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Hemophilia A

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1. Antihemophilic factor VIII (recombinant, B-domain truncated), PEGylated (Esperoct) - hemophilia A (congenital factor VIII deficiency)

Antihemophilic factor VIII (recombinant, B-domain truncated), PEGylated (Esperoct) - 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 related to the original authorization of a product

2020 Health Canada - Drug and Health Product Register

2. Antifibrinolytic therapy for preventing oral bleeding in patients with haemophilia or Von Willebrand disease undergoing minor oral surgery or dental extractions. Full Text available with Trip Pro

Antifibrinolytic therapy for preventing oral bleeding in patients with haemophilia or Von Willebrand disease undergoing minor oral surgery or dental extractions. Minor oral surgery or dental extractions (oral or dental procedures) are widely performed and can be complicated by hazardous oral bleeding, especially in people with an inherited bleeding disorder such as haemophilia or Von Willebrand disease (VWD). The amount and severity of singular bleedings depend on disease-related factors (...) , such as the severity of the haemophilia, both local and systemic patient factors (such as periodontal inflammation, vasculopathy or platelet dysfunction) and intervention-related factors (such as the type and number of teeth extracted or the dimension of the wound surface). Similar to local haemostatic measures and suturing, antifibrinolytic therapy is a cheap, safe and potentially effective treatment to prevent bleeding complications in individuals with bleeding disorders undergoing oral or dental procedures

2019 Cochrane

3. Damoctocog alfa (haemophilia A) - Benefit assessment according to §35a Social Code Book V

and efficacy of BAY 94-9027: a prolonged-half-life factor VIII. J Thromb Haemost 2017; 15(3): 411-419. 4. Coyle TE, Reding MT, Lin JC, Michaels LA, Shah A, Powell J. Phase I study of BAY 94- 9027: a PEGylated B-domain-deleted recombinant factor VIII with an extended half-life, in subjects with hemophilia A. J Thromb Haemost 2014; 12(4): 488-496. The full report (German version) is published under https://www.iqwig.de/en/projects-results/projects/drug-assessment/a18-86-damoctocog-alfa- haemophilia-a-benefit (...) Damoctocog alfa (haemophilia A) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Damoctocog alfa pegol (Hämophilie A) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 27 March 2019). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission No. A18-86

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

4. Emicizumab (haemophilia A) - Benefit assessment according to §35a Social Code Book V

recombinant factor VIII in adults with severe hemophilia A (SPINART). Res Pract Thromb Haemost 2013; 11(6): 1119-1127. Extract of dossier assessment A19-26 Version 1.0 Emicizumab (haemophilia A) 13 June 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - 16 - 9. Manco-Johnson MJ, Kempton CL, Reding MT, Lissitchkov T, Goranov S, Gercheva L et al. Corrigendum to "Randomized, controlled, parallel-group trial of routine prophylaxis vs. on-demand treatment with sucrose-formulated recombinant (...) study to collect high-quality documentation of bleeds, health-related quality of life (HRQoL), and safety outcomes in patients with hemophilia A treated with standard-of-care treatment: study details [online]. In: ClinicalTrials.gov. 30.05.2017. URL: https://ClinicalTrials.gov/show/NCT02476942. 18. Baxter. ADVATE (Octocog alfa): Fachinformation [online]. 06.2018 [Accessed: 11.02.2019]. URL: https://www.fachinfo.de. Extract of dossier assessment A19-26 Version 1.0 Emicizumab (haemophilia A) 13 June

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

5. Lonoctocog Alfa (Afstyla) - Hemophilia A

Lonoctocog Alfa (Afstyla) - Hemophilia A Terms of use - Canada.ca Language selection Search Search Canada.ca Search Topics menu Main Menu You are here: Terms of use From These Terms of Use govern the access and use of Clinical Information released by Health Canada for non-commercial purposes. By clicking the button “I agree” and accepting these Terms of Use and upon being granted access to the Clinical Information, you, and, if applicable, the organization on behalf of which you are accessing

2019 Health Canada - drugs and medical devices

6. Turoctocog alfa pegol (Esperoct) - haemophilia A

Turoctocog alfa pegol (Esperoct) - haemophilia A Official address Domenico Scarlattilaan 6 ? 1083 HS Amsterdam ? The Netherlands An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 © European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged. EMA/244278/2019 EMEA/H/C/004883 Esperoct (turoctocog alfa pegol) An overview (...) of Esperoct and why it is authorised in the EU What is Esperoct and what is it used for? Esperoct is a medicine used to treat and prevent bleeding in patients with haemophilia A, an inherited bleeding disorder caused by the lack of a clotting protein known as factor VIII. Esperoct can be used in adults and children from 12 years of age. Esperoct contains the active substance turoctocog alfa pegol. How is Esperoct used? Esperoct can only be obtained with a prescription and treatment should be started

