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A Phase 2a Study to Evaluate Viral Kinetics and Safety of Telaprevir in Participants With Genotype 2 or 3 Hepatitis C Infection

2013年6月7日 更新者：Tibotec BVBA

A Phase IIa Randomized, Partially Blinded Trial of Telaprevir (VX-950) in Treatment-Naive Subjects With Chronic Genotype 2 or 3 Hepatitis C Infection

The purpose of this study is to assess the effect of telaprevir on early hepatitis (inflammation of the liver) C virus (HCV) viral kinetics in treatment-naive participants who are chronically (lasting a long time) infected with genotype 2 or 3 HCV.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

This is a Phase 2a multicenter (when more than one hospital or medical school team work on a medical research study), partially blinded, randomized (study drug assigned by chance) stratified (arrange in groups for analysis of results e.g., stratify by age, sex, etc.) for genotype, multiple dose study. The trial will consist of Screening period (6 weeks), Treatment period (24 or 26 weeks) and Follow-up period (24 weeks). The Treatment period will include 2 weeks investigational treatment phase and a 24 week standard treatment phase. All the eligible participants who were never treated for HCV will be enrolled for the trial and will receive the investigational treatment regimen to which they have been randomly assigned for 2 weeks. After this in the standard treatment phase participants will receive the standard treatment of care consisting of pegylated interferon (Peg-IFN)-alfa-2a 180 microgram once weekly and ribavirin (RBV) 400 milligram twice per day. Efficacy will primarily be evaluated by HCV viral load quantification. Participant's safety will be monitored throughout the study.

研究の種類

介入

入学 (実際)

52

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

  • イギリス
      • London、イギリス
  • スウェーデン
      • Stockholm、スウェーデン
  • フランス
      • Clichy、フランス
      • Creteil N/A、フランス
      • Lyon、フランス
      • Paris、フランス
      • Vandoeuvre Les Nancy、フランス

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:

  • Participants chronically infected with genotype 2 or 3 hepatitis C virus (HCV) with amount of virus in the blood greater than 10,000 international units per milliliter (IU/ml)
  • Participants who were never treated for hepatitis C virus infection
  • Participants without any significant lab abnormalities
  • Participants who agree to the use of two effective methods of contraception
  • Participant who were judged to be in good health

Exclusion Criteria:

  • Participants who had contraindications for starting anti-HCV therapy
  • Participants who had history or evidence of liver cirrhosis (serious liver disorder in which connective tissue replaces normal liver tissue, and liver failure often occurs) or decompensated liver disease or hepatocellular carcinoma (type of cancer)
  • Participant infected with human immunodeficiency virus (a life-threatening infection that you can get from an infected person's blood or from having sex with an infected person) or hepatitis B virus
  • Females who are pregnant (carrying an unborn baby), planning to be pregnant or breastfeeding
  • Participants who have hypersensitivity to tartrazine

