AzTrials
AzTrials

Chronic Hepatitis C VirusNCT02629172

Drug Use-results Survey in Patients Infected With Hepatitis C Virus Genotype 1

An observational study of Chronic Hepatitis C Virus, run by AbbVie at 388 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The main objective of this study is to evaluate the safety and effectiveness of paritaprevir/ritonavir/ombitasvir used for patients infected with HCV genotype 1 in daily practice in Japan. Read more about this study

Who is it for?
Ages Up to 120 years
Conditions the study is for
Chronic Hepatitis C Virus
How many people
3,043 participants
Where
388 sitesJapan
Study dates
5 Jan 2016to 28 Feb 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 120 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Chronic Hepatitis C

Who may be able to join

  • HCV genotype 1 patients treated with paritaprevir/ritonavir/ombitasvir in daily practice

Who cannot join

  • Patients who have been previously treated with paritaprevir/ritonavir/ombitasvir

Trial locations and contacts

388 sites in 1 country.

300 sites in 1 country

Japan300 sites

  • Ageo Central General Hospital /ID# 153002

    Ageo, 362-0075

  • Sangane Clinic /ID# 162885

    Aichi, 444-0124

  • Banbuntane Hotokukai Hospital /ID# 160909

    Aichi, 454-8509

  • Masuda Family Clinic /ID# 155961

    Aki-takata, 739-1101

  • Akita Kousei Medical Center /ID# 152183

    Akita, 011-0948

  • Takahashi Naika /ID# 162888

    Amagasaki, 660-0814

  • Kansai Rosai Hospital /ID# 152239

    Amagasaki, 660-8511

  • Ikeda Hospital /ID# 152135

    Amagasaki, 661-0002

  • Kato Michio Hepatology Clinic /ID# 152138

    Amagasaki, Hyogo, 661-0012

  • Aomori Prefectural Central Hos /ID# 161749

    Aomori, 030-8553

  • Konoe Hospital /ID# 158066

    Arao, 864-0032

  • Japanese Red Cross Asahikawa /ID# 153552

    Asahikawa, 070-0061

  • Asakura Medical Association Ho /ID# 152999

    Asakura, 838-0069

  • Azumino Red Cross Hospital /ID# 160801

    Azumino, 399-8205

  • Chiba Aoba Municipal Hospital /ID# 153016

    Chiba, 260-0852

  • Chiba University Hospital /ID# 152988

    Chiba, 260-8677

  • NHO Chiba-East-Hospital /ID# 152217

    Chiba, 260-8712

  • Saisei Hospital /ID# 152277

    Chiba, 262-8506

  • Fujishima Clinic /ID# 152216

    Chiba, 299-4301

  • Seirei Sakura Citizen Hospital /ID# 152296

    Chiba

  • Aioi Clinic /ID# 150059

    Chichibu, 368-0026

  • Shonan Ishiguro Clinic /ID# 165272

    Chigasaki, 253-0043

  • Shonan Tobu Sogo Hospital /ID# 152979

    Chigasaki, 253-0083

  • Chikugo City Hospital /ID# 152318

    Chikugo, 833-0041

  • Chitose City Hospital /ID# 156386

    Chitose-shi

  • Tokyo Teishin Hospital /ID# 157457

    Chiyoda-ku, Tokyo, 102-8798

  • University of Yamanashi Hospital /ID# 152164

    Chuo-shi, Yamanashi, 409-3898

  • MIne Internal Medicine Clinic /ID# 155885

    Fuchū, 183-0034

  • Tama Medical Center /ID# 158101

    Fuchū, 183-8524

  • Fuji City General Hospital /ID# 159456

    Fuji

  • Kusunoki Hospital /ID# 152072

    Fujioka, Gunma, 3750024

  • Shonan Fujisawa Tokushukai Hospital /ID# 152967

    Fujisawa-shi, Kanagawa, 251-0041

  • Fukuchiyama City Hospital /ID# 157455

    Fukuchiyama

  • Fukui Prefectural Hospital /ID# 152137

    Fukui, 910-0846

  • Fukui Prefectural Hospital /ID# 152976

    Fukui, 910-0846

  • University of Fukui Hospital /ID# 152169

