- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02247934
Development of a Patient-Reported Outcome Measure to Assess Symptoms in Patients With Primary Sclerosing Cholangitis (PSC)
February 8, 2016 updated by: Gilead Sciences
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.
Study Overview
Status
Completed
Conditions
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:
- Identify the most common symptoms, as well as the most important symptoms, for patients with PSC, and
- 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.
Study Type
Observational
Enrollment (Actual)
26
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado Hospital, Denver Health Medical Center
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Florida
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Miami, Florida, United States, 33136
- University of Miami Miller School of Medicine - Schiff Center for Liver Diseases
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Maryland
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Bethesda, Maryland, United States, 20814
- Evidera
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Washington
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Seattle, Washington, United States, 98104
- Organ Care Research Swedish Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants will be recruited from approximately 5 clinical sites based in the United States.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Concept elicitation interviews (Step I)
Approximately 20 participants will be included.
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Cognitive interviews (Step II)
Approximately 30 participants will be included.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
List Primary Sclerosing Cholangitis (PSC) Symptoms for inclusion in patient questionnaire
Time Frame: Up to 12 months
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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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Rob Myers, MD, Gilead Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
September 5, 2014
First Submitted That Met QC Criteria
September 23, 2014
First Posted (Estimate)
September 25, 2014
Study Record Updates
Last Update Posted (Estimate)
February 9, 2016
Last Update Submitted That Met QC Criteria
February 8, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A-13601-000
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Primary Sclerosing Cholangitis
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Medical University of WarsawNational Science Centre, PolandRecruitingPrimary Sclerosing Cholangitis (PSC)Poland
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Mayo ClinicActive, not recruiting
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Cascade Pharmaceuticals, IncCovanceCompletedPrimary Sclerosing Cholangitis (PSC)United States
-
HighTide Biopharma Pty LtdCompletedPrimary Sclerosing Cholangitis (PSC)United States, Canada
-
Intercept PharmaceuticalsCompletedPrimary Sclerosing Cholangitis (PSC)United States, Italy
-
Mirum Pharmaceuticals, Inc.CompletedPrimary Sclerosing Cholangitis (PSC)United States, United Kingdom, Canada
-
Mayo ClinicCompletedPrimary Sclerosing Cholangitis (PSC)United States
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Gilead SciencesCompletedPrimary Sclerosing Cholangitis (PSC)United States, Belgium, Canada, Germany, United Kingdom, Italy, Spain, Denmark, Netherlands, Sweden
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Brigham and Women's HospitalCompletedSclerosing CholangitisUnited States
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Boston Scientific CorporationCompletedPrimary Sclerosing Cholangitis (PSC)United States, Canada, Netherlands, Norway