TerminatedNot Applicable

Oxidative Stress, Inflammation and Acute Decompensation in Urea Cycle Disorders

Stopped: DSMB suggested closure due to low enrollment

United States, Canada10 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

Sex

ALL

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Urea Cycle Disorders trials

Who can participate

Sex

ALL

See this in plain English?

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