JP2022051964A5 - - Google Patents
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- JP2022051964A5 JP2022051964A5 JP2022020759A JP2022020759A JP2022051964A5 JP 2022051964 A5 JP2022051964 A5 JP 2022051964A5 JP 2022020759 A JP2022020759 A JP 2022020759A JP 2022020759 A JP2022020759 A JP 2022020759A JP 2022051964 A5 JP2022051964 A5 JP 2022051964A5
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- 102100026735 Coagulation factor VIII Human genes 0.000 claims 17
- 101000911390 Homo sapiens Coagulation factor VIII Proteins 0.000 claims 17
- 150000001413 amino acids Chemical class 0.000 claims 8
- 230000000694 effects Effects 0.000 claims 8
- 238000001356 surgical procedure Methods 0.000 claims 8
- 229920001184 polypeptide Polymers 0.000 claims 6
- 102000004196 processed proteins & peptides Human genes 0.000 claims 6
- 108090000765 processed proteins & peptides Proteins 0.000 claims 6
- FWMNVWWHGCHHJJ-SKKKGAJSSA-N 4-amino-1-[(2r)-6-amino-2-[[(2r)-2-[[(2r)-2-[[(2r)-2-amino-3-phenylpropanoyl]amino]-3-phenylpropanoyl]amino]-4-methylpentanoyl]amino]hexanoyl]piperidine-4-carboxylic acid Chemical compound C([C@H](C(=O)N[C@H](CC(C)C)C(=O)N[C@H](CCCCN)C(=O)N1CCC(N)(CC1)C(O)=O)NC(=O)[C@H](N)CC=1C=CC=CC=1)C1=CC=CC=C1 FWMNVWWHGCHHJJ-SKKKGAJSSA-N 0.000 claims 4
- 108010054218 Factor VIII Proteins 0.000 claims 3
- 102000001690 Factor VIII Human genes 0.000 claims 3
- 229960000301 factor viii Drugs 0.000 claims 3
- 239000000539 dimer Substances 0.000 claims 2
- 239000000178 monomer Substances 0.000 claims 2
- 238000011084 recovery Methods 0.000 claims 2
- 238000011287 therapeutic dose Methods 0.000 claims 2
- 201000003542 Factor VIII deficiency Diseases 0.000 claims 1
- 208000009292 Hemophilia A Diseases 0.000 claims 1
- 208000032843 Hemorrhage Diseases 0.000 claims 1
- 125000003275 alpha amino acid group Chemical group 0.000 claims 1
- 208000034158 bleeding Diseases 0.000 claims 1
- 230000000740 bleeding effect Effects 0.000 claims 1
- 230000015271 coagulation Effects 0.000 claims 1
- 238000005345 coagulation Methods 0.000 claims 1
- 238000002297 emergency surgery Methods 0.000 claims 1
- 230000013632 homeostatic process Effects 0.000 claims 1
- 238000007917 intracranial administration Methods 0.000 claims 1
- 238000007912 intraperitoneal administration Methods 0.000 claims 1
- 230000002265 prevention Effects 0.000 claims 1
- 208000024891 symptom Diseases 0.000 claims 1
Claims (20)
- 外科手術を必要とするヒト対象において第ＶＩＩＩ因子（「ＦＶＩＩＩ」）レベルの恒常性を維持するための組成物であって、
凝固活性を有する機能的ＦＶＩＩＩとＦｃを含む長時間作用型ＦＶＩＩＩポリペプチドの治療的用量を含み、
前記組成物は、複数回投与で投与され、少なくとも約５５ＩＵ／ｋｇから約６０ＩＵ／ｋｇまでの前記長時間作用型ＦＶＩＩＩポリペプチドが前記複数回投与の各々において投与され、前記複数投与が、２回の投与間が１２時間～５日の投与間隔で投与されることを特徴とし、前記対象が、外科的予防、術中管理、または外科手術のための治療を必要としている、組成物。 - 前記投与後の前記対象における血漿第ＶＩＩＩ因子：Ｃのトラフレベルが３ＩＵ／ｄＬより上に維持される、請求項１に記載の組成物。
