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Hepatitis C VirusNCT02581020

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

An observational study of Hepatitis C Virus, run by AbbVie at 53 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

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hepatitis C Virus
How many people
344 participants
Where
53 sitesJapan
Study dates
14 Jan 2016to 8 Dec 2020
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

53 sites in 1 country.

53 sites in 1 country

Japan53 sites

  • Asakura Medical Association Ho /ID# 155963

    Asakura, 838-0069

  • Juntendo University Hospital /ID# 153545

    Bunkyo-ku, Tokyo, 113-8431

  • The University of Tokyo Hospital /ID# 158121

    Bunkyo-ku, Tokyo, 113-8655

  • University of Yamanashi Hospital /ID# 153547

    Chuo-shi, Yamanashi, 409-3821

  • Fukuiken Saiseikai Hospital /ID# 162898

    Fukui, 918-8235

  • National Hospital Organization Kyushu Medical Center /ID# 161759

    Fukuoka, Fukuoka, 810-8563

  • Fukuoka University Hospital /ID# 155965

    Fukuoka, Fukuoka, 814-0180

  • Gifu Municipal Hospital /ID# 152227

    Gifu, 500-8323

  • Gifu Prefectural Genl Med Ctr /ID# 154796

    Gifu, 500-8727

  • Hamamatsu University Hospital /ID# 152176

    Hamamatsu, Shizuoka, 431-3192

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

    Hiroshima, Hiroshima, 730-8619

  • Hiroshima University Hospital /ID# 152232

    Hiroshima, Hiroshima, 734-8551

  • Hitachi General Hospital /ID# 160800

    Hitachi-shi, Ibaraki, 317-0077

  • Ikeda Municipal Hospital /ID# 150062

    Ikeda, 563-8510

  • Tokyo Med Uni Ibaraki Med Ctr /ID# 152127

    Inashiki, 300-0332

  • Nippon Med Chiba Hokusoh Hosp /ID# 164155

    Inzai, 270-1613

  • Saitama Medical University Hospital /ID# 153544

    Iruma-gun, Saitama, 350-0451

  • Kagoshima Uni Med and Dental /ID# 157438

    Kagoshima, 890-8520

  • Duplicate_Kanazawa University Hospital /ID# 152226

    Kanazawa, Ishikawa-ken, 920-8641

  • Toranomon Hospital Kajigaya /ID# 152129

    Kawasaki, 213-8587

  • Kawasaki Municipal Tama Hospit /ID# 153546

    Kawasaki, 214-0021

  • Kagawa University Hospital /ID# 153548

    Kita-gun, Kagawa-ken, 761-0793

  • Kumamoto Shinto General Hospital /ID# 150061

    Kumamoto, Kumamoto, 8628655

  • Kurume University Hospital /ID# 152123

    Kurume-shi, Fukuoka, 830-0011

  • Gunma University Hospital /ID# 158118

    Maebashi, Gunma, 371-8511

  • Matsuyama Red Cross Hospital /ID# 152125

    Matsuyama, Ehime, 790-8524

  • Ehime Prefectural Central Hosp /ID# 158106

    Matsuyama, 790-0024

  • Toranomon Hospital /ID# 152124

    Minato-ku, Tokyo, 105-8470

  • Kitasato University Kitasato Institute Hospital /ID# 152145

    Minato-ku, Tokyo, 108-8642

  • Nagoya City University Hospital /ID# 157439

    Nagoya, Aichi-ken, 467-8602

  • Obihiro kosei Hospital /ID# 157437

    Obihiro-shi, Hokkaido, 080-0024

  • Ogaki Municipal Hospital /ID# 158105

    Ogaki-shi, Gifu, 503-8502

  • Okayama University Hospital /ID# 150060

    Okayama, Okayama-ken, 700-8558

  • Kawasaki Hosp, Kawasaki Med /ID# 152180

    Okayama, 700-0821

  • Osaka City General Hospital /ID# 152126

    Osaka, Osaka, 534-0021

  • Japanese Red Cross Osaka Hospital /ID# 155964

    Osaka, Osaka, 543-8555

  • Osaka Hospital /ID# 152177

    Osaka, 572-0854

  • Saga University Hospital /ID# 161757

    Saga, Saga-ken, 849-8501

  • Japanese Red Cross Saitama Hos /ID# 166898

    Saitama, 338-8553

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

    Sapporo, Hokkaido, 060-0033

  • Dokkyo Medical University Hospital /ID# 152225

    Shimotsuga-gun, Tochigi, 321-0293

  • Jichi Medical University Hospital /ID# 153018

    Shimotsuke-shi, Tochigi, 329-0498

  • Saiseikai Suita Hospital /ID# 153549

    Suita, 564-0013

  • Kagawa Prefectural Central Hos /ID# 152179

    Takamatsu, 760-0065

  • National Hospital Organization Takasaki General Medical Center /ID# 152128

    Takasaki-shi, Gunma, 370-0829

  • Nat Hosp Org Minami Wakayama /ID# 153550

    Tanabe, 646-8558

  • Toshiba General Hospital /ID# 152122

    Tokyo, 140-8522

  • JP Red Cross Musashino Hosp /ID# 152175

    Tokyo, 180-8610

  • Toyama Prefectural Central Hospital /ID# 164156

    Toyama, Toyama, 930-8550

  • Yamaguchi University Hospital /ID# 166899

    Ube-shi, Yamaguchi, 755-8505

  • Duplicate_Yokohama City University Medical Center /ID# 159474

    Yokohama, Kanagawa, 232-0024

  • Yokohama City University Hospital /ID# 165252

    Yokohama, Kanagawa, 236-0004

  • Oita University Hospital /ID# 165274

    Yufu-shi, 879-5503

Other trials in Japan

About this study

Official title: A Follow-up Study to Assess the Durability of Response and Persistence of Resistance to AbbVie's 2 Direct-acting Antiviral Agent (2D) Therapy in Japanese Subjects Who Participated in Phase 2 or 3 Clinical Studies for the Treatment of Chronic Hepatitis C Virus (HCV) Infection

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.

Keywords
Hepatitis C, Follow-up, Observation, Japanese
Medical subject headings
Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02581020
Study groupRoleWhat they receive
1Participants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hepatitis C virus ribonucleic acid (HCV RNA) levels

    HCV RNA levels in plasma

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

Secondary outcomes (5)

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

    Measured: For approximately 5 years

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

    Measured: For approximately 5 years

  3. Percentage of participants with hepatocellular carcinoma

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

  4. Number of participants with serious adverse events (SAEs)

    All serious adverse events will be monitored during the observation period.

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

  5. Hepatitis C virus ribonucleic acid (HCV RNA) levels

    HCV RNA levels in plasma

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

Timeline

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

  1. First posted20 Oct 2015 (estimated)
  2. Study start14 Jan 2016
  3. Primary completion8 Dec 2020
  4. Study completion8 Dec 2020

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
Other
Enrolment
344 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02581020
Sponsor's protocol ID
P15-349
Status last verified
Jan 2021
First submitted
19 Oct 2015
Last updated
8 Dec 2021
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 Hepatitis C Virus, run by AbbVie at 53 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 2 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 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 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?

Hepatitis C virus ribonucleic acid (HCV RNA) levels (time frame: 60 months after completion of the 2D treatment in M12-536 or M13-004 study). 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 NCT02581020.

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 8 Dec 2021.

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