Drug Use-Results Survey in Participants Infected With Hepatitis C Virus Genotype 2

Completed

• Conditions: Chronic Hepatitis C Virus

• Registration Number: NCT02945228
• Lead Sponsor: AbbVie

Brief Summary

The main objective of this study is to evaluate the safety and effectiveness of paritaprevir/ritonavir/ombitasvir with ribavirin used for participants infected with chronic hepatitis C virus (HCV) genotype 2 in daily practice in Japan.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-25
• Study First Submitted QC: 2016-10-25
• Study Start: 2016-10-26
• Study First Posted: 2016-10-26
• Primary Completion: 2019-07-26
• Study Completion: 2019-07-26
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-11
• Last Update Posted: 2020-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 449

Inclusion Criteria

• HCV genotype 2 participants treated with paritaprevir/ritonavir/ombitasvir plus ribavirin in daily practice.

Exclusion Criteria

• Participants who have been previously treated with paritaprevir/ritonavir/ombitasvir and ribavirin.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with Sustained Virologic Response (SVR12)	12 weeks after last dose of study drug.	Hepatitis C virus (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last dose of study drug.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants with Virologic Failure After Treatment (relapse)	Post-treatment 24 weeks	Undetectable viremia (HCV RNA less than LLOQ) at the end of the 16 weeks treatment but subsequent viremia (HCV RNA greater than or equal to LLOQ) during the follow-up period of 24 weeks after treatment.
Percentage of Participants with Virologic Failure During Treatment (breakthrough)	Up to 12 Weeks	HCV RNA levels reach less than the LLOQ, then increase to greater than or equal to the LLOQ at any point during treatment.
Percentage of Participants with Sustained Virologic Response (SVR24)	24 weeks after the last dose of study drug	HCV RNA less than the LLOQ 24 weeks after the last dose of study drug.

Trial Locations

Locations (170)

Aichi Medical University Hosp /ID# 161892; 🇯🇵 Nagakute, Aichi, Japan

Matsuyama Red Cross Hosp /ID# 162953; 🇯🇵 Matsuyama, Ehime, Japan

NHO Kyushu Medical Center /ID# 162956; 🇯🇵 Fukuoka-shi, Fukuoka, Japan

Kurume University Hospital /ID# 164158; 🇯🇵 Kurume-shi, Fukuoka, Japan

Kusunoki Hospital /ID# 158119; 🇯🇵 Fujioka, Gunma, Japan

National Hospital Organization Takasaki General Medical Center /ID# 160877; 🇯🇵 Takasaki-shi, Gunma, Japan

NHO Fukuyama Medical Center /ID# 162909; 🇯🇵 Fukuyama-shi, Hiroshima, Japan

Fukuyama City Hospital /ID# 161889; 🇯🇵 Fukuyama-shi, Hiroshima, Japan

The Hospital of Hyogo College of Medicine /ID# 162913; 🇯🇵 Nishinomiya-shi, Hyogo, Japan

Nanpuh Hospital /ID# 168348; 🇯🇵 Kagoshima-shi, Kagoshima, Japan

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