- 前記投与が、前記対象における出血症状出現を防止する、請求項１または２に記載の組成物。
- 前記外科手術が大手術である、請求項１～３のいずれか一項に記載の組成物。
- 前記大手術が、頭蓋内手術、腹腔内手術、胸腔内手術または関節置換術である、請求項４に記載の組成物。
- 前記外科手術が緊急外科手術である、請求項１～５のいずれか一項に記載の組成物。
- 前記治療的用量が、約５６ＩＵ／ｋｇ、約５７ＩＵ／ｋｇ、約５８ＩＵ／ｋｇ、約５９ＩＵ／ｋｇ、または約６０ＩＵ／ｋｇである、請求項１～６のいずれか一項に記載の組成物。
- 前記投与間隔が、１２時間～２４時間、２４時間～４８時間、または４８時間～７２時間である、請求項１～７のいずれか一項に記載の組成物。
- 前記投与間隔が１２時間～２４時間である、請求項１～８のいずれか一項に記載の組成物。
- 前記機能的ＦＶＩＩＩが、全長ＦＶＩＩＩ、成熟ＦＶＩＩＩ、または、Ｂドメインが完全もしくは部分的に欠失したＦＶＩＩＩを含む、請求項１～９のいずれか一項に記載の組成物。
- 前記長時間作用型第ＶＩＩＩ因子が、対象への投与の際に、以下の特性：
前記対象の平均クリアランス（ＣＬ）（活性）が、約２．３３±１．０８ｍＬ／時／ｋｇ以下である；
前記対象の平均滞留時間（ＭＲＴ）（活性）が、前記機能的ＦＶＩＩＩからなるポリペプチドの平均ＭＲＴ（活性）よりも約１．５倍長い；
前記対象の半減期（ｔ １／２ ）（活性）が、前記機能的ＦＶＩＩＩからなるポリペプチドの平均ｔ １／２ （活性）よりも約１．５倍長い；
前記対象の平均増分回収率（Ｋ値）が、前記機能的ＦＶＩＩＩからなるポリペプチドの平均増分回収率の約９０％である；
前記対象の定常状態での分布容積（Ｖｓｓ）（活性）の平均が約３７．７～７９．４ｍＬ／ｋｇである；および
前記対象の平均ＡＵＣ／用量（活性）が、ＩＵ／ｋｇ当たり約１９．２ＩＵ ＊ ｈ／ｄＬ～ＩＵ／ｋｇ当たり８１．７ＩＵ ＊ ｈ／ｄＬである
のうち１つ以上を有する、請求項１～１０のいずれか一項に記載の組成物。 - 前記投与間隔が２４時間～７２時間である、請求項１～１１のいずれか一項に記載の組成物。
- 前記投与間隔が２４時間～４８時間である、請求項１～１２のいずれか一項に記載の組成物。
- 前記機能的ＦＶＩＩＩが、配列番号２のアミノ酸１～１４３８、または、配列番号６のアミノ酸１～２３３２と少なくとも９０％または９５％同一であるアミノ酸配列を含む、請求項１～１３のいずれか一項に記載の組成物。
- 前記機能的ＦＶＩＩＩが、配列番号２のアミノ酸１～１４３８、または、配列番号６のアミノ酸１～２３３２を含む、請求項１４に記載の組成物。
- 前記Ｆｃが、配列番号２のアミノ酸１４３９～１６６５、または、配列番号６のアミノ酸２３３３～２５５９と少なくとも９０％または９５％同一である、請求項１～１５のいずれか一項に記載の組成物。
- 前記Ｆｃが、配列番号２のアミノ酸１４３９～１６６５、または、配列番号６のアミノ酸２３３３～２５５９を含む、請求項１６に記載の組成物。
- 前記対象が血友病Ａを有する、請求項１～１７のいずれか一項に記載の組成物。
- 前記長時間作用型ＦＶＩＩＩポリペプチドが、ＦＶＩＩＩＦｃ単量体二量体ハイブリッドである、請求項１～１８のいずれか一項に記載の組成物。
- 前記ＦＶＩＩＩＦｃ単量体二量体ハイブリッドが、２つのＦｃ分子を含み、前記Ｆｃ分子の一方が、前記ＦＶＩＩＩの軽鎖のＣ末端と融合される、請求項１９に記載の組成物。
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2023036392A JP2023071969A (ja) | 2009-12-06 | 2023-03-09 | 第ＶＩＩＩ－Ｆｃ因子キメラおよびハイブリッドポリペプチドならびにその使用法 |
Applications Claiming Priority (15)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US26707009P | 2009-12-06 | 2009-12-06 | |
| US61/267,070 | 2009-12-06 | ||
| US28505409P | 2009-12-09 | 2009-12-09 | |
| US61/285,054 | 2009-12-09 | ||
| US30159210P | 2010-02-04 | 2010-02-04 | |
| US61/301,592 | 2010-02-04 | ||
| US36306510P | 2010-07-09 | 2010-07-09 | |
| US61/363,065 | 2010-07-09 | ||
| US37311310P | 2010-08-12 | 2010-08-12 | |
| US61/373,113 | 2010-08-12 | ||
| US41092910P | 2010-11-07 | 2010-11-07 | |
| US61/410,929 | 2010-11-07 | ||
| US41967610P | 2010-12-03 | 2010-12-03 | |
| US61/419,676 | 2010-12-03 | ||
| JP2019202433A JP2020019821A (ja) | 2009-12-06 | 2019-11-07 | 第ＶＩＩＩ−Ｆｃ因子キメラおよびハイブリッドポリペプチドならびにその使用法 |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2019202433A Division JP2020019821A (ja) | 2009-12-06 | 2019-11-07 | 第ＶＩＩＩ−Ｆｃ因子キメラおよびハイブリッドポリペプチドならびにその使用法 |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2023036392A Division JP2023071969A (ja) | 2009-12-06 | 2023-03-09 | 第ＶＩＩＩ－Ｆｃ因子キメラおよびハイブリッドポリペプチドならびにその使用法 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2022051964A JP2022051964A (ja) | 2022-04-01 |
