Outcomes in Liver Disease Patient With and Without HIV Co-infection-Sub Study 2: HCV Treatment: Health Related Quality
1 other identifier
observational
150
1 country
1
Brief Summary
The main questions being addressed are (1) how patient reported outcomes change during treatment for HCV, (2) how treatment impacts liver function and liver status, and (3) how much treatment costs from the payer's perspective and the patient's perspective. The hypothesis being tested is that treatment has a negative effect on the quality of life during treatment. The negative effect is expected to be temporary. Successful treatment, which is equated with a virological cure of the infection, is expected to result in an improvement in quality of life compared to baseline and to improvement in markers of liver function and liver status. Costs of treatment are expected to be $80,000-$200,000 per virological cure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2015
CompletedFirst Posted
Study publicly available on registry
April 27, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 18, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 18, 2018
CompletedFebruary 26, 2019
February 1, 2019
2.6 years
April 22, 2015
February 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in vitality score, Short form 36 (SF36)
Change in vitality score at week 24 as compared to baseline
baseline and week 24
Secondary Outcomes (6)
Change in work productivity and activity impairment (WPAI) questionnaire
baseline and week 24
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
baseline and week 24
Change in quality of life symptoms, Chronic Liver Disease Questionnaire-HCV (CLDQ-HCV)
baseline and week 24
Change in Medication adherence survey
baseline and week 24
Change in Medication and co-morbidities questionnaire
baseline and week 24
- +1 more secondary outcomes
Eligibility Criteria
Patients initiating treatment for HCV infection are the source of potential subjects.
You may qualify if:
- Adult
- Positive test for HCV RNA and planning to start HCV treatment soon
- Able to travel to Mount Sinai
- Must understand and speak English
- Planning to initiate treatment for HCV infection in the near future
- Willing to sign informed consent and participate
You may not qualify if:
- Pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Icahn School of Medicine at Mount Sinailead
- Gilead Sciencescollaborator
Study Sites (1)
Icahn School of Medicine
New York, New York, 10029, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea D Branch, PhD
Icahn School of Medicine
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2015
First Posted
April 27, 2015
Study Start
June 1, 2015
Primary Completion
January 18, 2018
Study Completion
January 18, 2018
Last Updated
February 26, 2019
Record last verified: 2019-02