Approval Probability
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Advate · 1 trial · 2 indications
BMD was measured as Z-scores/T-scores using Dual-Energy X-ray Absorptiometry (DEXA) scanning; specifically looking at Spine, Hip/Neck, and Hip total scores. BMD Z-scores compare what would be expected in someone your age and body size. A Z-score, is a unit of standard deviation, where above 0 would indicate the bones are more dense than expected, while a Z-score below 0 would indicate the bones were less dense.
Hemophilia Joint Health Score (HJHS); with a higher score representing worst outcomes, scores could range from 0 (no problems) to a max score of 120 (severe problems).
Visual Analog Scale (VAS) via the EQ-5D-3L was used to report participants self-rated health. EQ-5D-3L total score ranges from 5 (no problems) to 15 (significant problems). VAS scores could range from 0 (worst health ever) to 100 (best health ever).
cytokines were measured using ELISA/magnetic bead multiplex kits. We calculated concentration change from hour 0 to hour 24. Cytokines: FGF, C-Terminal telopeptide (CTX-1), Dickkopf WNT signaling pathway inhibitor 1(DKK1), Eotaxin, fibroblast growth factor 23(FGF23), interferon gamma, interleukin 13, interleukin 1 beta, interleukin receptor 1 antagonist, interleukin 2, interleukin 4, interleukin 6, interleukin 17, interleukin 8, interleukin 9 Insulin, interferon gamma induced protein 10 (IP10), Leptin, monocyte chemoattractant protein1, monocyte chemoattractant protein1, macrophage inflammatory protein 1a (MIP1a), osteoclasts, Osteoprotegerin, osteopontin, platelet derived growth factors, parathyroid horomone, Recepter activator of nuclear factor kappa-B ligand (RANKL), chemokine ligand 5, sclerostin, transforming growth factor-beta 1, transforming growth factor beta 2, transforming growth factor beta 3, tumor necrosis factor alpha, vascular endothelial growth factor, MIP1b.
| Arm | Type | Description |
|---|---|---|
| Open label | EXPERIMENTAL | Everyone receives Advate (antihemophilic factor) on Day 1 and 3. |
| Name | Type | Description |
|---|---|---|
| Advate | DRUG | Patients who are currently taking Advate as their factor replacement will be eligible for the 5-day study. |
Inclusion Criteria: 1. Males with a diagnosis of hemophilia A with a historic baseline FVIII level ≤ 2%. 2. Age \> 16 years old 3. Currently using ADVATE as FVIII replacement therapy Exclusion Criteria: 1. Subject or guardian is unwilling or unable to give written informed consent and/or assent 2...
Advate is used for hemophilia, a bleeding disorder. It is being studied in the context of hemophilia A and bone disease. The drug is in Phase 3 clinical development and is being developed by Baxter International Inc. (BAX).
Advate targets biomarkers of bone metabolism in patients with hemophilia A. The Phase 3 trial is specifically designed to prospectively evaluate these biomarkers, indicating a focus on the relationship between hemophilia and bone health.
Advate is developed by Baxter International Inc., a company traded on the stock exchange under the ticker symbol BAX. The drug is currently in Phase 3 clinical trials for hemophilia.
Advate is in Phase 3 clinical development. It has completed one trial, which was a Phase 3 study. The drug is investigational and not yet approved, as it is still undergoing clinical trials.
Advate has one completed clinical trial, identified as NCT02306694. This Phase 3 study, titled 'Prospective Biomarkers of Bone Metabolism in Hemophilia A,' enrolled 16 male participants aged 16 years and older in the United States. The trial was uncontrolled and not randomized or double-blinded.
Advate is not known to have alternative names. It is a distinct drug candidate developed by Baxter International Inc. for hemophilia, currently in Phase 3 clinical trials.