Clinical trials: Hepatic Disease
Chronic Hepatitis C
A Study to Assess the Relative Bioavailability Three New Formulations of Telaprevir in Healthy Subjects
The purpose of this study is to evaluate the relative bioavailability, safety, and tolerability of 3 new formulations of telaprevir relative to the Incivek 375-mg tablets.
- Trial name
- NCT01511432
- Testing
- telaprevir formulation A, telaprevir Formulation B, telaprevir Formulation C
- Where
- 2 sites in United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
HepatoCellular Carcinoma, Liver Cancer
Autologous Immune Killer Cells to Treat Liver Cancer Patients as an Adjunct Therapy
The purpose of this study is to evaluate the efficacy of ex vivo expanded autologous immune killer cells in treating hepatocellular carcinoma patients in： 1. Reduction of tumor size 2.
- Trial name
- NCT03592706
- Testing
- IKC (Immune Killer Cells), TACE (Transcatheter Arterial Chemoembolization)
- Where
- Taiwan
- Volunteers
- 60 people
- Sponsor
- Ivy Life Sciences, Co., Ltd
Alpha1-Antitrypsin Deficiency
Long-term Safety of Alpha1-Proteinase Inhibitor (Human) in Japanese Subjects With Alpha1 Antitrypsin Deficiency (GTI1401-OLE)
This is a multi-center, open-label study to evaluate the long-term safety of weekly intravenous (IV) infusions of 60 mg/kg alpha1-PI (human), modified process (Alpha-1 MP) in adult participants with Alpha1 Antitrypsin Deficiency…
- Trial name
- NCT02870348
- Testing
- Alpha-1 MP
- Where
- 3 sites in Japan
- Volunteers
- 4 people
- Sponsor
- Grifols Therapeutics LLC
Hepatitis A
Comparison of Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines in Young Adults
A phase IV, randomization, single center, controlled clinical trial to compare the safety, immunogenicity,three-year immune persistence of inactivated hepatitis A vaccine (HAV) with one- or two-dose regimen and live attenuated…
- Trial name
- NCT01865968
- Testing
- Inactivated HAV vaccine, Live attenuated HAV vaccine
- Where
- China
- Volunteers
- 239 people, healthy volunteers welcome
- Sponsor
- Sinovac Biotech Co., Ltd
Hepatitis B
Safety and Antiviral Activity Study of Clevudine 30 mg QD in Patients With HBeAg(-) Chronic HBV
The purpose of this study is to determine safety and efficacy of 30mg daily dose of clevudine (L-FMAU) at 24 weeks of treatment in chronic HBV infected patients with HBeAg negative
- Trial name
- NCT00313274
- Testing
- Clevudine
- Where
- 30 sites in South Korea
- Volunteers
- 80 people
- Sponsor
- Bukwang Pharmaceutical
Solid Tumor, Adult, Impaired Liver Function
Oral Docetaxel in Patients With Normal or Impaired Liver Function
This is an open label, single centre pharmacological and safety study to define the safety and pharmacokinetics of ModraDoc006/r in a weekly dosing schedule in patients with impaired liver function who might have benefit from a…
- Trial name
- NCT05084456
- Testing
- ModraDoc006/r
- Where
- Netherlands
- Sponsor
- Modra Pharmaceuticals
Hepatitis C, Viruses
TMC435-TiDP16-C107: This Study Measures the (Possible) Influence of TMC435 on the Activity of a Selected Set of Drug-degrading Proteins by Measuring the Blood Levels of Drugs That Have Been Taken Together With TMC435 and That Are Known to be Specifically Degraded by These Drug-degrading Proteins.
The purpose of this study is to determine whether TMC435 influences the activity of certain drug-degrading proteins in the human body.
- Trial name
- NCT00866853
- Testing
- TMC435
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Infections, Human Immunodeficiency Virus and Hepatitis
Relative Bioavailability Study of GSK1265744 Formulations
This is a single-center, randomized, open-label, balanced, 3 way crossover study (3 periods) in healthy adult subjects. During each period, subjects will receive a single dose of GSK1265744 oral formulation in the fasted state…
- Trial name
- NCT01648257
- Testing
- GSK1265744 Na Salt Tablets, GSK1265744 Free Acid Nanomilled Capsules, GSK1265744 Free Acid Micronized Capsules
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Non-alcoholic Fatty Liver Disease
A Research Study Looking at How a Single Dose of the Medicine NNC0194-0499 Behaves in Chinese Men
This study looks at how a new study medicine called NNC0194-0499 behaves in the body of Chinese men. Three different dose levels will be tested. Participant will get only one of the three different dose levels of NNC0194-0499.
- Trial name
- NCT05742919
- Testing
- NNC0194-0499, NC0194-0499
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Hepatitis C
Placebo-controlled, Dose-escalation Study of the Safety of IMO-2125 (Immunomodulatory Oligonucleotide) in Hepatitis C-infected Patients
First-in-humans, phase 1, dose-escalation study with 4 dose levels of single-agent IMO-2125.
- Trial name
- NCT00728936
- Testing
- IMO-2125
- Where
- 7 sites in United States, Puerto Rico
- Volunteers
- 58 people
- Sponsor
- Idera Pharmaceuticals, Inc.
Hepatitis C
Safety and Efficacy Study of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Genotype 1 and 3 Chronic HCV Infection
This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir plus ribavirin administered for 16 weeks and 24 weeks in participants with chronic genotype 1 (GT1) or genotype 3 (GT3) hepatitis C virus…
- Trial name
- NCT01896193
- Testing
- SOF, RBV
- Where
- 16 sites in Russia
- Volunteers
- 127 people
- Sponsor
- Gilead Sciences
Chronic Obstructive Pulmonary Disease, Alpha1-antitrypsin Deficiency
Stage 1 Study of ARALAST NP and GLASSIA in A1PI Deficiency
The purpose of this study is to conduct a pilot study to evaluate the safety and efficacy of weekly administration of Alpha1-Proteinase Inhibitor (A1PI) augmentation therapy in subjects with A1PI deficiency and emphysema/ chronic…
- Trial name
- NCT02722304
- Testing
- ARALAST NP 60 mg/kg, ARALAST NP 120 mg/kg, GLASSIA 60 mg/kg
- Where
- 17 sites in United States, Australia and 1 more
- Volunteers
- 7 people
- Sponsor
- Baxalta now part of Shire
Carcinoma, Hepatocellular
Safety Study of BAY73-4506 in Patients With Hepatocellular Carcinoma
The purpose of this study is to determine whether BAY73-4506 treatment is safe and can shrink or delay the growth of tumors in patients with unresectable liver cancer.
- Trial name
- NCT01003015
- Testing
- BAY73-4506
- Where
- 13 sites in Germany, Italy and 2 more
- Volunteers
- 36 people
- Sponsor
- Bayer
Non-Alcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
Saroglitazar Magnesium in Patients With Nonalcoholic Fatty Liver Disease and/or Nonalcoholic Steatohepatitis
This is a randomized, double-blind, placebo-controlled study in up to 104 patients with a diagnosis of Non-alcoholic fatty Liver disease (NAFLD) and/or Non-alcoholic steatohepatitis (NASH).
- Trial name
- EVIDENCES IV (NCT03061721)
- Testing
- Saroglitazar magnesium 1 mg, Saroglitazar magnesium 2 mg, Saroglitazar magnesium 4 mg
- Where
- 18 sites in United States
- Volunteers
- 106 people
- Sponsor
- Zydus Therapeutics Inc.
Infection, Human Immunodeficiency Virus
Single-dose Pharmacokinetics of BMS-626529, Administered as BMS-663068, in Subjects With Hepatic Impairment Compared to Healthy Subjects
A single oral dose study in subjects with hepatic impairment and healthy control subjects. Subjects will stay at the clinical facility where interval blood samplings will be obtained and examined for drug effect.
- Trial name
- NCT02467335
- Testing
- BMS-663068
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
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
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD9550 Following Single Ascending Dose Administration to Healthy Participants
This is a Phase I Randomised Single-blind Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD9550 Following Single Ascending Dose Administration to Healthy Participants.
- Trial name
- NCT05848440
- Testing
- AZD9550
- Where
- United Kingdom
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Lymphoma
Revlimid® Capsules Drug Use-results Surveillance (Relapsed or Refractory ATLL)
To understand the safety and efficacy of Revlimid® Capsules 2.5 mg and 5 mg (hereinafter referred to as Revlimid) under actual conditions of use in patients with relapsed or refractory adult T-cell leukemia lymphoma (hereinafter…
- Trial name
- NCT03098589
- Testing
- Revlimid
- Where
- Japan
- Volunteers
- 1,149 people
- Sponsor
- Celgene
Phenylketonuria
A Trial to Examine if Repinatrabit is Processed Differently in Adults With Reduced Liver or Kidney Function Compared to Adults With Normal Liver and Kidney Function
This trial is intended to understand how the body processes repinatrabit in people with moderate liver impairment and severe kidney impairment and also to compare these results with people of similar age, weight, and sex who have…
- Trial name
- NCT07713758
- Testing
- Repinatrabit
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Hepatitis C
Sofosbuvir (GS-7977) in Combination With PEG and Ribavirin for 12 Weeks in Treatment Experienced Subjects With Chronic HCV Infection Genotype 2 or 3
This study is to evaluate the safety, tolerability, and antiviral efficacy of sofosbuvir (SOF) in combination with peginterferon alfa 2a (PEG) and ribavirin (RBV) administered for 12 weeks in participants with chronic genotype 2…
- Trial name
- NCT01808248
- Testing
- SOF, PEG, RBV
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- Gilead Sciences
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