NCT02247934

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 26 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 patients' day-to-day functioning.

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 well as the most important symptoms, for patients with PSC, and 2. Assess whether these symptoms impact day-to-day functioning An instrument will be developed based on the symptoms reported and in Step II of the study, the performance of the instrument will be assessed with further interviews.

Conditions

• Primary Sclerosing Cholangitis

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2014-09-25
• Last updated: 2016-02-09

Locations

5 sites across 1 country: United States