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

June 11, 2020 updated by: AbbVie

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

449

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Amagasaki, Hyogo, Japan, 661-0012
        • Kato Michio Hepatology Clinic /ID# 159476
      • Aomori-shi, Japan, 030-8553
        • Aomori Prefectural Central Hos /ID# 160822
      • Arida, Japan, 649-0316
        • Mantani Clinic /ID# 168353
      • Asahikawa, Japan, 070-0061
        • Japanese Red Cross Asahikawa /ID# 165265
      • Asahikawa-shi, Japan, 070-8610
        • Asahikawa City Hospital /ID# 167703
      • Chiba, Japan, 260-0042
        • National Hospital Organization /ID# 168346
      • Chiba, Japan, 260-8677
        • Chiba University Hospital /ID# 160875
      • Chiba, Japan
        • Seirei Sakura Citizen Hospital /ID# 166896
      • Chichibu, Japan, 368-0042
        • Kenseido-iin /ID# 164166
      • Fuji, Japan
        • Fuji City General Hospital /ID# 165278
      • Fukui, Japan, 910-0846
        • Fukui Prefectural Hospital /ID# 168344
      • Fukui, Japan, 910-0846
        • Fukui Prefectural Hospital /ID# 169552
      • Fukui, Japan, 910-1104
        • University of Fukui Hospital /ID# 166933
      • Fukuoka, Japan
        • Chihaya Hospital /ID# 161893
      • Fukuyama, Japan, 721-0975
        • Morichika Internal Medicine /ID# 168351
      • Gifu, Japan, 500-8323
        • Gifu Municipal Hospital /ID# 165287
      • Habikino-osaka, Japan, 583-0872
        • Shiroyama Hospital /ID# 164963
      • Hachinohe, Japan
        • Aomori Rosai Hospital /ID# 167702
      • Hamamatsu, Japan, 335-0023
        • Tamakoshi Clinic /ID# 165282
      • Higashihiroshima, Japan, 739-0041
        • Higashihiroshima Medical Ctr /ID# 168343
      • Higashiibaraki-gun, Japan, 311-3117
        • Mito Medical Center /ID# 171046
      • Higashiomi, Shiga, Japan, 521-1223
        • Higashiomicity Notogawa Hosp /ID# 161891
      • Higashiosaka, Japan, 579-8013
        • Shin-ishikiri Clinic /ID# 169643
      • Higashiosaka, Japan, 579-8056
        • Wakakusa Daiichi Hospital /ID# 166882
      • Hiroshima, Japan, 730-0052
        • Hiroshima Red Cross Hosp Atomi /ID# 162912
      • Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital /ID# 160815
      • Hiroshima, Japan, 739-0651
        • Hiroshima-Nishi Medical Center /ID# 169642
      • Hiroshima, Japan, 739-1742
        • Koyo New Town Hospital /ID# 161890
      • Hyogo, Japan, 671-1561
        • Taishi Hospital /ID# 165291
      • Iizuka, Japan, 820-0018
        • Iizuka Hospital /ID# 161886
      • Ikeda, Japan, 563-8510
        • Ikeda Municipal Hospital /ID# 160814
      • Inashiki, Japan, 300-0332
        • Tokyo Med Uni Ibaraki Med Ctr /ID# 162955
      • Inzai, Japan, 270-1613
        • Nippon Med Chiba Hokusoh Hosp /ID# 162902
      • Iruma-gun, Japan, 350-0451
        • Saitama Medical University Hos /ID# 161768
      • Itoigawa, Japan, 941-0006
        • Itoigawa Sogo Hospital /ID# 166884
      • Iwade, Japan, 649-6216
        • Kamiiwade Internal Med-Neuro /ID# 166881
      • Kaizuka, Japan
        • Kaizuka City Hospital /ID# 165256
      • Kamisu, Japan, 314-0112
        • Kamisu Saiseikai Hospital /ID# 167701
      • Kanagawa, Japan, 166-0004
        • Kiyokawa Hospital /ID# 164961
      • Kanagawa, Japan
        • Hiratsuka City Hospital /ID# 161884
      • Kanagawa, Japan
        • Niwa Hospital /ID# 167684
      • Kanonji, Japan, 3440067
        • Fuji Clinic /ID# 160820
      • Kasama, Japan, 309-1703
        • Ibaraki Prefectural Cent. Hosp /ID# 164962
      • Kashiwa-shi, Japan, 277-0004
        • The Jikei Univ. Kashiwa Hosp. /ID# 166888
      • Kashiwazaki, Japan, 945-0035
        • Kashiwazaki General Hospital a /ID# 168352
      • Kasugai, Japan, 486-0914
        • Kawase Clinic /ID# 164957
      • Kawagoe, Japan, 350-0043
        • Hirose Clinic /ID# 167699
      • Kawagoe, Japan, 350-1123
        • Sekishindo Hospital /ID# 162960
