Health Condition 1: null- Acquired Hemophilia A
Conditions
Interventions
Intervention1: OBI-1: OBI-1 will be administered as an intravenous infusion at a rate of 1 to 2 mL/min.
Subjects will be infused with OBI-1 at an initial dose of 200 U/kg.
The dose of OBI-1 administer
Sponsors
Baxter Innovations GmbH
Max Neeman Medical International Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1)Males or females >=18 years of age. 2) Written informed consent from subject, trusted person or person who is legally authorized to sign on behalf of the subject (Legal Representative in U.S.), depending on local regulations 3) Subjects with acquired hemophilia with autoimmune inhibitors to human factor VIII, with a clinical diagnosis established by the following criteria: a) Prolonged activated partial thromboplastin time (aPTT) b) Prothrombin time (PT) c) Abnormal aPTT mixing study (patient-normal control 1:1) consistent with a factor VIII inhibitor d) Reduced factor VIII activity level (below 10%) 4) Has a serious bleeding episode, as documented by the investigator 5) Be willing and able to follow all instructions and attend all study visits. 6) Subjects taking anti-thrombotics (such as clopidogrel, heparin or heparin analogue) may be included provided three half lives have elapsed since the last dose of the agent. 7) Life expectancy of at least 90 days prior to the onset of the bleeding episode. 8) Subjects of reproductive age must use acceptable methods of contraception and if female, undergo pregnancy testing as part of the screening process.
Exclusion criteria
Exclusion criteria: 1) Hemodynamically unstable after blood transfusion, fluid resuscitation and pharmacologic or volume replacement pressor therapy. This hemodynamic instability is characterized by symptomatic hypotension resulting in vital organ dysfunction, such as cardiac ischemia, oliguria (urine volume Exclusion Criteria: 2) Has an established reason for bleeding that is not correctable. 3) Bleeding episode assessed likely to resolve on its own if left untreated. 4) Anti-OBI-1 inhibitor that exceeds 20 BU (prospectively or retrospectively) 5) Subsequent bleeding episode at the site of the initial qualifying bleeding episode within 2 weeks following the final OBI-1 dose for the initial qualifying bleeding episode, or subsequent bleeding episode at a different site than the initial qualifying bleeding episode within 1 week following the final OBI-1 dose for the initial qualifying bleeding episode will not be considered â??newâ?? qualifying bleeding episodes. Prior history of bleeding disorder other than acquired hemophilia. 7) Known major sensitivity (anaphylactoid reactions) to therapeutic products of porcine or hamster origin; examples include therapeutics of porcine origin (e.g. previously marketed porcine factor VIII, Hyate-C®) and recombinant therapeutics prepared from hamster cells (e.g. Humira®, Advate® and Enbrel®) 8) Use of hemophilia medication: rFVIIa within 3 hours prior to OBI-1 administration, or aPCC treatment within 6 hours prior to OBI-1 administration. 9) Participation in any other clinical study within 30 days of the first OBI-1 treatment. 10) Anticipated need for treatment or device during the study that may interfere with the evaluation of the safety or efficacy of OBI-1, or whose safety or efficacy may be affected by OBI-1. 11) Is currently pregnant or breastfeeding, or planning to become pregnant or father a child during the study. 12) Abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the subjectâ??s safety or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study. 13) Inability or unwillingness to comply with the study design, protocol requirements, or the follow-up procedures. 14) Patient of majority age under legal protection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy outcome is response at 24 hours after initiation of OBI-1 therapyTimepoint: 24 hours after initiation of First dose of OBI-1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of factor VIII levels after administration of OBI-1Timepoint: Assessment of response after administration of OBI-1 | — |
Countries
Canada, France, Germany, Hungary, India, Italy, Sweden, United Kingdom, United States of America
Contacts
Public ContactDr Shariq Anwar
Max Neeman International
Outcome results
None listed