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：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：TVR then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2
Participants who are never treated for chronic hepatitis C (inflammation of the liver) genotype 2 will receive telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants will then be treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of pegylated interferon 180 microgram (mcg) will be administered as a subcutaneous injection once a week. RBV will be taken orally as 400 mg tablets 2 times a day. Total duration of treatment will be 26 weeks.
薬：Telaprevir
Telaprevir 750 mg tablet will be administered three times a day orally for 2 weeks.
他の名前：
  • VX-950
薬：Peg-IFN-alfa-2a + Ribavirin (Standard Treatment)
Standard treatment of Peg-IFN-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (400 mg as oral tablet twice daily) will be administered from Day 15 to Week 24 or 26 in the T2 & PR24 - genotype 2 and 3 group and from Day 1 to Week 24 or 26 in the T2/PR24 - genotype 2 and 3 group.
実験的：TVR with Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2
Participants who are never treated for CHC genotype 2 will receive TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which will be continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg will be administered as a subcutaneous injection once a week. RBV will be taken orally as 400 mg tablets 2 times a day. Total duration of treatment will be 24 weeks.
薬：Telaprevir
Telaprevir 750 mg tablet will be administered three times a day orally for 2 weeks.
他の名前：
  • VX-950
薬：Peg-IFN-alfa-2a + Ribavirin (Standard Treatment)
Standard treatment of Peg-IFN-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (400 mg as oral tablet twice daily) will be administered from Day 15 to Week 24 or 26 in the T2 & PR24 - genotype 2 and 3 group and from Day 1 to Week 24 or 26 in the T2/PR24 - genotype 2 and 3 group.
アクティブコンパレータ：Pbo with Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2
Participants who are never treated for CHC genotype 2 will receive TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which will be continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg will be administered as a subcutaneous injection once a week. RBV will be taken orally as 400 mg tablets 2 times a day. Total duration of treatment will be 24 weeks.
薬：Peg-IFN-alfa-2a + Ribavirin (Standard Treatment)
Standard treatment of Peg-IFN-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (400 mg as oral tablet twice daily) will be administered from Day 15 to Week 24 or 26 in the T2 & PR24 - genotype 2 and 3 group and from Day 1 to Week 24 or 26 in the T2/PR24 - genotype 2 and 3 group.
薬：Placebo
Matching placebo tablet to telaprevir will be administered three times a day orally for 2 weeks.
実験的：TVR then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3
Participants who are never treated for CHC genotype 3 will receive TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants will then be treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg will be administered as a subcutaneous injection once a week. RBV will be taken orally as 400 mg tablets 2 times a day. Total duration of treatment will be 26 weeks.
薬：Telaprevir
Telaprevir 750 mg tablet will be administered three times a day orally for 2 weeks.
他の名前：
  • VX-950
薬：Peg-IFN-alfa-2a + Ribavirin (Standard Treatment)
Standard treatment of Peg-IFN-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (400 mg as oral tablet twice daily) will be administered from Day 15 to Week 24 or 26 in the T2 & PR24 - genotype 2 and 3 group and from Day 1 to Week 24 or 26 in the T2/PR24 - genotype 2 and 3 group.
実験的：TVR with Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3
Participants who are never treated for CHC genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which will be continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg will be administered as a subcutaneous injection once a week. RBV will be taken orally as 400 mg tablets 2 times a day. Total duration of treatment will be 24 weeks.
薬：Telaprevir
Telaprevir 750 mg tablet will be administered three times a day orally for 2 weeks.
他の名前：
  • VX-950
薬：Peg-IFN-alfa-2a + Ribavirin (Standard Treatment)
Standard treatment of Peg-IFN-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (400 mg as oral tablet twice daily) will be administered from Day 15 to Week 24 or 26 in the T2 & PR24 - genotype 2 and 3 group and from Day 1 to Week 24 or 26 in the T2/PR24 - genotype 2 and 3 group.
アクティブコンパレータ：Pbo with Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3
Participants who are never treated for CHC genotype 3 will receive TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which will be continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg will be administered as a subcutaneous injection once a week. RBV will be taken orally as 400 mg tablets 2 times a day. Total duration of treatment will be 24 weeks.
薬：Peg-IFN-alfa-2a + Ribavirin (Standard Treatment)
Standard treatment of Peg-IFN-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (400 mg as oral tablet twice daily) will be administered from Day 15 to Week 24 or 26 in the T2 & PR24 - genotype 2 and 3 group and from Day 1 to Week 24 or 26 in the T2/PR24 - genotype 2 and 3 group.
薬：Placebo
Matching placebo tablet to telaprevir will be administered three times a day orally for 2 weeks.

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
Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Day 15
時間枠：Baseline, Pre-dose (Day 15)
Level of HCV RNA in plasma was measured using COBAS TaqMan HCV test v2.0 (an in vitro nucleic acid amplification test for quantitation of HCV RNA genotypes 1 through 6 in human serum or plasma, using the COBAS AmpliPrep Total Nucleic Acid Isolation Kit (TNAI) for preparation of highly purified total nucleic acid from serum or plasma and automated amplification and detection on TaqMan 48 Analyzer). Lower limit of quantification was 25 international units/milliliter (IU/ml) and limit of detection was 10 IU/ml. Assay used was reverse transcription-polymerase chain reaction (RT-PCR) methodology.
Baseline, Pre-dose (Day 15)
Maximum Plasma Concentration (Cmax) for Telaprevir on Day 1
時間枠：Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hour [hr])
The Cmax is defined as the maximum observed analyte concentration. The Cmax was measured in nanogram/milliliter (ng/ml).
Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hour [hr])
Time to Reach Maximum Plasma Concentration (Tmax) for Telaprevir on Day 1
時間枠：Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hr)
The Tmax is defined as the actual sampling time to reach maximum observed analyte concentration. The analyte concentration associated with Tmax is referred to as Cmax.
Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hr)
Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 1
時間枠：Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hr)
The AUC is defined as area under the plasma concentration-time curve over the dosing interval (8 hr), calculated by the lin-up/ log-down method.
Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hr)

