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

Completed

• Conditions: Hepatitis C Virus

• Registration Number: NCT02581020
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-19
• Study First Submitted QC: 2015-10-19
• Study First Posted: 2015-10-20
• Study Start: 2016-01-14
• Primary Completion: 2020-12-08
• Study Completion: 2020-12-08
• Status Verified: 2021-01
• Last Update Submitted: 2021-12-06
• Last Update Posted: 2021-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 344

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to Ombitasvir in Non-structural Viral Protein 5A (NS5A)	For approximately 5 years
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
Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to Paritaprevir in Non-structural Viral Protein 3 (NS3)	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

Trial Locations

Locations (53)

Nagoya City University Hospital /ID# 157439; 🇯🇵 Nagoya-shi, Aichi, Japan

Matsuyama Red Cross Hospital /ID# 152125; 🇯🇵 Matsuyama-shi, Ehime, Japan

National Hospital Organization Kyushu Medical Center /ID# 161759; 🇯🇵 Fukuoka-shi, Fukuoka, Japan

Fukuoka University Hospital /ID# 155965; 🇯🇵 Fukuoka-shi, Fukuoka, Japan

Kurume University Hospital /ID# 152123; 🇯🇵 Kurume-shi, Fukuoka, Japan

Ogaki Municipal Hospital /ID# 158105; 🇯🇵 Ogaki-shi, Gifu, Japan

Gunma University Hospital /ID# 158118; 🇯🇵 Maebashi-shi, Gunma, Japan

National Hospital Organization Takasaki General Medical Center /ID# 152128; 🇯🇵 Takasaki-shi, Gunma, Japan

Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital /ID# 152178; 🇯🇵 Hiroshima-shi, Hiroshima, Japan

Hiroshima University Hospital /ID# 152232; 🇯🇵 Hiroshima-shi, Hiroshima, Japan

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