Primary Sclerosing Cholangitis Clinical Trial
Official title:
Development of a Patient-Reported Outcome Measure to Assess Symptoms in Patients With Primary Sclerosing Cholangitis (PSC)
Verified date | February 2016 |
Source | Gilead Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 26 |
Est. completion date | October 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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) |
Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Hospital, Denver Health Medical Center | Aurora | Colorado |
United States | Evidera | Bethesda | Maryland |
United States | Duke University Medical Center | Durham | North Carolina |
United States | University of Miami Miller School of Medicine - Schiff Center for Liver Diseases | Miami | Florida |
United States | Organ Care Research Swedish Medical Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Gilead Sciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | List Primary Sclerosing Cholangitis (PSC) Symptoms for inclusion in patient questionnaire | Interview participants to generate a list of the most common symptoms, as well as the most important symptoms, experienced by patients with PSC, and whether each symptom impacts day-to-day functioning. | Up to 12 months | No |
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