplantation * Significant chronic medical co-morbidity that might confound the analysis as determined by the site investigators. * Significant co-morbidities include but are not limited to: * diabetes, liver failure + cirrhosis * renal failure * cardiac disease * chronic inflammatory diseases * asthma requiring daily long-term control medications * significant respiratory disease.

What they're measuring

Laboratory values indicating oxidative stress

Timeframe: Change from baseline to period of decompensation up to one year

Trial details

NCT IDNCT01541722

SponsorMark Batshaw

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2015-01

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