Drug Use-Results Survey in Participants Infected With Hepatitis C Virus Genotype 2
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 449
- HCV genotype 2 participants treated with paritaprevir/ritonavir/ombitasvir plus ribavirin in daily practice.
- 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
Scroll for more (160 remaining)Aichi Medical University Hosp /ID# 161892🇯🇵Nagakute, Aichi, Japan