An Open Label Study of the Effect of Telaprevir in Combination With Ribavirin and Peginterferon on HCV Infection in Stable Liver Transplant Patients
2015年6月1日 更新者：Vertex Pharmaceuticals Incorporated
A 2-Part, Open Label Study of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Chronically Infected With Genotype 1 Hepatitis C Virus Following Liver Transplantation
To assess efficacy of telaprevir, pegylated interferon alfa-2a (Peg-IFN-alfa-2a), and ribavirin (RBV) for hepatitis C virus (HCV) in a 48-week total treatment duration regimen following liver transplantation.
調査の概要
研究の種類
介入
入学 (実際)
61
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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Alabama
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Birmingham、Alabama、アメリカ
- Alabama
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Arizona
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Phoenix、Arizona、アメリカ
- Arizona
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California
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Los Angeles、California、アメリカ
- California
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Colorado
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Denver、Colorado、アメリカ
- Colorado
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Florida
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Bradenton、Florida、アメリカ
- Florida
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Miami、Florida、アメリカ
- Florida
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Illinois
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Evanston、Illinois、アメリカ
- Illinios
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Indiana
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Indianapolis、Indiana、アメリカ
- Indiana
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Massachusetts
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Burlington、Massachusetts、アメリカ
- Massachusetts
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Michigan
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Ann Arbor、Michigan、アメリカ
- Michigan
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Detroit、Michigan、アメリカ
- Michigan
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Missouri
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St Louis、Missouri、アメリカ
- Missouri
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Nebraska
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Omaha、Nebraska、アメリカ
- Nebraska
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New York
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New York、New York、アメリカ
- New York
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Rochester、New York、アメリカ
- New York
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North Carolina
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Charlotte、North Carolina、アメリカ
- North Carolina
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Ohio
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Cleveland、Ohio、アメリカ
- Ohio
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ
- Pennsylvania
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Texas
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Dallas、Texas、アメリカ
- Texas
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Houston、Texas、アメリカ
- Texas
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Alberta
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Calgary、Alberta、カナダ
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British Columbia
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Vancouver、British Columbia、カナダ
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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～65年 (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:
- Male and female participants between the ages of 18 and 65 years
- History of orthotopic liver transplantation less than 10 years before the Screening visit but no sooner than 6 months before Day 1
- Taking a stable immunosuppressant regimen based on either tacrolimus or cyclosporine without substantial dose changes over the past 3 months
- Naive to pegylated interferon/ribavirin treatment or experienced with pegylated interferon/ribavirin prior to transplantation with relapse, partial, or null response
Exclusion Criteria:
- Documented cirrhosis after liver transplantation
- Ascites or hepatic encephalopathy within 6 months before Screening
- Retransplantation for recurrent hepatitis C
- Treatment for hepatitis C post liver transplantation
- History within the past 3 months of: rejection within 3 months or greater than (>) 1 rejection within 12 months
- Current treatment with sirolimus or methylprednisolone. Low dose prednisone use (<5 milligram per day) is permitted
- History within 3 months of any bacterial infection requiring >1 week of intravenous antibiotics, cytomegalovirus viremia or cytomegalovirus infection with end-organ involvement, fungal disease (except cutaneous and mild oral thrush)
- History of post transplant lymphoproliferative disease
- Acceptable laboratory values at Screening as specified in the protocol
- Positive for human immunodeficiency virus 1/2 (HIV1/2) enzyme immunoassay (EIA) antibody screen or Hepatitis B deoxyribonucleic acid (DNA) or Hepatitis B surface antigen
- History of hepatocellular carcinoma with high risk of recurrence
- Any other cause of liver disease deemed clinically significant by the investigator in addition to hepatitis C
- Autoimmune-mediated disease
- History of acute pancreatitis within 5 years before the Screening visit
- Prior treatment with an hepatitis C virus (HCV) protease inhibitor
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：非ランダム化
- 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 |
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実験的：T/PR + Immunosuppressant Regimen (Tacrolimus)
Participants who were receiving tacrolimus (TAC) based immunosuppressant regimen at baseline, received telaprevir (T) 1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
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タブレット
他の名前：
タブレット
他の名前：
皮下注射
他の名前：
Cyclosporine (CsA) based immunosuppressant regimen or Tacrolimus (TAC) based immunosuppressant regimen, as per standard practice.
