{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,4,26]],"date-time":"2025-04-26T04:04:55Z","timestamp":1745640295514,"version":"3.40.4"},"reference-count":0,"publisher":"Jaypee Brothers Medical Publishing","issue":"7","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAPI"],"published-print":{"date-parts":[[2022,7,7]]},"abstract":"<jats:p>Purpose: To evaluate efficacy for an on-demand treatment of acute bleeding events, pharmacokinetics, safety, and tolerability of HemoRel-A\u00ae in severe hemophilia A.  Methods: A total of 44 male subjects with severe hemophilia A with an annualized bleed rate of 12 while on-demand treatment with factor VIII (FVIII) were enrolled in the study and received HemoRel-A\u00ae for bleed treatment. The efficacy of HemoRel-A\u00ae was evaluated based on a four-point scale (excellent, good, moderate, or none). Six-point pharmacokinetic (PK) assessment was performed following a single dose of 50 IU\/kg in 12 subjects after a 7-day wash-out period. Safety evaluations were performed at each visit and inhibitor testing was performed in all patients at screening and end of study.  Results: Forty-four male subjects received at least a single dose of the study medication and were included in the intent-to-treat (ITT) analysis and safety outcome. In 23 (7.52%) out of the 306 bleeding events, HemoRel-A\u00ae efficacy was rated as excellent, in 272 (88.89 %) bleeds it was rated as good, and in 11 (3.68%) bleeding events it was rated as moderate. No failure of efficacy was noted in any of the bleeding events. Thus overall out of 306 bleeding events, 295 (96.41%) showed excellent or good efficacy. Pharmacokinetic assessment based on plasma FVIII activity measured by the chromogenic assay in 12 patients showed comparative results similar to FVIII preparations. A total of 12 adverse events (AEs) were reported in this study. There was no inhibitor development in this previously treated patients (PTP) cohort.  Conclusion: HemoRel-A\u00ae was established to be efficacious and safe in the treatment of acute bleeding events in subjects with severe hemophilia A.  Trial registration number: CTRI\/2018\/05\/013790.  Registration date: 9th May 2018.<\/jats:p>","DOI":"10.5005\/japi-11001-0039","type":"journal-article","created":{"date-parts":[[2023,4,10]],"date-time":"2023-04-10T11:43:36Z","timestamp":1681127016000},"page":"72-75","source":"Crossref","is-referenced-by-count":0,"title":["A prospective, multicenter, clinical Study to evaluate the Safety, Pharmacokinetics, and Efficacy of Bleed Outcomes, with HemoRel-A\u00ae in severe Hemophilia A Patients"],"prefix":"10.59556","volume":"70","author":[{"given":"Mayur","family":"Mewada","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Subhaprakash","family":"Sanyal","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Savita","family":"Rangarajan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Prasad","family":"Apsangikar","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ajay","family":"Kumar Yadav","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Manoj","family":"Naik","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Santosh","family":"Nair","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"2914","published-online":{"date-parts":[[2022,7,1]]},"container-title":["Journal of the Association of Physicians of India"],"original-title":[],"deposited":{"date-parts":[[2025,4,25]],"date-time":"2025-04-25T10:57:13Z","timestamp":1745578633000},"score":1,"resource":{"primary":{"URL":"https:\/\/japi.org\/article\/files\/JAPI0039_p72-75.pdf"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,7,1]]},"references-count":0,"journal-issue":{"issue":"7","published-online":{"date-parts":[[2022,7,1]]},"published-print":{"date-parts":[[2022,7,7]]}},"URL":"https:\/\/doi.org\/10.5005\/japi-11001-0039","relation":{},"ISSN":["0004-5772"],"issn-type":[{"type":"print","value":"0004-5772"}],"subject":[],"published":{"date-parts":[[2022,7,1]]}}}