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AzTrials

Chronic Hepatitis C VirusNCT02945228

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

An observational study of Chronic Hepatitis C Virus, run by AbbVie at 170 sites in Japan.

Completed

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

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Chronic Hepatitis C Virus
How many people
449 participants
Where
170 sitesJapan
Study dates
26 Oct 2016to 26 Jul 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 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants with Chronic hepatitis C virus (HCV) genotype 2

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

170 sites in 1 country.

170 sites in 1 country

Japan170 sites

  • Kato Michio Hepatology Clinic /ID# 159476

    Amagasaki, Hyogo, 661-0012

  • Aomori Prefectural Central Hos /ID# 160822

    Aomori, 030-8553

  • Mantani Clinic /ID# 168353

    Arida, 649-0316

  • Japanese Red Cross Asahikawa /ID# 165265

    Asahikawa, 070-0061

  • Asahikawa City Hospital /ID# 167703

    Asahikawa-shi, 070-8610

  • National Hospital Organization /ID# 168346

    Chiba, 260-0042

  • Chiba University Hospital /ID# 160875

    Chiba, 260-8677

  • Seirei Sakura Citizen Hospital /ID# 166896

    Chiba

  • Kenseido-iin /ID# 164166

    Chichibu, 368-0042

  • University of Yamanashi Hospital /ID# 161770

    Chuo-shi, Yamanashi, 409-3898

  • Fuji City General Hospital /ID# 165278

    Fuji

  • Kusunoki Hospital /ID# 158119

    Fujioka, Gunma, 3750024

  • Fukui Prefectural Hospital /ID# 168344

    Fukui, 910-0846

  • Fukui Prefectural Hospital /ID# 169552

    Fukui, 910-0846

  • University of Fukui Hospital /ID# 166933

    Fukui, 910-1104

  • NHO Kyushu Medical Center /ID# 162956

    Fukuoka, Fukuoka, 810-8563

  • Chihaya Hospital /ID# 161893

    Fukuoka

  • Morichika Internal Medicine /ID# 168351

    Fukuyama, 721-0975

  • NHO Fukuyama Medical Center /ID# 162909

    Fukuyama-shi, Hiroshima, 720-8520

  • Fukuyama City Hospital /ID# 161889

    Fukuyama-shi, Hiroshima, 721-8511

  • Gifu Municipal Hospital /ID# 165287

    Gifu, 500-8323

  • Shiroyama Hospital /ID# 164963

    Habikino-osaka, 583-0872

  • Aomori Rosai Hospital /ID# 167702

    Hachinohe

  • Hamamatsu University Hospital /ID# 171048

    Hamamatsu, Shizuoka, 431-3125

  • Tamakoshi Clinic /ID# 165282

    Hamamatsu, 335-0023

  • Higashihiroshima Medical Ctr /ID# 168343

    Higashihiroshima, 739-0041

  • Mito Medical Center /ID# 171046

    Higashiibaraki-gun, 311-3117

  • Higashiomicity Notogawa Hosp /ID# 161891

    Higashiomi, Shiga, 521-1223

  • Shin-ishikiri Clinic /ID# 169643

    Higashiosaka, 579-8013

  • Wakakusa Daiichi Hospital /ID# 166882

    Higashiosaka, 579-8056

  • Hiroshima Red Cross Hosp Atomi /ID# 162912

    Hiroshima, 730-0052

  • Hiroshima University Hospital /ID# 160815

    Hiroshima, 734-8551

  • Hiroshima-Nishi Medical Center /ID# 169642

    Hiroshima, 739-0651

  • Koyo New Town Hospital /ID# 161890

    Hiroshima, 739-1742

  • Taishi Hospital /ID# 165291

    Hyōgo, 671-1561

  • Iizuka Hospital /ID# 161886

    Iizuka, 820-0018

  • Ikeda Municipal Hospital /ID# 160814

    Ikeda, 563-8510

  • Tokyo Med Uni Ibaraki Med Ctr /ID# 162955

    Inashiki, 300-0332

  • Nippon Med Chiba Hokusoh Hosp /ID# 162902

    Inzai, 270-1613

  • Saitama Medical University Hos /ID# 161768

    Iruma-gun, 350-0451

  • Itoigawa Sogo Hospital /ID# 166884

    Itoigawa, 941-0006

  • Kamiiwade Internal Med-Neuro /ID# 166881

