Status:
WITHDRAWN
Hemophilia Inhibitor Clinical Trials (INHIBIT) Platform
Lead Sponsor:
Margaret Ragni
Conditions:
Severe Hemophilia A
Eligibility:
MALE
4-99 years
Phase:
PHASE3
Brief Summary
This study will evaluate if Eloctate is superior to Emicizumab in reducing inhibitors in children with severe hemophilia when given before the first bleed (preemptive) and continued weekly to prevent ...
Detailed Description
This is a multi-center, randomized Phase III Clinical Trials Platform (INHIBIT) in which hemostatic agents will be compared using adaptive design to prevent and eradicate inhibitors in patients with s...
Eligibility Criteria
Inclusion
- Prevention Trial,
- Male children \>/= 4 months of age.
- Severe hemophilia A (FVIII \< 0.01 U/ml)
- No previous bleed or surgery requiring treatment (except circumcision)
- No previous factor VIII product (except for circumcision)
- Willingness to comply with weekly prophylaxis for 48 weeks
- Willingness of parent/caregiver to keep a personal diary of bleeding frequency and factor treatment.
- Willingness to make monthly visits and coagulation testing at weeks 4, 12, 24, 36, and 48 (end of study)
- Prevention Trial,
Exclusion
- Acquired hemophilia.
- Any bleeding disorder other than hemophilia A.
- Treatment with clotting factor previously, other than circumcision.
- Presence of an inhibitor to factor VIII.
- Use of an experimental drug(s).
- Surgery anticipated in the next 48 weeks.
- Life expectancy less than 5 years.
- Inability to comply with study requirements.
- Eradication Trial, Inclusion Criteria:
- Male adults or children with no age limitation.
- Severe hemophilia A (FVIII \<0.01 U/ml).
- Presence of an inhibitor to FVIII (anti-FVIII \> 5.0 B.U.)
- Willingness to comply with study drugs for up to 48 weeks.
- Willingness to keep a personal diary of bleed frequency and drug treatment.
- Willingness to make monthly visits and coagulation testing at weeks 4, 12, 24, 36, and 48 (end of study).
- Eradication Trial,
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2027
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02196207
Start Date
August 1 2020
End Date
July 1 2027
Last Update
August 20 2019
Active Locations (1)
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1
Hemophilia Center of Western Pennsylvania
Pittsburgh, Pennsylvania, United States, 15213