288. Autoimmune acquired coagulation factor deficiency Clinical trials / Disease details


Clinical trials : 205 Drugs : 238 - (DrugBank : 31) / Drug target genes : 18 - Drug target pathways : 26

  
7 trials found
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1NCT01968655
(ClinicalTrials.gov)
September 9, 201421/10/2013Expanded Access to B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodiesExpanded Access to B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodiesAcquired Hemophilia ABiological: OBI-1Baxalta now part of ShireNULLNo longer available18 YearsN/AAllUnited States
2EUCTR2011-000181-34-DE
(EUCTR)
27/06/201209/02/2012Study of a new factor VIII replacement for patients with acquired hemophilia AEfficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodies Acquired Haemophilia A
MedDRA version: 16.0;Level: LLT;Classification code 10053761;Term: Acquired hemophilia with anti FVIII, XI, or XIII;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: OBI-1
Product Code: OBI-1
INN or Proposed INN: obyoctocog alfa
Baxter Innovations GmbHNULLNot RecruitingFemale: yes
Male: yes
28United States;Hungary;Canada;Germany;Italy;United Kingdom;Sweden;India
3EUCTR2011-000181-34-IT
(EUCTR)
20/05/201207/08/2012Study of a new factor VIII replacement for patients with acquired hemophilia AEfficacy and Satefy of B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodies - NA Acquired Haemophilia A
MedDRA version: 14.1;Level: LLT;Classification code 10053761;Term: Acquired hemophilia with anti FVIII, XI, or XIII;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: OBI-1
Product Code: OBI-1
Other descriptive name: recombinant porcine coagulation factor VIII (B domain deleted)
INSPIRATION BIOPHARMACEUTICALSNULLNot RecruitingFemale: yes
Male: yes
28United States;Hungary;Canada;Germany;United Kingdom;Italy;Sweden;India
4EUCTR2011-000181-34-SE
(EUCTR)
10/05/201207/02/2012Study of a new factor VIII replacement for patients with acquired hemophilia AEfficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodies Acquired Haemophilia A
MedDRA version: 16.0;Level: LLT;Classification code 10053761;Term: Acquired hemophilia with anti FVIII, XI, or XIII;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: OBI-1
Product Code: OBI-1
INN or Proposed INN: obyoctocog alfa
Baxter Innovations GmbHNULLNot RecruitingFemale: yes
Male: yes
28United States;Hungary;Canada;Germany;Italy;United Kingdom;India;Sweden
5EUCTR2011-000181-34-HU
(EUCTR)
04/05/201215/02/2012Study of a new factor VIII replacement for patients with acquired hemophilia AEfficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodies Acquired Haemophilia A
MedDRA version: 16.0;Level: LLT;Classification code 10053761;Term: Acquired hemophilia with anti FVIII, XI, or XIII;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: OBI-1
Product Code: OBI-1
INN or Proposed INN: obyoctocog alfa
Baxter Innovations GmbHNULLNot RecruitingFemale: yes
Male: yes
28United States;Hungary;Canada;Germany;Italy;United Kingdom;Sweden;India
6EUCTR2011-000181-34-GB
(EUCTR)
29/06/201123/06/2011Study of a new factor VIII replacement for patients with acquired hemophilia AEfficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodies Acquired Haemophilia A
MedDRA version: 14.1;Level: LLT;Classification code 10053761;Term: Acquired hemophilia with anti FVIII, XI, or XIII;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: OBI-1
Product Code: OBI-1
INN or Proposed INN: obyoctocog alfa
Other descriptive name: recombinant porcine coagulation factor VIII (B-domain deleted)
Baxter Innovations GmbHNULLNot RecruitingFemale: yes
Male: yes
28United States;Hungary;Canada;Germany;Italy;United Kingdom;Sweden;India
7NCT01178294
(ClinicalTrials.gov)
November 10, 20106/8/2010Study of Modified Recombinant Factor VIII (OBI-1) in Subjects With Acquired Hemophilia AEfficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodiesAcquired Hemophilia ABiological: OBI-1Baxalta now part of ShireNULLCompleted18 YearsN/AAll29Phase 2/Phase 3United States;Canada;India;United Kingdom;France;Germany;Hungary;Italy;Sweden