    Iwade, 649-6216

  • Nanpuh Hospital /ID# 168348

    Kagoshima, Kagoshima-ken, 8928512

  • Kaizuka City Hospital /ID# 165256

    Kaizuka

  • Kamisu Saiseikai Hospital /ID# 167701

    Kamisu, 314-0112

  • Fuji Clinic /ID# 160820

    Kan’onjichō, 3440067

  • Kiyokawa Hospital /ID# 164961

    Kanagawa, 166-0004

  • Hiratsuka City Hospital /ID# 161884

    Kanagawa

  • Niwa Hospital /ID# 167684

    Kanagawa

  • Ibaraki Prefectural Cent. Hosp /ID# 164962

    Kasama, 309-1703

  • The Jikei Univ. Kashiwa Hosp. /ID# 166888

    Kashiwa-shi, 277-0004

  • Kashiwazaki General Hospital a /ID# 168352

    Kashiwazaki, 945-0035

  • Kawase Clinic /ID# 164957

    Kasugai, 486-0914

  • Hirose Clinic /ID# 167699

    Kawagoe, 350-0043

  • Sekishindo Hospital /ID# 162960

    Kawagoe, 350-1123

  • Saitama Medical Center, Saitama Medical University /ID# 162911

    Kawagoe-shi, Saitama, 350-8550

  • Kawaguchi Municipal Medical Ce /ID# 165270

    Kawaguchi, 333-0833

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

    Kawasaki, Kanagawa, 216-0015

  • Kawasaki Municipal Tama Hospit /ID# 165267

    Kawasaki, 214-0021

  • Kanto Rosai Hospital /ID# 165258

    Kawasaki-shi, Kanagawa

  • Kishiwada Tokushukai Hospital /ID# 164964

    Kishiwada, Osaka, 596-0042

  • Kokura Kinen Hospital /ID# 164969

    Kitakyushu, 802-0001

  • Kitasato University Medical Ce /ID# 158120

    Kitamoto, 364-0026

  • Kobe Asahi Hospital /ID# 161896

    Kobe, 653-0801

  • Kobe Adventist Hospital /ID# 161897

    Kobe

  • Tokyo Jikei Daisan Hospital /ID# 164159

    Komae-shi, Tokyo, 201-8601

  • Konan Kosei Hospital /ID# 165277

    Konan-shi, 483-8704

  • Cosmos Clinic /ID# 164161

    Kōriyama, 963-0209

  • Ishida Medical Clinic /ID# 166887

    Kōriyama, 963-8023

  • Dokkyo Medical University Saitama Medical Center /ID# 162907

    Koshigaya, Saitama, 343-0813

  • Hanada Internal Medicine Clin /ID# 165266

    Koshigaya, Saitam, 343-0015

  • Kumamoto University Hospital /ID# 167048

    Kumamoto, Kumamoto, 860-8556

  • Kumamoto Shinto General Hospital /ID# 165275

    Kumamoto, Kumamoto, 8628655

  • Kawasaki Medical School Hosp /ID# 162906

    Kurashiki, 701-0114

  • National Hosp Org Kure Med Cen /ID# 167689

    Kure, Hiroshima, 737-0023

  • Kurihara Central Hospital /ID# 171047

    Kurihara, 228-0014

  • Kuroishi Hospital /ID# 164971

    Kuroishi-aomori, 036-0541

  • Shin Koga Clinic /ID# 164972

    Kurume, 830-0033

  • Koga Hospital 21 /ID# 167698

    Kurume, 839-0801

  • Kurume University Hospital /ID# 164158

    Kurume-shi, Fukuoka, 830-0011

  • Hori Internal Medicine Clinic /ID# 167696

    Kushiro, 085-0005

  • NHO Kyoto Medical Center /ID# 162910

    Kyoto, 612-0861

  • Matsuzaki Internal Medicine Cl /ID# 164970

    Kyoto, 615-8101

  • Gibo Hepatorogy Clinic /ID# 161766

    Matsumoto, 399-0036

  • Matsuyama Red Cross Hosp /ID# 162953

    Matsuyama, Ehime, 7900826

  • Kizawa Memorial Hospital /ID# 162957

    Minokamo, 505-0034

  • Sumiyoshi Clinic Hospital /ID# 164163

    Mito, 310-0844

  • South Miyagi Medical Center /ID# 164965

    Miyagi, 989-1253

  • National Hospital Organization /ID# 168345

    Miyakonojō, 885-0014

  • Miyazaki Medical Center Hospit /ID# 165279

    Miyazaki, 880-0003

  • University of Miyazaki Hosp /ID# 166880

    Miyazaki, 889-1692

  • Matsushita Memorial Hospital /ID# 167693

    Moriguchi-shi, 570-0096

  • Aichi Medical University Hosp /ID# 161892

    Nagakute, Aichi-ken, 4801195

