PMID- 35833399
OWN - NLM
STAT- MEDLINE
DCOM- 20220715
LR  - 20220715
IS  - 0004-5772 (Print)
IS  - 0004-5772 (Linking)
VI  - 70
IP  - 7
DP  - 2022 Jul
TI  - A prospective, multicenter, clinical Study to evaluate the Safety, 
      Pharmacokinetics, and Efficacy of Bleed Outcomes, with HemoRel-A(R) in severe 
      Hemophilia A Patients.
PG  - 11-12
LID - 10.5005/japi-11001-0039 [doi]
AB  - PURPOSE: To evaluate efficacy for an on-demand treatment of acute bleeding 
      events, pharmacokinetics, safety, and tolerability of HemoRel-A(R) 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(R) for bleed treatment. The 
      efficacy of HemoRel-A(R) 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(R) 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(R) 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.
CI  - (c) Journal of the Association of Physicians of India 2011.
FAU - Mewada, Mayur
AU  - Mewada M
AD  - Assistant Professor, Department of Medicine, KJ Somaiya Medical College, Hospital 
      and Research Centre.
FAU - Sanyal, Subhaprakash
AU  - Sanyal S
AD  - Consultant Hematologist and Hemato-Oncologist, Fortis Hospitals Limited, Mumbai, 
      Maharashtra, India.
FAU - Rangarajan, Savita
AU  - Rangarajan S
AD  - Faculty of Medicine, University of Southampton, United Kingdom.
FAU - Apsangikar, Prasad
AU  - Apsangikar P
AD  - Head, Department of Medical Affairs and Pharmacovigilance.
FAU - Yadav, Ajay Kumar
AU  - Yadav AK
AD  - Head, Department of Clinical Research.
FAU - Naik, Manoj
AU  - Naik M
AD  - Head Pharmacovigilance.
FAU - Nair, Santosh
AU  - Nair S
AD  - Divisional Medical Head, Reliance Life Sciences Pvt. Ltd., Navi Mumbai, 
      Maharashtra, India.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PL  - India
TA  - J Assoc Physicians India
JT  - The Journal of the Association of Physicians of India
JID - 7505585
SB  - IM
MH  - *Hemophilia A/complications/drug therapy
MH  - Hemorrhage/chemically induced/drug therapy
MH  - Humans
MH  - Male
MH  - Prospective Studies
MH  - Treatment Outcome
EDAT- 2022/07/15 06:00
MHDA- 2022/07/16 06:00
CRDT- 2022/07/14 04:56
PHST- 2022/07/14 04:56 [entrez]
PHST- 2022/07/15 06:00 [pubmed]
PHST- 2022/07/16 06:00 [medline]
AID - 10.5005/japi-11001-0039 [doi]
PST - ppublish
SO  - J Assoc Physicians India. 2022 Jul;70(7):11-12. doi: 10.5005/japi-11001-0039.