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

NCT02581020 | Completed

• 1 other identifier: P15-349
• Study Type: observational
• Target: 344
• Locations: 1 country
• Sites: 53

Brief Summary

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.

Conditions

Hepatitis C Virus

Keywords

Hepatitis C; Follow-up; Observation; Japanese

Outcome Measures

Primary Outcomes (1)

• Hepatitis C virus ribonucleic acid (HCV RNA) levels

  HCV RNA levels in plasma

  60 months after completion of the 2D treatment in M12-536 or M13-004 study

Secondary Outcomes (5)

• Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to Paritaprevir in Non-structural Viral Protein 3 (NS3)

  For approximately 5 years

• Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to Ombitasvir in Non-structural Viral Protein 5A (NS5A)

  For approximately 5 years

• Percentage of participants with hepatocellular carcinoma

  Up to 60 month after completion of the 2D treatment in M12-536 or M13-004

• Number of participants with serious adverse events (SAEs)

  Up to 60 month after completion of the 2D treatment in M132-536 or M13-004 study

• Hepatitis C virus ribonucleic acid (HCV RNA) levels

  18, 24, 30, 36, 42, 48, 52 months after completion of the 2D treatment in M12-536 or M13-004 study

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants who were treated in Study M12-536 or M13-004 with 2D regimen (ombitasvir/ paritaprevir/ritonavir) and completed 48 weeks of follow-up.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (53)

Nagoya City University Hospital /ID# 157439

Nagoya, Aichi-ken, 467-8602, Japan

Location

Matsuyama Red Cross Hospital /ID# 152125

Matsuyama, Ehime, 790-8524, Japan

Location

National Hospital Organization Kyushu Medical Center /ID# 161759

Fukuoka, Fukuoka, 810-8563, Japan

Location

Fukuoka University Hospital /ID# 155965

Fukuoka, Fukuoka, 814-0180, Japan

Location

Kurume University Hospital /ID# 152123

Kurume-shi, Fukuoka, 830-0011, Japan

Location

Ogaki Municipal Hospital /ID# 158105

Ogaki-shi, Gifu, 503-8502, Japan

Location

Gunma University Hospital /ID# 158118

Maebashi, Gunma, 371-8511, Japan

Location

National Hospital Organization Takasaki General Medical Center /ID# 152128

Takasaki-shi, Gunma, 370-0829, Japan

Location

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

Hiroshima, Hiroshima, 730-8619, Japan

Location

Hiroshima University Hospital /ID# 152232

Hiroshima, Hiroshima, 734-8551, Japan

Location

Obihiro kosei Hospital /ID# 157437

Obihiro-shi, Hokkaido, 080-0024, Japan

Location

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

Sapporo, Hokkaido, 060-0033, Japan

Location

Hitachi General Hospital /ID# 160800

Hitachi-shi, Ibaraki, 317-0077, Japan

Location

Duplicate_Kanazawa University Hospital /ID# 152226

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

Kagawa University Hospital /ID# 153548

Kita-gun, Kagawa-ken, 761-0793, Japan

Location

Duplicate_Yokohama City University Medical Center /ID# 159474

Yokohama, Kanagawa, 232-0024, Japan

Location

Yokohama City University Hospital /ID# 165252

Yokohama, Kanagawa, 236-0004, Japan

Location

Kumamoto Shinto General Hospital /ID# 150061

Kumamoto, Kumamoto, 8628655, Japan

Location

Okayama University Hospital /ID# 150060

Okayama, Okayama-ken, 700-8558, Japan

Location

Osaka City General Hospital /ID# 152126

Osaka, Osaka, 534-0021, Japan

Location

Japanese Red Cross Osaka Hospital /ID# 155964

Osaka, Osaka, 543-8555, Japan

Location

Saga University Hospital /ID# 161757

Saga, Saga-ken, 849-8501, Japan

Location

Saitama Medical University Hospital /ID# 153544

Iruma-gun, Saitama, 350-0451, Japan

Location

Hamamatsu University Hospital /ID# 152176

Hamamatsu, Shizuoka, 431-3192, Japan

Location

Dokkyo Medical University Hospital /ID# 152225

Shimotsuga-gun, Tochigi, 321-0293, Japan

Location

Jichi Medical University Hospital /ID# 153018

Shimotsuke-shi, Tochigi, 329-0498, Japan

Location

Juntendo University Hospital /ID# 153545

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

The University of Tokyo Hospital /ID# 158121

Bunkyo-ku, Tokyo, 113-8655, Japan

Location

Toranomon Hospital /ID# 152124

Minato-ku, Tokyo, 105-8470, Japan

Location

Kitasato University Kitasato Institute Hospital /ID# 152145

Minato-ku, Tokyo, 108-8642, Japan

Location

Toyama Prefectural Central Hospital /ID# 164156

Toyama, Toyama, 930-8550, Japan

Location

Yamaguchi University Hospital /ID# 166899

Ube-shi, Yamaguchi, 755-8505, Japan

Location

University of Yamanashi Hospital /ID# 153547

Chuo-shi, Yamanashi, 409-3821, Japan

Location

Asakura Medical Association Ho /ID# 155963

Asakura, 838-0069, Japan

Location

Fukuiken Saiseikai Hospital /ID# 162898

Fukui, 918-8235, Japan

Location

Gifu Municipal Hospital /ID# 152227

Gifu, 500-8323, Japan

Location

Gifu Prefectural Genl Med Ctr /ID# 154796

Gifu, 500-8727, Japan

Location

Ikeda Municipal Hospital /ID# 150062

Ikeda, 563-8510, Japan

Location

Tokyo Med Uni Ibaraki Med Ctr /ID# 152127

Inashiki, 300-0332, Japan

Location

Nippon Med Chiba Hokusoh Hosp /ID# 164155

Inzai, 270-1613, Japan

Location

Kagoshima Uni Med and Dental /ID# 157438

Kagoshima, 890-8520, Japan

Location

Toranomon Hospital Kajigaya /ID# 152129

Kawasaki, 213-8587, Japan

Location

Kawasaki Municipal Tama Hospit /ID# 153546

Kawasaki, 214-0021, Japan

Location

Ehime Prefectural Central Hosp /ID# 158106

Matsuyama, 790-0024, Japan

Location

Kawasaki Hosp, Kawasaki Med /ID# 152180

Okayama, 700-0821, Japan

Location

Osaka Hospital /ID# 152177

Osaka, 572-0854, Japan

Location

Japanese Red Cross Saitama Hos /ID# 166898

Saitama, 338-8553, Japan

Location

Saiseikai Suita Hospital /ID# 153549

Suita, 564-0013, Japan

Location

Kagawa Prefectural Central Hos /ID# 152179

Takamatsu, 760-0065, Japan

Location

Nat Hosp Org Minami Wakayama /ID# 153550

Tanabe, 646-8558, Japan

Location

Toshiba General Hospital /ID# 152122

Tokyo, 140-8522, Japan

Location

JP Red Cross Musashino Hosp /ID# 152175

Tokyo, 180-8610, Japan

Location

Oita University Hospital /ID# 165274

Yufu-shi, 879-5503, Japan

Location

Related Links

• clinical study report synopsis

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 19, 2015
• First Posted: October 20, 2015
• Study Start: January 14, 2016
• Primary Completion: December 8, 2020
• Study Completion: December 8, 2020
• Last Updated: December 8, 2021

Record last verified: 2021-01

Locations

JP (53)