Clinical trials: Hepatic Disease
HBV, Chronic HBV Infection
Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Negative Hepatitis B (China)
The primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with hepatitis…
- Trial name
- NCT02836236
- Testing
- TAF, TDF
- Where
- 29 sites in China
- Volunteers
- 155 people
- Sponsor
- Gilead Sciences
Hepatitis C, Chronic
Efficacy and Safety of 24 vs 48 Weeks of Pegetron® (Peginterferon Alfa-2b + Ribavirin) in Naïve Genotype 1 Hepatitis C (Study P05016)(TERMINATED)
This is a Phase IIIB randomized, controlled, multi-centre, open-label study of 24 versus 48 weeks therapy with Pegetron® (peginterferon alfa-2b + ribavirin) at standard doses in naïve Hepatitis C Virus (HCV) genotype 1 high viral…
- Trial name
- NCT00423800
- Testing
- Combination of pegylated interferon alfa-2b (PEG) and ribavirin (RBV)
- Volunteers
- 56 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis, Hepatitis C, Chronic
PEG-Intron Plus Rebetol Treatment of Chronic Hepatitis C Subjects Who Failed Response to Alpha-Interferon Plus Ribavirin (Study P02370)
The objective of this study is to determine the effectiveness of PEG-Intron 1.5 ug/kg/wk plus REBETOL (ribavirin) 800-1400 mg/day in adults with chronic hepatitis C with moderate to severe liver fibrosis or cirrhosis who failed…
- Conditions
- Hepatitis, Hepatitis C, Chronic, Fibrosis, Liver Cirrhosis
- Trial name
- NCT00039871
- Testing
- PegIntron (peginterferon alfa-2b; SCH 54031), REBETOL (ribavirin; SCH 18908)
- Volunteers
- 2,333 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C, Chronic
Efficacy of Peginterferon Alfa-2b (SCH 054031) vs Glycyrrhizin in Interferon (IFN)-Treated Patients With Chronic Hepatitis C and F2/F3 Liver Fibrosis (P04773)
The objective of this study is to compare the efficacy of peginterferon alfa-2b (PegIFN-2b) monotherapy administered at a dose of 0.5 ug/kg vs stronger neo minophagen C (SNMC) in participants with chronic hepatitis C (CHC) and…
- Trial name
- NCT00686881
- Testing
- Peginterferon alfa-2b (PegIFN-2b), Comparator: Stronger neo minophagen C (SNMC)
- Volunteers
- 261 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatic Insufficiency
The Influence of Hepatic Insufficiency on the Pharmacokinetics of Elbasvir (MK-8742) (MK-8742-009)
The purpose of this study is to evaluate the pharmacokinetics (PK) profile of elbasvir (MK-8742) after a single dose to participants with mild, moderate, or severe hepatic insufficiency compared with healthy controls.
- Trial name
- NCT01797536
- Testing
- Elbasvir
- Where
- 2 sites in United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hypercholesterolemia
Pharmacokinetic and Tolerability of Alirocumab SAR236553 (REGN727) in Patients With Hepatic Impairment and in Healthy Subjects
Primary Objective: Study the effect of mild or moderate hepatic impairment on the pharmacokinetics of alirocumab SAR236553 (REGN727).
- Trial name
- NCT01670734
- Testing
- alirocumab SAR236553 (REGN727)
- Where
- 2 sites in France, Moldova
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Sanofi
Liver Neoplasms
TheraSphere Japan Pre-Market Study
To investigate the safety and effectiveness of BSJ019T in Japanese patients with primary or secondary liver who are not candidate for standard treatment.
- Trial name
- INDIGO (NCT07377487)
- Testing
- TheraSphere Y-90 glass microsphere
- Where
- 5 sites in Japan
- Volunteers
- 51 people
- Sponsor
- Boston Scientific Corporation
Chronic Liver Disease
Study to Evaluate Efficacy, Safety and Tolerability of PENNEL Capsule in the Patients With Chronic Liver Disease
The test agent in this study is a product of biphenylmethyl dicarboxylate (BDD) with garlic oil. The two components were confirmed to have complementary effects because of different operational mechanism in animal experiments…
- Trial name
- NCT01393665
- Testing
- PENNEL capsule
- Where
- 2 sites in South Korea
- Volunteers
- 88 people
- Sponsor
- PharmaKing
Chronic Hepatitis B, Hepatitis B, Chronic
Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 1)
This study is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and the durability of hepatitis B virus surface antigen (HBsAg) suppression observed with bepirovirsen for 24 weeks (with loading doses) as…
- Trial name
- NCT05630807
- Testing
- Bepirovirsen
- Where
- 177 sites in United States, Argentina and 24 more
- Volunteers
- 981 people
- Sponsor
- GlaxoSmithKline
Primary Liver Cancer, SCLC
A Multicenter Phase I Study of MRX34, MicroRNA miR-RX34 Liposomal Injection
This is a study to evaluate the safety of MRX34 in patients with primary liver cancer or other selected solid tumors or hematologic malignancies. The drug is given intravenously, for 5 days in a row and then two weeks off.
- Conditions
- Primary Liver Cancer, SCLC, Lymphoma, Melanoma
- Trial name
- NCT01829971
- Testing
- MRX34
- Where
- 10 sites in United States, South Korea
- Volunteers
- 155 people
- Sponsor
- Mirna Therapeutics, Inc.
