Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

This was a randomized, open-label, active-control, multicenter study to evaluate efficacy, safety, and pharmacokinetics of ABT-493/ABT-530 in chronic HCV GT2-infected direct-acting antiviral agent (DAA) treatment-naïve Japanese adult participants without cirrhosis. The participants were randomized in a 2:1 ratio to ABT-493/ABT-530 for 8 weeks (Arm A) and sofosbuvir plus ribavirin for 12 weeks (Arm B). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02723084
Study type Interventional
Source AbbVie
Contact
Status Completed
Phase Phase 3
Start date April 8, 2016
Completion date March 24, 2017

See also
  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 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 NCT01396005 - A Study to Evaluate the Pharmacokinetic Effect of SCH 503034 (Boceprevir) on Methadone or Buprenorphine/Naloxone Plasma Concentrations (P08123) Phase 1
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 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 NCT01479881 - A Study in Healthy Participants Investigating the Effect of TMC435 on the Pharmacokinetics of Immunosuppressants Cyclosporine and Tacrolimus Phase 1
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