CClinicalTrials.gg
CompletedNCT02247934Updated Feb 9, 2016

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

An observational study in Primary Sclerosing Cholangitis, sponsored by Gilead Sciences. Completed at 5 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-02-09.

Sponsored by Gilead Sciences · Observational

Study type
Observational
Time perspective
Cross-sectional
Enrollment
26
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Primary Sclerosing Cholangitis

Keywords

  • Primary sclerosing cholangitis
  • PSC
03

In context

Cholangitis

228 studies on the registry are indexed under Cholangitis; 32 are open to participants now.

This study's enrollment of 26 is below the median of 140 across 65 observational studies indexed under Cholangitis.

Browse Cholangitis studies →

Lead sponsor

Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
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.

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

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)
05

Study design

Time perspective
Cross-sectional
Enrollment
26 participants (actual)
Patient registry
No

Groups and cohorts

  • Concept elicitation interviews (Step I)

    Approximately 20 participants will be included.

  • Cognitive interviews (Step II)

    Approximately 30 participants will be included.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 12 months

07

Study locations

5 sites
  • University of Colorado Hospital, Denver Health Medical Center
    Aurora, Colorado 80045, United States
  • University of Miami Miller School of Medicine - Schiff Center for Liver Diseases
    Miami, Florida 33136, United States
  • Evidera
    Bethesda, Maryland 20814, United States
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
  • Organ Care Research Swedish Medical Center
    Seattle, Washington 98104, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02247934
Lead sponsor
Gilead Sciences
Responsible party
Sponsor
First posted
Sep 25, 2014
Start date
Oct 2014
Primary completion
Oct 2015
Completion
Oct 2015
Last update
Feb 9, 2016

Study contacts

Rob Myers, MD
study director · Gilead Sciences

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion