The Hemophilia Inhibitor Prevention Trial

Stopped early · Phase 3

Conditions studied: Hemophilia A Without Inhibitor

In brief

This is a multi-center randomized phase III clinical trial, the Inhibitor Prevention Trial, in which Eloctate will be compared with Emicizumab, using adaptive design, to prevent inhibitors in patients with severe hemophilia A.

Key facts

Study ID

NCT04303559

Run by

Margaret Ragni

People needed

1

Starts

2021-10-11

Expected to finish

2022-06-16

Last updated by the study team

2023-04-11

Who can join

Age: 0 and older, up to 4. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male children >= 4 months and up to 4 years of age.
• Severe hemophilia A (FVIII < 0.01 U/ml).
• No evidence of an inhibitor i.e. anti-FVIII < 0.6 B.U.
• No more than 3 FVIII exposures (Factor VIII concentrate, cryoprecipitate, or fresh frozen plasma), including circumcision.

You may not qualify if…

• Acquired hemophilia or any bleeding disorder other than hemophilia A.
• Treatment with clotting factor or emicizumab previously.
• Use of an experimental drug(s).
• Surgery anticipated in the next 48 weeks.
• Life expectancy less than 5 years.
• Parent/caretaker unable or unwilling to keep a personal diary of bleeding frequency and study drug treatment, make monthly visits and blood draws at weeks 4, 12, 24, 36, and 48.
• Other illness, condition or reason in the opinion of the investigator that would make the patient unsuitable for the trial.

Where it is running

• University of Arkansas Medical Sciences Childrens Hospital — Little Rock, Arkansas, United States
• Hemophilia Center of Western PA — Pittsburgh, Pennsylvania, United States
• University of Pittsburgh and Hemophilia Center Western PA — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.