Evaluation of HepQuant SHUNT to Assess Liver Disease; Substudy Within GS-US-416-2124
연구 개요
상세 설명
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
연구 유형
단계
- 초기 1단계
연락처 및 위치
연구 장소
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California
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Coronado, California, 미국, 92118
- Southern California Research Center
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Florida
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Miami, Florida, 미국, 33136
- University of Miami
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Georgia
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Atlanta, Georgia, 미국, 30322
- Emory University
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Minnesota
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Minneapolis, Minnesota, 미국, 55455
- University of Minnesota
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Mississippi
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Jackson, Mississippi, 미국, 39216
- University of Mississippi Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- UNIVERSITY of PENNSYLVANIA
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Texas
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Dallas, Texas, 미국, 75203
- The Liver Institute at Methodist Dallas Medical Center
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San Antonio, Texas, 미국, 78215
- American Research Corporation at the Texas Liver Institute
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Utah
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Murray, Utah, 미국, 84107
- Intermountain Medical Center
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Virginia
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Newport News, Virginia, 미국, 23602
- Liver Institute of Virginia
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Richmond, Virginia, 미국, 23226
- Liver Institute of Virginia
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Richmond, Virginia, 미국, 23298
- VCU Health System
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Washington
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Seattle, Washington, 미국, 98104
- University of Washington
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
다른 이름들:
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위약 비교기: Prednisolone + Placebo
Placebo + Prednisolone for 28 days HepQuant SHUNT Test |
위약
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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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To compare the change in (DSI ) Disease Severity Index between GS-4997 treatment and placebo arms
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Secondary Outcome 1
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Greg Everson, MD, HepQuant, LLC
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- HepQuant-002-2124
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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