MedPath

Drug Use-Results Survey in Participants Infected With Hepatitis C Virus Genotype 2

Completed
Conditions
Chronic Hepatitis C Virus
Registration Number
NCT02945228
Lead Sponsor
AbbVie
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
449
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Percentage of Participants with Sustained Virologic Response (SVR12)12 weeks after last dose of study drug.

Hepatitis C virus (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last dose of study drug.

Secondary Outcome Measures
NameTimeMethod
Percentage of Participants with Virologic Failure After Treatment (relapse)Post-treatment 24 weeks

Undetectable viremia (HCV RNA less than LLOQ) at the end of the 16 weeks treatment but subsequent viremia (HCV RNA greater than or equal to LLOQ) during the follow-up period of 24 weeks after treatment.

Percentage of Participants with Virologic Failure During Treatment (breakthrough)Up to 12 Weeks

HCV RNA levels reach less than the LLOQ, then increase to greater than or equal to the LLOQ at any point during treatment.

Percentage of Participants with Sustained Virologic Response (SVR24)24 weeks after the last dose of study drug

HCV RNA less than the LLOQ 24 weeks after the last dose of study drug.

Trial Locations

Locations (170)

Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 167688

🇯🇵

Osaka-shi, Osaka, Japan

Osaka Medical College Hospital /ID# 162908

🇯🇵

Takatsuki -shi, Osaka, Japan

Osaka Red Cross Hospital /ID# 161888

🇯🇵

Osaka-shi, Osaka, Japan

Osaka City University Hospital /ID# 165290

🇯🇵

Osaka-shi, Osaka, Japan

Aichi Medical University Hosp /ID# 161892

🇯🇵

Nagakute, Aichi, Japan

Matsuyama Red Cross Hosp /ID# 162953

🇯🇵

Matsuyama, Ehime, Japan

NHO Kyushu Medical Center /ID# 162956

🇯🇵

Fukuoka-shi, Fukuoka, Japan

National Hospital Organization Takasaki General Medical Center /ID# 160877

🇯🇵

Takasaki-shi, Gunma, Japan

Kusunoki Hospital /ID# 158119

🇯🇵

Fujioka, Gunma, Japan

Fukuyama City Hospital /ID# 161889

🇯🇵

Fukuyama-shi, Hiroshima, Japan

The Hospital of Hyogo College of Medicine /ID# 162913

🇯🇵

Nishinomiya-shi, Hyogo, Japan

Nanpuh Hospital /ID# 168348

🇯🇵

Kagoshima-shi, Kagoshima, Japan

Yokohama City Univ Medical Ctr /ID# 162905

🇯🇵

Yokohama, Kanagawa, Japan

St. Marianna University School of Medicine Hospital /ID# 160876

🇯🇵

Kawasaki, Kanagawa, Japan

Okayama University Hospital /ID# 165268

🇯🇵

Okayama-shi, Okayama, Japan

Kumamoto University Hospital /ID# 167048

🇯🇵

Kumamoto-shi, Kumamoto, Japan

Kumamoto Shinto General Hospital /ID# 165275

🇯🇵

Kumamoto-shi, Kumamoto, Japan

Saitama Medical Center, Saitama Medical University /ID# 162911

🇯🇵

Kawagoe-shi, Saitama, Japan

Dokkyo Medical University Saitama Medical Center /ID# 162907

🇯🇵

Koshigaya, Saitama, Japan

Tokyo Jikei Daisan Hospital /ID# 164159

🇯🇵

Komae-shi, Tokyo, Japan

Hamamatsu University Hospital /ID# 171048

🇯🇵

Hamamatsu, Shizuoka, Japan

University of Yamanashi Hospital /ID# 161770

🇯🇵

Chuo-shi, Yamanashi, Japan

