NCT04303559|TerminatedPhase 3ResultsDMCFDA Drug
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The INHIBIT Trials IDSMB, in a letter dated 05-18-22, recommended, given the slow enrollment, that the INHIBIT Trials be discontinued due to futility.
Multicenter, Randomized Phase III Inhibitor Prevention Trial, Comparing Eloctate vs. Emicizumab to Prevent Inhibitor Formation in Severe Hemophilia A
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · (HRSA) Health Resources and Services Administration
interventional
1
1 country
3
Study Start
October 11, 2021
Actual (reported)Primary Completion
April 6, 2022
Actual (reported)Study Completion
June 16, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 16, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2, 2020
Actual (reported)March 11, 2020
Actual (reported)October 11, 2021
Actual (reported)April 6, 2022
Actual (reported)June 16, 2022
Actual (reported)April 11, 2023
Actual (reported)Inhibitor Formation
The proportion developing anti-FVIII inhibitors.
48 weeks
Bleeding Events
48 weeks
FVIII Trough Level
48 weeks
Human Leukocyte Antigen (HLA) Haplotype
48 weeks
FVIII Mutation
48 weeks
Number of FVIII Exposures
48 weeks
Arm A: Eloctate 65 IU/kg will be administered weekly by intravenous infusion in previously untreated children with severe hemophilia A beginning before the first bleed and continued up to 48 weeks.
Arm B: Emicizumab 1.5 mg/kg will be administered weekly by subcutaneous injection (following 3 mg/kg/wk x4 induction) in previously untreated children with severe hemophilia A beginning before the first bleed and continue up to 48 weeks.
This is a factor VIII-Fc fusion protein.
This is a bispecific monoclonal antibody FVIII mimic.
University of Arkansas Medical Sciences Childrens Hospital
Little Rock, Arkansas, 72202, United States
Hemophilia Center of Western PA
Pittsburgh, Pennsylvania, 15213, United States
University of Pittsburgh and Hemophilia Center Western PA
Pittsburgh, Pennsylvania, 15213, United States
Ragni MV, George LA; Members of Working Group 1, the NHLBI State of the Science Workshop on factor VIII inhibitors: Generating a national blueprint for future research. The national blueprint for future factor VIII inhibitor clinical trials: NHLBI State of the Science (SOS) Workshop on factor VIII inhibitors. Haemophilia. 2019 Jul;25(4):581-589. doi: 10.1111/hae.13717.
Ebbert PT, Xavier F, Malec LM, Seaman CD, Ragni MV. Observational study of recombinant factor VIII-Fc, rFVIIIFc, in hemophilia A. Thromb Res. 2020 Nov;195:51-54. doi: 10.1016/j.thromres.2020.07.004. Epub 2020 Jul 5.
Margaret V Ragni, MD, MPH
University of Pittsburgh
1 participants (actual enrollment reported by the registry).
First Submitted
March 2, 2020
First Posted
March 11, 2020
Study Start
October 11, 2021
Contact the study team to confirm eligibility.
Bertolet M, Brooks MM, Ragni MV. The design of a Bayesian platform trial to prevent and eradicate inhibitors in patients with hemophilia. Blood Adv. 2020 Nov 10;4(21):5433-5441. doi: 10.1182/bloodadvances.2020002789.
Primary Completion
April 6, 2022
Actual (reported)Study Completion
June 16, 2022
Actual (reported)Last Updated
April 11, 2023
Results First Posted
April 11, 2023
Record last verified: 2023-03
A biologic specimen and data repository for this trial will be available at the Graduate School of Public Health (GSPH) Data Center repository for investigators who make formal application request and is formally approved by the Coordinating Center (Pitt) and Data Center (GSPH).
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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