Expanded Access to B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodies

• Register: ClinicalTrials.gov
• Last refreshed on: 17 May 2021
• Main ID: NCT01968655
• Date of registration: 21/10/2013
• Prospective Registration: Yes
• Primary sponsor: Baxalta now part of Shire
• Public title: Expanded Access to B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodies
• Scientific title: Expanded Access to B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodies
• Date of first enrolment: September 9, 2014
• Recruitment status: No longer available
• URL: https://clinicaltrials.gov/show/NCT01968655
• Study type: Expanded Access

Countries of recruitment

United States

Contacts

• Name: Study Director
• Affiliation: Takeda

Key inclusion & exclusion criteria

Inclusion Criteria:

- Written informed consent from participant or their legal representative.

- Participants with acquired hemophilia with autoimmune inhibitors to human factor VIII.

- Has a serious bleeding episode, as documented by the investigator.

- Be willing and able to follow all instructions and attend all study visits.

- Participants taking anti-thrombotics may be included depending on the time elapsed
since taking such medications.

- Life expectancy of at least 90 days prior to the onset of the bleeding episode.

Exclusion Criteria:

- Hemodynamically unstable after blood transfusion, fluid resuscitation and
pharmacologic or volume replacement pressor therapy.

- Has an established reason for bleeding that is not correctable.

- Bleeding episode assessed likely to resolve on its own if left untreated.

- Anti-OBI-1 inhibitor that exceeds 20 BU (prospectively or retrospectively).

- 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 "new" qualifying bleeding
episodes.

- Prior history of bleeding disorder other than acquired hemophilia.

- Known major sensitivity (anaphylactoid reactions) to pig or hamster products.

- Use of hemophilia medication within 3 to 6 (depending on medication) hours prior to
OBI-1 administration.

- Participation in any other clinical study within 30 days of the first OBI 1 treatment.

- Anticipated need for treatment or device during the study that may interfere with the
evaluation.

- Abnormal baseline findings

- Inability or unwillingness to comply with the study design, protocol requirements, or
the follow-up procedures.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Acquired Hemophilia A

Intervention(s)

Biological: OBI-1

Secondary ID(s)

OBI-1-301a

Source(s) of Monetary Support

Please refer to primary and secondary sponsors