Shashikant Apte
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View article: Concizumab prophylaxis in people with hemophilia A or B without inhibitors: patient-reported outcome results from the phase 3 explorer8 study
Concizumab prophylaxis in people with hemophilia A or B without inhibitors: patient-reported outcome results from the phase 3 explorer8 study Open
PRO data from the phase 3 explorer8 study provided additional support for concizumab prophylaxis compared with no prophylaxis as a treatment option for patients with HA/HB.
View article: Concizumab prophylaxis in people with haemophilia A or haemophilia B without inhibitors (explorer8): a prospective, multicentre, open-label, randomised, phase 3a trial
Concizumab prophylaxis in people with haemophilia A or haemophilia B without inhibitors (explorer8): a prospective, multicentre, open-label, randomised, phase 3a trial Open
Novo Nordisk.
View article: Disease and treatment burden of patients with haemophilia entering the explorer6 non‐interventional study
Disease and treatment burden of patients with haemophilia entering the explorer6 non‐interventional study Open
Objectives We aimed to characterise baseline disease and treatment burden in a large population with haemophilia A/B, both with (HAwI/HBwI) and without (HA/HB) inhibitors. Methods The prospective, non‐interventional explorer6 study include…
View article: OC 59.1 Concizumab Prophylaxis in Patients with Haemophilia A or B without Inhibitors: Efficacy and Safety Results from the Primary Analysis of the Phase 3 Explorer8 Study
OC 59.1 Concizumab Prophylaxis in Patients with Haemophilia A or B without Inhibitors: Efficacy and Safety Results from the Primary Analysis of the Phase 3 Explorer8 Study Open
extravascular space.In murine HB models the presence (CRM+) or absence (CRM-) of dysfunctional FIX can impact the PK (and in turn hemostatic efficacy) of the therapeutic FIX.We hypothesized that the PK parameters of EHL FIX products that h…
View article: Correction to: Efficacy and Safety of Biosimilar Romiplostim Versus Innovator Romiplostim in Patients with Chronic Immune Thrombocytopenia
Correction to: Efficacy and Safety of Biosimilar Romiplostim Versus Innovator Romiplostim in Patients with Chronic Immune Thrombocytopenia Open
View article: Moroctocog Alfa (AF-CC) for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Patients with Hemophilia A in India
Moroctocog Alfa (AF-CC) for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Patients with Hemophilia A in India Open
Purpose Hemophilia A is an X-linked congenital disorder, characterized by factor VIII (FVIII) deficiency. Globally, India has the highest population of patients with hemophilia, and there is a clear unmet need for appropriate and effective…
View article: Efficacy and Safety of Biosimilar Romiplostim Versus Innovator Romiplostim in Patients with Chronic Immune Thrombocytopenia
Efficacy and Safety of Biosimilar Romiplostim Versus Innovator Romiplostim in Patients with Chronic Immune Thrombocytopenia Open
Romiplostim is a Food and Drug Administration (FDA)-approved therapy for immune thrombocytopenia (ITP). Biosimilar is a biological product that has no clinical meaningful difference from an existing FDA-approved reference product. It has a…
View article: Managing invasive procedures in haemophilia patients with limited resources, extended half‐life concentrates or non‐replacement therapies in 2022
Managing invasive procedures in haemophilia patients with limited resources, extended half‐life concentrates or non‐replacement therapies in 2022 Open
New treatment possibilities and modalities are now available globally for patients with haemophilia requiring surgery or invasive procedures. The first is the appropriate application of low‐dose protocols of clotting factor concentrates (C…
View article: Patient blood management in India - Review of current practices and feasibility of applying appropriate standard of care guidelines. A position paper by an interdisciplinary expert group
Patient blood management in India - Review of current practices and feasibility of applying appropriate standard of care guidelines. A position paper by an interdisciplinary expert group Open
In a developing country like India, with limited resources and access to healthcare facilities, dealing with massive hemorrhage is a major challenge. This challenge gets compounded by pre-existing anemia, hemostatic disorders, and logistic…
View article: Tweaking the ISLH Slide Making Criteria- Is it worth?
