Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT- 267 (ABT-450/r/ABT-267) in Japanese Adults With Genotype 2 Chronic Hepatitis C Virus (HCV) Infection (GIFT-II)
An Open-label Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) Co-administered With Ribavirin (RBV) for 12 or 16 Weeks in Treatment-Naïve and Treatment-Experienced Japanese Adults With Genotype 2 Chronic Hepatitis C Virus (HCV) Infection With and Without Compensated Cirrhosis (GIFT-II)
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 3
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Chronic HCV-infection prior to study enrollment
- Screening laboratory result indicating HCV genotype 2 infection
- Subject has plasma HCV ribonucleic acid (RNA) level greater than 10,000 IU/mL at Screening
- Voluntarily sign an informed consent
Exclusion Criteria:
- Co-infection of Hepatitis B Virus (HBV), human immunodeficiency virus (HIV) and any HCV genotype other than genotype 2
- Prior therapy with direct acting antiviral agents for the treatment of HCV, including telaprevir, simeprevir and boceprevir
- Any cause of liver disease other than chronic HCV-infection, including but not limited to the following: hemochromatosis; alpha-1 antitrypsin deficiency; Wilson's disease; autoimmune hepatitis; alcoholic liver disease; drug-related liver disease
- Clinically significant laboratory abnormalities
- Uncontrolled clinically significant disease, disorder or medical illness
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:ABT-450/r/ABT-267 plus RBV for 12 weeks
ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based ribavirin (RBV; 400 to 1,000 mg/day, divided twice daily) for 12 weeks
|
タブレット;リトナビルおよびABT-267と共製剤化されたABT-450
他の名前:
カプセル
|
実験的:ABT-450/r/ABT-267 plus RBV for 16 weeks
ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
|
タブレット;リトナビルおよびABT-267と共製剤化されたABT-450
他の名前:
カプセル
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Percentage of Non-cirrhotic, Treatment-naive Participants in Each Treatment Group With a Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
時間枠:12 weeks after last dose of study drug
|
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.
|
12 weeks after last dose of study drug
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period
時間枠:12 or 16 weeks (end of treatment period)
|
On-treatment virologic failure was defined as rebound (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA [> 1 log10 IU/mL above nadir] at any time point during treatment) or failure to suppress HCV during treatment (all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment).
|
12 or 16 weeks (end of treatment period)
|
Percentage of Participants With Post-treatment Relapse
時間枠:within 12 weeks after the last dose of study drug
|
Relapse by post-treatment Week 12 was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug for a participant with HCV RNA < LLOQ at the final treatment visit and who completed study treatment.
Completion of treatment was defined as a study drug duration ≥ 77 days for the 12-week treatment arm or ≥ 105 days for the 16-week treatment arm.
|
within 12 weeks after the last dose of study drug
|
Percentage of Participants With SVR12 Weeks Post-treatment for Each Treatment Arm Within Different Subpopulations
時間枠:12 weeks after last dose of study drug
|
The percentage of participants with SVR12 in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; noncirrhotic participants who relapsed after prior IFN-based therapy (relapsers); noncirrhotic T-exp participants who were non-responders to prior IFN-based therapy; noncirrhotic T-exp participants who were intolerant to IFN-based therapy; participants with compensated cirrhosis.
|
12 weeks after last dose of study drug
|
Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period for Each Treatment Arm Within Different Subpopulations
時間枠:12 or 16 weeks (end of treatment period)
|
The percentage of participants with on-treatment virologic failure in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; participants with compensated cirrhosis. On-treatment virologic failure was defined as rebound (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA [> 1 log10 IU/mL above nadir] at any time point during treatment) or failure to suppress HCV during treatment (all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment). |
12 or 16 weeks (end of treatment period)
|
Percentage of Participants With Post-treatment Relapse Within Different Subpopulations
時間枠:within 12 weeks after the last dose of study drug
|
The percentage of participants with relapse by post-treatment Week 12 in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; participants with compensated cirrhosis. Relapse by post-treatment Week 12 was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug for a participant with HCV RNA < LLOQ at the final treatment visit and who completed study treatment. Completion of treatment was defined as a study drug duration ≥ 77 days for the 12-week treatment arm or ≥ 105 days for the 16-week treatment arm. |
within 12 weeks after the last dose of study drug
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター:Yasunori Yachi、AbbVie GK.
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- M14-153
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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AbbVie (prior sponsor, Abbott)完了
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