  • Suzuki Clinic /ID# 165264

    Nagareyama, 270-0157

  • Meitetsu Hospital /ID# 165288

    Nagoya, 451-8511

  • Nagoya Central Hospital /ID# 166879

    Nagoya, 453-0801

  • Aikawa Minnano-shinryojo /ID# 164168

    Nagoya, 458-0011

  • Meijo Hospital /ID# 164966

    Nagoya-aichi, 460-0001

  • Nara City Hospital /ID# 162959

    Nara, 530-0025

  • Tani Internal Medicine Clinic /ID# 164974

    Nayoro, 096-0018

  • Ooka Clinic /ID# 161887

    Nishinomiya, 663-8124

  • The Hospital of Hyogo College of Medicine /ID# 162913

    Nishinomiya-shi, Hyōgo, 663-8501

  • Noshiro Yamamoto Med. Assoc. /ID# 162964

    Noshiro, 016-0151

  • Manna Clinic /ID# 169548

    Odawara, 250-0214

  • Oita Midical Center /ID# 164960

    Ōita, 870-0263

  • Okayama University Hospital /ID# 165268

    Okayama, Okayama-ken, 700-8558

  • Okayama Saiseikai Outpatient Center Hospital /ID# 159475

    Okayama, 700-0013

  • Omuta City Hospital /ID# 164967

    Omuta, 836-0861

  • Kita-harima Medical Center /ID# 164165

    Ono, 675-1327

  • Onomichi Central General Hospi /ID# 162903

    Onomichi

  • Osaka Red Cross Hospital /ID# 161888

    Osaka, Osaka, 543-8555

  • Osaka City University Hospital /ID# 165290

    Osaka, Osaka, 545-0051

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

    Osaka, Osaka, 550-0006

  • Kenporen Osaka Central Hospita /ID# 164956

    Osaka, 530-0001

  • Asai Naika /ID# 167691

    Osaka, 537-0024

  • Osaka Inter. Cancer Institute /ID# 166889

    Osaka, 541-8567

  • Osaka Police Hospital /ID# 161769

    Osaka, 543-0035

  • Asai Naika Iin /ID# 164955

    Osaka, 546-0043

  • Utajima Ueda Clinic /ID# 161894

    Osaka, 555-0012

  • Tamai Clinic /ID# 164162

    Osaka, 557-0002

  • Osaka Hospital /ID# 164157

    Osaka, 572-0854

  • Seko Internal Medicine Clinic /ID# 164169

    Ōtsu, 520-0802

  • Kawazoe Internal Medicine Clin /ID# 165292

    Saga, 849-1113

  • Saitama Citizens Medical Ctr /ID# 169550

    Saitama, 331-0054

  • Sainokuni Higashiomiya Medical /ID# 167700

    Saitama, 331-0804

  • Honda Internal Clinic /ID# 161767

    Saitama, 349-0115

  • Saitama Cooperative Hospital /ID# 167697

    Saitama

  • Minamitani Clinic /ID# 160821

    Sakai, 590-0026

  • Kaisei Hospital /ID# 164973

    Sapporo, 001-0033

  • Sendai Kousei Hospital /ID# 162961

    Sendai, 980-0873

  • Tokyo Women's Medical University Hospital /ID# 167685

    Shinjuku-ku, Tokyo, 162-8666

  • Saka General Hospital /ID# 162962

    Shiogama-miyagi, 985-0024

  • Saiseikai Suita Hospital /ID# 165289

    Suita, 564-0013

  • Suita Municipal Hospital /ID# 164958

    Suita-osaka, 564-0082

  • Kagawa Prefectural Central Hos /ID# 160816

    Takamatsu, 760-0065

  • Sawada Hepatology & Gastro /ID# 165255

    Takaraduka, 665-0881

  • National Hospital Organization Takasaki General Medical Center /ID# 160877

    Takasaki-shi, Gunma, 370-0829

  • Tenjin Tanaka Internal Medicin /ID# 166883

    Takatsuki, 569-1123

  • Osaka Medical College Hospital /ID# 162908

    Takatsuki -shi, Osaka, 569-8686

  • Hamada Clinic /ID# 171045

    Tatebayashi, 374-0053

  • Todachuo General Hospital /ID# 165280

    Toda-shi, Saitama, 335-0023

  • Eastern Chiba Medical Center /ID# 165257

    Togane, Chiba, 283-0826

  • Delta Clinic /ID# 164167

    Tokorozawa, 359-0037

  • The Jikei University Hospital /ID# 169547

    Tokyo, 105-8461

  • Abbott Japan /ID# 144983

    Tokyo, 108-6303

  • Juntendo University Hospital /ID# 161771

    Tokyo, 113-8431

  • Nippon Medical School Hospital /ID# 164164

