Hepatitis C InfectionNCT02427204
Outcomes in Liver Disease Patient With and Without HIV Co-infection-Sub Study 2: HCV Treatment: Health Related Quality
An observational study of Hepatitis C Infection, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C Infection
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 18 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients initiating treatment for HCV infection are the source of potential subjects.
Who may be able to join
- 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
Who cannot join
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes in Liver Disease Patient With and Without HIV Co-infection-Sub Study 2: HCV Treatment: Health Related Quality of Life, Fatigue, Work Productivity, Liver Status and Cost-per-SVR/Health Care Utilization
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.
Read the detailed description
The objectives of the study are to collect information about patient reported outcomes before, during, and after treatment for hepatitis C virus infection, to determine the impact of treatment on liver function and stiffness (an indicator of inflammation and fibrosis), and to determine the cost of treatment.
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.
The purpose of the study is to give patients and providers information about what to expect while undergoing treatment for HCV and to provide information for future cost-effectiveness studies. Previous studies of liver biopsy and transient elastography demonstrate that liver scarring regresses in a significant percentage of patients who achieve an SVR; however, the majority of patients who had liver cirrhosis at the time they achieved an SVR continued to have portal hepatitis and high levels of alpha smooth muscle actin ( D'Ambrosio R, et al., Hepatology, 2012). Particularly because interferon is known to cause autoimmune disease, it is possible that some residual liver abnormalities are due to interferon exposure. If this is the case, liver abnormalities may regress more rapidly and completely in patients receiving interferon-free regimens. Currently, there are no real-world data about the impact of new regimens on liver status as measured by transient elastography. This project will fill an important gap by providing information about changes in liver stiffness in patients receiving the newest therapies for HCV.
- Conditions
- Hepatitis C Infection
- Keywords
- Hepatitis C infection, Hepatitis C treatment
- Medical subject headings
- Hepatitis C
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vitality score, Short form 36 (SF36)
Change in vitality score at week 24 as compared to baseline
Measured: baseline and week 24
Secondary outcomes (6)
Change in work productivity and activity impairment (WPAI) questionnaire
Change in activity at week 24 as compared to baseline
Measured: baseline and week 24
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Change in function at week 24 as compared to baseline
Measured: baseline and week 24
Change in quality of life symptoms, Chronic Liver Disease Questionnaire-HCV (CLDQ-HCV)
Change in quality of life symptoms at week 24 as compared to baseline
Measured: baseline and week 24
Change in Medication adherence survey
Change in medication adherence at week 24 as compared to baseline
Measured: baseline and week 24
Change in Medication and co-morbidities questionnaire
Change in medication and co-morbidities at week 24 as compared to baseline
Measured: baseline and week 24
Lost wages: Change in work ability
Change in work ability at week 24 as compared to baseline
Measured: baseline and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2015 (estimated)
- Study startJun 2015
- Primary completion18 Jan 2018
- Study completion18 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C InfectionStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Andrea D Branch, PhD, Principal investigator, Icahn School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427204
- Sponsor's protocol ID
- GCO 14-1959
- Status last verified
- Feb 2019
- First submitted
- 22 Apr 2015
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes in Liver Disease Patient With and Without HIV Co-infection-Sub Study 2: HCV Treatment: Health Related Quality of Life, Fatigue, Work Productivity, Liver Status and Cost-per-SVR/Health Care Utilization
- ClinicalTrials.gov ID
- NCT02427204
- Acronym / sponsor ID
- GCO 14-1959
- Conditions
- Hepatitis C Infection
- Keywords
- Hepatitis C infection, Hepatitis C treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- Jun 2015
- Primary completion
- 18 Jan 2018 (actual)
- Study completion
- 18 Jan 2018 (actual)
- First posted
- 27 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objectives of the study are to collect information about patient reported outcomes before, during, and after treatment for hepatitis C virus infection, to determine the impact of treatment on liver function and stiffness (an indicator of inflammation and fibrosis), and to determine the cost of treatment.
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.
The purpose of the study is to give patients and providers information about what to expect while undergoing treatment for HCV and to provide information for future cost-effectiveness studies. Previous studies of liver biopsy and transient elastography demonstrate that liver scarring regresses in a significant percentage of patients who achieve an SVR; however, the majority of patients who had liver cirrhosis at the time they achieved an SVR continued to have portal hepatitis and high levels of alpha smooth muscle actin ( D'Ambrosio R, et al., Hepatology, 2012). Particularly because interferon is known to cause autoimmune disease, it is possible that some residual liver abnormalities are due to interferon exposure. If this is the case, liver abnormalities may regress more rapidly and completely in patients receiving interferon-free regimens. Currently, there are no real-world data about the impact of new regimens on liver status as measured by transient elastography. This project will fill an important gap by providing information about changes in liver stiffness in patients receiving the newest therapies for HCV.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients initiating treatment for HCV infection are the source of potential subjects.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in vitality score, Short form 36 (SF36)
Time frame: baseline and week 24
Change in vitality score at week 24 as compared to baseline
6 secondary outcomes
Change in work productivity and activity impairment (WPAI) questionnaire
Time frame: baseline and week 24
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Time frame: baseline and week 24
Change in quality of life symptoms, Chronic Liver Disease Questionnaire-HCV (CLDQ-HCV)
Time frame: baseline and week 24
Change in Medication adherence survey
Time frame: baseline and week 24
Change in Medication and co-morbidities questionnaire
Time frame: baseline and week 24
Lost wages: Change in work ability
Time frame: baseline and week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea D Branch, PhD principal investigator
Icahn School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C Infection, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in vitality score, Short form 36 (SF36) (time frame: baseline and week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.