二次結果の測定

結果測定
メジャーの説明
時間枠
Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 15
時間枠：Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr)
The AUC is defined as area under the plasma concentration-time curve over the dosing interval (8 hr), calculated by the lin-up/ log-down method.
Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr)
Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Week 24 and Week 26
時間枠：Baseline and Week 24/26
Levels of HCV RNA in plasma were measured using COBAS TaqMan HCV test v2.0. Lower limit of quantification was 25 IU/ml and limit of detection was 10 IU/ml. The assay used real time RT-PCR methodology. End of treatment (EOT) for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.
Baseline and Week 24/26
Maximum Plasma Concentration (Cmax) for Telaprevir on Day 15
時間枠：Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr)
The Cmax is defined as the maximum observed analyte concentration. The Cmax is measured in ng/ml.
Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr)
Minimum Plasma Concentration (Cmin) for Telaprevir on Day 15
時間枠：Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr)
The Cmin is defined as minimum plasma concentration between 0 hr and dosing interval. The Cmin is measured in ng/ml.
Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr)
Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml)
時間枠：Baseline, Day 12, 15, Week 4, 6, 14 and EOT (Week 24/26 or early discontinuation)
Virological response was defined as having HCV RNA level less than a particular threshold that is less than 10 IU/ml (undetectable).
Baseline, Day 12, 15, Week 4, 6, 14 and EOT (Week 24/26 or early discontinuation)
Median Time to Virological Response (HCV RNA Level < 10 IU/ml)
時間枠：Baseline up to EOT
Virological response was defined as having HCV RNA level less than a particular threshold which is either less than 10 IU/ml (undetectable) or less than 25 IU/ml (unquantifiable).Time to virological response was defined as the number of days from the start of medication intake necessary to go for the first time below the threshold value. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.
Baseline up to EOT
Percentage of Participants With Viral Breakthrough
時間枠：Baseline, Day 12, 15 and Week 24/26
Viral breakthrough was defined as an increase in HCV RNA levels by more than 1 log10 in HCV RNA level from the lowest level reached, or a value of HCV RNA > 100 IU/ml in participants whose HCV RNA had previously become undetectable (< 10 IU/ml) or unquantifiable (< 25 IU/ml) during the considered treatment phase. It was considered as confirmed when the criterion for viral breakthrough is fulfilled at two or more consecutive time points or at the last observed time point in case of trial termination. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.
Baseline, Day 12, 15 and Week 24/26
Percentage of Participants Who Demonstrated Virological Relapse
時間枠：24 weeks after EOT
Relapse was defined as confirmed detectable HCV RNA (>=10 IU/ml) during the follow-up period up to 24 weeks after last medication intake and after previous undetectable HCV RNA (< 10 IU/ml) at EOT. No relapse was defined as having no confirmed detectable HCV RNA (>=10 IU/ml) during the follow-up period and after previous undetectable HCV RNA (< 10 IU/ml) at EOT. Missing follow-up means no HCV RNA measurements during the follow-up period and after previous undetectable HCV RNA (< 10 IU/ml) at EOT. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.
24 weeks after EOT
Percentage of Participants Who Achieved Sustained Virological Response (SVR)
時間枠：Week 12, 24 after EOT
The SVR was defined as having HCV RNA undetectable at EOT, not showing relapse up to follow-up Week 12 (SVR12) or follow-up Week 24 (SVR24), and HCV RNA undetectable at follow-up Week 12 (SVR12) or follow-up Week 24 (SVR24), respectively. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.
Week 12, 24 after EOT

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

Tibotec BVBA

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

2007年12月1日

一次修了 (実際)

2008年6月1日

研究の完了 (実際)

2009年5月1日

試験登録日

最初に提出

2007年11月19日

QC基準を満たした最初の提出物

2007年11月19日

最初の投稿 (見積もり)

2007年11月20日

学習記録の更新

投稿された最後の更新 (見積もり)

2013年6月17日

QC基準を満たした最後の更新が送信されました

2013年6月7日

最終確認日

2013年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • CR013513
  • VX-950-TiDP24-C209

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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