An Efficacy and Safety Study of a 8 or 12-Week Treatment Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naive and Experienced Participants With Chronic Genotype 4 Hepatitis C Virus Infection
2016年10月13日 更新者：Janssen-Cilag International NV
A Phase 2a, Partly Randomized, Open-label Trial to Investigate the Efficacy and Safety of an 8 or 12-Week Treatment Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naive and Experienced Subjects With Chronic Genotype 4 Hepatitis C Infection
The purpose of this study is to evaluate the efficacy of simeprevir in combination with sofosbuvir for 8 or 12 weeks versus a historical control, with respect to the percentage of participants with sustained virologic response at 12 weeks after end of treatment (SVR12) in the overall population.
調査の概要
詳細な説明
This is a partly randomized, open-label (identity of study drug will be known to volunteer and study staff), multicenter (when more than one hospital or medical school team work on a medical research study) study.
The study will consist of a screening period of up to 4 weeks, an open-label treatment period of 8 weeks or 12 weeks, and a post-treatment follow-up period until 24 weeks after end of treatment (EOT).
Participants without cirrhosis will be assigned to Group A wherein half of the participants will receive 8 week treatment in Group A1 and remaining participants will receive 12 week treatment in Group A2.
Participants with cirrhosis, will be assigned to Group B to receive simeprevir in combination with sofosbuvir for 12 weeks.
The duration of participation for each participant, including the screening period, will be approximately 36 or 40 weeks for 8 or 12 week treatment, respectively.
Efficacy will be primarily assessed by percentage of participants with SVR12.
Participants' safety will be evaluated throughout the study.
研究の種類
介入
入学 (実際)
63
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Cairo、エジプト
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Menoufiya、エジプト
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～70年 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- Participant must have hepatitis C virus (HCV) genotype 4 infection (confirmed at screening)
- Participant must have HCV ribonucleic acid (RNA) greater than (>) 10,000 international unit per milliliter (IU/mL) at screening
- In participants with cirrhosis, a documented hepatic imaging procedure (ultrasound, computed tomography [CT] scan, or magnetic resonance imaging [MRI]) within 6 months before baseline (Day 1) to exclude hepatocellular carcinoma is required
- A woman of childbearing potential must have a negative serum (beta human chorionic gonadotropin at screening and a negative urine pregnancy test on Day 1 before first dose of study drug
- Females of childbearing potential or males with a female partner of childbearing potential must agree to use 2 highly effective contraceptive methods (one of which is a barrier method; eg, condom or diaphragm) from Day 1 (baseline) and continue until 30 days after the end of treatment (EOT) (or longer if dictated by local regulations), or not be heterosexually active, or be a vasectomized male subject or a female subject with a vasectomized partner, or be a female (subject or partner of male subject) of non-childbearing potential (ie, postmenopausal for at least 2 years or surgically sterile)
Exclusion Criteria:
- Participant has evidence of clinical hepatic decompensation (history or current evidence of ascites, bleeding varices, or hepatic encephalopathy)
- Participant has any liver disease of non-HCV etiology. This includes, but is not limited to, acute hepatitis A, drug- or alcohol-related liver disease, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis, or any other non-HCV liver disease considered clinically significant by the investigator
- Participant is infected/co-infected with non-genotype 4 HCV
- Participant has any other active clinically significant disease or clinically significant findings during screening of medical history, physical examination, laboratory testing or electrocardiogram (ECG) recordings that, in the investigator's opinion, would compromise the participant's safety or could interfere with the participant participating in and completing the study
- Participant has history of malignancy within 5 years of the screening visit (exceptions: skin carcinomas, carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator is considered cured with minimal risk of recurrence)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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 |
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実験的：Group A1
Participants without cirrhosis will receive simeprevir 150 milligram (mg) capsule along with sofosbuvir 400 mg tablet, orally, once daily for 8 weeks.
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Simeprevir 150 mg capsule orally, once daily for 8 weeks in Group A1, 12 weeks in Group A2 and Group B.
Sofosbuvir 400 mg tablet orally, once daily for 8 weeks in Group A1, 12 weeks in Group A2 and Group B.
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実験的：Group A2
Participants without cirrhosis will receive simeprevir 150 mg capsule along with sofosbuvir 400 mg tablet, orally, once daily for 12 weeks.
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Simeprevir 150 mg capsule orally, once daily for 8 weeks in Group A1, 12 weeks in Group A2 and Group B.
Sofosbuvir 400 mg tablet orally, once daily for 8 weeks in Group A1, 12 weeks in Group A2 and Group B.
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実験的：Group B
Participants with cirrhosis will receive simeprevir 150 mg capsule along with sofosbuvir 400 mg tablet, orally, once daily for 12 weeks.
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Simeprevir 150 mg capsule orally, once daily for 8 weeks in Group A1, 12 weeks in Group A2 and Group B.
Sofosbuvir 400 mg tablet orally, once daily for 8 weeks in Group A1, 12 weeks in Group A2 and Group B.
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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 |
|---|---|---|
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Percentage of Participants With Sustained Virologic Response at Week 12 After End of Treatment (SVR12)
時間枠：12 weeks after end of treatment (EOT) (EOT; Week 8 for Group A1, Week 12 for Group A2 and Group B)
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SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]), detectable or undetectable at 12 weeks after EOT.
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12 weeks after end of treatment (EOT) (EOT; Week 8 for Group A1, Week 12 for Group A2 and Group B)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percentage of Participants With Sustained Virologic Response at Week 4 After End of Treatment (SVR4)
時間枠：4 weeks after EOT (EOT; Week 8 for Group A1, Week 12 for Group A2 and Group B)
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SVR4 is defined as HCV RNA <LLOQ;15 IU/mL, at 4 weeks after EOT.
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4 weeks after EOT (EOT; Week 8 for Group A1, Week 12 for Group A2 and Group B)
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Percentage of Participants With Sustained Virologic Response at Week 24 After End of Treatment (SVR24)
時間枠：24 weeks after EOT (EOT; Week 8 for Group A1, Week 12 for Group A2 and Group B)
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SVR24 is defined as HCV RNA <LLOQ;15 IU/mL, at 24 weeks after EOT.
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24 weeks after EOT (EOT; Week 8 for Group A1, Week 12 for Group A2 and Group B)
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Percentage of Participants With on-treatment Failure
時間枠：EOT (EOT; Week 8 for Group A1, Week 12 for Group A2 and Group B)
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Participants will be considered on-treatment failures if they have (confirmed) detectable HCV RNA, that is <LLOQ;15 IU/mL, detectable or greater than or equal to (>=) LLOQ at EOT.
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EOT (EOT; Week 8 for Group A1, Week 12 for Group A2 and Group B)
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Percentage of Participants With Viral Relapse
時間枠：EOT (Week 8 for Group A1, Week 12 for Group A2 and Group B), Weeks 4, 12 and 24 after end of treatment
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Participants will be considered to have viral relapse if they do not achieve SVR at Week 4, 12 and 24 after EOT and meet the following conditions 1) HCV RNA <LLOQ;15 IU/mL, undetectable at EOT, 2) HCV RNA >=LLOQ;15 IU/mL during the follow-up period.
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EOT (Week 8 for Group A1, Week 12 for Group A2 and Group B), Weeks 4, 12 and 24 after end of treatment
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Percentage of Participants With On-treatment Response
時間枠：Week 1, 2, 4, 8 and EOT for all groups, Week 12 for Group A2 and Group B
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On-treatment virologic response is defined as the change from baseline in log10 hepatitis C virus ribonucleic acid.
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Week 1, 2, 4, 8 and EOT for all groups, Week 12 for Group A2 and Group B
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Percentage of Participants With Viral Breakthrough
時間枠：Week 1 up to Week 8 in Group A1, Week 1 up to Week 12 in Group A2 and Group B
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Viral breakthrough is defined as confirmed >1.0 log10 increase in HCV RNA from nadir or confirmed HCV RNA >100 IU/mL in participants who had previously achieved HCV RNA <LLOQ; 15 IU/mL.
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Week 1 up to Week 8 in Group A1, Week 1 up to Week 12 in Group A2 and Group B
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2014年12月1日
一次修了 (実際)
2015年10月1日
研究の完了 (実際)
2015年10月1日
試験登録日
最初に提出
2014年10月28日
QC基準を満たした最初の提出物
2014年10月28日
最初の投稿 (見積もり)
2014年10月30日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年10月14日
QC基準を満たした最後の更新が送信されました
2016年10月13日
最終確認日
2016年9月1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
- CR104970
- TMC435HPC2014 (その他の識別子：Janssen-Cilag International NV)
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