Clinical trials: Chronic Hepatitis, B Virus
Hepatitis C Virus Infection
Efficacy and Safety of Glecaprevir (ABT-493)/Pibrentasvir (ABT 530) (GLE/PIB) in Combination With Sofosbuvir and Ribavirin in Participants With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie Clinical Study
The purpose of this study was to evaluate the efficacy and safety of co-administration of glecaprevir (ABT-493)/pibrentasvir (ABT 530) plus sofosbuvir (SOF) plus ribavirin (RBV) in hepatitis C virus (HCV) genotype (GT) 1 …
- Trial name
- MAGELLAN-3 (NCT02939989)
- Testing
- Sofosbuvir, Glecaprevir/Pibrentasvir, Ribavirin
- Where
- 26 sites in United States, Australia and 10 more
- Volunteers
- 33 people
- Sponsor
- AbbVie
Hepatocellular Carcinoma, HIV
Hepatocellular Carcinoma in HIV-infected Patients
Observational study. All HIV-infected patients who have been diagnosed of hepatocellular carcinoma (HCC), following the American Association for the Study of Liver Diseases (AASLD) criteria, in the participant centers are…
- Conditions
- Hepatocellular Carcinoma, HIV, Chronic Hepatitis C, Hepatitis B Virus
- Trial name
- GEHEP-002 (NCT02785835)
- Where
- 30 sites in Spain
- Volunteers
- 477 people
- Sponsor
- Hospital Universitario de Valme
Chronic Hepatitis B Virus Infection
A 2 PART STUDY EVALUATING EDP-721 IN HEALTHY SUBJECTS AND EDP-721 IN COMBINATION WITH EDP-514 IN PATIENTS WITH CHRONIC HEPATITIS B VIRUS INFECTION.
Part 1 is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of EDP-721 in healthy subjects.
- Trial name
- NCT04971512
- Testing
- EDP-721, EDP-721 (Part 2), EDP-514
- Where
- New Zealand
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Enanta Pharmaceuticals, Inc
Chronic Hepatitis C Virus Infection
Ropeginterferon Alfa-2b (P1101) Phase 3 Study in Interferon Treatment-Naive Subjects With HCV Genotype 2 Infection
Primary objective: To demonstrate non-inferiority in sustained virologic response (SVR, undetectable HCV RNA at Follow up week 12) between PEG-Intron 1.5 µg per kg SC Q1W + Ribavirin 800-1400 mg PO daily and P1101 400 µg SC Q2W +…
- Trial name
- NCT04382937
- Testing
- P1101 + Ribavirin, PEG-Intron + Ribavirin
- Where
- 39 sites in China, South Korea and 1 more
- Volunteers
- 222 people
- Sponsor
- PharmaEssentia
Chronic Hepatitis B Virus
T-cell Dysfunction in Chronic HBV Infection
Chronic hepatitis B (CHB) infection remains an important public health with more than 240 million people chronically infected despite the existence of an effective vaccine.
- Trial name
- VHB-Roche (NCT05099458)
- Testing
- Additional blood sampling (100 ml)
- Where
- France
- Volunteers
- 50 people
- Sponsor
- University Hospital, Strasbourg, France
Hepatitis C Virus (HCV)
Glecaprevir/Pibrentasvir Drug Use Results Survey in Patients Infected With Hepatitis C Virus Genotype 1-6
This multi-center, post-marketing, observational study evaluates the real world safety and effectiveness of glecaprevir plus pibrentasvir use in participants infected with the hepatitis C virus genotype 1 - 6.
- Trial name
- NCT03341871
- Where
- Japan
- Volunteers
- 1,095 people
- Sponsor
- AbbVie
Chronic Hepatitis C, Hepatitis C Virus
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without RBV in Subjects With Chronic Hepatitis C Virus (HCV) Genotypes 2, 3, 4, 5 or 6 Infection
The purpose of this phase 2/3, open-label, multipart, multicenter study was to evaluate the efficacy, and safety of co-administration of ABT-493 and ABT-530 with and without ribavirin (RBV) in chronic HCV genotype 2 (GT2-)…
- Trial name
- NCT02243293
- Testing
- ABT-493, ABT-530, ribavirin (RBV)
- Volunteers
- 694 people
- Sponsor
- AbbVie
Chronic Hepatitis C, Hepatitis C Virus
A Study Comparing Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Dosed With Daclatasvir in Adults With HCV Genotype 3 Infection
The purpose of this study was to compare the safety and efficacy of ABT-493/ABT-530 to the combination of sofosbuvir (SOF) and daclatasvir (DCV) in adults with genotype 3 (GT3) chronic hepatitis C virus (HCV) infection.