Aomori Prefectural Central Hos /ID# 160822

🇯🇵

Aomori-shi, Japan

Kato Michio Hepatology Clinic /ID# 159476

🇯🇵

Amagasaki, Hyogo, Japan

Mantani Clinic /ID# 168353

🇯🇵

Arida, Japan

Asahikawa City Hospital /ID# 167703

🇯🇵

Asahikawa-shi, Japan

National Hospital Organization /ID# 168346

🇯🇵

Chiba, Japan

Japanese Red Cross Asahikawa /ID# 165265

🇯🇵

Asahikawa, Japan

Chiba University Hospital /ID# 160875

🇯🇵

Chiba, Japan

Seirei Sakura Citizen Hospital /ID# 166896

🇯🇵

Chiba, Japan

Kenseido-iin /ID# 164166

🇯🇵

Chichibu, Japan

Fuji City General Hospital /ID# 165278

🇯🇵

Fuji, Japan

Fukui Prefectural Hospital /ID# 168344

🇯🇵

Fukui, Japan

Fukui Prefectural Hospital /ID# 169552

🇯🇵

Fukui, Japan

University of Fukui Hospital /ID# 166933

🇯🇵

Fukui, Japan

Chihaya Hospital /ID# 161893

🇯🇵

Fukuoka, Japan

Morichika Internal Medicine /ID# 168351

🇯🇵

Fukuyama, Japan

Gifu Municipal Hospital /ID# 165287

🇯🇵

Gifu, Japan

Shiroyama Hospital /ID# 164963

🇯🇵

Habikino-osaka, Japan

Tamakoshi Clinic /ID# 165282

🇯🇵

Hamamatsu, Japan

Aomori Rosai Hospital /ID# 167702

🇯🇵

Hachinohe, Japan

Higashihiroshima Medical Ctr /ID# 168343

🇯🇵

Higashihiroshima, Japan

Mito Medical Center /ID# 171046

🇯🇵

Higashiibaraki-gun, Japan

Hiroshima-Nishi Medical Center /ID# 169642

🇯🇵

Hiroshima, Japan

Wakakusa Daiichi Hospital /ID# 166882

🇯🇵

Higashiosaka, Japan

Hiroshima Red Cross Hosp Atomi /ID# 162912

🇯🇵

Hiroshima, Japan

Higashiomicity Notogawa Hosp /ID# 161891

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Higashiomi, Shiga, Japan

Shin-ishikiri Clinic /ID# 169643

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Higashiosaka, Japan

Hiroshima University Hospital /ID# 160815

🇯🇵

Hiroshima, Japan

Koyo New Town Hospital /ID# 161890

🇯🇵

Hiroshima, Japan

Taishi Hospital /ID# 165291

🇯🇵

Hyogo, Japan

Nippon Med Chiba Hokusoh Hosp /ID# 162902

🇯🇵

Inzai, Japan

Tokyo Med Uni Ibaraki Med Ctr /ID# 162955

🇯🇵

Inashiki, Japan

Iizuka Hospital /ID# 161886

🇯🇵

Iizuka, Japan

Ikeda Municipal Hospital /ID# 160814

🇯🇵

Ikeda, Japan

Itoigawa Sogo Hospital /ID# 166884

🇯🇵

Itoigawa, Japan

Saitama Medical University Hos /ID# 161768

🇯🇵

Iruma-gun, Japan

Kamisu Saiseikai Hospital /ID# 167701

🇯🇵

Kamisu, Japan

Kamiiwade Internal Med-Neuro /ID# 166881

🇯🇵

Iwade, Japan

Kiyokawa Hospital /ID# 164961

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Kanagawa, Japan

Niwa Hospital /ID# 167684

🇯🇵

Kanagawa, Japan

Fuji Clinic /ID# 160820

🇯🇵

Kanonji, Japan

Kashiwazaki General Hospital a /ID# 168352

🇯🇵

Kashiwazaki, Japan

The Jikei Univ. Kashiwa Hosp. /ID# 166888

🇯🇵

Kashiwa-shi, Japan

Kawase Clinic /ID# 164957

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Kasugai, Japan

Sekishindo Hospital /ID# 162960

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Kawagoe, Japan

Hirose Clinic /ID# 167699

🇯🇵

Kawagoe, Japan

Kawaguchi Municipal Medical Ce /ID# 165270

🇯🇵

Kawaguchi, Japan

Kanto Rosai Hospital /ID# 165258

🇯🇵

Kawasaki-shi, Kanagawa, Japan

Kawasaki Municipal Tama Hospit /ID# 165267

🇯🇵

Kawasaki, Japan

Kishiwada Tokushukai Hospital /ID# 164964

🇯🇵

Kishiwada, Osaka, Japan

Kokura Kinen Hospital /ID# 164969

🇯🇵

Kitakyusyu, Japan

Kitasato University Medical Ce /ID# 158120

🇯🇵

Kitamoto, Japan

Kobe Asahi Hospital /ID# 161896

🇯🇵

Kobe, Japan

Kobe Adventist Hospital /ID# 161897

🇯🇵

Kobe, Japan

Konan Kosei Hospital /ID# 165277

🇯🇵

Konan-shi, Japan

Ishida Medical Clinic /ID# 166887

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Koriyama, Japan

Cosmos Clinic /ID# 164161

🇯🇵

Koriyama, Japan

National Hosp Org Kure Med Cen /ID# 167689

🇯🇵

Kure, Hiroshima, Japan

Hanada Internal Medicine Clin /ID# 165266

🇯🇵

Koshigaya, Saitam, Japan

Kawasaki Medical School Hosp /ID# 162906

🇯🇵

Kurashiki, Japan

Kuroishi Hospital /ID# 164971

🇯🇵

Kuroishi-aomori, Japan

Kurihara Central Hospital /ID# 171047

🇯🇵

Kurihara, Japan

Shin Koga Clinic /ID# 164972

🇯🇵

Kurume, Japan

Koga Hospital 21 /ID# 167698

🇯🇵

Kurume, Japan

Hori Internal Medicine Clinic /ID# 167696

🇯🇵

Kushiro, Japan

NHO Kyoto Medical Center /ID# 162910

🇯🇵

Kyoto, Japan

Matsuzaki Internal Medicine Cl /ID# 164970

🇯🇵

Kyoto, Japan

South Miyagi Medical Center /ID# 164965

🇯🇵

Miyagi, Japan

Sumiyoshi Clinic Hospital /ID# 164163

🇯🇵

Mito, Japan

Gibo Hepatorogy Clinic /ID# 161766

🇯🇵

Matsumoto, Japan

Kizawa Memorial Hospital /ID# 162957

🇯🇵

Minokamo, Japan

Matsushita Memorial Hospital /ID# 167693

🇯🇵

Moriguchi-shi, Japan

National Hospital Organization /ID# 168345

🇯🇵

Miyakonojo, Japan

Suzuki Clinic /ID# 165264

🇯🇵

Nagareyama, Japan

University of Miyazaki Hosp /ID# 166880

🇯🇵

Miyazaki-shi, Japan

Miyazaki Medical Center Hospit /ID# 165279

🇯🇵

Miyazaki, Japan

Meijo Hospital /ID# 164966

🇯🇵

Nagoya-aichi, Japan

Nagoya Central Hospital /ID# 166879

🇯🇵

Nagoya-shi, Japan

Meitetsu Hospital /ID# 165288

🇯🇵

Nagoya, Japan

Aikawa Minnano-shinryojo /ID# 164168

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Nagoya, Japan

Nara City Hospital /ID# 162959

🇯🇵

Nara, Japan

Tani Internal Medicine Clinic /ID# 164974

🇯🇵

Nayoro, Japan

Ooka Clinic /ID# 161887

🇯🇵

Nishinomiya, Japan

Noshiro Yamamoto Med. Assoc. /ID# 162964

🇯🇵

Noshiro, Japan

Manna Clinic /ID# 169548

🇯🇵

Odawara, Japan

Omuta City Hospital /ID# 164967

🇯🇵

Omuta, Japan

Onomichi Central General Hospi /ID# 162903

🇯🇵

Onomichi, Japan

Okayama Saiseikai Outpatient Center Hospital /ID# 159475

🇯🇵

Okayama, Japan

Kita-harima Medical Center /ID# 164165

🇯🇵

ONO, Japan

Kenporen Osaka Central Hospita /ID# 164956

🇯🇵

Osaka, Japan

Asai Naika /ID# 167691

🇯🇵

Osaka, Japan

Tamai Clinic /ID# 164162

🇯🇵

Osaka, Japan

Osaka Police Hospital /ID# 161769

🇯🇵

Osaka, Japan

Asai Naika Iin /ID# 164955

🇯🇵

Osaka, Japan

Osaka Inter. Cancer Institute /ID# 166889

🇯🇵

Osaka, Japan

Utajima Ueda Clinic /ID# 161894

🇯🇵

Osaka, Japan

Seko Internal Medicine Clinic /ID# 164169

🇯🇵

Otsu, Japan

Osaka Hospital /ID# 164157

🇯🇵

Osaka, Japan

Kawazoe Internal Medicine Clin /ID# 165292

🇯🇵

Saga, Japan

