Acquired Hemophilia ANCT01968655
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
A study testing OBI-1 in people with Acquired Hemophilia A, run by Baxalta now part of Shire at 4 sites in United States.
Trial summary
To provide emergency access to OBI-1 for patients with Acquired Hemophilia and a serious bleeding episode who do not have access to an active clinical study site associated with the OBI-1-301 study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Hemophilia A
- What is being tested?
- OBI-1
- How many people
- Not given
- Where
- 4 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
National Institutes of Health Warren G. Magnuson Clinical Center
Bethesda, Maryland, 20892
Tufts Medical Center
Boston, Massachusetts, 02111
Penn State
Hershey, Pennsylvania, 17033
Vanderbilt Hemostasis/Hemophilia Clinic
Nashville, Tennessee, 37232
About this study
To provide emergency access to OBI-1 for patients with Acquired Hemophilia and a serious bleeding episode who do not have access to an active clinical study site associated with the OBI-1-301 study.
- Conditions
- Acquired Hemophilia A
- Being tested
- OBI-1
- Keywords
- Factor VIII Inhibitory Auto-antibodies
- Medical subject headings
- Factor 8 deficiency, acquired
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OBI-1Biological
Also called B-Domain Deleted Recombinant Porcine Factor VIII
OBI-1 is a B domain deleted recombinant porcine factor VIII
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Hemophilia AStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Baxalta now part of Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968655
- Sponsor's protocol ID
- OBI-1-301a
- Status last verified
- May 2021
- First submitted
- 21 Oct 2013
- Last updated
- 5 May 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01968655
- Acronym / sponsor ID
- OBI-1-301a
- Conditions
- Acquired Hemophilia A
- Keywords
- Factor VIII Inhibitory Auto-antibodies
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Baxalta now part of ShireIndustry (pharma, biotech, devices)
- First posted
- 24 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To provide emergency access to OBI-1 for patients with Acquired Hemophilia and a serious bleeding episode who do not have access to an active clinical study site associated with the OBI-1-301 study.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OBI-1Also: B-Domain Deleted Recombinant Porcine Factor VIIIOBI-1 is a B domain deleted recombinant porcine factor VIII | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OBI-1 in people with Acquired Hemophilia A, run by Baxalta now part of Shire at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2021.