Outcomes in Liver Disease Patient With and Without HIV Co-infection-Sub Study 2: HCV Treatment: Health Related Quality
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
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
New York
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New York、New York、アメリカ、10029
- Icahn School of Medicine
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- Pregnant
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 観測モデル:ケースのみ
- 時間の展望:見込みのある
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Change in vitality score, Short form 36 (SF36)
時間枠:baseline and week 24
|
Change in vitality score at week 24 as compared to baseline
|
baseline and week 24
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Change in work productivity and activity impairment (WPAI) questionnaire
時間枠:baseline and week 24
|
Change in activity at week 24 as compared to baseline
|
baseline and week 24
|
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
時間枠:baseline and week 24
|
Change in function at week 24 as compared to baseline
|
baseline and week 24
|
Change in quality of life symptoms, Chronic Liver Disease Questionnaire-HCV (CLDQ-HCV)
時間枠:baseline and week 24
|
Change in quality of life symptoms at week 24 as compared to baseline
|
baseline and week 24
|
Change in Medication adherence survey
時間枠:baseline and week 24
|
Change in medication adherence at week 24 as compared to baseline
|
baseline and week 24
|
Change in Medication and co-morbidities questionnaire
時間枠:baseline and week 24
|
Change in medication and co-morbidities at week 24 as compared to baseline
|
baseline and week 24
|
Lost wages: Change in work ability
時間枠:baseline and week 24
|
Change in work ability at week 24 as compared to baseline
|
baseline and week 24
|
協力者と研究者
協力者
捜査官
- 主任研究者:Andrea D Branch, PhD、Icahn School of Medicine
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- GCO 14-1959
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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