      • Kawaguchi, Japan, 333-0833
        • Kawaguchi Municipal Medical Ce /ID# 165270
      • Kawasaki, Japan, 214-0021
        • Kawasaki Municipal Tama Hospit /ID# 165267
      • Kawasaki-shi, Kanagawa, Japan
        • Kanto Rosai Hospital /ID# 165258
      • Kishiwada, Osaka, Japan, 596-0042
        • Kishiwada Tokushukai Hospital /ID# 164964
      • Kitakyusyu, Japan, 802-0001
        • Kokura Kinen Hospital /ID# 164969
      • Kitamoto, Japan, 364-0026
        • Kitasato University Medical Ce /ID# 158120
      • Kobe, Japan, 653-0801
        • Kobe Asahi Hospital /ID# 161896
      • Kobe, Japan
        • Kobe Adventist Hospital /ID# 161897
      • Konan-shi, Japan, 483-8704
        • Konan Kosei Hospital /ID# 165277
      • Koriyama, Japan, 963-0209
        • Cosmos Clinic /ID# 164161
      • Koriyama, Japan, 963-8023
        • Ishida Medical Clinic /ID# 166887
      • Koshigaya, Saitam, Japan, 343-0015
        • Hanada Internal Medicine Clin /ID# 165266
      • Kurashiki, Japan, 701-0114
        • Kawasaki Medical School Hosp /ID# 162906
      • Kure, Hiroshima, Japan, 737-0023
        • National Hosp Org Kure Med Cen /ID# 167689
      • Kurihara, Japan, 228-0014
        • Kurihara Central Hospital /ID# 171047
      • Kuroishi-aomori, Japan, 036-0541
        • Kuroishi Hospital /ID# 164971
      • Kurume, Japan, 830-0033
        • Shin Koga Clinic /ID# 164972
      • Kurume, Japan, 839-0801
        • Koga Hospital 21 /ID# 167698
      • Kushiro, Japan, 085-0005
        • Hori Internal Medicine Clinic /ID# 167696
      • Kyoto, Japan, 612-0861
        • NHO Kyoto Medical Center /ID# 162910
      • Kyoto, Japan, 615-8101
        • Matsuzaki Internal Medicine Cl /ID# 164970
      • Matsumoto, Japan, 399-0036
        • Gibo Hepatorogy Clinic /ID# 161766
      • Minokamo, Japan, 505-0034
        • Kizawa Memorial Hospital /ID# 162957
      • Mito, Japan, 310-0844
        • Sumiyoshi Clinic Hospital /ID# 164163
      • Miyagi, Japan, 989-1253
        • South Miyagi Medical Center /ID# 164965
      • Miyakonojo, Japan, 885-0014
        • National Hospital Organization /ID# 168345
      • Miyazaki, Japan, 880-0003
        • Miyazaki Medical Center Hospit /ID# 165279
      • Miyazaki-shi, Japan, 889-1692
        • University of Miyazaki Hosp /ID# 166880
      • Moriguchi-shi, Japan, 570-0096
        • Matsushita Memorial Hospital /ID# 167693
      • Nagareyama, Japan, 270-0157
        • Suzuki Clinic /ID# 165264
      • Nagoya, Japan, 451-8511
        • Meitetsu Hospital /ID# 165288
      • Nagoya, Japan, 458-0011
        • Aikawa Minnano-shinryojo /ID# 164168
      • Nagoya-aichi, Japan, 460-0001
        • Meijo Hospital /ID# 164966
      • Nagoya-shi, Japan, 453-0801
        • Nagoya Central Hospital /ID# 166879
      • Nara, Japan, 530-0025
        • Nara City Hospital /ID# 162959
      • Nayoro, Japan, 096-0018
        • Tani Internal Medicine Clinic /ID# 164974
      • Nishinomiya, Japan, 663-8124
        • Ooka Clinic /ID# 161887
      • Noshiro, Japan, 016-0151
        • Noshiro Yamamoto Med. Assoc. /ID# 162964
      • ONO, Japan, 675-1327
        • Kita-harima Medical Center /ID# 164165
      • Odawara, Japan, 250-0214
        • Manna Clinic /ID# 169548
      • Oita, Japan, 870-0263
        • Oita Midical Center /ID# 164960
      • Okayama, Japan, 700-0013
        • Okayama Saiseikai Outpatient Center Hospital /ID# 159475
      • Omuta, Japan, 836-0861
        • Omuta City Hospital /ID# 164967
      • Onomichi, Japan
        • Onomichi Central General Hospi /ID# 162903
      • Osaka, Japan, 530-0001
        • Kenporen Osaka Central Hospita /ID# 164956
      • Osaka, Japan, 537-0024
        • Asai Naika /ID# 167691
      • Osaka, Japan, 541-8567
        • Osaka Inter. Cancer Institute /ID# 166889
      • Osaka, Japan, 543-0035
        • Osaka Police Hospital /ID# 161769
      • Osaka, Japan, 546-0043
        • Asai Naika Iin /ID# 164955
      • Osaka, Japan, 555-0012
        • Utajima Ueda Clinic /ID# 161894
      • Osaka, Japan, 557-0002
        • Tamai Clinic /ID# 164162
      • Osaka, Japan, 572-0854
        • Osaka Hospital /ID# 164157
      • Otsu, Japan, 520-0802
        • Seko Internal Medicine Clinic /ID# 164169
      • Saga, Japan, 849-1113
        • Kawazoe Internal Medicine Clin /ID# 165292
      • Saitama, Japan, 331-0054
        • Saitama Citizens Medical Ctr /ID# 169550
      • Saitama, Japan, 331-0804
        • Sainokuni Higashiomiya Medical /ID# 167700
      • Saitama, Japan, 349-0115
        • Honda Internal Clinic /ID# 161767
      • Saitama, Japan
        • Saitama Cooperative Hospital /ID# 167697
      • Sakai, Japan, 590-0026
        • Minamitani Clinic /ID# 160821
      • Sapporo, Japan, 001-0033
        • Kaisei Hospital /ID# 164973
      • Sendai, Japan, 980-0873
        • Sendai Kousei Hospital /ID# 162961
      • Shiogama-miyagi, Japan, 985-0024
        • Saka General Hospital /ID# 162962
      • Suita, Japan, 564-0013
        • Saiseikai Suita Hospital /ID# 165289
      • Suita-osaka, Japan, 564-0082
        • Suita Municipal Hospital /ID# 164958
      • Takamatsu, Japan, 760-0065
        • Kagawa Prefectural Central Hos /ID# 160816
      • Takaraduka, Japan, 665-0881
        • Sawada Hepatology & Gastro /ID# 165255
      • Takatsuki, Japan, 569-1123
        • Tenjin Tanaka Internal Medicin /ID# 166883
      • Tatebayashi, Japan, 374-0053
        • Hamada Clinic /ID# 171045
      • Toda-shi, Saitama, Japan, 335-0023
        • Todachuo General Hospital /ID# 165280
      • Togane, Chiba, Japan, 283-0826
        • Eastern Chiba Medical Center /ID# 165257
      • Tokorozawa, Japan, 359-0037
        • Delta Clinic /ID# 164167
      • Tokyo, Japan, 105-8461
        • The Jikei University Hospital /ID# 169547
      • Tokyo, Japan, 108-6303
        • Abbott Japan /ID# 144983
      • Tokyo, Japan, 113-8431
        • Juntendo University Hospital /ID# 161771
      • Tokyo, Japan, 113-8602
        • Nippon Medical School Hospital /ID# 164164
      • Tokyo, Japan, 130-8575
        • Tokyo Metropolitan Bokutoh Hos /ID# 167686
      • Tokyo, Japan, 173-0021
        • Ohashi Medical Office /ID# 164968
      • Tokyo, Japan, 177-0033
        • Juntendo Univ Nerima Hosp /ID# 164160
      • Tokyo, Japan, 180-8610
        • JP Red Cross Musashino Hosp /ID# 162904
      • Toon, Japan, 791-0204
        • Ehime University Hospital /ID# 161885
      • Toyoma, Japan, 930-0194
        • Toyama University Hospital /ID# 169551
      • Toyonaka, Japan, 560-8565
        • Toyonaka Municipal Hospital /ID# 167692
      • Tsu, Mie, Japan, 514-0062
        • Mie Syokaki Clinic /ID# 161895
      • Utsunomiya, Japan, 321-0974
        • Saiseikai Utsunomiya Hospital /ID# 162958
      • Uwajima, Japan, 798-0032
        • Seike Clinic /ID# 166890
      • Wakayama, Japan, 640-8158
        • Saiseikai Wakayama Hospital /ID# 162954
      • Wakayama-shi, Japan, 640-8505
        • Wakayama Rosai Hospital /ID# 165254
      • Yachiyo, Japan, 276-0046
        • Tokyo Women's Medical Universi /ID# 167694
      • Yamagata, Japan, 990-0064
        • Tohoku Central Hospital /ID# 166897
      • Yamaguchi, Japan, 753-0047
        • Okuda Gastrointestinal Medicin /ID# 168349
      • Yatomi-shi, Japan, 498-0017
        • Kainan Hospital /ID# 164959
      • Yatsushiro-shi, Japan
        • Kumamoto Rosai Hospital /ID# 167695
      • Yokkaichi, Japan, 510-0885
        • Mie Prefectural General Medica /ID# 162963
      • Yokohama-shi, Japan, 227-0043
        • Showa Univ Fujigaoka Hosp /ID# 162952
      • Yufu-shi, Japan, 879-5503
        • Oita University Hospital /ID# 169549
      • Yugawara, Japan, 259-0313
        • Yamaguchi Surgery Clinic /ID# 167704
      • Yuki, Japan, 307-0001
        • Josai Hospital /ID# 168347
    • Aichi
      • Nagakute, Aichi, Japan, 4801195
        • Aichi Medical University Hosp /ID# 161892
    • Ehime
      • Matsuyama, Ehime, Japan, 7900826
        • Matsuyama Red Cross Hosp /ID# 162953
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 810-8563
