Evaluation of HepQuant SHUNT to Assess Liver Disease; Substudy Within GS-US-416-2124
調査の概要
詳細な説明
The main study is a Phase 2, double blind, proof-of-concept, randomized study evaluating the safety, tolerability, and biological activity of GS-4997 in combination with prednisolone, compared to prednisolone alone, in subjects with severe, histologically-confirmed AH.
This substudy uses the HepQuant SHUNT Liver Diagnostic test to assess severity of disease at baseline and to track disease progression or improvement over the 24 weeks of the study. The HepQuant SHUNT test will be performed at baseline (Day 1) and at Weeks 1, 2, 4, 12, and 24 regardless of treatment Arm.
GS-4997 Dose and Mode of Administration. Subjects will be randomized 1:1 to either:
- Treatment Group A: GS-4997 18 mg (1 x 18 mg tablet) AND prednisolone 40 mg (4 x 10 mg tablets), both administered orally once daily
- Treatment Group B: GS-4997 placebo (1 tablet) AND prednisolone 40 mg (4 x 10 mg tablets), both administered orally once daily
研究の種類
段階
- 初期フェーズ 1
連絡先と場所
研究場所
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California
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Coronado、California、アメリカ、92118
- Southern California Research Center
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Florida
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Miami、Florida、アメリカ、33136
- University of Miami
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Georgia
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Atlanta、Georgia、アメリカ、30322
- Emory University
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Minnesota
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Minneapolis、Minnesota、アメリカ、55455
- University of Minnesota
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Mississippi
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Jackson、Mississippi、アメリカ、39216
- University of Mississippi Medical Center
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- University of Pennsylvania
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Texas
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Dallas、Texas、アメリカ、75203
- The Liver Institute at Methodist Dallas Medical Center
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San Antonio、Texas、アメリカ、78215
- American Research Corporation at the Texas Liver Institute
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Utah
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Murray、Utah、アメリカ、84107
- Intermountain Medical Center
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Virginia
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Newport News、Virginia、アメリカ、23602
- Liver Institute of Virginia
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Richmond、Virginia、アメリカ、23226
- Liver Institute of Virginia
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Richmond、Virginia、アメリカ、23298
- VCU Health System
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Washington
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Seattle、Washington、アメリカ、98104
- University of Washington
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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
説明
Inclusion Criteria:
- Willing and able to give informed consent prior to any study specific procedures being performed. In individuals with hepatic encephalopathy (HE) which may impair decision-making, consent will be obtained per hospital procedures (eg, by Legally Authorized Representative)
- Clinical diagnosis of severe AH
- Maddrey's DF ≥ 32 at screening
Exclusion Criteria:
Key Exclusion Criteria:
- Pregnant or lactating females;
- Other causes of liver disease including chronic hepatitis B (hepatitis B surface antigen [HBsAg] positive), chronic hepatitis C (HCV RNA positive), acetaminophen hepatotoxicity, biliary obstruction, and autoimmune liver disease;
- Serum AST >400 U/L or ALT >300 U/L;
- MELD >30 at screening;
- Maddrey's DF >60 at screening;
- Grade 4 Hepatic Encephalopathy (HE) by West Haven criteria;
- Concomitant or previous history of hepatocellular carcinoma;
- History of liver transplantation;
- HIV Ab positive;
- Clinical suspicion of pneumonia;
- Uncontrolled sepsis;
- Uncontrolled gastrointestinal (GI) bleeding or controlled GI bleeding within 7 days of screening that was associated with shock or required transfusion of more than 3 units of blood;
- Type 1 hepatorenal syndrome (HRS) or renal failure defined as a serum creatinine >221 μmol/L (>2.5 mg/dL) or the requirement for renal replacement therapy;
- Individuals dependent on inotropic (eg, epinephrine or norepinephrine) or ventilatory support (ie, endotracheal intubation or positive-pressure ventilation);
- Portal vein thrombosis;
- Acute pancreatitis;
- Cessation of alcohol consumption for more than 2 months before Baseline/ Day 1 NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
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
- 主な目的：診断
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：GS-4997 + Prednisolone
GS-4997 + Prednisolone for 28 days HepQuant SHUNT Test |
Experimental drug
Control drug that is also administered with the Experimental drug, GS-4997.
This drug is used in both arms.
The HepQuant SHUNT Liver Diagnostic Kit is intended for use in the quantitative detection of 13C-cholate and d4-cholate in blood serum, collected after the intravenous administration of 13C-cholate and the oral ingestion of d4-cholate. The device is indicated to assess the severity of liver disease. For use by health care professionals. Administer the test under a physician's supervision. The HepQuant Analytical Testing Laboratory must analyze the serum samples.
他の名前：
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プラセボコンパレーター：Prednisolone + Placebo
Placebo + Prednisolone for 28 days HepQuant SHUNT Test |
プラセボ
Control drug that is also administered with the Experimental drug, GS-4997.
This drug is used in both arms.
The HepQuant SHUNT Liver Diagnostic Kit is intended for use in the quantitative detection of 13C-cholate and d4-cholate in blood serum, collected after the intravenous administration of 13C-cholate and the oral ingestion of d4-cholate. The device is indicated to assess the severity of liver disease. For use by health care professionals. Administer the test under a physician's supervision. The HepQuant Analytical Testing Laboratory must analyze the serum samples.
他の名前：
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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 |
|---|---|---|
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To compare the change in (DSI ) Disease Severity Index between GS-4997 treatment and placebo arms
時間枠：HepQuant Shunt testing will be done at baseline (Day1), Week 1, Week 4, Week 12, Week 24
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Using the SHUNT DSI to evaluate the liver, this outcome will compare the two arms to determine if SHUNT DSI is able to measure a change between the experimental and control groups.
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HepQuant Shunt testing will be done at baseline (Day1), Week 1, Week 4, Week 12, Week 24
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Secondary Outcome 1
時間枠：HepQuant Shunt testing will be done at baseline (Day1), Week 1, Week 4, Week 12, Week 24
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To determine the relationship of baseline Disease Severity Index (DSI) to mortality risk;
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HepQuant Shunt testing will be done at baseline (Day1), Week 1, Week 4, Week 12, Week 24
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Secondary Outcome 2
時間枠：HepQuant Shunt testing will be done at baseline (Day1), Week 1, Week 4, Week 12, Week 24
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To determine the relationship of change in Disease Severity Index (DSI) to mortality risk
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HepQuant Shunt testing will be done at baseline (Day1), Week 1, Week 4, Week 12, Week 24
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Secondary Outcome 3
時間枠：HepQuant Shunt testing will be done at baseline (Day1), Week 1, Week 4, Week 12, Week 24
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To correlate baseline Disease Severity Index (DSI) with baseline Maddrey, MELD, and Lille scorestest with the pharmacokinetics of GS-4997
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HepQuant Shunt testing will be done at baseline (Day1), Week 1, Week 4, Week 12, Week 24
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Secondary Outcome 4
時間枠：HepQuant Shunt testing will be done at baseline (Day1), Week 1, Week 4, Week 12, Week 24
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To determine the relationship between baseline Disease Severity Index (DSI), Maddrey, MELD, and Lille scores and mortality
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HepQuant Shunt testing will be done at baseline (Day1), Week 1, Week 4, Week 12, Week 24
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Greg Everson, MD、HepQuant, LLC
研究記録日
主要日程の研究
研究開始 (予想される)
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 (実際)
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
- HepQuant-002-2124
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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