Chronic Hepatitis B
Phase 1b/2a Study of ABI-H0731 in Patients With Chronic Hepatitis B
The purpose of this protocol is to obtain pharmacodynamic and pharmacokinetic data on ABI-H0731 and to provide the opportunity for preliminary evaluation of combination therapy of ABI-H0731 with currently approved antiviral…
- Trial name
- NCT03109730
- Testing
- ABI-H0731, Entecavir, Tenofovir Disoproxil Fumarate
- Where
- 14 sites in Australia, Hong Kong and 3 more
- Volunteers
- 38 people
- Sponsor
- Assembly Biosciences
Hepatitis C Virus
A Study to Examine Patient Characteristics, Health Care Management and Health Outcomes of Hepatitis C Virus (HCV) Patients Treated With Simeprevir
The purpose of this study is to evaluate the effectiveness of a simeprevir-containing hepatitis C virus (HCV) treatment regimen as measured by sustained virologic response (SVR).
- Trial name
- NCT02103699
- Testing
- No intervention
- Where
- 32 sites in United States
- Volunteers
- 315 people
- Sponsor
- Janssen Scientific Affairs, LLC
Hepatitis C
Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Grazoprevir (MK-5172-013)
This study will compare the pharmacokinetics (PK) of grazoprevir (MK-5172) when administered to participants with mild, moderate or severe hepatic insufficiency (assessed by the criteria of the Child-Pugh's scale) with the PK of…
- Trial name
- NCT01390428
- Testing
- Grazoprevir
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hepatocellular Carcinoma
Dual TORC1/TORC2 Inhibitor ATG-008 (CC-223) in HBV Positive Advanced Hepatocellular Carcinoma (HCC) Subjects
This is an Asian multi-regional clinical trial (MRCT) in which ATG-008 will be administered orally to hepatitis B positive (HBV+) HCC subjects who have received at least one prior line of systemic therapy.
- Trial name
- NCT03591965
- Testing
- ATG-008
- Where
- 30 sites in China, South Korea and 1 more
- Volunteers
- 73 people
- Sponsor
- Antengene Therapeutics Limited
Hepatocellular Carcinoma, Metastatic Cancer
Holmium-166 Retrospective Collection of Real-World Data
The primary objective of the study is to further describe the general safety and clinical performance of QuiremSpheresTM Holmium-166 Microspheres and QuiremScoutTM Holmium-166 Microspheres in a real-world post-market setting…
- Trial name
- RECORD (NCT05111795)
- Testing
- Selective Internal Radiation Therapy with QuiremSpheresTM Holmium-166 Microspheres
- Where
- 12 sites in Belgium, Germany and 5 more
- Volunteers
- 146 people
- Sponsor
- Terumo Europe N.V.
Chronic Hepatitis C, Hepatitis C
Study of AT-527 in Healthy and HCV-Infected Subjects
This study has multiple parts. It will assess the safety, tolerability and pharmacokinetics (PK) of AT-527 in healthy subjects and subjects infected with hepatitis C virus (HCV).
- Conditions
- Chronic Hepatitis C, Hepatitis C, Hepatitis C, Chronic
- Trial name
- NCT03219957
- Testing
- AT-527
- Where
- 2 sites in Belgium, Moldova
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Atea Pharmaceuticals, Inc.
Advanced Hepatocellular Carcinoma
Evaluation of the Efficacy of Long-acting Release Octreotide in Patients With Advanced Hepatocellular Carcinoma
Hepatocellular carcinoma (HCC) is one of the most common malignant disease worldwide with an increasing incidence in industrialized countries. For patients with advanced HCC no efficient treatment is currently available.
- Trial name
- NCT00241020
- Testing
- Octreotide
- Volunteers
- 270 people
- Sponsor
- Novartis Pharmaceuticals
Carcinoma, Hepatocellular, Metastatic Colorectal Cancer
Vandetanib-eluting Radiopaque Embolic Beads in Patients With Resectable Liver Malignancies
This is a pilot, open label single arm phase 0 window of opportunity study of vandetanib-eluting radiopaque beads in patients with resectable liver malignancies.
- Trial name
- VEROnA (NCT03291379)
- Testing
- BTG-002814
- Where
- United Kingdom
- Volunteers
- 8 people
- Sponsor
- Boston Scientific Corporation
HCV Infection
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
A multicenter prospective study to evaluate the clinical performance, usability, and contrived result interpretation of the INSTI® HCV Antibody Test (INSTI HCV) with fingerstick (FS) whole blood specimens from participants with…
- Trial name
- NCT07904403
- Testing
- INSTI HCV Antibody Test
- Volunteers
- 1,660 people, healthy volunteers welcome
- Sponsor
- bioLytical Laboratories
Pruritus
Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis
This phase 2 trial will evaluate the effects of EP547 in subjects with cholestatic pruritus due to Primary Biliary Cholangitis (PBC) or Primary Sclerosing Cholangitis (PSC)
- Trial name
- PACIFIC (NCT05525520)
- Testing
- EP547
- Where
- 52 sites in United States, Belgium and 6 more
- Volunteers
- 62 people
- Sponsor
- Escient Pharmaceuticals, Inc
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