The Durability of Response and Persistence of Resistance to AbbVie's 2 Direct-acting Antiviral Agent (2D) Therapy in Japanese Subjects

NCT ID: NCT02581020

Last Updated: 2021-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

344 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-14

Study Completion Date

2020-12-08

Brief Summary

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This study seeks to assess the durability of response and persistence of resistance to ombitasvir/ paritaprevir/ritonavir in Japanese participants who enrolled in a Phase 2 or 3 clinical study with these agents for the treatment of chronic hepatitis C.

Detailed Description

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Conditions

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Hepatitis C Virus

Keywords

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Hepatitis C Follow-up Observation Japanese

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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1

Participants who were treated with 2D regimen (ombitasvir/ paritaprevir/ ritonavir) and completed 48 weeks of follow up from the prior Phase 2 or 3 studies conducted in Japan.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Participants treated in Study M12-536 or M13-004 with the 2D regimen (ombitasvir/ paritaprevir/ ritonavir) and completed 48 weeks of follow-up, regardless of SVR achievement.
* Participants who agree to sign the informed consent

Exclusion Criteria

* Participants treated with a direct-acting antiviral agent (DAA) immediately after Study M12-536 or M13-004.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Nagoya City University Hospital /ID# 157439

Nagoya, Aichi-ken, Japan

Site Status

Matsuyama Red Cross Hospital /ID# 152125

Matsuyama, Ehime, Japan

Site Status

National Hospital Organization Kyushu Medical Center /ID# 161759

Fukuoka, Fukuoka, Japan

Site Status

Fukuoka University Hospital /ID# 155965

Fukuoka, Fukuoka, Japan

Site Status

Kurume University Hospital /ID# 152123

Kurume-shi, Fukuoka, Japan

Site Status

Ogaki Municipal Hospital /ID# 158105

Ogaki-shi, Gifu, Japan

Site Status

Gunma University Hospital /ID# 158118

Maebashi, Gunma, Japan

Site Status

National Hospital Organization Takasaki General Medical Center /ID# 152128

Takasaki-shi, Gunma, Japan

Site Status

Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital /ID# 152178

Hiroshima, Hiroshima, Japan

Site Status

Hiroshima University Hospital /ID# 152232

Hiroshima, Hiroshima, Japan

Site Status

Obihiro kosei Hospital /ID# 157437

Obihiro-shi, Hokkaido, Japan

Site Status

Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 153019

Sapporo, Hokkaido, Japan

Site Status

Hitachi General Hospital /ID# 160800

Hitachi-shi, Ibaraki, Japan

Site Status

Duplicate_Kanazawa University Hospital /ID# 152226

Kanazawa, Ishikawa-ken, Japan

Site Status

Kagawa University Hospital /ID# 153548

Kita-gun, Kagawa-ken, Japan

Site Status

Duplicate_Yokohama City University Medical Center /ID# 159474

Yokohama, Kanagawa, Japan

Site Status

Yokohama City University Hospital /ID# 165252

Yokohama, Kanagawa, Japan

Site Status

Kumamoto Shinto General Hospital /ID# 150061

Kumamoto, Kumamoto, Japan

Site Status

Okayama University Hospital /ID# 150060

Okayama, Okayama-ken, Japan

Site Status

Osaka City General Hospital /ID# 152126

Osaka, Osaka, Japan

Site Status

Japanese Red Cross Osaka Hospital /ID# 155964

Osaka, Osaka, Japan

Site Status

Saga University Hospital /ID# 161757

Saga, Saga-ken, Japan

Site Status

Saitama Medical University Hospital /ID# 153544

Iruma-gun, Saitama, Japan

Site Status

Hamamatsu University Hospital /ID# 152176

Hamamatsu, Shizuoka, Japan

Site Status

Dokkyo Medical University Hospital /ID# 152225

Shimotsuga-gun, Tochigi, Japan

Site Status

Jichi Medical University Hospital /ID# 153018

Shimotsuke-shi, Tochigi, Japan

Site Status

Juntendo University Hospital /ID# 153545

Bunkyo-ku, Tokyo, Japan

Site Status

The University of Tokyo Hospital /ID# 158121

Bunkyo-ku, Tokyo, Japan

Site Status

Toranomon Hospital /ID# 152124

Minato-ku, Tokyo, Japan

Site Status

Kitasato University Kitasato Institute Hospital /ID# 152145

Minato-ku, Tokyo, Japan

Site Status

Toyama Prefectural Central Hospital /ID# 164156

Toyama, Toyama, Japan

Site Status

Yamaguchi University Hospital /ID# 166899

Ube-shi, Yamaguchi, Japan

Site Status

University of Yamanashi Hospital /ID# 153547

Chuo-shi, Yamanashi, Japan

Site Status

Asakura Medical Association Ho /ID# 155963

Asakura, , Japan

Site Status

Fukuiken Saiseikai Hospital /ID# 162898

Fukui, , Japan

Site Status

Gifu Municipal Hospital /ID# 152227

Gifu, , Japan

Site Status

Gifu Prefectural Genl Med Ctr /ID# 154796

Gifu, , Japan

Site Status

Ikeda Municipal Hospital /ID# 150062

Ikeda, , Japan

Site Status

Tokyo Med Uni Ibaraki Med Ctr /ID# 152127

Inashiki, , Japan

Site Status

Nippon Med Chiba Hokusoh Hosp /ID# 164155

Inzai, , Japan

Site Status

Kagoshima Uni Med and Dental /ID# 157438

Kagoshima, , Japan

Site Status

Toranomon Hospital Kajigaya /ID# 152129

Kawasaki, , Japan

Site Status

Kawasaki Municipal Tama Hospit /ID# 153546

Kawasaki, , Japan

Site Status

Ehime Prefectural Central Hosp /ID# 158106

Matsuyama, , Japan

Site Status

Kawasaki Hosp, Kawasaki Med /ID# 152180

Okayama, , Japan

Site Status

Osaka Hospital /ID# 152177

Osaka, , Japan

Site Status

Japanese Red Cross Saitama Hos /ID# 166898

Saitama, , Japan

Site Status

Saiseikai Suita Hospital /ID# 153549

Suita, , Japan

Site Status

Kagawa Prefectural Central Hos /ID# 152179

Takamatsu, , Japan

Site Status

Nat Hosp Org Minami Wakayama /ID# 153550

Tanabe, , Japan

Site Status

Toshiba General Hospital /ID# 152122

Tokyo, , Japan

Site Status

JP Red Cross Musashino Hosp /ID# 152175

Tokyo, , Japan

Site Status

Oita University Hospital /ID# 165274

Yufu-shi, , Japan

Site Status

Countries

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Japan

Related Links

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Other Identifiers

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P15-349

Identifier Type: -

Identifier Source: org_study_id