Drug Use-results Survey in Patients Infected With Hepatitis C Virus Genotype 1
- Conditions
- Chronic Hepatitis C Virus
- Registration Number
- NCT02629172
- Lead Sponsor
- AbbVie
- Brief Summary
The main objective of this study is to evaluate the safety and effectiveness of paritaprevir/ritonavir/ombitasvir used for patients infected with HCV genotype 1 in daily practice in Japan.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3043
- HCV genotype 1 patients treated with paritaprevir/ritonavir/ombitasvir in daily practice
- Patients who have been previously treated with paritaprevir/ritonavir/ombitasvir
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 the last dose of study drug Hepatitis C virus ribonucleic acid less than the lower limit of quantification 12 weeks after the last dose of study drug.
- Secondary Outcome Measures
Name Time Method Percentage of Participants with Virologic Failure After Treatment Post-treatment 24 weeks Confirmed quantifiable hepatitis C virus ribonucleic acid (HCV RNA) at the end of 12 week treatment but subsequent viremia with HCV RNA greater than or equal to the lower limit of quantitation during follow-up period of 24 weeks after treatment.
Percentage of Participants with Sustained Virologic Response (SVR24) 24 weeks after the last dose of study drug Hepatitis C virus ribonucleic acid less than the lower limit of quantification 24 weeks after the last dose of study drug.
Percentage of Participants with Virologic Failure During Treatment Up to Week 12 HCV RNA levels reach less than the lower limit of quantitation (LLOQ), then increase to greater than or equal to the LLOQ at any point during treatment.
Trial Locations
- Locations (388)
Aichi Medical University Hosp /ID# 152220
🇯🇵Nagakute, Aichi, Japan
Nagoya City University Hospital /ID# 153642
🇯🇵Nagoya-shi, Aichi, Japan
Japanese Red Cross Narita Hosp /ID# 155894
🇯🇵Narita-shi, Chiba, Japan
Kikkoman General Hospital /ID# 152139
🇯🇵Noda, Chiba, Japan
Matsuyama Red Cross Hosp /ID# 152271
🇯🇵Matsuyama, Ehime, Japan
NHO Kyushu Medical Center /ID# 153001
🇯🇵Fukuoka-shi, Fukuoka, Japan
Fukuoka University Hospital /ID# 152272
🇯🇵Fukuoka-shi, Fukuoka, Japan
Kurume University Hospital /ID# 152099
🇯🇵Kurume-shi, Fukuoka, Japan
Gifu University Hospital /ID# 152993
🇯🇵Gifu-shi, Gifu, Japan
Kusunoki Hospital /ID# 152072
🇯🇵Fujioka, Gunma, Japan
Scroll for more (378 remaining)Aichi Medical University Hosp /ID# 152220🇯🇵Nagakute, Aichi, Japan