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Trial record 3 of 92 for:    Primary Sclerosing Cholangitis

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

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ClinicalTrials.gov Identifier: NCT02247934
Recruitment Status : Completed
First Posted : September 25, 2014
Last Update Posted : February 9, 2016
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief 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.

Condition or disease
Primary Sclerosing Cholangitis

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.


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Study Type : Observational
Actual Enrollment : 26 participants
Time Perspective: Cross-Sectional
Official Title: Development of a Patient-Reported Outcome Measure to Assess Symptoms in Patients With Primary Sclerosing Cholangitis (PSC)
Study Start Date : October 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015


Group/Cohort
Concept elicitation interviews (Step I)
Approximately 20 participants will be included.
Cognitive interviews (Step II)
Approximately 30 participants will be included.



Primary Outcome Measures :
  1. List Primary Sclerosing Cholangitis (PSC) Symptoms for inclusion in patient questionnaire [ Time Frame: Up to 12 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be recruited from approximately 5 clinical sites based in the United States.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247934


Locations
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United States, Colorado
University of Colorado Hospital, Denver Health Medical Center
Aurora, Colorado, United States, 80045
United States, Florida
University of Miami Miller School of Medicine - Schiff Center for Liver Diseases
Miami, Florida, United States, 33136
United States, Maryland
Evidera
Bethesda, Maryland, United States, 20814
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Washington
Organ Care Research Swedish Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Rob Myers, MD Gilead Sciences

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02247934     History of Changes
Other Study ID Numbers: A-13601-000
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: February 9, 2016
Last Verified: February 2016
Keywords provided by Gilead Sciences:
Primary sclerosing cholangitis
PSC
Additional relevant MeSH terms:
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Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases