Clinical trials: Gastrointestinal Infections
HBeAg-positive Chronic Hepatitis B
Study to Compare Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF) in Participants With Chronic Hepatitis B Infection Who Are Positive for Hepatitis B e Antigen
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
- NCT01940471
- Testing
- TAF, TDF
- Where
- 160 sites in United States, Australia and 17 more
- Volunteers
- 875 people
- Sponsor
- Gilead Sciences
Hepatitis B
A Phase IIIb: Long-Term Outcomes for Hepatitis B (HepB) Patients in Some Previous Entecavir (ETV) Trials
The purpose of this study is to follow patients treated in entecavir Phase III and rollover studies for safety experience and Hepatitis B virus (HBV)-related complications.
- Trial name
- NCT01337479
- Volunteers
- 1,097 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis C, HCV
TD-6450 MAD Study in HCV Infected Subjects
This proof of concept study is designed to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of TD-6450 in treatment naïve subjects with GT-1, GT-2 or GT-3 chronic HCV.
- Trial name
- NCT02116543
- Testing
- TD-6450
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- Theravance Biopharma
Chronic Hepatitis C
Study of Efficacy and Safety of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in Chronic Hepatitis C Participants With Child-Pugh (CP)-B Hepatic Insufficiency (MK-5172-059)
This study is being done to evaluate the efficacy and safety of the drug combination grazoprevir (GZR; MK-5172) + elbasvir (EBR; MK-8742) in participants with chronic hepatitis C virus (HCV) genotype (GT) 1, 4, or 6 infection and…
- Trial name
- NCT02115321
- Testing
- Grazoprevir, Elbasvir, MK-5172A
- Volunteers
- 40 people
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Hepatitis B
A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection
This is a first in human (FIH), multi-center, dose-finding, and dose-escalation Phase I clinical study of RO7565020 to investigate the safety and tolerability and to characterize the pharmacokinetics and pharmacodynamics…
- Trial name
- NCT05763576
- Testing
- RO7565020, Nucleos(t)ide analogue (NUC) treatment
- Where
- 9 sites in United States, Hong Kong and 5 more
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Hepatitis C
Evaluation of the Bioavailability of Two ABT-072 Tablet Formulations as Compared to ABT-072 Capsule Formulation
The purpose of this study is to assess the bioavailability, safety, tolerability and pharmacokinetics of two tablet formulations as compared to the capsule formulation suspended in liquid.
- Trial name
- NCT00947440
- Testing
- ABT-072
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Abbott
Hepatitis B, Chronic
A Clinical Study to Evaluate the Efficacy of TQA3038 Injection in Patients With Chronic Hepatitis B
This study is divided into two parts. Phase Ib is a randomized, double-blind, placebo-controlled trial, designed to evaluate the safety, tolerability, pharmacokinetic characteristics, preliminary efficacy, and immunogenicity of…
- Trial name
- NCT06452693
- Testing
- Nucleotide drugs Control group
- Where
- 22 sites in China
- Volunteers
- 162 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Chronic Hepatitis B
Safety Study of HBV DNA Vaccine to Treat Patients With Chronic Hepatitis B Infection
The purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given and any effects it may have on subjects' wellbeing.
- Trial name
- NCT00277576
- Testing
- ppdpSC18 administered by PMED
- Where
- 9 sites in Hong Kong, Singapore and 2 more
- Volunteers
- 48 people
- Sponsor
- PowderMed
Infections, Meningococcal
Study to Asses DTPw-HBV/Hib at 15-18 Months (m) and Mencevax™ ACW at 24 to 30 m in Primed Subjects
The purpose of this study is to assess the safety and reactogenicity of a booster dose of diphtheria-tetanus-whole cell pertussis-hepatitis B virus/Haemophilus influenzae type b vaccine (DTPw-HBV/Hib) at 15-18 m and to assess the…
- Trial name
- NCT00317109
- Testing
- Tritanrix™- HepB, Hiberix™, Mencevax™ ACW
- Where
- 3 sites in South Africa
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis C
Safety and Biological Activity of InfraDure Biopump Secreting Sustained Interferon in HCV Patients
This will be a Phase I-II, open-label, single center, uncontrolled, dose-escalation study. The trial will be conducted in Israel at the Tel Aviv Sourasky Medical Center.
- Trial name
- NCT01433133
- Testing
- implantation
- Volunteers
- 3 people
- Sponsor
- Medgenics Medical Israel Ltd.
Hepatitis C, Chronic
A Study of Combination Treatment With an HCV Polymerase Inhibitor (RO5024048) and an HCV Protease Inhibitor (RO5190591/Danoprevir) in Genotype 1 Chronic Hepatitis C Patients
This 7 cohort study will evaluate the efficacy and safety of combination treatment with an HCV nucleoside polymerase inhibitor(RO5024048)and an HCV protease inhibitor(RO5190591/ITMN-191/danoprevir) in patients with chronic…
- Trial name
- NCT00801255
- Testing
- RO5024048, danoprevir
- Where
- 5 sites in Australia, New Zealand
- Volunteers
- 88 people
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis B
Study of ARC-520 in Patient With Chronic Hepatitis B Virus
Patients with chronic HBV infection will receive ARC-520 in combination with entecavir or tenofovir and be evaluated for safety and efficacy.
- Trial name
- NCT02349126
- Testing
- ARC-520 Injection
- Where
- Australia
- Sponsor
- Arrowhead Pharmaceuticals
Hepatitis C
Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir in Adults With Chronic HCV Infection Who Have Previously Received Treatment With Direct-Acting Antiviral Therapy
The primary objectives of this study are to evaluate the safety and efficacy of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic hepatitis C virus (HCV) infection who have previously…
- Trial name
- POLARIS-1 (NCT02607735)
- Testing
- SOF/VEL/VOX
- Where
- 86 sites in United States, Australia and 6 more
- Volunteers
- 416 people
- Sponsor
- Gilead Sciences
HIV-1 Infection, HCV Infection
Efficacy, Safety, and Tolerability of Ledipasvir/Sofosbuvir (LDV/SOF) Treatment for HIV/HCV Co-infected Participants Who Switch to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Emtricitabine/Rilpivirine/Tenofovir Alafenamide (F/R/TAF) Prior to LDV/SOF HCV Treatment
This study will evaluate efficacy of ledipasvir/sofosbuvir (LDV/SOF) and safety and tolerability of switching to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) or emtricitabine/rilpivirine/tenofovir…
- Trial name
- Co-STARs (NCT02707601)
- Testing
- E/C/F/TAF, F/R/TAF, LDV/SOF
- Where
- 43 sites in United States, Puerto Rico
- Volunteers
- 150 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis C
Phase 1b Study of Omega DUROS® in Patients With Chronic Hepatitis C Who Relapsed After Prior Treatment
Omega DUROS® is an implantable drug delivery system designed to deliver omega interferon subcutaneously at a constant rate for 90 days.
- Trial name
- NCT00519792
- Testing
- Omega DUROS device
- Where
- 8 sites in United States, Puerto Rico
- Volunteers
- 60 people
- Sponsor
- Intarcia Therapeutics
Hepatitis B
Immunogenicity and Safety of Primary and Booster Vaccination With DTPa-HBV-IPV/Hib Vaccine
This study will assess the immunogenicity, safety and reactogenicity of GSK Biological's DTPa-HBV-IPV/ Hib vaccine as compared to GSK's DTPa-IPV/Hib vaccine co-administered with HBV according to a three-dose immunisation course…
- Trial name
- NCT00880477
- Testing
- DTPa-HBV-IPV/Hib vaccine, DTPa-IPV/Hib vaccine, EngerixTM-B
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Cystic Fibrosis
A Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI®
The objectives of the study are to demonstrate that Tobrineb®/Actitob®/Bramitob® is non-inferior to TOBI® in the primary efficacy variable, forced expiratory volume in one second (FEV1) percent of predicted normal, and to compare…
- Trial name
- CT03 Core (NCT00885365)
- Testing
- tobramycin / Bramitob, tobramycin / TOBI
- Where
- 44 sites in Czechia, France and 6 more
- Volunteers
- 324 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Hepatitis B, Chronic
An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Positive Chronic Hepatitis B in Vietnam
This prospective, multicenter, observational study will evaluate the sustained response in patients with HBeAg positive chronic hepatitis B who are treated with Pegasys according to standard of care and in line with the current…
- Trial name
- NCT01886300
- Where
- 3 sites in Vietnam
- Volunteers
- 16 people
- Sponsor
- Hoffmann-La Roche
Cirrhosis
Breath Test to Assess Hepatic Metabolic Reserve and to Predict Hepatic Decompensation in Cirrhotics
The three objectives of this trial are: 1. To demonstrate that a decline in hepatic metabolic function as measured by BreathID will correlate with changes in CTP and MELD scores in patients with cirrhosis. 2.
- Trial name
- NCT00375011
- Where
- 3 sites in United States, Israel
- Volunteers
- 200 people
- Sponsor
- Meridian Bioscience, Inc.
Hepatitis C Virus
TMC435-TiDP16-C112 - Interaction Trial With Antidepressants
The purpose of this study is to investigate the effect of steady-state concentrations of TMC435 150mg q.d. (once a day) on the steady-state pharmacokinetics of escitalopram 10 mg q.d., and vice versa.
- Trial name
- NCT01090700
- Testing
- TMC435, Escitalopram, TMC435 + Escitalopram
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
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