    Tokyo, 113-8602

  • Tokyo Metropolitan Bokutoh Hos /ID# 167686

    Tokyo, 130-8575

  • Ohashi Medical Office /ID# 164968

    Tokyo, 173-0021

  • Juntendo Univ Nerima Hosp /ID# 164160

    Tokyo, 177-0033

  • JP Red Cross Musashino Hosp /ID# 162904

    Tokyo, 180-8610

  • Ehime University Hospital /ID# 161885

    Tōon, 791-0204

  • Toyama University Hospital /ID# 169551

    Toyoma, 930-0194

  • Toyonaka Municipal Hospital /ID# 167692

    Toyonaka, 560-8565

  • Mie Syokaki Clinic /ID# 161895

    TSU, MIE, 514-0062

  • Saiseikai Utsunomiya Hospital /ID# 162958

    Utsunomiya, 321-0974

  • Seike Clinic /ID# 166890

    Uwajima, 798-0032

  • Saiseikai Wakayama Hospital /ID# 162954

    Wakayama, 640-8158

  • Wakayama Rosai Hospital /ID# 165254

    Wakayama, 640-8505

  • Tokyo Women's Medical Universi /ID# 167694

    Yachiyo, 276-0046

  • Tohoku Central Hospital /ID# 166897

    Yamagata, 990-0064

  • Okuda Gastrointestinal Medicin /ID# 168349

    Yamaguchi, 753-0047

  • Kainan Hospital /ID# 164959

    Yatomi-shi, 498-0017

  • Kumamoto Rosai Hospital /ID# 167695

    Yatsushiro-shi

  • Mie Prefectural General Medica /ID# 162963

    Yokkaichi, 510-0885

  • Yokohama City Univ Medical Ctr /ID# 162905

    Yokohama, Kanagawa, 232-0024

  • Showa Univ Fujigaoka Hosp /ID# 162952

    Yokohama, 227-0043

  • Oita University Hospital /ID# 169549

    Yufu-shi, 879-5503

  • Yamaguchi Surgery Clinic /ID# 167704

    Yugawara, 259-0313

  • Josai Hospital /ID# 168347

    Yūki, 307-0001

Other trials in Japan

About this study

Official title: 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.

Keywords
Genotype 2, Paritaprevir, Hepatitis C Virus (HCV), Ritonavir, Ombitasvir
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 NCT02945228
Study groupRoleWhat they receive
Chronic infection of hepatitis C virus (HCV) genotype 2Participants 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 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 (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last dose of study drug.

    Measured: 12 weeks after last dose of study drug.

Secondary outcomes (3)

  1. Percentage of Participants with Virologic Failure During Treatment (breakthrough)

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

    Measured: Up to 12 Weeks

  2. Percentage of Participants with Virologic Failure After Treatment (relapse)

    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.

    Measured: Post-treatment 24 weeks

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

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

    Measured: 24 weeks after the last dose of study drug

Timeline

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

  1. First posted26 Oct 2016 (estimated)
  2. Study start26 Oct 2016
  3. Primary completion26 Jul 2019
  4. Study completion26 Jul 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
449 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02945228
Sponsor's protocol ID
P15-764
Status last verified
Jun 2020
First submitted
25 Oct 2016
Last updated
12 Jun 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 170 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 12 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 170 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 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 NCT02945228.

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 12 Jun 2020.

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