Clinical trial NCT02581020: The Durability of Response and Persistence of Resistance to AbbVie's 2 Direct-acting Antiviral Agent (2D) Therapy in Japanese Subjects
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C Virus
Keywords: Hepatitis C
Follow-up
Observation
Japanese
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2015-10-20
Enrollment: 344
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who were treated in Study M12-536 or M13-004 with 2D regimen (ombitasvir/ paritaprevir/ritonavir) and completed 48 weeks of follow-up.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Hepatitis C virus ribonucleic acid (HCV RNA) levels
timeFrame: 60 months after completion of the 2D treatment in M12-536 or M13-004 study
Secondary outcomes:
measure: Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to Paritaprevir in Non-structural Viral Protein 3 (NS3)
timeFrame: For approximately 5 years
measure: Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to Ombitasvir in Non-structural Viral Protein 5A (NS5A)
timeFrame: For approximately 5 years
measure: Percentage of participants with hepatocellular carcinoma
timeFrame: Up to 60 month after completion of the 2D treatment in M12-536 or M13-004
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Up to 60 month after completion of the 2D treatment in M132-536 or M13-004 study
measure: Hepatitis C virus ribonucleic acid (HCV RNA) levels
timeFrame: 18, 24, 30, 36, 42, 48, 52 months after completion of the 2D treatment in M12-536 or M13-004 study
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
facility: Nagoya City University Hospital /ID# 157439
state: Aichi
city: Matsuyama-shi
country: Japan
facility: Matsuyama Red Cross Hospital /ID# 152125
state: Ehime
city: Fukuoka-shi
country: Japan
facility: National Hospital Organization Kyushu Medical Center /ID# 161759
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Fukuoka University Hospital /ID# 155965
state: Fukuoka
city: Kurume-shi
country: Japan
facility: Kurume University Hospital /ID# 152123
state: Fukuoka
city: Ogaki-shi
country: Japan
facility: Ogaki Municipal Hospital /ID# 158105
state: Gifu
city: Maebashi-shi
country: Japan
facility: Gunma University Hospital /ID# 158118
state: Gunma
city: Takasaki-shi
country: Japan
facility: National Hospital Organization Takasaki General Medical Center /ID# 152128
state: Gunma
city: Hiroshima-shi
country: Japan
facility: Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital /ID# 152178
state: Hiroshima
city: Hiroshima-shi
country: Japan
facility: Hiroshima University Hospital /ID# 152232
state: Hiroshima
city: Obihiro-shi
country: Japan
facility: Obihiro kosei Hospital /ID# 157437
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 153019
state: Hokkaido
city: Hitachi-shi
country: Japan
facility: Hitachi General Hospital /ID# 160800
state: Ibaraki
city: Kanazawa-shi
country: Japan
facility: Duplicate_Kanazawa University Hospital /ID# 152226
state: Ishikawa
city: Kita-gun
country: Japan
facility: Kagawa University Hospital /ID# 153548
state: Kagawa
city: Yokohama-shi
country: Japan
facility: Duplicate_Yokohama City University Medical Center /ID# 159474
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Yokohama City University Hospital /ID# 165252
state: Kanagawa
city: Kumamoto-shi
country: Japan
facility: Kumamoto Shinto General Hospital /ID# 150061
state: Kumamoto
city: Okayama-shi
country: Japan
facility: Okayama University Hospital /ID# 150060
state: Okayama
city: Osaka-shi
country: Japan
facility: Osaka City General Hospital /ID# 152126
state: Osaka
city: Osaka-shi
country: Japan
facility: Japanese Red Cross Osaka Hospital /ID# 155964
state: Osaka
city: Saga-shi
country: Japan
facility: Saga University Hospital /ID# 161757
state: Saga
city: Iruma-gun
country: Japan
facility: Saitama Medical University Hospital /ID# 153544
state: Saitama
city: Hamamatsu-shi
country: Japan
facility: Hamamatsu University Hospital /ID# 152176
state: Shizuoka
city: Shimotsuga-gun
country: Japan
facility: Dokkyo Medical University Hospital /ID# 152225
state: Tochigi
city: Shimotsuke-shi
country: Japan
facility: Jichi Medical University Hospital /ID# 153018
state: Tochigi
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital /ID# 153545
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: The University of Tokyo Hospital /ID# 158121
state: Tokyo
city: Minato-ku
country: Japan
facility: Toranomon Hospital /ID# 152124
state: Tokyo
city: Minato-ku
country: Japan
facility: Kitasato University Kitasato Institute Hospital /ID# 152145
state: Tokyo
city: Toyama-shi
country: Japan
facility: Toyama Prefectural Central Hospital /ID# 164156
state: Toyama
city: Ube-shi
country: Japan
facility: Yamaguchi University Hospital /ID# 166899
state: Yamaguchi
city: Chuo-shi
country: Japan
facility: University of Yamanashi Hospital /ID# 153547
state: Yamanashi
city: Asakura
country: Japan
facility: Asakura Medical Association Ho /ID# 155963
city: Fukui
country: Japan
facility: Fukuiken Saiseikai Hospital /ID# 162898
city: Gifu
country: Japan
facility: Gifu Municipal Hospital /ID# 152227
city: Gifu
country: Japan
facility: Gifu Prefectural Genl Med Ctr /ID# 154796
city: Ikeda
country: Japan
facility: Ikeda Municipal Hospital /ID# 150062
city: Inashiki
country: Japan
facility: Tokyo Med Uni Ibaraki Med Ctr /ID# 152127
city: Inzai
country: Japan
facility: Nippon Med Chiba Hokusoh Hosp /ID# 164155
city: Kagoshima
country: Japan
facility: Kagoshima Uni Med and Dental /ID# 157438
city: Kawasaki
country: Japan
facility: Toranomon Hospital Kajigaya /ID# 152129
city: Kawasaki
country: Japan
facility: Kawasaki Municipal Tama Hospit /ID# 153546
city: Matsuyama
country: Japan
facility: Ehime Prefectural Central Hosp /ID# 158106
city: Okayama
country: Japan
facility: Kawasaki Hosp, Kawasaki Med /ID# 152180
city: Osaka
country: Japan
facility: Osaka Hospital /ID# 152177
city: Saitama
country: Japan
facility: Japanese Red Cross Saitama Hos /ID# 166898
city: Suita
country: Japan
facility: Saiseikai Suita Hospital /ID# 153549
city: Takamatsu
country: Japan
facility: Kagawa Prefectural Central Hos /ID# 152179
city: Tanabe
country: Japan
facility: Nat Hosp Org Minami Wakayama /ID# 153550
city: Tokyo
country: Japan
facility: Toshiba General Hospital /ID# 152122
city: Tokyo
country: Japan
facility: JP Red Cross Musashino Hosp /ID# 152175
city: Yufu-shi
country: Japan
facility: Oita University Hospital /ID# 165274
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: