Outcomes in Liver Disease Patient With and Without HIV Co-infection-Sub Study 2: HCV Treatment: Health Related Quality

Completed

Conditions studied: Hepatitis C Infection

In brief

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.

Key facts

Study ID

NCT02427204

Run by

Icahn School of Medicine at Mount Sinai

People needed

150

Starts

2015-06-01

Expected to finish

2018-01-18

Last updated by the study team

2019-02-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Icahn School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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