The Durability of Response and Persistence of Resistance to AbbVie's 2 Direct-acting Antiviral Agent (2D) Therapy in Japanese Subjects
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 344
- 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
- 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)
Kurume University Hospital /ID# 152123
🇯🇵Kurume-shi, Fukuoka, Japan
Kawasaki Municipal Tama Hospit /ID# 153546
🇯🇵Kawasaki, Japan
Hiroshima University Hospital /ID# 152232
🇯🇵Hiroshima-shi, Hiroshima, Japan
Duplicate_Kanazawa University Hospital /ID# 152226
🇯🇵Kanazawa-shi, Ishikawa, Japan
JP Red Cross Musashino Hosp /ID# 152175
🇯🇵Tokyo, Japan
Kawasaki Hosp, Kawasaki Med /ID# 152180
🇯🇵Okayama, Japan
Jichi Medical University Hospital /ID# 153018
🇯🇵Shimotsuke-shi, Tochigi, Japan
Saitama Medical University Hospital /ID# 153544
🇯🇵Iruma-gun, Saitama, Japan
Nagoya City University Hospital /ID# 157439
🇯🇵Nagoya-shi, Aichi, Japan
Fukuoka University Hospital /ID# 155965
🇯🇵Fukuoka-shi, Fukuoka, Japan
Ogaki Municipal Hospital /ID# 158105
🇯🇵Ogaki-shi, Gifu, Japan
Toyama Prefectural Central Hospital /ID# 164156
🇯🇵Toyama-shi, Toyama, Japan
Kumamoto Shinto General Hospital /ID# 150061
🇯🇵Kumamoto-shi, Kumamoto, Japan
Asakura Medical Association Ho /ID# 155963
🇯🇵Asakura, Japan
Japanese Red Cross Osaka Hospital /ID# 155964
🇯🇵Osaka-shi, Osaka, Japan
Fukuiken Saiseikai Hospital /ID# 162898
🇯🇵Fukui, Japan
Nippon Med Chiba Hokusoh Hosp /ID# 164155
🇯🇵Inzai, Japan
Hitachi General Hospital /ID# 160800
🇯🇵Hitachi-shi, Ibaraki, Japan
Duplicate_Yokohama City University Medical Center /ID# 159474
🇯🇵Yokohama-shi, Kanagawa, Japan
Kagoshima Uni Med and Dental /ID# 157438
🇯🇵Kagoshima, Japan
Saiseikai Suita Hospital /ID# 153549
🇯🇵Suita, Japan
Osaka Hospital /ID# 152177
🇯🇵Osaka, Japan
Toranomon Hospital /ID# 152124
🇯🇵Minato-ku, Tokyo, Japan
Kagawa University Hospital /ID# 153548
🇯🇵Kita-gun, Kagawa, Japan
Yokohama City University Hospital /ID# 165252
🇯🇵Yokohama-shi, Kanagawa, Japan
The University of Tokyo Hospital /ID# 158121
🇯🇵Bunkyo-ku, Tokyo, Japan
Ehime Prefectural Central Hosp /ID# 158106
🇯🇵Matsuyama, Japan
University of Yamanashi Hospital /ID# 153547
🇯🇵Chuo-shi, Yamanashi, Japan
Japanese Red Cross Saitama Hos /ID# 166898
🇯🇵Saitama, Japan
Oita University Hospital /ID# 165274
🇯🇵Yufu-shi, Japan
Matsuyama Red Cross Hospital /ID# 152125
🇯🇵Matsuyama-shi, Ehime, Japan
National Hospital Organization Kyushu Medical Center /ID# 161759
🇯🇵Fukuoka-shi, Fukuoka, 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
Obihiro kosei Hospital /ID# 157437
🇯🇵Obihiro-shi, Hokkaido, Japan
Tokyo Med Uni Ibaraki Med Ctr /ID# 152127
🇯🇵Inashiki, Japan
Gifu Municipal Hospital /ID# 152227
🇯🇵Gifu, Japan
Okayama University Hospital /ID# 150060
🇯🇵Okayama-shi, Okayama, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 153019
🇯🇵Sapporo-shi, Hokkaido, Japan
Osaka City General Hospital /ID# 152126
🇯🇵Osaka-shi, Osaka, Japan
Saga University Hospital /ID# 161757
🇯🇵Saga-shi, Saga, Japan
Dokkyo Medical University Hospital /ID# 152225
🇯🇵Shimotsuga-gun, Tochigi, Japan
Yamaguchi University Hospital /ID# 166899
🇯🇵Ube-shi, Yamaguchi, Japan
Gifu Prefectural Genl Med Ctr /ID# 154796
🇯🇵Gifu, Japan
Toranomon Hospital Kajigaya /ID# 152129
🇯🇵Kawasaki, Japan
Hamamatsu University Hospital /ID# 152176
🇯🇵Hamamatsu-shi, Shizuoka, Japan
Toshiba General Hospital /ID# 152122
🇯🇵Tokyo, Japan
Ikeda Municipal Hospital /ID# 150062
🇯🇵Ikeda, Japan
Kagawa Prefectural Central Hos /ID# 152179
🇯🇵Takamatsu, Japan
Nat Hosp Org Minami Wakayama /ID# 153550
🇯🇵Tanabe, Japan
Juntendo University Hospital /ID# 153545
🇯🇵Bunkyo-ku, Tokyo, Japan
Kitasato University Kitasato Institute Hospital /ID# 152145
🇯🇵Minato-ku, Tokyo, Japan