Development of a Patient-Reported Outcome Measure to Assess Symptoms in Patients With Primary Sclerosing Cholangitis (PSC)

Completed

Conditions studied: Primary Sclerosing Cholangitis

In brief

The objectives of this qualitative study are to elicit concepts about symptoms that are important to patients with primary sclerosing cholangitis (PSC), as well as the key impacts of symptoms on patients' day-to-day functioning.

Key facts

Study ID

NCT02247934

Run by

Gilead Sciences

People needed

26

Starts

2014-10-01

Expected to finish

2015-10-01

Last updated by the study team

2016-02-09

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed diagnosis of PSC based on liver biopsy or diagnostic imaging, with diagnosis made at least three months prior to screening
• Patient report of PSC symptoms associated with PSC diagnosis
• Able to speak, read, and understand English
• Willing and able to provide written informed consent to participate in the research study

You may not qualify if…

• Patients with other causes of liver or biliary disease, including viral hepatitis, alcoholic liver disease, primary biliary cirrhosis, and secondary sclerosing cholangitis
• Patient with history of liver cirrhosis
• Patients with history of cholangiocarcinoma
• Patients who have received a liver transplant
• Patients currently enrolled in PSC clinical trials; and
• STEP II ONLY: Enrolled in or participated in Step I of this study (concept elicitation)

Where it is running

• University of Colorado Hospital, Denver Health Medical Center — Aurora, Colorado, United States
• University of Miami Miller School of Medicine - Schiff Center for Liver Diseases — Miami, Florida, United States
• Evidera — Bethesda, Maryland, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Organ Care Research Swedish Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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