Tweaking the ISLH Slide Making Criteria- Is it worth? Open
View article: Turoctocog alfa is safe for the treatment of Indian patients with hemophilia A: Guardian 10 trial results
Turoctocog alfa is safe for the treatment of Indian patients with hemophilia A: Guardian 10 trial results Open
The trial results demonstrated that turoctocog alfa is a safe treatment option for the prophylaxis and treatment of bleeding episodes in previously treated adolescent and adult patients with hemophilia A in the Indian population.
View article: Invasive procedures in patients with haemophilia: Review of low‐dose protocols and experience with extended half‐life FVIII and FIX concentrates and non‐replacement therapies
Invasive procedures in patients with haemophilia: Review of low‐dose protocols and experience with extended half‐life FVIII and FIX concentrates and non‐replacement therapies Open
The performance of surgery and invasive procedures in patients with haemophilia is currently facing new challenges globally. The first is the appropriate application of low‐dose protocols of clotting factor concentrates (CFC) achieving ade…
View article: Safety and Efficacy of Intravenous Immunoglobulin (Flebogamma <sup>®</sup> 10% DIF) in Patients with Immune Thrombocytopenic Purpura
Safety and Efficacy of Intravenous Immunoglobulin (Flebogamma <sup>®</sup> 10% DIF) in Patients with Immune Thrombocytopenic Purpura Open
Flebogamma® 10% DIF administered over two consecutive days was safe and effective in adults and children with chronic ITP.
View article: Pharmacokinetics, clot strength and safety of a new fibrinogen concentrate: randomized comparison with active control in congenital fibrinogen deficiency
Pharmacokinetics, clot strength and safety of a new fibrinogen concentrate: randomized comparison with active control in congenital fibrinogen deficiency Open
View article: Pharmacokinetics, safety and efficacy of a recombinant factor <scp>IX</scp> product, trenonacog alfa in previously treated haemophilia B patients
Pharmacokinetics, safety and efficacy of a recombinant factor <span>IX</span> product, trenonacog alfa in previously treated haemophilia B patients Open
Introduction Trenonacog alfa ( IB 1001) is a recombinant factor IX ( rFIX ) manufactured in Chinese hamster ovary ( CHO ) cells. IB 1001 was evaluated in a multicentre clinical trial with haemophilia B patients. Aim The aim was to establis…
View article: Safety and Efficacy of a 10% Intravenous Immunoglobulin Preparation in Patients with Immune Thrombocytopenic Purpura: Results of Two International, Multicenter Studies
Safety and Efficacy of a 10% Intravenous Immunoglobulin Preparation in Patients with Immune Thrombocytopenic Purpura: Results of Two International, Multicenter Studies Open
Flebogamma 10% DIF was effective and safe in patients with primary ITP.
View article: A Randomized Trial of Factor VIII and Neutralizing Antibodies in Hemophilia A
A Randomized Trial of Factor VIII and Neutralizing Antibodies in Hemophilia A Open
Patients treated with plasma-derived factor VIII containing von Willebrand factor had a lower incidence of inhibitors than those treated with recombinant factor VIII. (Funded by the Angelo Bianchi Bonomi Foundation and others; ClinicalTria…
View article: Immuno-hematological analysis of Congenital AML associated with Downs Syndrome
Immuno-hematological analysis of Congenital AML associated with Downs Syndrome Open
Congenital leukemia is very rare, diagnosed in first month of life and often associated with Down’s syndrome. Congenital Acute myeloid leukemia (AML) is more common over acute lymphoblastic leukemia (ALL). The hematological parameters such…
View article: Pre-Transplant Consolidation and Cost Effectiveness of RIC Allogeneic SCT in Patients of AML-CR1 in India
Pre-Transplant Consolidation and Cost Effectiveness of RIC Allogeneic SCT in Patients of AML-CR1 in India Open
An allogeneic SCT (alloSCT) with a reduced intensity conditioning regimen (RIC) in first remission (CR1) is an attractive option to fulfill the requirements of relatively low cost without compromising efficacy. The need for consolidation c…