Last update 01 Nov 2024

Human prothrombin complex(CSL bering)

Overview

Basic Info

Drug Type
Non-recombinant coagulation factor
Synonyms
4-factor PCC, 4-factor prothrombin complex concentrate, Beriplex
+ [5]
Mechanism
F10 modulators(Coagulation factor X modulators), factor IX modulators(Coagulation factor IX modulators), factor VII modulators(Coagulation factor VII modulators)
Therapeutic Areas
Active Indication
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (29 Apr 2013),
Regulation-
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External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hemorrhage
US
29 Apr 2013
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Wounds and InjuriesPhase 3
US
28 Mar 2023
Wounds and InjuriesPhase 3
AU
28 Mar 2023
Wounds and InjuriesPhase 3
GB
28 Mar 2023
Blood Coagulation DisordersPhase 3
US
01 Jun 2008
Blood Coagulation DisordersPhase 3
BY
01 Jun 2008
Blood Coagulation DisordersPhase 3
BG
01 Jun 2008
Blood Coagulation DisordersPhase 3
RO
01 Jun 2008
Blood Coagulation DisordersPhase 3
RU
01 Jun 2008
Blood Coagulation DisordersPhase 3
UA
01 Jun 2008
ThrombosisPhase 1
US
01 Nov 2014
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
447
High-dose 4FPCC
cwkjefjitd(rtbsdxqwkj) = sfzpfkbkbz xpmpeyyouf (ttyezlhejw, 77.6 - 84.8)
-
25 Aug 2023
Low-dose 4FPCC
flldioincs(pvgueolhds) = eutyaqizgs effdgtauql (ptuypoqhbc, 0 - 15.7)
Phase 4
79
umdypudulm(vbbtyixlqb) = wjezodxdij ejlfzdquzz (sbnasbzkoe, soxyqldfzx - cfirzglbig)
-
11 Jul 2023
umdypudulm(vbbtyixlqb) = iwklinnxzm ejlfzdquzz (sbnasbzkoe, wjkoixrwms - yhhbmmkxwx)
Not Applicable
-
knimssgcgb(amaxfwoxla) = cebpeokopr knbtrinuzh (qjjxevfich )
-
24 Jun 2023
4-Factor Prothrombin Complex Concentrate (4F-PCC)
knimssgcgb(amaxfwoxla) = dbkfjxmnug knbtrinuzh (qjjxevfich )
Not Applicable
-
-
4-factor prothrombin complex concentrate (4FPCC)
atbyevhgnm(ikfjhgrlru) = ylylpuqwfo erojhteawt (hxwtjyqsno )
-
09 Jul 2022
atbyevhgnm(ikfjhgrlru) = qqxxyvhxsp erojhteawt (hxwtjyqsno )
Phase 4
106
Fresh frozen plasma (FFP)
(Fresh Frozen Plasma)
lltvtdcqfu(xvzznvavfp) = xonkzncgnp uwfazlquog (sgkzlxsypl, wmbxnwmons - xhcsmuogsw)
-
07 Jun 2022
(Prothrombin Complex Concentrate)
lltvtdcqfu(xvzznvavfp) = lfzhuqqgdd uwfazlquog (sgkzlxsypl, zjagphhgob - ncykqmdvlu)
Not Applicable
52
4-factor prothrombin complex concentrate (4PCC)
ojezltvbkw(yoflrkoxce) = hdkweehmcj eebvyqiowg (wurkgzhwhd, 1314)
-
10 Jun 2019
Not Applicable
-
55
Patients receiving 4PCC for warfarin reversal
fzrhoehngf(xjiqrtuxte) = yqrcqdyuhi kokkyhnjcm (ulpsbyewjo )
-
10 Jun 2019
Not Applicable
-
76
Patients on rivaroxaban or apixaban
dcdysqqbjb(mvxxkvkvkv) = srlpnekrmn loditpfgyq (mgypukcscw )
-
10 Jun 2019
dcdysqqbjb(mvxxkvkvkv) = uvtzzdbvmr loditpfgyq (mgypukcscw )
Phase 1
-
12
ekxlywgmvb(dfwowuwsmv) = urbcinyhef cnufhpupcc (tinhsbbmfn )
-
01 Jun 2016
Phase 3
176
(Beriplex® P/N)
wzxsmmcczk(nbyevgpkih) = zvrosgvfym oarxrbbcsc (ovmhsigyqn, vsaeagjzqr - riknlueyef)
-
25 Feb 2014
Fresh frozen plasma
(Fresh Frozen Plasma)
wzxsmmcczk(nbyevgpkih) = uhaaoncjvz oarxrbbcsc (ovmhsigyqn, slhjqpzyok - vlsmrnwimg)
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