Clinical trial NCT02945228: Drug Use-Results Survey in Participants Infected With Hepatitis C Virus Genotype 2
Official title: Drug Use-Results Survey in Patients Infected With Hepatitis C Virus Genotype 2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis C Virus
Keywords: Genotype 2
Paritaprevir
Hepatitis C Virus (HCV)
Ritonavir
Ombitasvir
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2016-10-26
Enrollment: 449
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with Chronic hepatitis C virus (HCV) genotype 2

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.


Eligibility criteria: Inclusion Criteria:

* HCV genotype 2 participants treated with paritaprevir/ritonavir/ombitasvir plus ribavirin in daily practice.

Exclusion Criteria:

* Participants who have been previously treated with paritaprevir/ritonavir/ombitasvir and ribavirin.

Primary outcomes:
measure: Percentage of Participants with Sustained Virologic Response (SVR12)
timeFrame: 12 weeks after last dose of study drug.
Secondary outcomes:
measure: Percentage of Participants with Virologic Failure During Treatment (breakthrough)
timeFrame: Up to 12 Weeks
measure: Percentage of Participants with Virologic Failure After Treatment (relapse)
timeFrame: Post-treatment 24 weeks
measure: Percentage of Participants with Sustained Virologic Response (SVR24)
timeFrame: 24 weeks after the last dose of study drug
Other outcomes:
Locations:
city: Nagakute
country: Japan
facility: Aichi Medical University Hosp /ID# 161892
state: Aichi
city: Matsuyama
country: Japan
facility: Matsuyama Red Cross Hosp /ID# 162953
state: Ehime
city: Fukuoka-shi
country: Japan
facility: NHO Kyushu Medical Center /ID# 162956
state: Fukuoka
city: Kurume-shi
country: Japan
facility: Kurume University Hospital /ID# 164158
state: Fukuoka
city: Fujioka
country: Japan
facility: Kusunoki Hospital /ID# 158119
state: Gunma
city: Takasaki-shi
country: Japan
facility: National Hospital Organization Takasaki General Medical Center /ID# 160877
state: Gunma
city: Fukuyama-shi
country: Japan
facility: NHO Fukuyama Medical Center /ID# 162909
state: Hiroshima
city: Fukuyama-shi
country: Japan
facility: Fukuyama City Hospital /ID# 161889
state: Hiroshima
city: Nishinomiya-shi
country: Japan
facility: The Hospital of Hyogo College of Medicine /ID# 162913
state: Hyogo
city: Kagoshima-shi
country: Japan
facility: Nanpuh Hospital /ID# 168348
state: Kagoshima
city: Kawasaki
country: Japan
facility: St. Marianna University School of Medicine Hospital /ID# 160876
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City Univ Medical Ctr /ID# 162905
state: Kanagawa
city: Kumamoto-shi
country: Japan
facility: Kumamoto University Hospital /ID# 167048
state: Kumamoto
city: Kumamoto-shi
country: Japan
facility: Kumamoto Shinto General Hospital /ID# 165275
state: Kumamoto
city: Okayama-shi
country: Japan
facility: Okayama University Hospital /ID# 165268
state: Okayama
city: Osaka-shi
country: Japan
facility: Osaka Red Cross Hospital /ID# 161888
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka City University Hospital /ID# 165290
state: Osaka
city: Osaka-shi
country: Japan
facility: Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 167688
state: Osaka
city: Takatsuki -shi
country: Japan
facility: Osaka Medical College Hospital /ID# 162908
state: Osaka
city: Kawagoe-shi
country: Japan
facility: Saitama Medical Center, Saitama Medical University /ID# 162911
state: Saitama
city: Koshigaya
country: Japan
facility: Dokkyo Medical University Saitama Medical Center /ID# 162907
state: Saitama
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital /ID# 171048
state: Shizuoka
city: Komae-shi
country: Japan
facility: Tokyo Jikei Daisan Hospital /ID# 164159
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Women's Medical University Hospital /ID# 167685
state: Tokyo
city: Chuo-shi
country: Japan
facility: University of Yamanashi Hospital /ID# 161770
state: Yamanashi
city: Amagasaki, Hyogo
country: Japan
facility: Kato Michio Hepatology Clinic /ID# 159476
city: Aomori-shi
country: Japan
facility: Aomori Prefectural Central Hos /ID# 160822
city: Arida
country: Japan
facility: Mantani Clinic /ID# 168353
city: Asahikawa-shi
country: Japan
facility: Asahikawa City Hospital /ID# 167703
city: Asahikawa
country: Japan
facility: Japanese Red Cross Asahikawa /ID# 165265
city: Chiba
country: Japan
facility: National Hospital Organization /ID# 168346
city: Chiba
country: Japan
facility: Chiba University Hospital /ID# 160875
city: Chiba
country: Japan
facility: Seirei Sakura Citizen Hospital /ID# 166896
city: Chichibu
country: Japan
facility: Kenseido-iin /ID# 164166
city: Fuji
country: Japan
facility: Fuji City General Hospital /ID# 165278
city: Fukui
country: Japan
facility: Fukui Prefectural Hospital /ID# 168344
city: Fukui
country: Japan
facility: Fukui Prefectural Hospital /ID# 169552
city: Fukui
country: Japan
facility: University of Fukui Hospital /ID# 166933
city: Fukuoka
country: Japan
facility: Chihaya Hospital /ID# 161893
city: Fukuyama
country: Japan
facility: Morichika Internal Medicine /ID# 168351
city: Gifu
country: Japan
facility: Gifu Municipal Hospital /ID# 165287
city: Habikino-osaka
country: Japan
facility: Shiroyama Hospital /ID# 164963
city: Hachinohe
country: Japan
facility: Aomori Rosai Hospital /ID# 167702
city: Hamamatsu
country: Japan
facility: Tamakoshi Clinic /ID# 165282
city: Higashihiroshima
country: Japan
facility: Higashihiroshima Medical Ctr /ID# 168343
city: Higashiibaraki-gun
country: Japan
facility: Mito Medical Center /ID# 171046
city: Higashiomi, Shiga
country: Japan
facility: Higashiomicity Notogawa Hosp /ID# 161891
city: Higashiosaka
country: Japan
facility: Shin-ishikiri Clinic /ID# 169643
city: Higashiosaka
country: Japan
facility: Wakakusa Daiichi Hospital /ID# 166882
city: Hiroshima
country: Japan
facility: Hiroshima Red Cross Hosp Atomi /ID# 162912
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital /ID# 160815
city: Hiroshima
country: Japan
facility: Hiroshima-Nishi Medical Center /ID# 169642
city: Hiroshima
country: Japan
facility: Koyo New Town Hospital /ID# 161890
city: Hyogo
country: Japan
facility: Taishi Hospital /ID# 165291
city: Iizuka
country: Japan
facility: Iizuka Hospital /ID# 161886
city: Ikeda
country: Japan
facility: Ikeda Municipal Hospital /ID# 160814
city: Inashiki
country: Japan
facility: Tokyo Med Uni Ibaraki Med Ctr /ID# 162955
city: Inzai
country: Japan
facility: Nippon Med Chiba Hokusoh Hosp /ID# 162902
city: Iruma-gun
country: Japan
facility: Saitama Medical University Hos /ID# 161768
city: Itoigawa
country: Japan
facility: Itoigawa Sogo Hospital /ID# 166884
city: Iwade
country: Japan
facility: Kamiiwade Internal Med-Neuro /ID# 166881
city: Kaizuka
country: Japan
facility: Kaizuka City Hospital /ID# 165256
city: Kamisu
country: Japan
facility: Kamisu Saiseikai Hospital /ID# 167701
city: Kanagawa
country: Japan
facility: Kiyokawa Hospital /ID# 164961
city: Kanagawa
country: Japan
facility: Hiratsuka City Hospital /ID# 161884
city: Kanagawa
country: Japan
facility: Niwa Hospital /ID# 167684
city: Kanonji
country: Japan
facility: Fuji Clinic /ID# 160820
city: Kasama
country: Japan
facility: Ibaraki Prefectural Cent. Hosp /ID# 164962
city: Kashiwa-shi
country: Japan
facility: The Jikei Univ. Kashiwa Hosp. /ID# 166888
city: Kashiwazaki
country: Japan
facility: Kashiwazaki General Hospital a /ID# 168352
city: Kasugai
country: Japan
facility: Kawase Clinic /ID# 164957
city: Kawagoe
country: Japan
facility: Hirose Clinic /ID# 167699
city: Kawagoe
country: Japan
facility: Sekishindo Hospital /ID# 162960
city: Kawaguchi
country: Japan
facility: Kawaguchi Municipal Medical Ce /ID# 165270
city: Kawasaki-shi, Kanagawa
country: Japan
facility: Kanto Rosai Hospital /ID# 165258
city: Kawasaki
country: Japan
facility: Kawasaki Municipal Tama Hospit /ID# 165267
city: Kishiwada, Osaka
country: Japan
facility: Kishiwada Tokushukai Hospital /ID# 164964
city: Kitakyusyu
country: Japan
facility: Kokura Kinen Hospital /ID# 164969
city: Kitamoto
country: Japan
facility: Kitasato University Medical Ce /ID# 158120
city: Kobe
country: Japan
facility: Kobe Asahi Hospital /ID# 161896
city: Kobe
country: Japan
facility: Kobe Adventist Hospital /ID# 161897
city: Konan-shi
country: Japan
facility: Konan Kosei Hospital /ID# 165277
city: Koriyama
country: Japan
facility: Cosmos Clinic /ID# 164161
city: Koriyama
country: Japan
facility: Ishida Medical Clinic /ID# 166887
city: Koshigaya, Saitam
country: Japan
facility: Hanada Internal Medicine Clin /ID# 165266
city: Kurashiki
country: Japan
facility: Kawasaki Medical School Hosp /ID# 162906
city: Kure, Hiroshima
country: Japan
facility: National Hosp Org Kure Med Cen /ID# 167689
city: Kurihara
country: Japan
facility: Kurihara Central Hospital /ID# 171047
city: Kuroishi-aomori
country: Japan
facility: Kuroishi Hospital /ID# 164971
city: Kurume
country: Japan
facility: Shin Koga Clinic /ID# 164972
city: Kurume
country: Japan
facility: Koga Hospital 21 /ID# 167698
city: Kushiro
country: Japan
facility: Hori Internal Medicine Clinic /ID# 167696
city: Kyoto
country: Japan
facility: NHO Kyoto Medical Center /ID# 162910
city: Kyoto
country: Japan
facility: Matsuzaki Internal Medicine Cl /ID# 164970
city: Matsumoto
country: Japan
facility: Gibo Hepatorogy Clinic /ID# 161766
city: Minokamo
country: Japan
facility: Kizawa Memorial Hospital /ID# 162957
city: Mito
country: Japan
facility: Sumiyoshi Clinic Hospital /ID# 164163
city: Miyagi
country: Japan
facility: South Miyagi Medical Center /ID# 164965
city: Miyakonojo
country: Japan
facility: National Hospital Organization /ID# 168345
city: Miyazaki-shi
country: Japan
facility: University of Miyazaki Hosp /ID# 166880
city: Miyazaki
country: Japan
facility: Miyazaki Medical Center Hospit /ID# 165279
city: Moriguchi-shi
country: Japan
facility: Matsushita Memorial Hospital /ID# 167693
city: Nagareyama
country: Japan
facility: Suzuki Clinic /ID# 165264
city: Nagoya-aichi
country: Japan
facility: Meijo Hospital /ID# 164966
city: Nagoya-shi
country: Japan
facility: Nagoya Central Hospital /ID# 166879
city: Nagoya
country: Japan
facility: Meitetsu Hospital /ID# 165288
city: Nagoya
country: Japan
facility: Aikawa Minnano-shinryojo /ID# 164168
city: Nara
country: Japan
facility: Nara City Hospital /ID# 162959
city: Nayoro
country: Japan
facility: Tani Internal Medicine Clinic /ID# 164974
city: Nishinomiya
country: Japan
facility: Ooka Clinic /ID# 161887
city: Noshiro
country: Japan
facility: Noshiro Yamamoto Med. Assoc. /ID# 162964
city: Odawara
country: Japan
facility: Manna Clinic /ID# 169548
city: Oita
country: Japan
facility: Oita Midical Center /ID# 164960
city: Okayama
country: Japan
facility: Okayama Saiseikai Outpatient Center Hospital /ID# 159475
city: Omuta
country: Japan
facility: Omuta City Hospital /ID# 164967
city: Onomichi
country: Japan
facility: Onomichi Central General Hospi /ID# 162903
city: ONO
country: Japan
facility: Kita-harima Medical Center /ID# 164165
city: Osaka
country: Japan
facility: Kenporen Osaka Central Hospita /ID# 164956
city: Osaka
country: Japan
facility: Asai Naika /ID# 167691
city: Osaka
country: Japan
facility: Osaka Inter. Cancer Institute /ID# 166889
city: Osaka
country: Japan
facility: Osaka Police Hospital /ID# 161769
city: Osaka
country: Japan
facility: Asai Naika Iin /ID# 164955
city: Osaka
country: Japan
facility: Utajima Ueda Clinic /ID# 161894
city: Osaka
country: Japan
facility: Tamai Clinic /ID# 164162
city: Osaka
country: Japan
facility: Osaka Hospital /ID# 164157
city: Otsu
country: Japan
facility: Seko Internal Medicine Clinic /ID# 164169
city: Saga
country: Japan
facility: Kawazoe Internal Medicine Clin /ID# 165292
city: Saitama
country: Japan
facility: Saitama Citizens Medical Ctr /ID# 169550
city: Saitama
country: Japan
facility: Sainokuni Higashiomiya Medical /ID# 167700
city: Saitama
country: Japan
facility: Honda Internal Clinic /ID# 161767
city: Saitama
country: Japan
facility: Saitama Cooperative Hospital /ID# 167697
city: Sakai
country: Japan
facility: Minamitani Clinic /ID# 160821
city: Sapporo
country: Japan
facility: Kaisei Hospital /ID# 164973
city: Sendai
country: Japan
facility: Sendai Kousei Hospital /ID# 162961
city: Shiogama-miyagi
country: Japan
facility: Saka General Hospital /ID# 162962
city: Suita-osaka
country: Japan
facility: Suita Municipal Hospital /ID# 164958
city: Suita
country: Japan
facility: Saiseikai Suita Hospital /ID# 165289
city: Takamatsu
country: Japan
facility: Kagawa Prefectural Central Hos /ID# 160816
city: Takaraduka
country: Japan
facility: Sawada Hepatology & Gastro /ID# 165255
city: Takatsuki
country: Japan
facility: Tenjin Tanaka Internal Medicin /ID# 166883
city: Tatebayashi
country: Japan
facility: Hamada Clinic /ID# 171045
city: Toda-shi, Saitama
country: Japan
facility: Todachuo General Hospital /ID# 165280
city: Togane, Chiba
country: Japan
facility: Eastern Chiba Medical Center /ID# 165257
city: Tokorozawa
country: Japan
facility: Delta Clinic /ID# 164167
city: Tokyo
country: Japan
facility: The Jikei University Hospital /ID# 169547
city: Tokyo
country: Japan
facility: Abbott Japan /ID# 144983
city: Tokyo
country: Japan
facility: Juntendo University Hospital /ID# 161771
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital /ID# 164164
city: Tokyo
country: Japan
facility: Tokyo Metropolitan Bokutoh Hos /ID# 167686
city: Tokyo
country: Japan
facility: Ohashi Medical Office /ID# 164968
city: Tokyo
country: Japan
facility: Juntendo Univ Nerima Hosp /ID# 164160
city: Tokyo
country: Japan
facility: JP Red Cross Musashino Hosp /ID# 162904
city: Toon
country: Japan
facility: Ehime University Hospital /ID# 161885
city: Toyoma
country: Japan
facility: Toyama University Hospital /ID# 169551
city: Toyonaka
country: Japan
facility: Toyonaka Municipal Hospital /ID# 167692
city: Tsu, Mie
country: Japan
facility: Mie Syokaki Clinic /ID# 161895
city: Utsunomiya
country: Japan
facility: Saiseikai Utsunomiya Hospital /ID# 162958
city: Uwajima
country: Japan
facility: Seike Clinic /ID# 166890
city: Wakayama-shi
country: Japan
facility: Wakayama Rosai Hospital /ID# 165254
city: Wakayama
country: Japan
facility: Saiseikai Wakayama Hospital /ID# 162954
city: Yachiyo
country: Japan
facility: Tokyo Women's Medical Universi /ID# 167694
city: Yamagata
country: Japan
facility: Tohoku Central Hospital /ID# 166897
city: Yamaguchi
country: Japan
facility: Okuda Gastrointestinal Medicin /ID# 168349
city: Yatomi-shi
country: Japan
facility: Kainan Hospital /ID# 164959
city: Yatsushiro-shi
country: Japan
facility: Kumamoto Rosai Hospital /ID# 167695
city: Yokkaichi
country: Japan
facility: Mie Prefectural General Medica /ID# 162963
city: Yokohama-shi
country: Japan
facility: Showa Univ Fujigaoka Hosp /ID# 162952
city: Yufu-shi
country: Japan
facility: Oita University Hospital /ID# 169549
city: Yugawara
country: Japan
facility: Yamaguchi Surgery Clinic /ID# 167704
city: Yuki
country: Japan
facility: Josai Hospital /ID# 168347
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: