Clinical trials: Hepatitis
Hepatitis B, Chronic
Lamivudine and Adefovir Dipivoxil Fixed Dose Combination
This is a phase I study being conducted to support the clinical development program of a FDC product of the nucleoside analogue lamivudine and the nucleotide analogue adefovir dipivoxil.
- Trial name
- NCT01353742
- Testing
- Lamivudine, Adefovir dipivoxil, Fixed dose combination (Lamivudine and Adefovir dipivoxil)
- Where
- Hong Kong
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis C Infection
A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs in Adults With Hepatitis C Virus Infection, Who Are Either Treatment-naive or Treatment-experienced in Brazil
The purpose of this study is to evaluate the proportion of subjects achieving sustained virologic response 12 weeks post-treatment (SVR12) in adults with genotype 1 (GT1) chronic HCV infection, who received treatment with 3…
- Trial name
- NCT02442271
- Testing
- ombitasvir/paritaprevir/ritonavir and dasabuvir, ribavirin
- Volunteers
- 222 people
- Sponsor
- AbbVie
Hepatitis C
Use-Results Surveillance Study of Sovaldi® Plus Rebetol® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection
This use-results post-marketing surveillance (PMS) study for Sovaldi® tablets (sofosbuvir, SOF) administered in combination with Rebetol® capsules (ribavirin, REB) will evaluate the safety and efficacy of SOF administered in…
- Trial name
- NCT02562742
- Testing
- SOF, REB
- Where
- 45 sites in Japan
- Volunteers
- 554 people
- Sponsor
- Gilead Sciences
Hepatitis A
Comparative Immunogenicity Study of Two Hepatitis A Vaccines
Hepatitis A is the most prevalent hepatitis which account for approximately 45% . The susceptible population is Children and adolescence, also the morbidity in adult presented rising trend in recent years.
- Trial name
- NCT03231605
- Testing
- Hepatitis A Vaccine
- Where
- China
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- China National Biotec Group Company Limited
Hepatitis C
Cross-Over Study to Assess the Cardiovascular Effects of GSK2336805
This is a single-center, randomized, two part, double-blind, crossover study in healthy adult subjects to assess the effect of a single dose of GSK2336805 150mg on cardiac function comparing with placebo using echocardiography as…
- Trial name
- NCT01424540
- Testing
- GSK2336805 150mg
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis C
Effect of Omeprazole and Ritonavir on GSK2336805 Pharmacokinetics in Healthy Adults
This study is a Phase I open label drug interaction study to evaluate the effect of omeprazole and ritonavir on GSK2336805.
- Trial name
- NCT01458054
- Testing
- Cohort 1 (GSK2336805 60mg x 1 dose, Omeprazole 40 mg q24h x 4 days, GSK2336805 60 mg x 1 dose and Omeprazole 40 mg x 1 dose), Cohort 2 (GSK2336805 30mg x 1 dose, Ritonavir 100mg q12h x 4 days, and Ritonavir 100mg q12h x 1 dose)
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B, Chronic
An Observational Study of Pegasys (Peginterferon Alfa-2a) in Chinese Patients With HBeAg Negative Chronic Hepatitis B
This multicenter, prospective, observational study will evaluate the use in clinical practice and the efficacy and safety of Pegasys (peginterferon alfa-2a) in Chinese participants with HBeAg negative chronic hepatitis B.
- Trial name
- NCT01730508
- Testing
- Pegylated Interferon Alfa (Peginterferon Alfa)
- Where
- 88 sites in China
- Volunteers
- 978 people
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis C, Decompensated Cirrhosis
A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Ribavirin in Adults With Genotype 1 and Ombitasvir/Paritaprevir/Ritonavir With Ribavirin in Adults With Genotype 4 Chronic Hepatitis C Virus Infection and Decompensated Cirrhosis
The primary objectives of this study are to assess the safety and the SVR12 rate of ombitasvir/paritaprevir/ritonavir and dasabuvir with RBV in GT1-infected participants with decompensated cirrhosis.
- Conditions
- Chronic Hepatitis C, Decompensated Cirrhosis, Hepatitis C Virus
- Trial name
- TURQUOISE-CPB (NCT02219477)
- Testing
- ombitasvir/paritaprevir/ritonavir, dasabuvir, ribavirin
- Volunteers
- 36 people
- Sponsor
- AbbVie
Hepatitis C
A First Time in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Single and Repeat Doses of GSK2485852 in Chronically Infected Hepatitis C Subjects
GSK2485852 is a Hepatitis C NS5B site IV non-nucleoside polymerase inhibitor being developed for the treatment of chronic HCV infection.
- Trial name
- NCT01332552
- Testing
- GSK2485852 70 mg, GSK2485852 420 mg, GSK2485852 630 mg
- Where
- 5 sites in United States
- Volunteers
- 27 people
- Sponsor
- GlaxoSmithKline
Hepatitis C
A Study to Evaluate the Efficacy, Safety and Tolerability of TMC435 in Combination With PegIFN Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naïve or Treatment-Experienced, Chronic Hepatitis C Virus Genotype-4 Infected Patients
The purpose of this study to evaluate the efficacy, safety and tolerability of TMC435 in combination with Peginterferon alfa-2a (PegINF alfa-2a) and ribavirin (RBV) in both treatment-naïve and treatment experienced, chronic…
- Trial name
- RESTORE (NCT01567735)
- Testing
- TMC435
- Where
- 8 sites in Belgium, France
- Volunteers
- 107 people
- Sponsor
- Janssen R&D Ireland
Hepatitis B
HEPSERA Post Marketing Surveillance
An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of adefovir dipivoxil administered in Korean CHB patients according to the prescribing information
- Trial name
- HEPSERA PMS (NCT01329419)
- Testing
- adefovir dipivoxil
- Volunteers
- 4,393 people
- Sponsor
- GlaxoSmithKline
Hepatitis C
A First Time in Human Study to Assess GSK2336805 in Healthy Volunteers and Single Doses in Chronically Infected Hepatitis C Patients.
This study is a three Part, Phase 1, randomized, dose-escalation, fusion, placebo-controlled, double-blind study to determine the safety, tolerability and Pharmacokinetic (PK) profile of GSK2336805 in healthy subjects and the…
- Trial name
- NCT01277692
- Testing
- GSK2336805 10mg, GSK2336805 30mg, GSK2236805 100mg
- Where
- 3 sites in United States
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis C Virus Infection
Use-Results Surveillance Study of Sovaldi® Plus Copegus® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection
This post-marketing surveillance (PMS) study for Sovaldi® tablets (sofosbuvir, SOF) administered in combination with Copegus® tablets (ribavirin, COPE) will evaluate the safety and efficacy of SOF administered in combination with…
- Trial name
- NCT02537379
- Testing
- SOF, COPE
- Where
- 45 sites in Japan
- Volunteers
- 552 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis B
An Extension to Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B
This study is to evaluate the safety of telbivudine for up to 21 months of open-label treatment in patients with chronic hepatitis B who have completed the CLDT600A2407 trial.
- Trial name
- NCT00467545
- Testing
- telbivudine
- Where
- 6 sites in South Korea
- Volunteers
- 44 people
- Sponsor
- Novartis Pharmaceuticals
Hepatitis B, Chronic
To Evaluate Antiviral Efficacy of Telbivudine in Hepatitis B Antigen Positive (HbeAg-positive) Compensated Chronic Hepatitis B (CHB)
This study is to evaluate the antiviral efficacy of add-on adefovir to telbivudine in non-responders to telbivudine monotherapy after 24 and 36 initial weeks.
- Trial name
- NCT00537537
- Testing
- Telbivudine
- Where
- 3 sites in India
- Volunteers
- 100 people
- Sponsor
- Novartis Pharmaceuticals
Hepatitis B, Chronic
Prospective Exploratory Study to Evaluate the Safety and Efficacy of Telbivudine in the Fifth Year of Treatment in Chinese Patients With Compensated Chronic Hepatitis B
This study will explore efficacy and safety of Telbivudine in the fifth year of treatment.
- Trial name
- NCT00646503
- Testing
- Telbivudine
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Novartis
Hepatitis C
SOF (Sovaldi®) +RBV for 16 or 24 Weeks and SOF+RBV+Peg-IFN for 12 Weeks in Adults With Genotype 2 or 3 Chronic HCV Infection
This study will assess the efficacy, safety, and tolerability of 16 or 24 weeks of sofosbuvir (Sovaldi®; SOF) + ribavirin (RBV), and 12 weeks of SOF+RBV+ pegylated interferon (Peg-IFN) in treatment-naive and treatment-experienced…
- Trial name
- NCT01962441
- Testing
- SOF, RBV, Peg-IFN
- Where
- 78 sites in United States, Australia and 3 more
- Volunteers
- 601 people
- Sponsor
- Gilead Sciences
Hepatitis B
Telbivudine Versus the Combination of Telbivudine and Valtorcitabine in Patients With Chronic Hepatitis B
This study is being conducted to compare the effectiveness of the combination of valtorcitabine and telbivudine to telbivudine alone in patients with chronic hepatitis B.
- Trial name
- NCT00128544
- Testing
- telbivudine, valtorcitabine
- Where
- 3 sites in Hong Kong, New Zealand and 1 more
- Volunteers
- 130 people
- Sponsor
- Novartis
Hepatitis B, Diphtheria
Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly
This study will assess the immunogenicity of GlaxoSmithKline (GSK) Biologicals' (formerly SmithKline Beecham Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared to the separate administration of DTPa-HBV-IPV…
- Conditions
- Hepatitis B, Diphtheria, Haemophilus Influenzae Type b (Hib), Poliomyelitis
- Trial name
- NCT01457495
- Testing
- DTPa-HBV-IPV/Hib (Infanrix-hexa™), DTPa-IPV/Hib (Infanrix-IPV/Hib™), HBV (Engerix™-B)
- Volunteers
- 312 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B, Diphtheria
Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib, Compared to DTPa-HBV-IPV and Hib Administered Separately
This study will assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals' (formerly SB Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared with separate administration of DTPa-HBV-IPV (Infanrix…
- Conditions
- Hepatitis B, Diphtheria, Haemophilus Influenzae Type b (Hib), Poliomyelitis
- Trial name
- NCT01457508
- Testing
- DTPa-HBV-IPV/Hib (Infanrix hexa™), DTPa-HBV-IPV (Infanrix penta™), Hib (Hiberix™)
- Volunteers
- 440 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline