Emicizumab prophylaxis for the treatment of people with moderate or mild Hemophilia A without Factor VIII inhibitors: results from the primary analysis of the HAVEN 6 study
Bibliographic record
Abstract
Introduction Emicizumab is a bispecific monoclonal antibody that substitutes for missing activated factor (F)VIII in people with hemophilia A (HA). This primary analysis ofHAVEN 6 (NCT04158648) aims to assess safety and efficacy of emicizumab prophylaxis in people with non-severe HA without FVIII inhibitors. Method HAVEN 6 is a Phase III, open-label study of emicizumab in people with moderate or mild HA without FVIII inhibitors who warrant prophylaxis as assessed by Investigator. Informed consent and ethics approval were obtained. Participants received subcutaneous emicizumab 3mg/kg weekly for 4 weeks, then 1.5mg/kg weekly, 3mg/kg every 2 weeks, or 6mg/kg every 4 weeks. Safety endpoints include adverse events (AEs), serious AEs (SAEs) and AEs of special interest, including thromboembolic events (TEs) and thrombotic microangiopathies (TMAs). Efficacy endpoints include negative binomial regression model estimates of annualized bleed rates (ABRs) ([ Tab. 1 ]). Tab. 1 Efficacy
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.005 | 0.006 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.003 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".