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

NCT02945228 | Completed

• 1 other identifier: P15-764
• Study Type: observational
• Target: 449
• Locations: 1 country
• Sites: 170

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.

Conditions

Chronic Hepatitis C Virus

Keywords

Genotype 2; Paritaprevir; Hepatitis C Virus (HCV); Ritonavir; Ombitasvir

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with Sustained Virologic Response (SVR12)

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

  12 weeks after last dose of study drug.

Secondary Outcomes (3)

• Percentage of Participants with Virologic Failure During Treatment (breakthrough)

  Up to 12 Weeks

• Percentage of Participants with Virologic Failure After Treatment (relapse)

  Post-treatment 24 weeks

• Percentage of Participants with Sustained Virologic Response (SVR24)

  24 weeks after the last dose of study drug

Study Arms (1)

Chronic infection of hepatitis C virus (HCV) genotype 2

Participants with confirmed chronic HCV genotype 2, receiving paritaprevir/ritonavir/ombitasvir and ribavirin according to standard of care and in line with the current local label

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with Chronic hepatitis C virus (HCV) genotype 2

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (170)

Aichi Medical University Hosp /ID# 161892

Nagakute, Aichi-ken, 4801195, Japan

Location

Matsuyama Red Cross Hosp /ID# 162953

Matsuyama, Ehime, 7900826, Japan

Location

NHO Kyushu Medical Center /ID# 162956

Fukuoka, Fukuoka, 810-8563, Japan

Location

Kurume University Hospital /ID# 164158

Kurume-shi, Fukuoka, 830-0011, Japan

Location

Kusunoki Hospital /ID# 158119

Fujioka, Gunma, 3750024, Japan

Location

National Hospital Organization Takasaki General Medical Center /ID# 160877

Takasaki-shi, Gunma, 370-0829, Japan

Location

NHO Fukuyama Medical Center /ID# 162909

Fukuyama-shi, Hiroshima, 720-8520, Japan

Location

Fukuyama City Hospital /ID# 161889

Fukuyama-shi, Hiroshima, 721-8511, Japan

Location

The Hospital of Hyogo College of Medicine /ID# 162913

Nishinomiya-shi, Hyōgo, 663-8501, Japan

Location

Nanpuh Hospital /ID# 168348

Kagoshima, Kagoshima-ken, 8928512, Japan

Location

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

Kawasaki, Kanagawa, 216-0015, Japan

Location

Yokohama City Univ Medical Ctr /ID# 162905

Yokohama, Kanagawa, 232-0024, Japan

Location

Kumamoto University Hospital /ID# 167048

Kumamoto, Kumamoto, 860-8556, Japan

Location

Kumamoto Shinto General Hospital /ID# 165275

Kumamoto, Kumamoto, 8628655, Japan

Location

Okayama University Hospital /ID# 165268

Okayama, Okayama-ken, 700-8558, Japan

Location

Osaka Red Cross Hospital /ID# 161888

Osaka, Osaka, 543-8555, Japan

Location

Osaka City University Hospital /ID# 165290

Osaka, Osaka, 545-0051, Japan

Location

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

Osaka, Osaka, 550-0006, Japan

Location

Osaka Medical College Hospital /ID# 162908

Takatsuki -shi, Osaka, 569-8686, Japan

Location

Saitama Medical Center, Saitama Medical University /ID# 162911

Kawagoe-shi, Saitama, 350-8550, Japan

Location

Dokkyo Medical University Saitama Medical Center /ID# 162907

Koshigaya, Saitama, 343-0813, Japan

Location

Hamamatsu University Hospital /ID# 171048

Hamamatsu, Shizuoka, 431-3125, Japan

Location

Tokyo Jikei Daisan Hospital /ID# 164159

Komae-shi, Tokyo, 201-8601, Japan

Location

Tokyo Women's Medical University Hospital /ID# 167685

Shinjuku-ku, Tokyo, 162-8666, Japan

Location

University of Yamanashi Hospital /ID# 161770

Chuo-shi, Yamanashi, 409-3898, Japan

Location

Kato Michio Hepatology Clinic /ID# 159476

Amagasaki, Hyogo, 661-0012, Japan

Location

Aomori Prefectural Central Hos /ID# 160822

Aomori, 030-8553, Japan

Location

Mantani Clinic /ID# 168353

Arida, 649-0316, Japan

Location

Japanese Red Cross Asahikawa /ID# 165265

Asahikawa, 070-0061, Japan

Location

Asahikawa City Hospital /ID# 167703

Asahikawa-shi, 070-8610, Japan

Location

National Hospital Organization /ID# 168346

Chiba, 260-0042, Japan

Location

Chiba University Hospital /ID# 160875

Chiba, 260-8677, Japan

Location

Seirei Sakura Citizen Hospital /ID# 166896

Chiba, Japan

Location

Kenseido-iin /ID# 164166

Chichibu, 368-0042, Japan

Location

Fuji City General Hospital /ID# 165278

Fuji, Japan

Location

Fukui Prefectural Hospital /ID# 168344

Fukui, 910-0846, Japan

Location

Fukui Prefectural Hospital /ID# 169552

Fukui, 910-0846, Japan

Location

University of Fukui Hospital /ID# 166933

Fukui, 910-1104, Japan

Location

Chihaya Hospital /ID# 161893

Fukuoka, Japan

Location

Morichika Internal Medicine /ID# 168351

Fukuyama, 721-0975, Japan

Location

Gifu Municipal Hospital /ID# 165287

Gifu, 500-8323, Japan

Location

Shiroyama Hospital /ID# 164963

Habikino-osaka, 583-0872, Japan

Location

Aomori Rosai Hospital /ID# 167702

Hachinohe, Japan

Location

Tamakoshi Clinic /ID# 165282

Hamamatsu, 335-0023, Japan

Location

Higashihiroshima Medical Ctr /ID# 168343

Higashihiroshima, 739-0041, Japan

Location

Mito Medical Center /ID# 171046

Higashiibaraki-gun, 311-3117, Japan

Location

Higashiomicity Notogawa Hosp /ID# 161891

Higashiomi, Shiga, 521-1223, Japan

Location

Shin-ishikiri Clinic /ID# 169643

Higashiosaka, 579-8013, Japan

Location

Wakakusa Daiichi Hospital /ID# 166882

Higashiosaka, 579-8056, Japan

Location

Hiroshima Red Cross Hosp Atomi /ID# 162912

Hiroshima, 730-0052, Japan

Location

Hiroshima University Hospital /ID# 160815

Hiroshima, 734-8551, Japan

Location

Hiroshima-Nishi Medical Center /ID# 169642

Hiroshima, 739-0651, Japan

Location

Koyo New Town Hospital /ID# 161890

Hiroshima, 739-1742, Japan

Location

Taishi Hospital /ID# 165291

Hyōgo, 671-1561, Japan

Location

Iizuka Hospital /ID# 161886

Iizuka, 820-0018, Japan

Location

Ikeda Municipal Hospital /ID# 160814

Ikeda, 563-8510, Japan

Location

Tokyo Med Uni Ibaraki Med Ctr /ID# 162955

Inashiki, 300-0332, Japan

Location

Nippon Med Chiba Hokusoh Hosp /ID# 162902

Inzai, 270-1613, Japan

Location

Saitama Medical University Hos /ID# 161768

Iruma-gun, 350-0451, Japan

Location

Itoigawa Sogo Hospital /ID# 166884

Itoigawa, 941-0006, Japan

Location

Kamiiwade Internal Med-Neuro /ID# 166881

Iwade, 649-6216, Japan

Location

Kaizuka City Hospital /ID# 165256

Kaizuka, Japan

Location

Kamisu Saiseikai Hospital /ID# 167701

Kamisu, 314-0112, Japan

Location

Kiyokawa Hospital /ID# 164961

Kanagawa, 166-0004, Japan

Location

Hiratsuka City Hospital /ID# 161884

Kanagawa, Japan

Location

Niwa Hospital /ID# 167684

Kanagawa, Japan

Location

Fuji Clinic /ID# 160820

Kan’onjichō, 3440067, Japan

Location

Ibaraki Prefectural Cent. Hosp /ID# 164962

Kasama, 309-1703, Japan

Location

The Jikei Univ. Kashiwa Hosp. /ID# 166888

Kashiwa-shi, 277-0004, Japan

Location

Kashiwazaki General Hospital a /ID# 168352

Kashiwazaki, 945-0035, Japan

Location

Kawase Clinic /ID# 164957

Kasugai, 486-0914, Japan

Location

Hirose Clinic /ID# 167699

Kawagoe, 350-0043, Japan

Location

Sekishindo Hospital /ID# 162960

Kawagoe, 350-1123, Japan

Location

Kawaguchi Municipal Medical Ce /ID# 165270

Kawaguchi, 333-0833, Japan

Location

Kawasaki Municipal Tama Hospit /ID# 165267

Kawasaki, 214-0021, Japan

Location

Kanto Rosai Hospital /ID# 165258

Kawasaki-shi, Kanagawa, Japan

Location

Kishiwada Tokushukai Hospital /ID# 164964

Kishiwada, Osaka, 596-0042, Japan

Location

Kokura Kinen Hospital /ID# 164969

Kitakyushu, 802-0001, Japan

Location

Kitasato University Medical Ce /ID# 158120

Kitamoto, 364-0026, Japan

Location

Kobe Asahi Hospital /ID# 161896

Kobe, 653-0801, Japan

Location

Kobe Adventist Hospital /ID# 161897

Kobe, Japan

Location

Konan Kosei Hospital /ID# 165277

Konan-shi, 483-8704, Japan

Location

Hanada Internal Medicine Clin /ID# 165266

Koshigaya, Saitam, 343-0015, Japan

Location

Cosmos Clinic /ID# 164161

Kōriyama, 963-0209, Japan

Location

Ishida Medical Clinic /ID# 166887

Kōriyama, 963-8023, Japan

Location

Kawasaki Medical School Hosp /ID# 162906

Kurashiki, 701-0114, Japan

Location

National Hosp Org Kure Med Cen /ID# 167689

Kure, Hiroshima, 737-0023, Japan

Location

Kurihara Central Hospital /ID# 171047

Kurihara, 228-0014, Japan

Location

Kuroishi Hospital /ID# 164971

Kuroishi-aomori, 036-0541, Japan

Location

Shin Koga Clinic /ID# 164972

Kurume, 830-0033, Japan

Location

Koga Hospital 21 /ID# 167698

Kurume, 839-0801, Japan

Location

Hori Internal Medicine Clinic /ID# 167696

Kushiro, 085-0005, Japan

Location

NHO Kyoto Medical Center /ID# 162910

Kyoto, 612-0861, Japan

Location

Matsuzaki Internal Medicine Cl /ID# 164970

Kyoto, 615-8101, Japan

Location

Gibo Hepatorogy Clinic /ID# 161766

Matsumoto, 399-0036, Japan

Location

Kizawa Memorial Hospital /ID# 162957

Minokamo, 505-0034, Japan

Location

Sumiyoshi Clinic Hospital /ID# 164163

Mito, 310-0844, Japan

Location

South Miyagi Medical Center /ID# 164965

Miyagi, 989-1253, Japan

Location

National Hospital Organization /ID# 168345

Miyakonojō, 885-0014, Japan

Location

Miyazaki Medical Center Hospit /ID# 165279

Miyazaki, 880-0003, Japan

Location

University of Miyazaki Hosp /ID# 166880

Miyazaki, 889-1692, Japan

Location

Matsushita Memorial Hospital /ID# 167693

Moriguchi-shi, 570-0096, Japan

Location

Suzuki Clinic /ID# 165264

Nagareyama, 270-0157, Japan

Location

Meitetsu Hospital /ID# 165288

Nagoya, 451-8511, Japan

Location

Nagoya Central Hospital /ID# 166879

Nagoya, 453-0801, Japan

Location

Aikawa Minnano-shinryojo /ID# 164168

Nagoya, 458-0011, Japan

Location

Meijo Hospital /ID# 164966

Nagoya-aichi, 460-0001, Japan

Location

Nara City Hospital /ID# 162959

Nara, 530-0025, Japan

Location

Tani Internal Medicine Clinic /ID# 164974

Nayoro, 096-0018, Japan

Location

Ooka Clinic /ID# 161887

Nishinomiya, 663-8124, Japan

Location

Noshiro Yamamoto Med. Assoc. /ID# 162964

Noshiro, 016-0151, Japan

Location

Manna Clinic /ID# 169548

Odawara, 250-0214, Japan

Location

Okayama Saiseikai Outpatient Center Hospital /ID# 159475

Okayama, 700-0013, Japan

Location

Omuta City Hospital /ID# 164967

Omuta, 836-0861, Japan

Location

Kita-harima Medical Center /ID# 164165

Ono, 675-1327, Japan

Location

Onomichi Central General Hospi /ID# 162903

Onomichi, Japan

Location

Kenporen Osaka Central Hospita /ID# 164956

Osaka, 530-0001, Japan

Location

Asai Naika /ID# 167691

Osaka, 537-0024, Japan

Location

Osaka Inter. Cancer Institute /ID# 166889

Osaka, 541-8567, Japan

Location

Osaka Police Hospital /ID# 161769

Osaka, 543-0035, Japan

Location

Asai Naika Iin /ID# 164955

Osaka, 546-0043, Japan

Location

Utajima Ueda Clinic /ID# 161894

Osaka, 555-0012, Japan

Location

Tamai Clinic /ID# 164162

Osaka, 557-0002, Japan

Location

Osaka Hospital /ID# 164157

Osaka, 572-0854, Japan

Location

Oita Midical Center /ID# 164960

Ōita, 870-0263, Japan

Location

Seko Internal Medicine Clinic /ID# 164169

Ōtsu, 520-0802, Japan

Location

Kawazoe Internal Medicine Clin /ID# 165292

Saga, 849-1113, Japan

Location

Saitama Citizens Medical Ctr /ID# 169550

Saitama, 331-0054, Japan

Location

Sainokuni Higashiomiya Medical /ID# 167700

Saitama, 331-0804, Japan

Location

Honda Internal Clinic /ID# 161767

Saitama, 349-0115, Japan

Location

Saitama Cooperative Hospital /ID# 167697

Saitama, Japan

Location

Minamitani Clinic /ID# 160821

Sakai, 590-0026, Japan

Location

Kaisei Hospital /ID# 164973

Sapporo, 001-0033, Japan

Location

Sendai Kousei Hospital /ID# 162961

Sendai, 980-0873, Japan

Location

Saka General Hospital /ID# 162962

Shiogama-miyagi, 985-0024, Japan

Location

Saiseikai Suita Hospital /ID# 165289

Suita, 564-0013, Japan

Location

Suita Municipal Hospital /ID# 164958

Suita-osaka, 564-0082, Japan

Location

Kagawa Prefectural Central Hos /ID# 160816

Takamatsu, 760-0065, Japan

Location

Sawada Hepatology & Gastro /ID# 165255

Takaraduka, 665-0881, Japan

Location

Tenjin Tanaka Internal Medicin /ID# 166883

Takatsuki, 569-1123, Japan

Location

Hamada Clinic /ID# 171045

Tatebayashi, 374-0053, Japan

Location

Todachuo General Hospital /ID# 165280

Toda-shi, Saitama, 335-0023, Japan

Location

Eastern Chiba Medical Center /ID# 165257

Togane, Chiba, 283-0826, Japan

Location

Delta Clinic /ID# 164167

Tokorozawa, 359-0037, Japan

Location

The Jikei University Hospital /ID# 169547

Tokyo, 105-8461, Japan

Location

Abbott Japan /ID# 144983

Tokyo, 108-6303, Japan

Location

Juntendo University Hospital /ID# 161771

Tokyo, 113-8431, Japan

Location

Nippon Medical School Hospital /ID# 164164

Tokyo, 113-8602, Japan

Location

Tokyo Metropolitan Bokutoh Hos /ID# 167686

Tokyo, 130-8575, Japan

Location

Ohashi Medical Office /ID# 164968

Tokyo, 173-0021, Japan

Location

Juntendo Univ Nerima Hosp /ID# 164160

Tokyo, 177-0033, Japan

Location

JP Red Cross Musashino Hosp /ID# 162904

Tokyo, 180-8610, Japan

Location

Toyama University Hospital /ID# 169551

Toyoma, 930-0194, Japan

Location

Toyonaka Municipal Hospital /ID# 167692

Toyonaka, 560-8565, Japan

Location

Ehime University Hospital /ID# 161885

Tōon, 791-0204, Japan

Location

Mie Syokaki Clinic /ID# 161895

TSU, MIE, 514-0062, Japan

Location

Saiseikai Utsunomiya Hospital /ID# 162958

Utsunomiya, 321-0974, Japan

Location

Seike Clinic /ID# 166890

Uwajima, 798-0032, Japan

Location

Saiseikai Wakayama Hospital /ID# 162954

Wakayama, 640-8158, Japan

Location

Wakayama Rosai Hospital /ID# 165254

Wakayama, 640-8505, Japan

Location

Tokyo Women's Medical Universi /ID# 167694

Yachiyo, 276-0046, Japan

Location

Tohoku Central Hospital /ID# 166897

Yamagata, 990-0064, Japan

Location

Okuda Gastrointestinal Medicin /ID# 168349

Yamaguchi, 753-0047, Japan

Location

Kainan Hospital /ID# 164959

Yatomi-shi, 498-0017, Japan

Location

Kumamoto Rosai Hospital /ID# 167695

Yatsushiro-shi, Japan

Location

Mie Prefectural General Medica /ID# 162963

Yokkaichi, 510-0885, Japan

Location

Showa Univ Fujigaoka Hosp /ID# 162952

Yokohama, 227-0043, Japan

Location

Oita University Hospital /ID# 169549

Yufu-shi, 879-5503, Japan

Location

Yamaguchi Surgery Clinic /ID# 167704

Yugawara, 259-0313, Japan

Location

Josai Hospital /ID# 168347

Yūki, 307-0001, Japan

Location

Related Links

• clinical study report synopsis

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: October 26, 2016
• Study Start: October 26, 2016
• Primary Completion: July 26, 2019
• Study Completion: July 26, 2019
• Last Updated: June 12, 2020

Record last verified: 2020-06

Locations

JP (170)