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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02247934
Other study ID # A-13601-000
Secondary ID
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


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
See also
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