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Hemophilia A

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1. Antihemophilic factor (recombinant, B-domain deleted, PEGylated) (Jivi) - for use in previously treated adults and adolescents (?12 years of age) with hemophilia A (congenital factor VIII deficiency)

Antihemophilic factor (recombinant, B-domain deleted, PEGylated) (Jivi) - for use in previously treated adults and adolescents (?12 years of age) with hemophilia A (congenital factor VIII deficiency) Search Page - Drug and Health Product Register Language selection Search and menus Search Search website Search Topics menu You are here: Summary Basis of Decision - - Health Canada Expand all Summary Basis of Decision (SBD) for Contact: Summary Basis of Decision (SBD) documents provide information

2019 Health Canada - Drug and Health Product Register

7. Medication management of acute bleeding in hemophilia B patients without inhibitors

Medication management of acute bleeding in hemophilia B patients without inhibitors

2017 DynaMed Plus

8. Medication management of acute bleeding in hemophilia B patients with inhibitors

Medication management of acute bleeding in hemophilia B patients with inhibitors

2017 DynaMed Plus

9. Medication management of acute bleeding in hemophilia A patients without inhibitors

Medication management of acute bleeding in hemophilia A patients without inhibitors

2017 DynaMed Plus

10. Medication management of acute bleeding in hemophilia A patients with inhibitors

Medication management of acute bleeding in hemophilia A patients with inhibitors

2017 DynaMed Plus

13. MASAC Recommendation for Liver Biopsies in Gene Therapy Trials for Hemophilia

MASAC Recommendation for Liver Biopsies in Gene Therapy Trials for Hemophilia 7 Penn Plaza · Suite 1204 New York, NY · 10001 (800) 42.HANDI · (212) 328.3700 · fax (212) 328.3777 www.hemophilia.org · info@hemophilia.org MASAC Document #256 MASAC RECOMMENDATION FOR LIVER BIOPSIES IN GENE THERAPY TRIALS FOR HEMOPHILIA The document was approved by the Medical and Scientific Advisory Council (MASAC) of the National Hemophilia Foundation (NHF) on March 29, 2019 and adopted by the NHF Board (...) of Directors on August 13, 2019. Currently, adeno-associated virus (AAV) has been identified as the most efficient method to transfer new genes into individuals with a variety of monogenic diseases. Nearly 200 clinical studies have utilized this vector for a number of monogenic diseases. At present multiple clinical trials for Hemophilia A and Hemophilia B are ongoing. This recommendation would also apply to other viral vectors in development for liver-directed gene therapy. AAV is a small parvovirus

2019 National Hemophilia Foundation

14. Bypassing agent prophylaxis in people with hemophilia A or B with inhibitors. (PubMed)

Bypassing agent prophylaxis in people with hemophilia A or B with inhibitors. People with hemophilia A or B with inhibitors are at high risk of bleeding complications. Infusion of bypassing agents, such as recombinant activated FVII (rFVIIa) and plasma-derived activated prothrombin complex concentrate, are suggested as alternative therapies to factor VIII (haemophilia A) or IX (haemophilia B) for individuals who no longer respond to these treatments because they develop inhibitory antibodies (...) . The ultimate goal of treatment is to preserve the individual's joints, otherwise destroyed by recurrent bleeds.To assess the effects of bypassing agent prophylaxis to prevent bleeding in people with hemophilia A or B and inhibitors.We searched for relevant studies from the Cystic Fibrosis and Genetic Disorders Group's Coagulopathies Trials Register, comprising of references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference

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2017 Cochrane

15. Rituximab for treating inhibitors in people with inherited severe hemophilia. (PubMed)

Rituximab for treating inhibitors in people with inherited severe hemophilia. Hemophilia A and B are inherited coagulation disorders characterized by a reduced or absent level of factor VIII or factor IX respectively. The severe form is characterized by a factor level less than 0.01 international units (IU) per milliliter. The development of inhibitors in hemophilia is the main complication of treatment, because the presence of these antibodies, reduces or even nullifies the efficacy (...) of replacement therapy, making it very difficult to control the bleeding. People with inhibitors continue to have significantly higher risks of morbidity and mortality, with considerable treatment costs. Given the wide 'off-label' use of rituximab for treating people with hemophilia and inhibitors, its efficacy and safety need to be evaluated. This is an update of a previously published Cochrane Review.To assess the efficacy and safety of rituximab for treating inhibitors in people with inherited severe

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2017 Cochrane

16. Subcutaneous concizumab prophylaxis in hemophilia A and hemophilia A/B with inhibitors: Phase 2 trial results. (PubMed)

Subcutaneous concizumab prophylaxis in hemophilia A and hemophilia A/B with inhibitors: Phase 2 trial results. Results from the main parts (24 weeks) of two concizumab phase 2 trials are presented: explorer4 (NCT03196284) in hemophilia A (HA) or B (HB) with inhibitors (HAwI/HBwI); explorer5 (NCT03196297) in HA without inhibitors. The trials aimed to evaluate the efficacy of daily subcutaneous concizumab prophylaxis (evaluated as annualized bleeding rate [ABR] at last dose level); secondary (...) the dose, and all patients chose to continue to the extension phase of the trials. Clinical proof of concept for the prevention of bleeding episodes was demonstrated in both trials. Estimated ABRs in HAwI and HBwI were lower vs. HA: 3.0 (95% confidence interval [CI]: 1.7;5.3) and 5.9 (95% CI: 4.2;8.5) vs. 7.0 (95% CI: 4.6;10.7), respectively. PK/PD results were as expected, with no difference between hemophilia subtypes for concizumab exposure, free tissue factor pathway inhibitor, thrombin generation

2019 Blood

17. Emicizumab for Hemophilia A with Inhibitors: Effectiveness and Value

Emicizumab for Hemophilia A with Inhibitors: Effectiveness and Value ©Institute for Clinical and Economic Review, 2018 Emicizumab for Hemophilia A with Inhibitors: Effectiveness and Value Evidence Report March 15, 2018 Prepared for ©Institute for Clinical and Economic Review, 2018 Page i Evidence Report: Emicizumab for Hemophilia A with Inhibitors ICER Staff University of Washington School of Pharmacy Modeling Group David Rind, MD Chief Medical Officer Institute for Clinical and Economic Review (...) to thank Molly Morgan, Aqsa Mugal, Erin Lawler, and Matt Seidner for their contributions to this report.©Institute for Clinical and Economic Review, 2018 Page ii Evidence Report: Emicizumab for Hemophilia A with Inhibitors About ICER The Institute for Clinical and Economic Review (ICER) is an independent non-profit research organization that evaluates medical evidence and convenes public deliberative bodies to help stakeholders interpret and apply evidence to improve patient outcomes and control costs

2018 California Technology Assessment Forum

18. MASAC Document Regarding Risks of Gene Therapy Trials for Hemophilia

MASAC Document Regarding Risks of Gene Therapy Trials for Hemophilia MASAC Document Regarding Risks of Gene Therapy Trials for Hemophilia | National Hemophilia Foundation Secondary menu Search form Search this site Search Main menu » » » » MASAC Document Regarding Risks of Gene Therapy Trials For Hemophilia PrintFriendly MASAC Document Regarding Risks of Gene Therapy Trials for Hemophilia Date: December 6, 2018 ID: 254 Revisions: 127; 212 Attachment Size 96.94 KB The National Hemophilia (...) . The knowledge gained from preclinical and clinical research has contributed to an iterative process that has incorporated sequential changes as new data are obtained and are integrated into new solutions to overcome existing hurdles. Numerous human Phase 1/2 clinical trials for hemophilia B and A have been conducted over the past decade (1-6). These trials have incorporated modifications of promoters, transgenes, and adeno-associated virus (AAV) vector serotypes, resulting in varying adverse events

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2018 National Hemophilia Foundation

19. Recommendation on the Use and Management of Emicizumab-kxwh (Hemlibra) for Hemophilia A with and without Inhibitors

Recommendation on the Use and Management of Emicizumab-kxwh (Hemlibra) for Hemophilia A with and without Inhibitors Recommendation on the Use and Management of Emicizumab-kxwh (Hemlibra®) for Hemophilia A with and without Inhibitors | National Hemophilia Foundation Secondary menu Search form Search this site Search Main menu » » » » Recommendation On The Use and Management of Emicizumab Kxwh Hemlibra For Hemophilia A With and Without Inhibitors PrintFriendly Recommendation on the Use (...) and Management of Emicizumab-kxwh (Hemlibra®) for Hemophilia A with and without Inhibitors Date: December 6, 2018 ID: 255 Attachment Size 619.83 KB Emicizumab is a recombinant, humanized, bispecific immunoglobulin G4 monoclonal antibody that substitutes for part of the cofactor function of activated factor VIII (FVIIIa) by bridging activated factor IX(FIXa) and factor X(FX). It is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children of all ages

2018 National Hemophilia Foundation

20. MASAC Recommendations on the NHF Genotyping Project for Persons with Hemophilia

MASAC Recommendations on the NHF Genotyping Project for Persons with Hemophilia MASAC Recommendations on the NHF Genotyping Project for Persons with Hemophilia | National Hemophilia Foundation Secondary menu Search form Search this site Search Main menu » » » » MASAC Recommendations On The NHF Genotyping Project For Persons With Hemophilia PrintFriendly MASAC Recommendations on the NHF Genotyping Project for Persons with Hemophilia Date: May 19, 2017 ID: 248 Revisions: 214; 96 Attachment Size (...) 197.06 KB NHF has formed a partnership to provide genotyping for the hemophilia community. My Life, Our Future, Genotyping for Progress in Hemophilia(MLOF), is a 4-way partnership between the National Hemophilia Foundation (NHF), Bloodworks Northwest (BWNW), (formerly the Puget Sound Blood Center [PSBC]), American Thrombosis Hemostasis Network (ATHN), and Bioverativ (formerly Biogen Idec). NHF will educate and publicize the Genotyping Project to individuals with hemophilia; BWNW will perform the DNA

2017 National Hemophilia Foundation

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