Saitama Citizens Medical Ctr /ID# 169550

🇯🇵

Saitama, Japan

Sainokuni Higashiomiya Medical /ID# 167700

🇯🇵

Saitama, Japan

Honda Internal Clinic /ID# 161767

🇯🇵

Saitama, Japan

Saitama Cooperative Hospital /ID# 167697

🇯🇵

Saitama, Japan

Minamitani Clinic /ID# 160821

🇯🇵

Sakai, Japan

Kaisei Hospital /ID# 164973

🇯🇵

Sapporo, Japan

Sendai Kousei Hospital /ID# 162961

🇯🇵

Sendai, Japan

Suita Municipal Hospital /ID# 164958

🇯🇵

Suita-osaka, Japan

Kagawa Prefectural Central Hos /ID# 160816

🇯🇵

Takamatsu, Japan

Saiseikai Suita Hospital /ID# 165289

🇯🇵

Suita, Japan

Sawada Hepatology & Gastro /ID# 165255

🇯🇵

Takaraduka, Japan

Hamada Clinic /ID# 171045

🇯🇵

Tatebayashi, Japan

Tenjin Tanaka Internal Medicin /ID# 166883

🇯🇵

Takatsuki, Japan

Eastern Chiba Medical Center /ID# 165257

🇯🇵

Togane, Chiba, Japan

Delta Clinic /ID# 164167

🇯🇵

Tokorozawa, Japan

The Jikei University Hospital /ID# 169547

🇯🇵

Tokyo, Japan

Abbott Japan /ID# 144983

🇯🇵

Tokyo, Japan

Nippon Medical School Hospital /ID# 164164

🇯🇵

Tokyo, Japan

Tokyo Metropolitan Bokutoh Hos /ID# 167686

🇯🇵

Tokyo, Japan

Juntendo University Hospital /ID# 161771

🇯🇵

Tokyo, Japan

Ohashi Medical Office /ID# 164968

🇯🇵

Tokyo, Japan

Juntendo Univ Nerima Hosp /ID# 164160

🇯🇵

Tokyo, Japan

Ehime University Hospital /ID# 161885

🇯🇵

Toon, Japan

JP Red Cross Musashino Hosp /ID# 162904

🇯🇵

Tokyo, Japan

Toyama University Hospital /ID# 169551

🇯🇵

Toyoma, Japan

Toyonaka Municipal Hospital /ID# 167692

🇯🇵

Toyonaka, Japan

Saiseikai Wakayama Hospital /ID# 162954

🇯🇵

Wakayama, Japan

Seike Clinic /ID# 166890

🇯🇵

Uwajima, Japan

Saiseikai Utsunomiya Hospital /ID# 162958

🇯🇵

Utsunomiya, Japan

Tokyo Women's Medical Universi /ID# 167694

🇯🇵

Yachiyo, Japan

Tohoku Central Hospital /ID# 166897

🇯🇵

Yamagata, Japan

Okuda Gastrointestinal Medicin /ID# 168349

🇯🇵

Yamaguchi, Japan

Kainan Hospital /ID# 164959

🇯🇵

Yatomi-shi, Japan

Showa Univ Fujigaoka Hosp /ID# 162952

🇯🇵

Yokohama-shi, Japan

Kumamoto Rosai Hospital /ID# 167695

🇯🇵

Yatsushiro-shi, Japan

Mie Prefectural General Medica /ID# 162963

🇯🇵

Yokkaichi, Japan

Oita University Hospital /ID# 169549

🇯🇵

Yufu-shi, Japan

Yamaguchi Surgery Clinic /ID# 167704

🇯🇵

Yugawara, Japan

Josai Hospital /ID# 168347

🇯🇵

Yuki, Japan

Kurume University Hospital /ID# 164158

🇯🇵

Kurume-shi, Fukuoka, Japan

NHO Fukuyama Medical Center /ID# 162909

🇯🇵

Fukuyama-shi, Hiroshima, Japan

Hiratsuka City Hospital /ID# 161884

🇯🇵

Kanagawa, Japan

Kaizuka City Hospital /ID# 165256

🇯🇵

Kaizuka, Japan

Ibaraki Prefectural Cent. Hosp /ID# 164962

🇯🇵

Kasama, Japan

Saka General Hospital /ID# 162962

🇯🇵

Shiogama-miyagi, Japan

Todachuo General Hospital /ID# 165280

🇯🇵

Toda-shi, Saitama, Japan

Wakayama Rosai Hospital /ID# 165254

🇯🇵

Wakayama-shi, Japan

Oita Midical Center /ID# 164960

🇯🇵

Oita, Japan

Mie Syokaki Clinic /ID# 161895

🇯🇵

Tsu, Mie, Japan

Tokyo Women's Medical University Hospital /ID# 167685

🇯🇵

Shinjuku-ku, Tokyo, Japan

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