        • NHO Kyushu Medical Center /ID# 162956
      • Kurume-shi, Fukuoka, Japan, 830-0011
        • Kurume University Hospital /ID# 164158
    • Gunma
      • Fujioka, Gunma, Japan, 3750024
        • Kusunoki Hospital /ID# 158119
      • Takasaki-shi, Gunma, Japan, 370-0829
        • National Hospital Organization Takasaki General Medical Center /ID# 160877
    • Hiroshima
      • Fukuyama-shi, Hiroshima, Japan, 720-8520
        • NHO Fukuyama Medical Center /ID# 162909
      • Fukuyama-shi, Hiroshima, Japan, 721-8511
        • Fukuyama City Hospital /ID# 161889
    • Hyogo
      • Nishinomiya-shi, Hyogo, Japan, 663-8501
        • The Hospital of Hyogo College of Medicine /ID# 162913
    • Kagoshima
      • Kagoshima-shi, Kagoshima, Japan, 8928512
        • Nanpuh Hospital /ID# 168348
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 216-0015
        • St. Marianna University School of Medicine Hospital /ID# 160876
      • Yokohama, Kanagawa, Japan, 232-0024
        • Yokohama City Univ Medical Ctr /ID# 162905
    • Kumamoto
      • Kumamoto-shi, Kumamoto, Japan, 860-8556
        • Kumamoto University Hospital /ID# 167048
      • Kumamoto-shi, Kumamoto, Japan, 8628655
        • Kumamoto Shinto General Hospital /ID# 165275
    • Okayama
      • Okayama-shi, Okayama, Japan, 700-8558
        • Okayama University Hospital /ID# 165268
    • Osaka
      • Osaka-shi, Osaka, Japan, 543-8555
        • Osaka Red Cross Hospital /ID# 161888
      • Osaka-shi, Osaka, Japan, 545-0051
        • Osaka City University Hospital /ID# 165290
      • Osaka-shi, Osaka, Japan, 550-0006
        • Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 167688
      • Takatsuki -shi, Osaka, Japan, 569-8686
        • Osaka Medical College Hospital /ID# 162908
    • Saitama
      • Kawagoe-shi, Saitama, Japan, 350-8550
        • Saitama Medical Center, Saitama Medical University /ID# 162911
      • Koshigaya, Saitama, Japan, 343-0813
        • Dokkyo Medical University Saitama Medical Center /ID# 162907
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 431-3125
        • Hamamatsu University Hospital /ID# 171048
    • Tokyo
      • Komae-shi, Tokyo, Japan, 201-8601
        • Tokyo Jikei Daisan Hospital /ID# 164159
      • Shinjuku-ku, Tokyo, Japan, 162-8666
        • Tokyo Women's Medical University Hospital /ID# 167685
    • Yamanashi
      • Chuo-shi, Yamanashi, Japan, 409-3898
        • University of Yamanashi Hospital /ID# 161770

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants with Chronic hepatitis C virus (HCV) genotype 2

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants with Sustained Virologic Response (SVR12)
Time Frame: 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.
12 weeks after last dose of study drug.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants with Virologic Failure During Treatment (breakthrough)
Time Frame: 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.
Up to 12 Weeks
Percentage of Participants with Virologic Failure After Treatment (relapse)
Time Frame: 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.
Post-treatment 24 weeks
Percentage of Participants with Sustained Virologic Response (SVR24)
Time Frame: 24 weeks after the last dose of study drug
HCV RNA less than the LLOQ 24 weeks after the last dose of study drug.
24 weeks after the last dose of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2016

Primary Completion (Actual)

July 26, 2019

Study Completion (Actual)

July 26, 2019

Study Registration Dates

First Submitted

October 25, 2016

First Submitted That Met QC Criteria

October 25, 2016

First Posted (Estimate)

October 26, 2016

Study Record Updates

Last Update Posted (Actual)

June 12, 2020

Last Update Submitted That Met QC Criteria

June 11, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P15-764

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Hepatitis C Virus

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe