- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03087968
Evaluation of HepQuant SHUNT to Assess Liver Disease; Substudy Within GS-US-416-2124
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Studietype
Fase
- Tidlig fase 1
Kontakter og plasseringer
Studiesteder
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California
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Coronado, California, Forente stater, 92118
- Southern California Research Center
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-
Florida
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Miami, Florida, Forente stater, 33136
- University of Miami
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Georgia
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Atlanta, Georgia, Forente stater, 30322
- Emory University
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55455
- University of Minnesota
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Mississippi
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Jackson, Mississippi, Forente stater, 39216
- University of Mississippi Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
- University of Pennsylvania
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Texas
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Dallas, Texas, Forente stater, 75203
- The Liver Institute At Methodist Dallas Medical Center
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San Antonio, Texas, Forente stater, 78215
- American Research Corporation at the Texas Liver Institute
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Utah
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Murray, Utah, Forente stater, 84107
- Intermountain Medical Center
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Virginia
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Newport News, Virginia, Forente stater, 23602
- Liver Institute of Virginia
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Richmond, Virginia, Forente stater, 23226
- Liver Institute of Virginia
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Richmond, Virginia, Forente stater, 23298
- VCU Health System
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Washington
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Seattle, Washington, Forente stater, 98104
- University of Washington
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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.
Andre navn:
|
Placebo komparator: 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.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
To compare the change in (DSI ) Disease Severity Index between GS-4997 treatment and placebo arms
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Secondary Outcome 1
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Greg Everson, MD, HepQuant, LLC
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Kjemisk-induserte lidelser
- Sykdommer i fordøyelsessystemet
- Alkoholrelaterte lidelser
- Stoffrelaterte lidelser
- Hepatitt
- Leversykdommer, alkoholholdig
- Alkohol-induserte lidelser
- Leversykdommer
- Hepatitt, alkoholiker
- Fysiologiske effekter av legemidler
- Anti-inflammatoriske midler
- Antineoplastiske midler
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Antineoplastiske midler, hormonelle
- Prednisolon
Andre studie-ID-numre
- HepQuant-002-2124
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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