A Phase 1 Study of MP-424, Peginterferon Alfa 2b, and Ribavirin in Hepatitis C
第1相
完了
NCT00630058
| 対象疾患 | Hepatitis C |
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| 相 | 第1相 |
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| スポンサー | Tanabe Pharma Corporation |
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| ステータス | 完了 |
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| 参加者数 | 20 名 |
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| 介入（薬剤） | MP-424(H), PEG-IFN-a-2b, RBV, MP-424 (L), PEG-IFN-a-2b, RBV |
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| 開始日 | 2008年4月 |
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| 完了日 | 2009年3月 |
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| 結果公開日 | 2013年1月18日 |
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概要
The purpose of this study is to assess the safety, pharmacokinetics, HCV RNA kinetics, and other viral characteristics after administration of two arms of MP-424 in combination with Peginterferon Alfa 2b (PEG-IFN-a-2b) and Ribavirin (RBV) to patients with chronic hepatitis C.
Cmax (Maximum Observed Concentration in Plasma) of MP-424
Data were collected at Day1 to Day85 · μg/mL
| Group A (MP-424 High) | 1.62 ± 0.43 μg/mL |
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| Group B (MP-424 Low) | 1.45 ± 0.83 μg/mL |
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| Group A (MP-424 High) | 3.96 ± 1.10 μg/mL |
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| Group B (MP-424 Low) | 3.06 ± 0.90 μg/mL |
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| Group A (MP-424 High) | 3.67 ± 0.87 μg/mL |
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| Group B (MP-424 Low) | 3.16 ± 1.10 μg/mL |
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Tmax (Time of Maximum Concentration in Plasma) of MP-424
Data were collected at Day1 to Day85 · hours
| Group A (MP-424 High) | 2.51 hours |
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| Group B (MP-424 Low) | 2.54 hours |
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| Group A (MP-424 High) | 2.50 hours |
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| Group B (MP-424 Low) | 2.45 hours |
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| Group A (MP-424 High) | 3.24 hours |
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| Group B (MP-424 Low) | 2.43 hours |
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AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424
Data were collected at Day1 to Day85 · μg/mL
| Group A (MP-424 High) | 7.53 ± 1.93 μg/mL |
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| Group B (MP-424 Low) | 6.55 ± 3.73 μg/mL |
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| Group A (MP-424 High) | 26.00 ± 6.77 μg/mL |
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| Group B (MP-424 Low) | 19.94 ± 5.97 μg/mL |
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| Group A (MP-424 High) | 25.00 ± 5.23 μg/mL |
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| Group B (MP-424 Low) | 21.35 ± 6.88 μg/mL |
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