2019 European Medicines Agency - EPARs

7. Emicizumab (Hemlibra) in haemophilia A. A first-choice preventive treatment for patients with factor VIII inhibitors

Emicizumab (Hemlibra) in haemophilia A. A first-choice preventive treatment for patients with factor VIII inhibitors Prescrire IN ENGLISH - Spotlight ''Emicizumab (Hemlibra°) in haemophilia A. A first-choice preventive treatment for patients with factor VIII inhibitors'', 1 December 2019 {1} {1} {1} | | > > > Emicizumab (Hemlibra°) in haemophilia A. A first-choice preventive treatment for patients with factor VIII inhibitors Spotlight Every month, the subjects in Prescrire’s Spotlight. 100 most (...) recent :  |   |   |   |   |   |   |   |   |  Spotlight Emicizumab (Hemlibra°) in haemophilia A. A first-choice preventive treatment for patients with factor VIII inhibitors FEATURED REVIEW Prescrire's editors have rated emicizumab prophylaxis in patients with haemophilia A in whom factor VIII is no longer effective due to the development of factor VIII inhibitors "a real advance". Reduced incidence of bleeding and greater

2019 Prescrire

8. Emicizumab (Hemlibra) - hemophilia A (congenital factor VIII deficiency) patients with factor VIII inhibitors as routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes.

Emicizumab (Hemlibra) - hemophilia A (congenital factor VIII deficiency) patients with factor VIII inhibitors as routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes. 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

9. Antihemophilic Factor VIII (Esperoct) - haemophilia A

Antihemophilic Factor VIII (Esperoct) - haemophilia A Terms of use - Canada.ca Language selection Search Search Canada.ca Search Topics menu Main Menu You are here: Terms of use From These Terms of Use govern the access and use of Clinical Information released by Health Canada for non-commercial purposes. By clicking the button “I agree” and accepting these Terms of Use and upon being granted access to the Clinical Information, you, and, if applicable, the organization on behalf of which you

2019 Health Canada - drugs and medical devices

10. 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

11. Pro-coagulant haemostatic factors for the prevention and treatment of bleeding in people without haemophilia. Full Text available with Trip Pro

Pro-coagulant haemostatic factors for the prevention and treatment of bleeding in people without haemophilia. Some hospital patients may be at risk of or may present with major bleeding. Abnormalities of clotting (coagulation) are often recorded in these people, and the traditional management has been with transfusions of blood components, either to prevent bleeding (prophylactic) or to treat bleeding (therapeutic). There is growing interest in the use of targeted therapies with specific pro

2018 Cochrane

12. Haemophilia

Biosciences, Novo Nordisk, CSL Behring, and Bayer. He has received grant funding from Baxter. PG has undertaken paid consultancy and/or received lecture fees from the following companies involved in haemophilia care: Bayer, CSL Behring, NovoNordisk, Pfizer/ BPL, Octapharma, Biogen Idec, and Biotest. NSK, NIR, and WKH are authors of reference(s) cited in this monograph. Peer reviewers The Mary Weinfeld Professor of Clinical Research in Hemophilia Mount Sinai School of Medicine New York NY Disclosures LA (...) Haemophilia Haemophilia - Symptoms, diagnosis and treatment | BMJ Best Practice You'll need a subscription to access all of BMJ Best Practice Search  Haemophilia Last reviewed: February 2019 Last updated: March 2018 Summary A bleeding disorder, usually inherited, characterised by the deficiency of coagulation factor VIII or IX. Occurs almost exclusively in males due to an X-linked pattern of inheritance. Graded as mild, moderate, or severe, based on factor VIII or IX level. Musculoskeletal

2018 BMJ Best Practice

13. Nonacog beta pegol (haemophilia B) ? Benefit assessment according to §35a Social Code Book V

and scientific questions was available for the present dossier assessment. IQWiG employees involved in the dossier assessment: ? Gregor Moritz ? Lars Beckmann ? Judith Gibbert ? Thomas Kaiser ? Florina Kerekes ? Ulrike Lampert ? Katrin Nink ? Corinna ten Thoren Keywords: nonacog beta pegol, hemophilia B, benefit assessment Extract of dossier assessment A17-57 Version 1.0 Nonacog beta pegol (haemophilia B) 26 January 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - iii - Table of contents (...) to determine minor, considerable, and major treatment effects in the early benefit assessment of new drugs. Biom J 2015; 58(1): 43-58 3. Collins PW, Young G, Knobe K, Karim FA, Angchaisuksiri P, Banner C et al. Recombinant long-acting glycoPEGylated factor IX in hemophilia B: a multinational randomized phase 3 trial. Blood 2014; 124(26): 3880-3886. 4. Novo Nordisk A/S. Safety and efficacy of NNC-0156-0000-0009 in haemophilia B patients (paradigm 2): full text view [online]. In: ClinicalTrials.gov