- Conditions
- Chronic Hepatitis C, Hepatitis C Virus, Genotype 3 Hepatitis C Virus
- Trial name
- ENDURANCE-3 (NCT02640157)
- Testing
- ABT-493/ABT-530, Sofosbuvir, Daclatasvir
- Volunteers
- 506 people
- Sponsor
- AbbVie
Chronic Hepatitis C Virus (HCV) Infection
A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus (HCV) Genotype 2 Infection
The purpose of this study is to evaluate the safety and efficacy of ABT-493/ABT-530 in adults with genotype 2 chronic hepatitis C virus (HCV) infection.
- Trial name
- ENDURANCE-2 (NCT02640482)
- Testing
- ABT-493/ABT-530
- Volunteers
- 304 people
- Sponsor
- AbbVie
Chronic Hepatitis C Virus, Hepatitis C Virus
A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Chronic Hepatitis C Virus Infection
The purpose of this phase 3, multicenter study is to evaluate the efficacy and safety of ABT-493/ABT-530 in Japanese adults with chronic Hepatitis C Virus (HCV)-infected, HCV direct-acting antiviral agent (DAA) treatment-naïve…
- Trial name
- CERTAIN-1 (NCT02707952)
- Testing
- ABT-493/ABT-530, OBV/PTV/r
- Volunteers
- 295 people
- Sponsor
- AbbVie
Chronic Hepatitis C Virus, Hepatitis C Virus
A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Genotype 2 Chronic Hepatitis C Virus Infection
The purpose of this phase 3 study is to evaluate the efficacy and safety of ABT-493/ABT-530 in comparison to sofosbuvir plus ribavirin for 12 weeks in Hepatitis C Virus (HCV) Genotype 2 (GT2) infected participants.
- Trial name
- CERTAIN-2 (NCT02723084)
- Testing
- ABT-493/ABT-530, sofosbuvir (SOF), ribavirin (RBV)
- Volunteers
- 136 people
- Sponsor
- AbbVie
Chronic Hepatitis C, Hepatitis C Virus
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-administration of ABT-493 and ABT-530 With and Without Ribavirin in Subjects With HCV Genotype 1, 4, 5, and 6 Infection
The purpose of this Phase 2, open-label, 2-part, multicenter study was to evaluate the efficacy, safety, and pharmacokinetics of co-administration of ABT-493 and ABT-530 with and without ribavirin (RBV) at different doses in…
- Conditions
- Chronic Hepatitis C, Hepatitis C Virus, HCV
- Trial name
- NCT02243280
- Testing
- ABT-493, ABT-530
- Volunteers
- 174 people
- Sponsor
- AbbVie
Chronic Hepatitis C, Hepatitis C Virus
A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Subjects With Genotype 1 Infection
This study seeks to evaluate the efficacy and safety of ABT-493/ABT-530 in participants with Genotype 1 hepatitis C virus infection without cirrhosis
- Conditions
- Chronic Hepatitis C, Hepatitis C Virus, HCV
- Trial name
- NCT02604017
- Testing
- ABT-493/ABT-530
- Volunteers
- 703 people
- Sponsor
- AbbVie
Hepatitis C Virus
The Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 4, 5, or 6 Infection (ENDURANCE-4)
The purpose of this study is to evaluate the effect of response to treatment by evaluating the percentage of subjects achieving a 12-week sustained virologic response (SVR12) after 12 weeks of treatment with ABT-493/ABT-530 and…
- Trial name
- ENDURANCE-4 (NCT02636595)
- Testing
- ABT-493/ABT-530
- Volunteers
- 121 people
- Sponsor
- AbbVie
Hepatitis C Virus Infection, Chronic Hepatitis C
A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis
The purpose of this study is to assess the safety and efficacy of ABT-493/ABT-530 following 12 weeks of treatment in adults with chronic Hepatitis C Virus Infection genotype 1, 2, 4, 5 or 6 infection and compensated cirrhosis.
