- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03087968
Evaluation of HepQuant SHUNT to Assess Liver Disease; Substudy Within GS-US-416-2124
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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
Type d'étude
Phase
- Première phase 1
Contacts et emplacements
Lieux d'étude
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California
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Coronado, California, États-Unis, 92118
- Southern California Research Center
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-
Florida
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Miami, Florida, États-Unis, 33136
- University of Miami
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Georgia
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Atlanta, Georgia, États-Unis, 30322
- Emory University
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-
Minnesota
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Minneapolis, Minnesota, États-Unis, 55455
- University of Minnesota
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Mississippi
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Jackson, Mississippi, États-Unis, 39216
- University of Mississippi Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19104
- University of Pennsylvania
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Texas
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Dallas, Texas, États-Unis, 75203
- The Liver Institute At Methodist Dallas Medical Center
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San Antonio, Texas, États-Unis, 78215
- American Research Corporation at the Texas Liver Institute
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Utah
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Murray, Utah, États-Unis, 84107
- Intermountain Medical Center
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Virginia
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Newport News, Virginia, États-Unis, 23602
- Liver Institute of Virginia
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Richmond, Virginia, États-Unis, 23226
- Liver Institute of Virginia
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Richmond, Virginia, États-Unis, 23298
- VCU Health System
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Washington
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Seattle, Washington, États-Unis, 98104
- University of Washington
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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.
Autres noms:
|
Comparateur placebo: Prednisolone + Placebo
Placebo + Prednisolone for 28 days HepQuant SHUNT Test |
Placebo
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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
To compare the change in (DSI ) Disease Severity Index between GS-4997 treatment and placebo arms
Délai: HepQuant Shunt testing will be done at baseline (Day1), Week 1, Week 4, Week 12, Week 24
|
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.
|
HepQuant Shunt testing will be done at baseline (Day1), Week 1, Week 4, Week 12, Week 24
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Secondary Outcome 1
Délai: HepQuant Shunt testing will be done at baseline (Day1), Week 1, Week 4, Week 12, Week 24
|
To determine the relationship of baseline Disease Severity Index (DSI) to mortality risk;
|
HepQuant Shunt testing will be done at baseline (Day1), Week 1, Week 4, Week 12, Week 24
|
Secondary Outcome 2
Délai: HepQuant Shunt testing will be done at baseline (Day1), Week 1, Week 4, Week 12, Week 24
|
To determine the relationship of change in Disease Severity Index (DSI) to mortality risk
|
HepQuant Shunt testing will be done at baseline (Day1), Week 1, Week 4, Week 12, Week 24
|
Secondary Outcome 3
Délai: HepQuant Shunt testing will be done at baseline (Day1), Week 1, Week 4, Week 12, Week 24
|
To correlate baseline Disease Severity Index (DSI) with baseline Maddrey, MELD, and Lille scorestest with the pharmacokinetics of GS-4997
|
HepQuant Shunt testing will be done at baseline (Day1), Week 1, Week 4, Week 12, Week 24
|
Secondary Outcome 4
Délai: HepQuant Shunt testing will be done at baseline (Day1), Week 1, Week 4, Week 12, Week 24
|
To determine the relationship between baseline Disease Severity Index (DSI), Maddrey, MELD, and Lille scores and mortality
|
HepQuant Shunt testing will be done at baseline (Day1), Week 1, Week 4, Week 12, Week 24
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Greg Everson, MD, HepQuant, LLC
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Troubles induits chimiquement
- Maladies du système digestif
- Troubles liés à l'alcool
- Troubles liés à une substance
- Hépatite
- Maladies du foie, alcoolique
- Troubles induits par l'alcool
- Maladies du foie
- Hépatite, Alcoolique
- Effets physiologiques des médicaments
- Agents anti-inflammatoires
- Agents antinéoplasiques
- Glucocorticoïdes
- Les hormones
- Hormones, substituts hormonaux et antagonistes hormonaux
- Agents antinéoplasiques, hormonaux
- Prednisolone
Autres numéros d'identification d'étude
- HepQuant-002-2124
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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