| JP2022051964A5 true JP2022051964A5 (ja) | 2022-04-12 |
| JP7244688B2 JP7244688B2 (ja) | 2023-03-22 |
Family
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Family Applications (7)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2012542240A Active JP5903048B2 (ja) | 2009-12-06 | 2010-12-06 | 第ＶＩＩＩ−Ｆｃ因子キメラおよびハイブリッドポリペプチドならびにその使用法 |
| JP2015012409A Active JP6062459B2 (ja) | 2009-12-06 | 2015-01-26 | 第ＶＩＩＩ−Ｆｃ因子キメラおよびハイブリッドポリペプチドならびにその使用法 |
| JP2016209535A Active JP6385410B2 (ja) | 2009-12-06 | 2016-10-26 | 第ＶＩＩＩ−Ｆｃ因子キメラおよびハイブリッドポリペプチドならびにその使用法 |
| JP2017220060A Active JP6641340B2 (ja) | 2009-12-06 | 2017-11-15 | 第ＶＩＩＩ−Ｆｃ因子キメラおよびハイブリッドポリペプチドならびにその使用法 |
| JP2019202433A Withdrawn JP2020019821A (ja) | 2009-12-06 | 2019-11-07 | 第ＶＩＩＩ−Ｆｃ因子キメラおよびハイブリッドポリペプチドならびにその使用法 |
| JP2022020759A Active JP7244688B2 (ja) | 2009-12-06 | 2022-02-14 | 第ＶＩＩＩ－Ｆｃ因子キメラおよびハイブリッドポリペプチドならびにその使用法 |
| JP2023036392A Pending JP2023071969A (ja) | 2009-12-06 | 2023-03-09 | 第ＶＩＩＩ－Ｆｃ因子キメラおよびハイブリッドポリペプチドならびにその使用法 |
Family Applications Before (5)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2012542240A Active JP5903048B2 (ja) | 2009-12-06 | 2010-12-06 | 第ＶＩＩＩ−Ｆｃ因子キメラおよびハイブリッドポリペプチドならびにその使用法 |
| JP2015012409A Active JP6062459B2 (ja) | 2009-12-06 | 2015-01-26 | 第ＶＩＩＩ−Ｆｃ因子キメラおよびハイブリッドポリペプチドならびにその使用法 |
| JP2016209535A Active JP6385410B2 (ja) | 2009-12-06 | 2016-10-26 | 第ＶＩＩＩ−Ｆｃ因子キメラおよびハイブリッドポリペプチドならびにその使用法 |
| JP2017220060A Active JP6641340B2 (ja) | 2009-12-06 | 2017-11-15 | 第ＶＩＩＩ−Ｆｃ因子キメラおよびハイブリッドポリペプチドならびにその使用法 |
| JP2019202433A Withdrawn JP2020019821A (ja) | 2009-12-06 | 2019-11-07 | 第ＶＩＩＩ−Ｆｃ因子キメラおよびハイブリッドポリペプチドならびにその使用法 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2023036392A Pending JP2023071969A (ja) | 2009-12-06 | 2023-03-09 | 第ＶＩＩＩ－Ｆｃ因子キメラおよびハイブリッドポリペプチドならびにその使用法 |
Country Status (30)
| Country | Link |
|---|---|
| US (5) | US9050318B2 (ja) |
| EP (4) | EP2506868B1 (ja) |
| JP (7) | JP5903048B2 (ja) |
| KR (1) | KR101770849B1 (ja) |
| CN (1) | CN102791285A (ja) |
| AU (5) | AU2010325787B2 (ja) |
| BR (1) | BR112012013502A2 (ja) |
| CA (2) | CA2782424C (ja) |
| CO (1) | CO6561782A2 (ja) |
| CY (2) | CY1119919T1 (ja) |
| DK (1) | DK2506868T3 (ja) |
| EA (2) | EA038618B1 (ja) |
| ES (2) | ES2880038T3 (ja) |
| HK (1) | HK1253887A1 (ja) |
| HR (2) | HRP20180135T1 (ja) |
| HU (1) | HUE036233T2 (ja) |
| IL (2) | IL220204B (ja) |
| LT (1) | LT2506868T (ja) |
| ME (1) | ME02964B (ja) |
| MX (2) | MX353233B (ja) |
| MY (1) | MY159135A (ja) |
| NO (1) | NO2506868T3 (ja) |
| NZ (2) | NZ703153A (ja) |
| PL (2) | PL3326643T3 (ja) |
| PT (2) | PT3326643T (ja) |
| RS (1) | RS56957B1 (ja) |
| SG (3) | SG10201907152YA (ja) |
| SI (1) | SI2506868T1 (ja) |
| WO (1) | WO2011069164A2 (ja) |
| ZA (1) | ZA201204874B (ja) |
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