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

14. Emicizumab (haemophilia A) - Benefit assessment according to §35a Social Code Book V

Emicizumab (haemophilia A) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Emicizumab (Hämophilie A) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 27 June 2018). Please note: This document was translated by an external translator and is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports (...) – Commission No. A18-20 Emicizumab (haemophilia A) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-20 Version 1.0 Emicizumab (haemophilia A) 27 June 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Emicizumab (haemophilia A) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 27

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

15. Rurioctocog alfa pegol (haemophilia A) - Benefit assessment according to §35a Social Code Book V

Rurioctocog alfa pegol (haemophilia A) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of the executive summary of the dossier assessment Rurioctocog alfa pegol (Hämophilie A) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 August 2018). Please note: This document was translated by an external translator and is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally (...) binding. IQWiG Reports – Commission No. A18-32 Rurioctocog alfa pegol (haemophilia A) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-32 Version 1.0 Rurioctocog alfa pegol (haemophilia A) 13 August 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Rurioctocog alfa pegol (haemophilia A) – Benefit assessment according to §35a Social Code Book V

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

16. Emicizumab for routine prophylaxis, to prevent bleeding or reduce frequency of bleeding episodes in patients with haemophilia A (congenital factor VIII deficiency), with factor VIII inhibitors

Emicizumab for routine prophylaxis, to prevent bleeding or reduce frequency of bleeding episodes in patients with haemophilia A (congenital factor VIII deficiency), with factor VIII inhibitors 1 Public Summary Document Application No. 1510 – Emicizumab for routine prophylaxis to prevent bleeding or reduce frequency of bleeding episodes in patients with haemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors Applicant: Roche Products Pty Ltd Date of MSAC consideration: MSAC (...) 74th Meeting, 22-23 November 2018 Context for decision: MSAC makes its advice in accordance with its Terms of Reference, visit the MSAC website 1. Purpose of application An application seeking public funding through listing on the National Blood Authority’s (NBA’s) National Product List (NPL) for routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in patients with haemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors was received from Roche

2018 Medical Services Advisory Committee

17. Extended half-life clotting factor concentrates for treatment of haemophilia A and B

Extended half-life clotting factor concentrates for treatment of haemophilia A and B 1 Public Summary Document Application No. 1511 – Extended half-life clotting factor concentrates for the treatment of haemophilia A and B Applicant: National Blood Authority Date of MSAC consideration: MSAC 73 rd Meeting, 26-27 July 2018 Context for decision: MSAC makes its advice in accordance with its Terms of Reference, visit the MSAC website 1. Purpose of application The application is to inform public (...) funding through the NBA. MSAC noted that the incidence of haemophilia A (caused by deficiency of factor VIII) is approximately 1 in 10,000, and the incidence of haemophilia B (caused by deficiency of factor IX) is approximately 1 in 50,000. Female carriers of gene mutations for coagulation protein factors may also exhibit symptoms. MSAC noted that there is a high disease burden in patients with moderate and severe haemophilia. Recurrent bleeding can cause arthropathy, intracranial and retroperitoneal

2018 Medical Services Advisory Committee

18. Recombinant Human Coagulation Factor IX-FC Fusion Protein (rFIXFc) (ALPROLIX) - hemophilia B (congenital factor IX deficiency or Christmas disease)

Recombinant Human Coagulation Factor IX-FC Fusion Protein (rFIXFc) (ALPROLIX) - hemophilia B (congenital factor IX deficiency or Christmas disease) 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 related to the original authorization of a product

2018 Health Canada - Drug and Health Product Register

19. Emicizumab (Hemlibra) - To prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called Factor VIII (FVIII) inhibitors.

Emicizumab (Hemlibra) - To prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called Factor VIII (FVIII) inhibitors. HEMLIBRA (emicizumab-kxwh) Injection U.S. Department of Health and Human Services Search FDA Submit search HEMLIBRA (emicizumab-kxwh) Injection HEMLIBRA Company: Genentech, Inc. Application No.: 761083 Approval Date: 11/16/2017 Persons with disabilities having problems accessing the PDF files below

2018 FDA - Drug Approval Package

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