Hepatitis C Virus Clinical Trial
Official title:
A Follow-up Study to Assess the Durability of Response and Persistence of Resistance to AbbVie's 2 Direct-acting Antiviral Agent (2D) Therapy in Japanese Subjects Who Participated in Phase 2 or 3 Clinical Studies for the Treatment of Chronic Hepatitis C Virus (HCV) Infection
| NCT number | NCT02581020 |
| Other study ID # | P15-349 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 14, 2016 |
| Est. completion date | December 8, 2020 |
| Verified date | January 2021 |
| Source | AbbVie |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 344 |
| Est. completion date | December 8, 2020 |
| Est. primary completion date | December 8, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Asakura Medical Association Ho /ID# 155963 | Asakura | |
| Japan | Juntendo University Hospital /ID# 153545 | Bunkyo-ku | Tokyo |
| Japan | The University of Tokyo Hospital /ID# 158121 | Bunkyo-ku | Tokyo |
| Japan | University of Yamanashi Hospital /ID# 153547 | Chuo-shi | Yamanashi |
| Japan | Fukuiken Saiseikai Hospital /ID# 162898 | Fukui | |
| Japan | Fukuoka University Hospital /ID# 155965 | Fukuoka-shi | Fukuoka |
| Japan | National Hospital Organization Kyushu Medical Center /ID# 161759 | Fukuoka-shi | Fukuoka |
| Japan | Gifu Municipal Hospital /ID# 152227 | Gifu | |
| Japan | Gifu Prefectural Genl Med Ctr /ID# 154796 | Gifu | |
| Japan | Hamamatsu University Hospital /ID# 152176 | Hamamatsu-shi | Shizuoka |
| 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 | Hitachi General Hospital /ID# 160800 | Hitachi-shi | Ibaraki |
| Japan | Ikeda Municipal Hospital /ID# 150062 | Ikeda | |
| Japan | Tokyo Med Uni Ibaraki Med Ctr /ID# 152127 | Inashiki | |
| Japan | Nippon Med Chiba Hokusoh Hosp /ID# 164155 | Inzai | |
| Japan | Saitama Medical University Hospital /ID# 153544 | Iruma-gun | Saitama |
| Japan | Kagoshima Uni Med and Dental /ID# 157438 | Kagoshima | |
| Japan | Duplicate_Kanazawa University Hospital /ID# 152226 | Kanazawa-shi | Ishikawa |
| Japan | Kawasaki Municipal Tama Hospit /ID# 153546 | Kawasaki | |
| Japan | Toranomon Hospital Kajigaya /ID# 152129 | Kawasaki | |
| Japan | Kagawa University Hospital /ID# 153548 | Kita-gun | Kagawa |
| Japan | Kumamoto Shinto General Hospital /ID# 150061 | Kumamoto-shi | Kumamoto |
| Japan | Kurume University Hospital /ID# 152123 | Kurume-shi | Fukuoka |
| Japan | Gunma University Hospital /ID# 158118 | Maebashi-shi | Gunma |
| Japan | Ehime Prefectural Central Hosp /ID# 158106 | Matsuyama | |
| Japan | Matsuyama Red Cross Hospital /ID# 152125 | Matsuyama-shi | Ehime |
| Japan | Kitasato University Kitasato Institute Hospital /ID# 152145 | Minato-ku | Tokyo |
| Japan | Toranomon Hospital /ID# 152124 | Minato-ku | Tokyo |
| Japan | Nagoya City University Hospital /ID# 157439 | Nagoya-shi | Aichi |
| Japan | Obihiro kosei Hospital /ID# 157437 | Obihiro-shi | Hokkaido |
| Japan | Ogaki Municipal Hospital /ID# 158105 | Ogaki-shi | Gifu |
| Japan | Kawasaki Hosp, Kawasaki Med /ID# 152180 | Okayama | |
| Japan | Okayama University Hospital /ID# 150060 | Okayama-shi | Okayama |
| Japan | Osaka Hospital /ID# 152177 | Osaka | |
| Japan | Japanese Red Cross Osaka Hospital /ID# 155964 | Osaka-shi | Osaka |
| Japan | Osaka City General Hospital /ID# 152126 | Osaka-shi | Osaka |
| Japan | Saga University Hospital /ID# 161757 | Saga-shi | Saga |
| Japan | Japanese Red Cross Saitama Hos /ID# 166898 | Saitama | |
| Japan | Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 153019 | Sapporo-shi | Hokkaido |
| Japan | Dokkyo Medical University Hospital /ID# 152225 | Shimotsuga-gun | Tochigi |
| Japan | Jichi Medical University Hospital /ID# 153018 | Shimotsuke-shi | Tochigi |
| Japan | Saiseikai Suita Hospital /ID# 153549 | Suita | |
| Japan | Kagawa Prefectural Central Hos /ID# 152179 | Takamatsu | |
| Japan | National Hospital Organization Takasaki General Medical Center /ID# 152128 | Takasaki-shi | Gunma |
| Japan | Nat Hosp Org Minami Wakayama /ID# 153550 | Tanabe | |
| Japan | JP Red Cross Musashino Hosp /ID# 152175 | Tokyo | |
| Japan | Toshiba General Hospital /ID# 152122 | Tokyo | |
| Japan | Toyama Prefectural Central Hospital /ID# 164156 | Toyama-shi | Toyama |
| Japan | Yamaguchi University Hospital /ID# 166899 | Ube-shi | Yamaguchi |
| Japan | Duplicate_Yokohama City University Medical Center /ID# 159474 | Yokohama-shi | Kanagawa |
| Japan | Yokohama City University Hospital /ID# 165252 | Yokohama-shi | Kanagawa |
| Japan | Oita University Hospital /ID# 165274 | Yufu-shi |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Hepatitis C virus ribonucleic acid (HCV RNA) levels | HCV RNA levels in plasma | 60 months after completion of the 2D treatment in M12-536 or M13-004 study | |
| Secondary | Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to Paritaprevir in Non-structural Viral Protein 3 (NS3) | For approximately 5 years | ||
| Secondary | Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to Ombitasvir in Non-structural Viral Protein 5A (NS5A) | For approximately 5 years | ||
| Secondary | Percentage of participants with hepatocellular carcinoma | Up to 60 month after completion of the 2D treatment in M12-536 or M13-004 | ||
| Secondary | Number of participants with serious adverse events (SAEs) | All serious adverse events will be monitored during the observation period. | Up to 60 month after completion of the 2D treatment in M132-536 or M13-004 study | |
| Secondary | Hepatitis C virus ribonucleic acid (HCV RNA) levels | HCV RNA levels in plasma | 18, 24, 30, 36, 42, 48, 52 months after completion of the 2D treatment in M12-536 or M13-004 study |
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