Hepatitis C Virus Clinical Trial
Official title:
A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Chronic Hepatitis C Virus Infection (CERTAIN-1)
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, and DAA treatment-experienced Japanese adult subjects.
The study consisted of two sub-studies that enrolled in parallel. Substudy 1 was randomized, open-label, and active-controlled, wherein HCV treatment-naïve or interferon (IFN)-experienced (i.e., DAA treatment-naïve), genotype (GT)1-infected participants without cirrhosis were enrolled. Substudy 2 was non-randomized, open label, and enrolled special populations of HCV-infected participants [GT1- or GT2-infected subjects with compensated cirrhosis, HCV GT3-, 4-, 5- and 6-infected subjects (with compensated cirrhosis or without cirrhosis), HCV GT1- and GT2-infected subjects who had failed prior DAA treatments (with compensated cirrhosis or without cirrhosis), HCV GT1- or GT2-infected subjects with severe renal impairment (with compensated cirrhosis or without cirrhosis)]. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02907996 -
Evaluate the Safety and Effectiveness of Sovaldi in Participants With Chronic Hepatitis C Virus (HCV) Infection in Korea
|
||
| Completed |
NCT02207088 -
Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease
|
Phase 3 | |
| Not yet recruiting |
NCT02893046 -
HCV Care Pathway in Ile-de-France
|
N/A | |
| Completed |
NCT01396005 -
A Study to Evaluate the Pharmacokinetic Effect of SCH 503034 (Boceprevir) on Methadone or Buprenorphine/Naloxone Plasma Concentrations (P08123)
|
Phase 1 | |
| Completed |
NCT01428063 -
Study With PegInterferon Alfa-2a, Ribavirin and BMS-790052 With or Without BMS-650032 for Participants in Some Hepatitis C Virus (HCV) Trials
|
Phase 2 | |
| Completed |
NCT01195181 -
Different PEG-interferon and Ribavirin Schedules for Chronic Hepatitis C in the Real Clinical Practice.
|
Phase 4 | |
| Completed |
NCT00219999 -
Hepatitis C Virus and the Humoral Immune System
|
N/A | |
| Completed |
NCT02243293 -
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
|
Phase 2/Phase 3 | |
| Completed |
NCT02265237 -
A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir Co-administered With Ribavirin (RBV) in Adults With Genotype 4 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (AGATE-1)
|
Phase 3 | |
| Not yet recruiting |
NCT06104046 -
Prevalence of Seroconversion of Hepatitis c Virus Among Children With CKD on Regular Hemodialysis
|
||
| Completed |
NCT02604017 -
A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Subjects With Genotype 1 Infection
|
Phase 3 | |
| Withdrawn |
NCT00947245 -
Japanese Bridging Study Conducted in the United States
|
Phase 1 | |
| Completed |
NCT01713283 -
Sofosbuvir Plus Ribavirin in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection
|
Phase 2 | |
| Completed |
NCT01479881 -
A Study in Healthy Participants Investigating the Effect of TMC435 on the Pharmacokinetics of Immunosuppressants Cyclosporine and Tacrolimus
|
Phase 1 | |
| Completed |
NCT01458535 -
A Study to Evaluate ABT-450 With Ritonavir (ABT-450/r) When Given Together With ABT-267 and With and Without Ribavirin (RBV) in Treatment-Naïve Subjects With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV)
|
Phase 2 | |
| Completed |
NCT01193361 -
Ph IIA Study (SOC +/- NS5B)
|
Phase 2 | |
| Completed |
NCT01241773 -
TMC435-TiDP16-C123 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and the Antiretroviral Agents Efavirenz and Raltegravir
|
Phase 1 | |
| Completed |
NCT01006031 -
Retreatment With High Doses of pegIFN Alfa-2a and Ribavirin of Previous Nonresponders HIV-coinfected Patients With Cirrhosis Due to HCV 1-4
|
Phase 2/Phase 3 | |
| Completed |
NCT00819026 -
Observational Trial of Hepatitis C Virus Infected Patients on Calcineurin Inhibitors
|
N/A | |
| Completed |
NCT00382798 -
Adaptive Phase I HCV Study With Nucleoside Analogue, in Combination With Interferon and Ribavirin
|
Phase 1/Phase 2 |