AHAEmi

Recruiting
99 years and younger
All
Phase N/A
2 participants needed
1 Location

Brief description of study

The primary objective of the present study is to evaluate the efficacy (effectiveness) of prophylactic (preventative doses) of emicizumab (FDA approved, also called Hemlibra) administered on a regular scheduled basis to prevent bleeds in patients with acquired hemophilia A (AHA). The secondary objectives are to study the safety of emicizumab in patients with AHA and to evaluate the timing, regimen and effect of immunosuppressive therapy (IST). Additional objectives- To compare bleeding and adverse events with the historic GTH-AH 01/2010 cohort and to assess the value and risks of time of initiation of IST by comparing with a parallel German/Austrian study. The number of clinically significant bleeds per patient-week until death or week 12 after starting of emicizumab treatment, whatever occurs first. Incidence and severity of adverse events, thromboembolic events, thrombotic microangiopathy in the 12 weeks after starting emicizumab treatment and mortality in the 24 weeks after starting emicizumab treatment. Bleeding-free survival in the 12 weeks after starting emicizumab treatment Mortality and cause of death
Days of treatment with and total dose of bypassing agents (recombinant factor VIIa, activated prothrombin complex concentrate) or recombinant porcine factor VIII (susoctocag alfa) or other factor VIII concentrates Days in hospital during 12 weeks of emicizumab treatment Number of patients achieving partial remission in the 24 weeks after starting emicizumab treatment Specifics (drug, amount and timing) of IST started during the 12 weeks of emicizumab prophylaxis Tracking PR and CR rates over 12 and 24 weeks

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Medical Research
  • Age: - 99 Years
  • Gender: All

TBD

Updated on 11 Sep 2024. Study ID: 855403

Find a site

What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Interested in the study

Select a study center that’s convenient for you, and get in touch with the study team.

Contact a study center