    Fukui, 910-1104

  • Tanaka Internal Medical Clinic /ID# 157499

    Fukui, 918-8055

  • NHO Kyushu Medical Center /ID# 153001

    Fukuoka, Fukuoka, 810-8563

  • Fukuoka University Hospital /ID# 152272

    Fukuoka, Fukuoka, 814-0180

  • Hopsital of the University of Occupational and Enviromental Health /ID# 152998

    Fukuoka, 8078556

  • Saiseikai Fukuoka General Hosp /ID# 152167

    Fukuoka, 810-0001

  • Fukuoka City Med Assoc Hosp /ID# 164143

    Fukuoka, 814-8522

  • Shimizu Clinic /ID# 152166

    Fukuoka, 815-0033

  • Chihaya Hospital /ID# 152223

    Fukuoka

  • Fukushima Med Univ Hosp /ID# 154735

    Fukushima, 960-1295

  • Clinic21 /ID# 153554

    Fukushima, 960-8031

  • Rai Clinic /ID# 164133

    Fukushima, 963-7769

  • Ishikawa Clinic /ID# 161747

    Fukuyama, 720-1262

  • Morichika Internal Medicine /ID# 162887

    Fukuyama, 721-0975

  • Fukuyama City Hospital /ID# 152322

    Fukuyama-shi, Hiroshima, 721-8511

  • Gifu University Hospital /ID# 152993

    Gifu, Gifu, 501-1194

  • Gifu Municipal Hospital /ID# 152283

    Gifu, 500-8323

  • Haramachi Red Cross Hospital /ID# 157447

    Gunma, 377-0801

  • Hospital Hakodate Hokkaido /ID# 159457

    Hakodate, 041-0821

  • Hamamatsu University Hospital /ID# 154651

    Hamamatsu, Shizuoka, 431-3125

  • Matsuda Internal Medicine /ID# 165064

    Hamamatsu-shizuoka, 435-0028

  • Handa City Hospital /ID# 152140

    Handa-shi, 475-0817

  • Mashiba Clinic /ID# 152097

    Hannō, 357-0024

  • Hashima City Hospital /ID# 154658

    Hashima, 501-6206

  • JA Hiroshima General Hospital /ID# 154729

    Hatsukaichi

  • Higashihiroshima Medical Ctr /ID# 152970

    Higashihiroshima, 739-0041

  • Mito Medical Center /ID# 154652

    Higashiibaraki-gun, 311-3117

  • Higashi-Omi Keiai Hospital /ID# 164954

    Higashiōmi, 527-0025

  • Higashiomicity Notogawa Hosp /ID# 152075

    Higashiomi, Shiga, 521-1223

  • Wakakusa Daiichi Hospital /ID# 152201

    Higashiosaka, 579-8056

  • Higashiosaka City General Hosp /ID# 153630

    Higashiosaka-shi, 578-8588

  • Kousei Hospital /ID# 152159

    Himeji, 670-0074

  • Kansai Medical University Hospital /ID# 152269

    Hirakata-shi, Osaka, 573-1191

  • Kajihara Clinic /ID# 159451

    Hiratsuka, 254-0077

  • Nakahata Gastroenterology Clin /ID# 164134

    Hirosaki

  • Hirosaki University Hospital /ID# 153633

    Hirosaki-aomori, 036-8203

  • Hiroshima Red Cross Hosp Atomi /ID# 152098

    Hiroshima, 730-0052

  • Nishihara Nakamura Med Clinic /ID# 155999

    Hiroshima, 731-0113

  • Hiroshima University Hospital /ID# 152319

    Hiroshima, 734-8551

  • Hiroshima-Nishi Medical Center /ID# 161744

    Hiroshima, 739-0651

  • Hiroshima Clinic /ID# 153614

    Hiroshima

  • Hiroshima General Hosp W JP /ID# 152077

    Hiroshima

  • Iwao Hospital /ID# 152306

    Hita, 877-0012

  • Hitachi, Ltd., Hitachi Gen Hos /ID# 161748

    Hitachi, 317-0077

  • Naganuma Municipal Hospital /ID# 152991

    Hokkaido, 069-1332

  • Japanese Red Cross Kitami Hosp /ID# 153010

    Hokkaido

  • Akashi City Hospital /ID# 150058

    Hyōgo

  • Ashiya Municipal Hospital /ID# 150054

    Hyōgo

  • Hyogo Prefectural Awaji Hosp /ID# 152237

    Hyōgo

  • Hyogo Prefectural Kakogawa Med /ID# 152280

    Hyōgo

  • Tokyo Dental College Ichikawa /ID# 154665

    Ichikawa-shi, 272-8513

  • Iizuka Hospital /ID# 152186

    Iizuka, 820-0018

  • Ikeda Municipal Hospital /ID# 152170

    Ikeda, 563-8510

  • Nagasaki Prefecture Iki Hospit /ID# 154674

    Iki, 811-5132

  • Nara Hosp Kinki Uni Fac Of Med /ID# 155895

    Ikoma, 630-0227

  • Saiseikai Imabari Hospital /ID# 158100

    Imabari, 799-1502

  • Ina Central Hospital /ID# 152144

    Ina, 396-0033

  • Tokyo Med Uni Ibaraki Med Ctr /ID# 152121

    Inashiki, 300-0332

  • Inuyama Chuo General /ID# 154672

    Inuyama, 484-0066

  • Saitama Medical University Hos /ID# 152073

    Iruma-gun, 350-0451

  • Saitama Medical University Hos /ID# 153616

    Iruma-gun, 350-0451

  • Ise Red Cross Hospital /ID# 154670

    Ise, 516-0008

  • Yamada Internal Medicine Clini /ID# 154786

    Isesaki, 372-0048

  • Katakai Clinic /ID# 152163

    Isesaki, 372-0813

  • Yawata Medical Center /ID# 152215

    Ishikawa, 9230833

  • Matto Ishikawa Public Hospital /ID# 153638

    Ishikawa

  • Kamiiwade Internal Med-Neuro /ID# 160802

    Iwade, 649-6216

  • Iwaki Kyoritsu General Hosp /ID# 153617

    Iwaki

  • Yoshioka Clinic /ID# 152305

    Iwaki

  • Nishimi Medical Clinic /ID# 161752

    Iwakuni, 741-0061

  • Kayanoki Internal Medicine Cli /ID# 152235

    Izumiōtsu, 595-0046

  • Juntendo Univ Shizuoka Hosp /ID# 153615

    Izunokuni-shi, 410-2295

  • Kawabata Internal Medicine Gas /ID# 153629

    Joetsu-niigata, 942-0061

  • Mitoyo General Hospital /ID# 152185

    Kagawa, 7691601

  • Nanpuh Hospital /ID# 153008

    Kagoshima, Kagoshima-ken, 8928512

  • Konan Kakogawa Hospital /ID# 158102

    Kakogawa

  • Shonan Kamakura General Hospital /ID# 152070

    Kamakura-shi, Kanagawa, 247-8533

  • Yoshii Internal Medicine /ID# 158067

    Kaminoyama, 999-3125

  • Fuji Clinic /ID# 152968

    Kan’onjichō, 3440067

  • Kiyokawa Hospital /ID# 152156

    Kanagawa, 166-0004

  • Nagase Medical Clinic /ID# 157498

    Kanagawa, 213-0033

  • Hiratsuka City Hospital /ID# 154730

    Kanagawa

  • Niwa Hospital /ID# 154762

    Kanagawa

  • Kanazawa University Ho /ID# 152174

    Kanazawa, Ishikawa-ken, 92086-41

  • Fujise Internal Medicine Clini /ID# 155886

    Kashiwa, 277-0075

  • The Jikei Univ. Kashiwa Hosp. /ID# 152281

    Kashiwa-shi, 277-0004

  • Fukuoka Tokushukai Medical Ctr /ID# 154654

    Kasuga-shi, 816-0864

  • Kawase Clinic /ID# 152969

    Kasugai, 486-0914

  • Sakamoto Internal Med Clinic /ID# 161745

    Katori, 287-0001

  • Sekishindo Hospital /ID# 154653

    Kawagoe, 350-1123

  • Saitama Medical Center, Saitama Medical University /ID# 153641

    Kawagoe-shi, Saitama, 350-8550

  • Saiseikai Kawaguchi Gen. Hosp. /ID# 153631

    Kawaguchi-saitama, 332-0021

  • Kawasaki Municipal Tama Hospit /ID# 152132

    Kawasaki, 214-0021

  • St. Marianna Univ Hospital /ID# 152218

    Kawasaki, 216-8511

  • Kanto Rosai Hospital /ID# 152202

    Kawasaki-shi, Kanagawa

  • Nakano Clinic /ID# 165262

    Kazuno, 018-5201

  • Kirishima Medical Center /ID# 152095

    Kirishima, 899-5112

  • Kojima Clinic /ID# 152285

    Kiryū, 376-0006

  • Kimitsu Chuo Hospital /ID# 152995

    Kisarazu, 292-8535

  • Kawazoe Internal Medicine Clin /ID# 154789

    Kishima-gun, 849-1113

  • Kishiwada Tokushukai Hospital /ID# 165260

    Kishiwada, Osaka, 596-0042

  • JR Kyushu Hospital /ID# 152074

    Kitakyushu, 800-0031

  • Kokura Kinen Hospital /ID# 152997

    Kitakyushu, 802-0001

  • Iwamoto Internal Medical Clini /ID# 152994

    Kitakyushu, 802-0832

  • Kitasato University Medical Ce /ID# 150053

    Kitamoto, 364-0026

  • Kobe University Hospital /ID# 153004

    Kobe, Hyōgo, 650-0017

  • Kobe City Medical Center West /ID# 152304

    Kobe, 653-0013

  • Kobe City Medical Center West /ID# 153005

    Kobe, 653-0013

  • Kobe Asahi Hospital /ID# 152173

    Kobe, 653-0801

  • Kochi Red Cross Hospital /ID# 159450

    Kochi, 780-0062

  • Hosoda Clinic /ID# 152978

    Kofu, 400-0067

  • Tokyo Jikei Daisan Hospital /ID# 155896

    Komae-shi, Tokyo, 201-8601

  • Cosmos Clinic /ID# 152298

    Kōriyama, 963-0209

  • Ishida Medical Clinic /ID# 152297

    Kōriyama, 963-8023

  • Hanada Internal Medicine Clin /ID# 155785

    Koshigaya, Saitam, 343-0015

  • Kumamoto Shinto General Hospital /ID# 152149

    Kumamoto, Kumamoto, 8628655

  • National Hosp Org Kumamoto /ID# 154783

    Kumamoto, 860-0008

  • Seto Hospital /ID# 150056

    Kumamoto, 861-3455

  • Kawasaki Medical School Hosp /ID# 152119

    Kurashiki, 701-0114

  • Kurashiki Central Hospital /ID# 154656

    Kurashiki, 710-0052

  • Mizushima Kyodo Hospital /ID# 152302

    Kurashiki, 712-8567

  • Fukura Clinic /ID# 165273

    Kurayoshi

  • National Hosp Org Kure Med Cen /ID# 152071

    Kure, Hiroshima, 737-0023

  • Kurihara Central Hospital /ID# 152295

    Kurihara, 228-0014

  • Kuroishi Hospital /ID# 153636

    Kuroishi-aomori, 036-0541

  • Kurume University Hospital /ID# 152099

    Kurume-shi, Fukuoka, 830-0011

  • Hori Internal Medicine Clinic /ID# 152291

    Kushiro, 085-0005

  • Kyoto Prefect Univ Med /ID# 152236

    Kyoto, Kyoto, 602-8566

  • Kyoto Prefect Univ Med /ID# 152981

    Kyoto, Kyoto, 602-8566

  • JP Red Cross Kyoto Daiichi Hos /ID# 152221

    Kyoto, Kyoto, 605-0981

  • Kyoto City Hospital /ID# 152188

    Kyoto, 604-8845

  • Nakajima Clinic /ID# 157480

    Kyoto, 606-8203

  • Aiseikai Yamashina Hospital /ID# 152100

    Kyoto, 607-8086

  • Sawa Clinic /ID# 162881

    Kyoto, 607-8344

  • NHO Kyoto Medical Center /ID# 152224

    Kyoto, 612-0861

  • Otokoyama Hospital /ID# 153017

    Kyoto, 6148366

  • Kagawa University Hospital /ID# 154731

    Kyoto, 615-8256

  • Machida Municipal Hospital /ID# 152184

    Machida, 194-0023

  • Gunma University Hospital /ID# 154669

    Maebashi, Gunma, 371-8511

  • Maebashi Red Cross Hospital /ID# 154707

    Maebashi

  • Kagawa Rosai Hospital /ID# 152131

    Marugame, 763-0013

  • Kono Naika clinic /ID# 152094

    Marugame, 763-0081

  • Masuda Red Cross Hospital /ID# 153635

    Masuda-shimane, 698-0003

  • Shinmatsudo Central General Ho /ID# 154668

    Matsudo, 270-0034

  • Matsudo City Hospital /ID# 154666

    Matsudo, 271-0064

  • Matsudo City Hospital /ID# 154764

    Matsudo, 271-0064

  • Gibo Hepatorogy Clinic /ID# 154763

    Matsumoto, 399-0036

  • Shinshu University Hospital /ID# 153632

    Matsumoto-shi, Nagano, 〒390-8621

  • Matsuyama Red Cross Hosp /ID# 152271

    Matsuyama, Ehime, 7900826

  • Ehime Prefectural Central Hosp /ID# 154675

    Matsuyama, 790-0024

  • Saiseikai Matsuyama Hospital /ID# 152270

    Matsuyama, 791-8026

  • Tajiri Hospital /ID# 152320

    Mimasaka, 707-0003

  • Kizawa Memorial Hospital /ID# 152096

    Minokamo, 505-0034

  • Kyorin University Hospital /ID# 152990

    Mitaka-shi, Tokyo, 181-8611

  • Sumiyoshi Clinic Hospital /ID# 152093

    Mito, 310-0844

  • Miyakonojo National Hospital /ID# 153007

    Miyakonojō, 885-0014

  • Miyazaki Medical Center Hospit /ID# 152154

    Miyazaki, 880-0003

  • Hepatopia Nishikohdai-naika /ID# 154788

    Miyazaki, 880-0941

  • Haga Red Cross Hospital /ID# 152085

    Mooka, Tochigi, 321-4306

  • Matsushita Memorial Hospital /ID# 154655

    Moriguchi-shi, 570-0096

  • Iwate Medical University Hospital /ID# 152076

    Morioka, Iwate, 020-8505

  • MC Ryokumeikai Yoshida Clinic /ID# 150055

    Morioka, 020-0832

  • Abe Saien Clinic /ID# 153014

    Morioka, 200024

  • Aichi Medical University Hosp /ID# 152220

    Nagakute, Aichi-ken, 4801195

  • Nagano Prefectural Kiso Hospit /ID# 152276

    Nagano, 397-0001

  • Kimura Clinic /ID# 152146

    Nagano

  • Tachikawa Medical Center /ID# 154784

    Nagaoka, 940-0052

  • Nagasaki University Hospital /ID# 152233

    Nagasaki, Nagasaki, 852-8501

  • Jap Red Cross Nagasaki Genbaku /ID# 152300

    Nagasaki, 852-8104

  • Jap Red Cross Nagasaki Genbaku /ID# 152303

    Nagasaki, 852-8104

  • Nagoya City University Hospital /ID# 153642

    Nagoya, Aichi-ken, 467-8602

  • NHO Nagoya Medical Center /ID# 152294

    Nagoya, 460-0001

  • Kita Hospital /ID# 158065

    Nagoya, 462-0804

  • Japanese Red Cross Nagoya Daii /ID# 158099

    Nagoya

  • Nakatsu Municipal Hospital /ID# 154673

    Nakatsu, 871-0011

  • Kouseiren Namerikawa Hospital /ID# 154706

    Namerikawa, 936-8585

  • Nara City Hospital /ID# 152189

    Nara, 530-0025

  • Miyagiwa Internal Med Clinic /ID# 155887

    Nara, 631-0011

  • Nara Prefectural Hospital /ID# 152234

    Nara

  • Japanese Red Cross Narita Hosp /ID# 155894

    Narita-shi, Chiba, 286-8523

  • Tani Internal Medicine Clinic /ID# 157448

    Nayoro, 096-0018

  • Kameda Clinic /ID# 162879

    Nishinomiya, 662-0841

  • Rinko Clinic /ID# 159449

    Nishinomiya, 662-0922

  • Ooka Clinic /ID# 162880

    Nishinomiya, 663-8124

  • The Hospital of Hyogo College of Medicine /ID# 157482

    Nishinomiya-shi, Hyōgo, 663-8501

  • Meiwa Hospital /ID# 152134

    Nishinomiya, Hyogo, 663-8186

  • Kikkoman General Hospital /ID# 152139

    Noda, Chiba, 278-0005

  • Noshiro Yamamoto Med. Assoc. /ID# 154785

    Noshiro, 016-0151

  • Obihiro Dai-ichi Hospital /ID# 152238

    Obihiro, 080-0014

  • Odawara Municipal Hospital /ID# 154761

    Odawara, 250-8558

  • Eguchi Hospital /ID# 152292

    Ogi, 845-0032

  • Tokai University Oiso Hospital /ID# 157456

    Ōiso

  • Oita Red Cross Hospital /ID# 152289

    Ōita, 870-0033

  • Oita Midical Center /ID# 154737

    Ōita, 870-0263

  • Oita Prefectural Hospital /ID# 165261

    Ōita, 870-0855

  • Mori Internal Medicine Clinic /ID# 157446

    Ōita, 870-0952

  • Aso Shoukaki-naika /ID# 164142

    Ōita, 879-4412

  • Okayama University Hospital /ID# 152287

    Okayama, Okayama-ken, 700-8558

  • Okayama Saiseikai Outpatient Center Hospital /ID# 150057

    Okayama, 700-0013

  • Kawaguchi Internal Medicine Cl /ID# 152301

    Okayama

  • Heartlife Hospital /ID# 153619

    Okinawa

  • Ome Municipal General Hospital /ID# 153653

    Ōme, 198-0042

  • Omuta City Hospital /ID# 152222

    Omuta, 836-0861

  • Nishimura Clinic /ID# 154790

    Omuta

  • Kita-harima Medical Center /ID# 153003

    Ono, 675-1327

  • Onomichi Central General Hospi /ID# 152150

    Onomichi

  • Osaka Saiseikai Nakatsu Hospital /ID# 155967

    Osaka, Osaka, 530-0012

  • Osaka Red Cross Hospital /ID# 152190

    Osaka, Osaka, 543-8555

  • Osaka City University Hospital /ID# 152160

    Osaka, Osaka, 545-0051

  • Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 152279

    Osaka, Osaka, 550-0006

  • Tazuke Kofukai Foundation /ID# 152182

    Osaka, 530-8480

  • Gokeikai Osaka Kaisei Hospital /ID# 153644

    Osaka, 532-0003

  • Otemae Hospital /ID# 152987

    Osaka, 540-0008

  • Center Clinic /ID# 161746

    Osaka, 540-0025

  • Osaka Police Hospital /ID# 154781

    Osaka, 543-0035

  • NTT WEST Osaka Hospital /ID# 157445

    Osaka, 543-0042

  • Mori Clinic /ID# 157489

    Osaka, 546-0042

  • Kansai Denryoku Hospital /ID# 155966

    Osaka, 553-0003

  • Tamai Clinic /ID# 164951

    Osaka, 557-0002

  • Osaka General Medical Center /ID# 160907

    Osaka, 558-8558

  • Kansai Medical Univ Takii Hosp /ID# 152130

    Osaka, 570-8507

  • Osaka Hospital /ID# 152168

    Osaka, 572-0854

  • Asai Orthopedic /ID# 153015

    Osaka

  • Osaka Gen Hosp West Railway /ID# 155962

    Osaka

  • Nasu Red Cross Hospital /ID# 152972

    Ōtawara, 324-0062

  • Shiga Univ Med Science Hosp /ID# 153628

    Ōtsu, Shiga, 520-2192

  • Otsu City Hospital /ID# 152155

    Ōtsu, 520-0804

  • Japanese Red Cross Otsu Shiga /ID# 153640

    Ōtsu

  • Ryugasaki Saiseikai Hospital /ID# 153639

    Ryūgasaki

  • Nakayama Medical Clinic /ID# 157481

    Saga, 849-0921

  • Imari Arita Kyoritsu Hospital /ID# 152321

    Saga, 849-4141

  • Saga Medical Center Koseikan /ID# 152989

    Saga-shi, SAGA, 840-8571

  • Japanese Red Cross Sagamihara /ID# 153000

    Sagamihara, 252-0157

  • Fuchinobe General Hospital /ID# 152996

    Sagamihara, 252-0206

  • Sagamino Hospital /ID# 154676

    Sagamihara, 252-0206

  • Saitama Citizens Medical Ctr /ID# 162882

    Saitama, 331-0054

  • Honda Internal Clinic /ID# 157497

    Saitama, 349-0115

  • Bellland General Hospital /ID# 152148

    Sakai, 599-8247

  • Osaka Rosai Hospital /ID# 152286

    Sakaishi

  • Nihonkai General Hospital /ID# 152973

    Sakata-shi, 998-0828

  • Takayanagi Clinic /ID# 152975

    Sakura, 385-0053

  • Hyogo-Chuo National Hospital /ID# 157441

    Sanda, 669-1515

  • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 152165

    Sapporo, Hokkaido, 060-0033

  • Sapporo Medical Univ Hosp /ID# 152992

    Sapporo, Hokkaido, 060-8543

  • Hokkaido University Hospital /ID# 152982

    Sapporo, 060-8648

  • IMS Sapporo Digestive Disease /ID# 154733

    Sapporo, 063-0842

  • Sapporo Hokuyu Hospital /ID# 154709

    Sapporo

  • Sasebo Chuo Hospital /ID# 154657

    Sasebo, 857-1195

  • Tohoku University Hospital /ID# 152980

    Sendai, Miyagi, 980-8574

  • JR Sendai Hospital /ID# 152240

    Sendai, 980-0022

  • Sendai Kousei Hospital /ID# 152181

    Sendai, 980-0873

  • Sendai Red Cross Hospital /ID# 160908

    Sendai, 982-0801

  • Shinmen Internal Medicine Clin /ID# 152172

    Sennan, 590-0504

  • Tosei General Hospital /ID# 154710

    Seto, 489-8642

  • Japanese Red Cross Medical Center /ID# 152219

    Shibuya-ku, Tokyo, 150-8935

  • NHO Shizuoka Medical Center /ID# 155897

    Shimizu-sho

  • Shimonoseki Medical Center /ID# 165263

    Shimonoseki, 750-0061

  • Dokkyo Medical University Hosp /ID# 152153

    Shimotsuga, 321-0293

  • Dokkyo Medical University Hosp /ID# 153656

    Shimotsuga, 321-0293

  • Anzunomori Clinic /ID# 157491

    Shimotsuke, 329-0432

  • Jichi Medical University Hospital /ID# 152069

    Shimotsuke-shi, Tochigi, 329-0498

  • Showa University Hospital /ID# 153618

    Shinagawa-ku, Tokyo

  • Tokyo Medical University Hospital /ID# 152288

    Shinjuku-ku, Tokyo, 160-0023

  • Tokyo Women's Medical University Hospital /ID# 152290

    Shinjuku-ku, Tokyo, 162-8666

  • Tokyo Women's Medical University Hospital /ID# 156383

    Shinjuku-ku, Tokyo, 162-8666

Other trials in Japan

About this study

Official title: Drug Use Results Survey in Patients Infected With Hepatitis C Virus Genotype 1

The main objective of this study is to evaluate the safety and effectiveness of paritaprevir/ritonavir/ombitasvir used for patients infected with HCV genotype 1 in daily practice in Japan.

Keywords
Hepatitis C Virus (HCV), Paritaprevir, Ombitasvir, Ritonavir, Genotype 1
Medical subject headings
Hepatitis C, Chronic, Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02629172
Study groupRoleWhat they receive
Chronic infection of hepatitis C virus (HCV) Genotype 1 (GT1)Participants with confirmed chronic hepatitis C genotype 1, receiving paritaprevir/ritonavir/ombitasvir according to standard of care and in line with the current local label

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants with Sustained Virologic Response (SVR12)

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

    Measured: 12 weeks after the last dose of study drug

Secondary outcomes (3)

  1. Percentage of Participants with Virologic Failure After Treatment

    Confirmed quantifiable hepatitis C virus ribonucleic acid (HCV RNA) at the end of 12 week treatment but subsequent viremia with HCV RNA greater than or equal to the lower limit of quantitation during follow-up period of 24 weeks after treatment.

    Measured: Post-treatment 24 weeks

  2. Percentage of Participants with Sustained Virologic Response (SVR24)

    Hepatitis C virus ribonucleic acid less than the lower limit of quantification 24 weeks after the last dose of study drug.

    Measured: 24 weeks after the last dose of study drug

  3. Percentage of Participants with Virologic Failure During Treatment

    HCV RNA levels reach less than the lower limit of quantitation (LLOQ), then increase to greater than or equal to the LLOQ at any point during treatment.

    Measured: Up to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2015 (estimated)
  2. Study start5 Jan 2016
  3. Primary completion28 Feb 2019
  4. Study completion28 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,043 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02629172
Sponsor's protocol ID
P15-336
Status last verified
Feb 2020
First submitted
10 Dec 2015
Last updated
24 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Hepatitis C Virus, run by AbbVie at 388 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 388 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants with Sustained Virologic Response (SVR12) (time frame: 12 weeks after the last dose of study drug). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02629172.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2020.

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