- Conditions
- Hepatitis C Virus Infection, Chronic Hepatitis C, Compensated Cirrhosis
- Trial name
- EXPEDITION-1 (NCT02642432)
- Testing
- ABT-493/ABT-530
- Volunteers
- 146 people
- Sponsor
- AbbVie
Chronic Hepatitis C, HCV
A Study to Evaluate the Safety and Efficacy of ABT-493/ABT-530 in Adult Post-Liver or Post-Renal Transplant Recipients With Chronic Hepatitis C Virus (MAGELLAN-2)
The purpose of this study is to assess the safety and efficacy of 12 weeks of treatment of ABT-493/ABT-530 (glecaprevir/pibrentasvir) in adults who are post primary orthotopic liver or renal transplant with chronic hepatitis C…
- Conditions
- Chronic Hepatitis C, HCV, Hepatitis C Virus
- Trial name
- NCT02692703
- Testing
- glecaprevir/pibrentasvir
- Volunteers
- 100 people
- Sponsor
- AbbVie
Hepatitis C Virus Infection, Human Immunodeficiency Virus Infection
A Study to Evaluate the Efficacy and Safety of Experimental Drugs ABT- 493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1-6 Infection and Human Immunodeficiency Virus -1 Coinfection (EXPEDITION-2)
The purpose of this study is to assess the efficacy and safety of ABT-493/ABT-530 in adults with chronic hepatitis C virus genotype 1-6 infection and human immunodeficiency virus-1 co-infection.
- Conditions
- Hepatitis C Virus Infection, Human Immunodeficiency Virus Infection, Chronic Hepatitis C, Compensated Cirrhosis and Non-cirrhotics
- Trial name
- EXPEDITION-2 (NCT02738138)
- Testing
- ABT-493 coformulated with ABT-530
- Volunteers
- 153 people
- Sponsor
- AbbVie
Hepatitis C Virus Infection, Human Immunodeficiency Virus Infection
A Multipart, Open-label Study to Evaluate the Safety and Efficacy of ABT-450/r/ABT-267 With and Without ABT-333 Coadministered With and Without Ribavirin in Adult With Genotype 1 or 4 Hepatitis C Virus (HCV) Infection and Human Immunodeficiency Virus, Type 1 Coinfection
The primary objectives of this study are to assess the safety of ABT-450/r/ABT-267 with and without ABT-333 coadministered with and without ribavirin (RBV) for 12 and 24 weeks in HCV GT1- or 4-infected participants with HIV-1…
- Conditions
- Hepatitis C Virus Infection, Human Immunodeficiency Virus Infection, Chronic Hepatitis C, Compensated Cirrhosis and Non-cirrhotics
- Trial name
- TURQUOISE-I (NCT01939197)
- Testing
- ABT-450/r/ABT-267, ABT-333, ribavirin
- Volunteers
- 318 people
- Sponsor
- AbbVie
Chronic Hepatitis C, Hepatitis C Virus
A Study to Evaluate the Safety and Antiviral Effect of Multiple Doses of ABT-493 and ABT-530 in Adults With Genotype 1 Hepatitis C Virus (HCV)
The purpose of this study is to evaluate the safety and antiviral effect of multiple doses of ABT-493 and ABT-530 in adults with genotype 1 HCV.
- Conditions
- Chronic Hepatitis C, Hepatitis C Virus, Compensated Cirrhosis
- Trial name
- NCT01995071
- Testing
- ABT-493, ABT-530, ABT-450/r/ABT-267, ABT-333
- Volunteers
- 89 people
- Sponsor
- AbbVie
Chronic Hepatitis C Virus Infection
A Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir With Sofosbuvir With or Without Ribavirin in Adults With Chronic Hepatitis C Virus Infection
The purpose of this study is to evaluate the safety and efficacy of Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) with sofosbuvir (SOF) with or without ribavirin (RBV) in adults with Genotype 2 Chronic Hepatitis C Virus (HCV)…
- Trial name
- Quartz II/III (NCT02292719)
- Testing
- OBV/PTV/r, Sofosbuvir, Ribavirin (RBV)
- Volunteers
- 70 people
- Sponsor
- AbbVie