Clinical trials: Chronic Hepatic
Chronic Liver Disease, Thrombocytopenia
Safety and Efficacy Study of Lusutrombopag for Thrombocytopenia in Patients With Chronic Liver Disease Undergoing Elective Invasive Procedures
The primary purpose of this study is to compare the efficacy of lusutrombopag with placebo for the treatment of thrombocytopenia in patients with chronic liver disease who are undergoing elective invasive procedures.
- Trial name
- L-PLUS 2 (NCT02389621)
- Testing
- Lusutrombopag
- Volunteers
- 215 people
- Sponsor
- Shionogi
Hepatic Failure, Hepatic Impairment
Single Dose Pharmacokinetics of Suboxone Study in Hepatic Impaired Subjects
The objective was to determine if hepatitis C virus (HCV) infection or mild to severe hepatic impairment (Child-Pugh Classes A, B, and C) altered the PK of buprenorphine, norbuprenorphine, or naloxone.
- Conditions
- Hepatic Failure, Hepatic Impairment, Chronic Hepatitis C Infection With Hepatic Coma
- Trial name
- NCT01846455
- Testing
- 2.0mg Buprenorphine/0.5mg Naloxone, Promethazine
- Where
- 3 sites in United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Indivior Inc.
Hepatitis C, Chronic
A Study of the Pharmacokinetics of Uprifosbuvir (MK-3682) and Ruzasvir (MK-8408) in Participants With Moderate and Severe Hepatic Insufficiency (MK-3682-029)
This is a non-randomized, open-label, single-dose study to evaluate the pharmacokinetics (PK) of uprifosbuvir (MK-3682), the M5 and M6 metabolites of uprifosbuvir, and ruzasvir (MK-8408), in participants with moderate hepatic…
- Trial name
- NCT02666352
- Testing
- Uprifosbuvir, Ruzasvir
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Thrombocytopenia Related to Chronic Liver Disease
Once-Daily Oral Avatrombopag Tablets Used in Subjects With Chronic Liver Diseases and Thrombocytopenia Prior to Elective Surgical or Diagnostic Procedures
The purpose of this study is to evaluate the efficacy of once-daily Oral avatrombopagin subjects with chronic liver diseases and thrombocytopenia prior to elective surgical or diagnostic procedures, to evaluate the safety of…
- Trial name
- NCT00914927
- Testing
- Avatrombopag
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- Eisai Inc.
Hepatitis C, Chronic
BI 207127 / Faldaprevir Combination Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b Chronic Hepatitis C Infection: HCVerso3
To assess the pharmacokenetic characteristics of 600 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of GT1b HCV infected patients with mild hepatic impairment (CPA) (Arm 1) versus 400 mg BID BI 207127 / 120…
- Trial name
- NCT01830127
- Testing
- Ribavirin, BI 207127 high dose, Faldaprevir
- Where
- 19 sites in United States, Germany and 2 more
- Volunteers
- 35 people
- Sponsor
- Boehringer Ingelheim
Acute-On-Chronic Liver Failure
Short-term Survival of Subjects With Acute-on-chronic Liver Failure After Plasma Exchange With Human Serum Albumin 5%
This is a Phase 3, multicenter, randomized, controlled, parallel-group, open-label study to evaluate the effects of plasma exchange using human serum albumin 5% (PE-A 5%) in acute-on-chronic liver failure (ACLF) subjects.
- Trial name
- APACHE (NCT03702920)
- Testing
- SMT + PE-A 5%, Standard Medical Treatment
- Where
- 30 sites in United States, Austria and 7 more
- Volunteers
- 274 people
- Sponsor
- Instituto Grifols, S.A.
Chronic Hepatitis C Virus, Hepatitis C, Chronic
A Phase 2, Safety and Efficacy of Bemnifosbuvir (BEM) and Ruzasvir (RZR) in Subjects With Chronic HCV
This is an open-label trial to evaluate safety and efficacy of treatment with BEM + RZR in subjects with chronic HCV infection.
- Conditions
- Chronic Hepatitis C Virus, Hepatitis C, Chronic, Hepatitis C, Hepatic Cirrhosis
- Trial name
- NCT05904470
- Testing
- Bemnifosbuvir, Ruzasvir
- Where
- 51 sites in United States, Brazil and 10 more
- Volunteers
- 275 people
- Sponsor
- Atea Pharmaceuticals, Inc.
Chronic Liver Disease
Prediction Value of the BreathID 13C-Methacetin Breath Test for Hepatic Decompensation
The objectives of this study are: To evaluate the ability of the Methacetin Breath Test (MBT) to detect hepatic decompensation events To evaluate the relationship between liver Biopsy and clinical outcome and show that the MBT…
- Trial name
- NCT02084160
- Where
- 4 sites in United States, Israel
- Volunteers
- 579 people
- Sponsor
- Meridian Bioscience, Inc.
Chronic Liver Disease
BreathID 13C-Methacetin Breath Test for Detecting Cirrhosis
This trial is a pivotal trial to validate the use of a 13 C labeled substrate called methacetin and the BreathID automatic breath testing system, for determination of cirrhosis in patients with chronic liver disease.
- Trial name
- MBT (NCT00736840)
- Testing
- c13 methacetin solution with breath analyzer
- Where
- 11 sites in United States, Israel
- Volunteers
- 414 people
- Sponsor
- Meridian Bioscience, Inc.
Non-alcoholic Steatohepatitis, Chronic Liver Disease
Eltrombopag To Reduce The Need For Platelet Transfusion In Subjects With Chronic Liver Disease And Thrombocytopenia Undergoing Elective Invasive Procedures
The purpose of this study is to assess the ability of eltrombopag to elevate platelet counts thereby reducing the need for platelet transfusions in chronic liver disease patients with thrombocytopenia undergoing elective invasive…
- Conditions
- Non-alcoholic Steatohepatitis, Chronic Liver Disease, HCV, NASH - Nonalcoholic Steatohepatitis
- Trial name
- ELEVATE (NCT00678587)
- Testing
- Eltrombopag
- Where
- 107 sites in United States, Argentina and 11 more
- Volunteers
- 292 people
- Sponsor
- GlaxoSmithKline
Chronic Hepatic Impairment
A Study to Assess Pharmacokinetics of Preladenant in Participants With Chronic Hepatic Impairment (P06513)
The purpose of this study is to compare the pharmacokinetics (PK) of preladenant after administration of a single 5 mg oral dose of preladenant in participants with hepatic impairment and healthy volunteers.
- Trial name
- NCT01465412
- Testing
- Preladenant
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Thrombocytopenia Associated With Chronic Liver Disease
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Once-daily Oral Avatrombopag in Japanese Subjects With Chronic Liver Diseases and Thrombocytopenia
This is a phase 2, randomized, double-blind, placebo-controlled, parallel group study using avatrombopag for Japanese subjects with thrombocytopenia associated with chronic liver disease.
- Trial name
- NCT02227693
- Testing
- avatrombopag
- Where
- 14 sites in Japan
- Volunteers
- 39 people
- Sponsor
- Eisai Co., Ltd.
Acute-On-Chronic Liver Failure, Ascites
Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT)®
A Phase 2, multi-center, randomized, controlled, open-label study to evaluate the effects of the intraperitoneal, liposomal formulation VS-01 in patients with an acute episode of hepatic and/or extrahepatic organ dysfunctions and…
- Trial name
- NCT05900050
- Testing
- VS-01 on top of SOC, SOC (Control Group)
- Where
- 26 sites in United States, Belgium and 5 more
- Volunteers
- 15 people
- Sponsor
- Genfit
Chronic Liver Disease
The SHUNT-V Study for Varices
The purpose of this study is to validate the Disease Severity Index (DSI) from the HepQuant SHUNT Liver Diagnostic Kit (Test) for likelihood of large esophageal varices.
- Trial name
- NCT03583996
- Testing
- HepQuant SHUNT Liver Diagnostic Test
- Where
- 26 sites in United States
- Volunteers
- 306 people
- Sponsor
- HepQuant, LLC
Cirrhosis, Liver
Antifibrotic Activity Of GI262570 In Chronic Hepatitis C Subjects
The purpose of this study is to examine the safety and effectiveness of GI262570 compared to placebo (a pill that looks exactly like GI262570 but contains no active medicine) in improving specific tests that indicate the degree…
- Trial name
- NCT00244751
- Testing
- GI262570 0.5 mg, GI262570 1.0 mg
- Where
- 121 sites in United States, Australia and 12 more
- Volunteers
- 265 people
- Sponsor
- GlaxoSmithKline
Hepatic Impairment
Pharmacokinetics, Safety and Tolerability of ITF2357 in Participants With Chronic Hepatic Impairment and With Normal Hepatic Function
This was a multicentric, open-label, non-randomized study to evaluate the pharmacokinetic, safety and tolerability of ITF2357 in participants with chronic hepatic impairment relative to matched participants with normal hepatic…
- Trial name
- NCT06736223
- Testing
- ITF2357
- Where
- 3 sites in Bulgaria, France
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Italfarmaco
Chronic Hepatitis C, Liver Fibrosis
Prevention of Disease Progress in Chronic Hepatitis C Patients With Liver Fibrosis (Study P02570AM2)(COMPLETED)
The objective of the study is to evaluate the safety and efficacy of PEG-Intron versus no treatment for the prevention of fibrosis progression in adult participants with moderate to severe liver fibrosis secondary to chronic…
- Trial name
- NCT00049842
- Testing
- peginterferon alfa-2b (SCH 54031)
- Volunteers
- 540 people
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Liver Disease, HepatoCellular Carcinoma
Proof of Concept Study Concerning Efficacy of P03277 MR Imaging in HCC Diagnosis
This study is an exploratory study aiming to collect data about diagnosis efficacy (sensitivity and specificity) of P03277 triphasic liver imaging for HCC in subjects with suspected small nodules and chronic liver disease.
- Trial name
- NCT02973516
- Testing
- P03277 at 0.1 mmol/kg, P03277 at 0.05 mmol/kg
- Where
- 2 sites in France
- Volunteers
- 41 people
- Sponsor
- Guerbet
Liver Diseases
Phase 2, Pharmacokinetics Study of Eltrombopag in Japanese Thrombocytopenic Subjects With Chronic Liver Disease
This is an open label, multi-centre, dose ranging study to assess efficacy, safety and pharmacokinetics of eltrombopag in thrombocytopenic subjects with chronic liver disease.
- Trial name
- NCT00861601
- Testing
- eltrombopag 12.5 milligrams (mg) tablet, eltrombopag 25 mg tablet
- Where
- 10 sites in Japan
- Volunteers
- 38 people
- Sponsor
- GlaxoSmithKline
Hepatitis B
Comparison of Entecavir to Adefovir in Chronic Hepatitis B Virus (HBV) Patients With Hepatic Decompensation
This is a phase IIIb comparative study of entecavir 1.0 mg once daily (QD) vs. adefovir 10 mg QD in patients who have chronic hepatitis B infection and hepatic decompensation.
- Trial name
- NCT00065507
- Testing
- Entecavir (ETV), Adefovir (ADV)
- Where
- 61 sites in United States, Brazil and 15 more
- Volunteers
- 195 people
- Sponsor
- Bristol-Myers Squibb