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

Primary Sclerosing Cholangitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02247934
• Other study ID #: A-13601-000
• Status: Completed
• Phase: N/A
• First received: September 5, 2014
• Last updated: February 8, 2016
• Start date: October 2014
• Est. completion date: October 2015

Study information

• Verified date: February 2016
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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)

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cholangitis
• Cholangitis, Sclerosing
• Primary Sclerosing Cholangitis

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

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