Immunosuppressant regimen were not considered study drugs.
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実験的：T/PR + Immunosuppressant Regimen (Cyclosporine)
Participants who were receiving cyclosporine (CsA) based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
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タブレット
他の名前：
タブレット
他の名前：
皮下注射
他の名前：
Cyclosporine (CsA) based immunosuppressant regimen or Tacrolimus (TAC) based immunosuppressant regimen, as per standard practice.
Immunosuppressant regimen were not considered study drugs.
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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 Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)
時間枠：12 weeks after last planned dose of study drug (up to Week 60)
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SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (<lower limit of quantification) at 12 weeks after last planned dose of study treatment.
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay.
The lower limit of quantification was 25 international units per milliliter (IU/mL).
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12 weeks after last planned dose of study drug (up to Week 60)
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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 Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)
時間枠：24 weeks after last planned dose of study drug (up to Week 72)
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SVR24 was defined as an undetectable HCV RNA Levels at 24 weeks after last planned dose of study treatment.
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay.
The lower limit of quantification was 25 IU/mL.
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24 weeks after last planned dose of study drug (up to Week 72)
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Percentage of Participants With Rapid Viral Response (RVR)
時間枠：Week 4
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The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay.
The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.
RVR was defined as undetectable HCV RNA 4 weeks after the start of study treatment.
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Week 4
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Percentage of Participants With Extended Rapid Viral Response (eRVR)
時間枠：Week 4 and Week 12
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The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay.
The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.
eRVR was defined as undetectable HCV RNA at both 4 weeks and 12 weeks after the start of study treatment.
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Week 4 and Week 12
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Percentage of Participants With On-Treatment Virologic Failure
時間枠：Baseline up to Week 48
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On-treatment virologic failure was defined as subjects who met futility or who completed the assigned treatment duration and had detectable HCV RNA at planned end of treatment (up to 48 weeks).
Data for this outcome was not planned to be reported by prior response.
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Baseline up to Week 48
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Percentage of Participants With Viral Relapse
時間枠：48 weeks
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48 weeks
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Pharmacokinetics of Telaprevir, Peg-IFN, RBV , and Selected Immunosuppressant Medications (Tacrolimus and Cyclosporine)
時間枠：48 weeks
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48 weeks
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Percentage of Participants Requiring Dose Titration of Immunosuppressant Medications
時間枠：48 weeks
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48 weeks
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Percentage of Participants With Biopsy Confirmed and Treated Rejection
時間枠：48 weeks
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48 weeks
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Percentage of Participants With Histological Evidence of Stabilization or Improvement in Inflammation Grade or Fibrosis Stage
時間枠：48 weeks
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48 weeks
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Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region
時間枠：48 weeks
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48 weeks
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
時間枠：Baseline up to Week 52
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Any adverse change from the participant's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not.
An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug.
SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event.
"Study drug" includes all investigational agents (including placebo, if applicable) administered during the course of the study.
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Baseline up to Week 52
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その他の成果指標
結果測定 |
時間枠 |
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Percentage of Participants With Sustained Viral Response 4 Weeks After Last Planned Dose of Study Drug (SVR4)
時間枠：4 weeks after last planned dose of study drug (up to Week 52)
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4 weeks after last planned dose of study drug (up to Week 52)
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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。
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
2012年2月1日
一次修了 (実際)
2014年4月1日
研究の完了 (実際)
2014年4月1日
試験登録日
最初に提出
2011年11月3日
QC基準を満たした最初の提出物
2011年11月3日
最初の投稿 (見積もり)
2011年11月8日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年6月18日
QC基準を満たした最後の更新が送信されました
2015年6月1日
最終確認日
2015年6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
- VX11-950-117
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