The Durability of Response and Persistence of Resistance to AbbVie's 2 Direct-acting Antiviral Agent (2D) Therapy in Japanese Subjects

AbbVie

Status: Completed

Conditions: Hepatitis C Virus

Study type: Observational

Funder types: Industry

Identifiers

NCT02581020

P15-349

Details and patient eligibility

About

This study seeks to assess the durability of response and persistence of resistance to ombitasvir/ paritaprevir/ritonavir in Japanese participants who enrolled in a Phase 2 or 3 clinical study with these agents for the treatment of chronic hepatitis C.

Enrollment: 344 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants treated in Study M12-536 or M13-004 with the 2D regimen (ombitasvir/ paritaprevir/ ritonavir) and completed 48 weeks of follow-up, regardless of SVR achievement.
• Participants who agree to sign the informed consent

Exclusion criteria

• Participants treated with a direct-acting antiviral agent (DAA) immediately after Study M12-536 or M13-004.

Trial design

344 participants in 1 patient group

1

Description:

Participants who were treated with 2D regimen (ombitasvir/ paritaprevir/ ritonavir) and completed 48 weeks of follow up from the prior Phase 2 or 3 studies conducted in Japan.