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

A Follow-up Study to Assess the Durability of Response and Persistence of Resistance to AbbVie's 2 Direct-acting Antiviral Agent (2D) Therapy in Japanese Subjects Who Participated in Phase 2 or 3 Clinical Studies for the Treatment of Chronic Hepatitis C Virus (HCV) Infection

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02581020

Enrollment

344

Registered

2015-10-20

Start date

2016-01-14

Completion date

2020-12-08

Last updated

2021-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C Virus

Keywords

Hepatitis C, Follow-up, Observation, Japanese

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Hepatitis C virus ribonucleic acid (HCV RNA) levels	60 months after completion of the 2D treatment in M12-536 or M13-004 study	HCV RNA levels in plasma

Secondary

Measure	Time frame	Description
Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to Paritaprevir in Non-structural Viral Protein 3 (NS3)	For approximately 5 years	—
Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to Ombitasvir in Non-structural Viral Protein 5A (NS5A)	For approximately 5 years	—
Percentage of participants with hepatocellular carcinoma	Up to 60 month after completion of the 2D treatment in M12-536 or M13-004	—
Number of participants with serious adverse events (SAEs)	Up to 60 month after completion of the 2D treatment in M132-536 or M13-004 study	All serious adverse events will be monitored during the observation period.
Hepatitis C virus ribonucleic acid (HCV RNA) levels	18, 24, 30, 36, 42, 48, 52 months after completion of the 2D treatment in M12-536 or M13-004 study	HCV RNA levels in plasma

Countries

Japan

Outcome results