An Efficacy and Safety Study of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in the Treatment of Chronic Hepatitis C Virus in Participants Who Are Co-Infected With Human Immunodeficiency Virus:C-EDGE CO-INFXN (MK-5172-061)
2021年1月15日 更新者:Merck Sharp & Dohme LLC
A Phase III Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen Grazoprevir (GZR) and Elbasvir (EBR) in Treatment-Naïve Subjects With Chronic HCV GT1, GT4, and GT6 Infection Who Are Co-Infected With HIV
The purpose of this study is to assess the efficacy and safety of grazoprevir (MK-5172) 100 mg in combination with elbasvir (MK-8742) 50 mg in the treatment of chronic hepatitis C virus (HCV) in participants who are co-infected with human immunodeficiency virus (HIV).
The primary hypothesis is that the percentage of participants who receive grazoprevir + elbasvir and achieve Sustained Virologic Response after 12 weeks of therapy (SVR12) will be greater than 70%.
調査の概要
研究の種類
介入
入学 (実際)
218
段階
- フェーズ 3
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年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Documented chronic HCV genotype (GT) 1, GT4, or GT6 infection with no evidence of non-typeable or mixed GT infection (positive for anti-HCV antibody, HCV RNA, or any of the listed GTs at least 6 months prior to screening must be confirmed by screening lab results)
- Treatment naïve for all anti-HCV treatments
- HIV-1 infection documented by laboratory test
- Currently naïve to treatment with any antiretroviral therapy (ART) and have no plans to initiate ART during this study OR on a HIV ART for at least 8 weeks prior to study entry
- Has not experienced any alteration(s) in HIV therapy within 4 weeks of randomization
- Has at least one viable antiretroviral regimen alternative beyond the current regimen in the event of HIV virologic failure or the development of anti-retroviral drug resistance
- Participants of reproductive potential must agree to remain abstinent from heterosexual activity OR use (or have their partner use) acceptable contraception during heterosexual activity while receiving study drug and for 14 days after last dose of study drug.
Exclusion Criteria:
- Evidence of decompensated liver disease manifested by the presence or history of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy or other signs of symptoms of advanced liver disease
- Co-infected with hepatitis B virus
- History of malignancy <=5 years prior to study start except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or is under evaluation for other active or suspected malignancy
- Taking or planning to take any HIV therapy that includes a ritonavir-boosted or unboosted protease inhibitor, efavirenz or etravirine
- Currently participating or has participated in a study with an investigational compound within 30 days of study start and is not willing to refrain from participating in another study during this study
- Clinically-relevant drug or alcohol abuse within 12 months of study start
- Pregnant, breast feeding, or expecting to conceive or donate eggs from Day 1 of the study throughout treatment and 14 days after the last dose of study medication, or longer if dictated by local regulations
- Organ transplants (including hematopoietic stem cell transplants) other than cornea and hair
- Poor venous access
- History of gastric surgery (e.g., stapling, bypass) or history of malabsorption disorders (e.g., celiac sprue disease)
- Medical condition requiring, or likely to require, chronic systemic administration of corticosteroids during this study
- History of opportunistic infection in the 6 months prior to study start
- Use of HIV drugs other than a dual nucleoside reverse transcriptase inhibitor (NRTI) backbone of tenofovir or abacavir and either emtricitibine or lamivudine PLUS raltegravir (or dolutegravir or rilpivirine)
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:なし
- 介入モデル:単一グループの割り当て
- 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:Grazoprevir+Elbasvir
Participants receive a fixed-dose combination (FDC) of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and are followed-up for 24 weeks.
|
MK-5172A FDC tablet: MK-5172 (100 mg)/MK-8742 (50 mg)
他の名前:
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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 |
|---|---|---|
|
Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)
時間枠:12 weeks after end of all therapy (Study Week 24)
|
Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 (High Pure System).
The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 15 IU/mL and a limit of detection of 9.3 IU/mL (in plasma).
SVR12 was defined as undetectable (<9.3 IU/mL) HCV RNA at 12 weeks after the end of all study therapy.
|
12 weeks after end of all therapy (Study Week 24)
|
|
Percentage of Participants Experiencing Adverse Events (AEs) During the Treatment Period and First 14 Follow-up Days
時間枠:Treatment Period plus first 14 follow-up days (up to 14 weeks)
|
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure.
Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
|
Treatment Period plus first 14 follow-up days (up to 14 weeks)
|
|
Percentage of Participants Discontinuing Study Therapy Due to AEs During the Treatment Period
時間枠:Treatment Period (up to 12 weeks)
|
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure.
Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
|
Treatment Period (up to 12 weeks)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of All Study Therapy (SVR24)
時間枠:24 weeks after end of all therapy (Study Week 36)
|
Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 (High Pure System).
The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 15 IU/mL and a limit of detection of 9.3 IU/mL (in plasma).
SVR24 was defined as undetectable (<9.3 IU/mL) HCV RNA at 24 weeks after the end of all study therapy.
|
24 weeks after end of all therapy (Study Week 36)
|
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。
スポンサー
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。
一般刊行物
- Jacobson IM, Lawitz E, Kwo PY, Hezode C, Peng CY, Howe AYM, Hwang P, Wahl J, Robertson M, Barr E, Haber BA. Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis. Gastroenterology. 2017 May;152(6):1372-1382.e2. doi: 10.1053/j.gastro.2017.01.050. Epub 2017 Feb 11.
- Asselah T, Reesink H, Gerstoft J, de Ledinghen V, Pockros PJ, Robertson M, Hwang P, Asante-Appiah E, Wahl J, Nguyen BY, Barr E, Talwani R, Serfaty L. Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis. Liver Int. 2018 Sep;38(9):1583-1591. doi: 10.1111/liv.13727. Epub 2018 Mar 31.
- Reau N, Robertson MN, Feng HP, Caro L, Yeh WW, Nguyen BT, Wahl J, Barr E, Hwang P, Klopfer SO. Concomitant proton pump inhibitor use does not reduce the efficacy of elbasvir/grazoprevir: A pooled analysis of 1,322 patients with hepatitis C infection. Hepatol Commun. 2017 Aug 22;1(8):757-764. doi: 10.1002/hep4.1081. eCollection 2017 Oct.
- Rockstroh JK, Nelson M, Katlama C, Lalezari J, Mallolas J, Bloch M, Matthews GV, Saag MS, Zamor PJ, Orkin C, Gress J, Klopfer S, Shaughnessy M, Wahl J, Nguyen BY, Barr E, Platt HL, Robertson MN, Sulkowski M. Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial. Lancet HIV. 2015 Aug;2(8):e319-27. doi: 10.1016/S2352-3018(15)00114-9. Epub 2015 Jul 9. Erratum In: Lancet HIV. 2015 Aug;2(8):e316. Lancet HIV. 2015 Oct;2(10):e416.
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 (実際)
2014年6月3日
一次修了 (実際)
2015年2月20日
研究の完了 (実際)
2015年5月22日
試験登録日
最初に提出
2014年4月2日
QC基準を満たした最初の提出物
2014年4月2日
最初の投稿 (見積もり)
2014年4月7日
学習記録の更新
投稿された最後の更新 (実際)
2021年2月5日
QC基準を満たした最後の更新が送信されました
2021年1月15日
最終確認日
2021年1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
- 5172-061
- 2014-000342-30 (EudraCT番号)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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