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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- fviii
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- surgery
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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 |
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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)
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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 |
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JP2022051964A JP2022051964A (ja) | 2022-04-01 |
JP2022051964A5 true JP2022051964A5 (ja) | 2022-04-12 |
JP7244688B2 JP7244688B2 (ja) | 2023-03-22 |
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Family Applications (7)
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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 |
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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 |
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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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