Status:
COMPLETED
Development of a Patient-Reported Outcome Measure to Assess Symptoms in Patients With Primary Sclerosing Cholangitis (PSC)
Lead Sponsor:
Gilead Sciences
Conditions:
Primary Sclerosing Cholangitis
Eligibility:
All Genders
18-70 years
Brief Summary
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 patie...
Detailed Description
In Step I, concept elicitation one-on-one interviews (via telephone or in person) will be conducted. The aims of the concept elicitation interviews are to: 1. Identify the most common symptoms, as we...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT02247934
Start Date
October 1 2014
End Date
October 1 2015
Last Update
February 9 2016
Active Locations (5)
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1
University of Colorado Hospital, Denver Health Medical Center
Aurora, Colorado, United States, 80045
2
University of Miami Miller School of Medicine - Schiff Center for Liver Diseases
Miami, Florida, United States, 33136
3
Evidera
Bethesda, Maryland, United States, 20814
4
Duke University Medical Center
Durham, North Carolina, United States, 27710