Doptelet (avatrombopag) / SOBI 
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 31 Diseases   42 Trials   42 Trials   576 News 


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  • ||||||||||  efgartigimod IV (ARGX-113 IV) / argenx, Broteio
    Review, Journal:  Reaserch Advances in the Treatment of Primary Immune Thrombocytopenia--Review (Pubmed Central) -  Jun 16, 2021   
    Recently, avatrombopag and fostamatinib have been approved by the FDA for the treatment of primary ITP in adults, while new drugs such as rozanolixizumab, efgartigimod, PRTX-100, decitabine and atorvastatin have shown efficacy in early clinical trials. This review summarizes the current accepted therapies for the clinical treatment of primary ITP in adults, and briefly discuss the progress of new therapies.
  • ||||||||||  Nplate (romiplostim) / Amgen, Kyowa Kirin, Doptelet (avatrombopag) / SOBI, Promacta (eltrombopag) / Novartis
    [VIRTUAL] Switching from Eltrombopag or Romiplostim to Avatrombopag in Immune Thrombocytopenia: A Multicenter Study of U.S. ITP Referral Centers (Room 3) -  Jun 9, 2021 - Abstract #ISTH2021ISTH_1211;    
    15 patients (33%) required rescue in the year prior to switching versus 9 (20%) following the switch.Avatrombopag Discontinuation: 2 patients (4%) discontinued for adverse events (headache, portal vein thrombosis) and 1 (2%) discontinued for lack of response. Conclusions : In a heavily-pretreated chronic ITP population, avatrombopag was effective following therapy with romiplostim or eltrombopag, with high response rates even in patients with inadequate response to a prior TPO-RA.
  • ||||||||||  Doptelet (avatrombopag) / SOBI
    Enrollment open, Trial completion date, Trial initiation date, Trial primary completion date:  EAST: Avatrombopag in Patients With End-stage Liver Disease and Thrombocytopenia (clinicaltrials.gov) -  Jun 4, 2021   
    P4,  N=150, Recruiting, 
    Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting | Trial completion date: Dec 2023 --> Dec 2022 | Initiation date: May 2021 --> Feb 2021 | Trial primary completion date: May 2023 --> Dec 2022
  • ||||||||||  Nplate (romiplostim) / Amgen, Kyowa Kirin
    Clinical, Journal:  Romiplostim in adults with newly diagnosed or persistent immune thrombocytopenia. (Pubmed Central) -  Jun 4, 2021   
    To identify data relating to romiplostim in adults with newly diagnosed or persistent ITP, we conducted a search of PubMed (with no time limit applied) and abstracts from 2019 EHA/ASH meetings using the term 'romiplostim.' Expert opinion: The findings from nine clinical trials, six real-world studies and ten case reports provide insight into the early use of romiplostim, which could help to reduce exposure to the adverse effects associated with prolonged corticosteroid use, as well as reduce the risk of severe bleeding. Additionally, given the durable responses observed in patients with newly diagnosed/persistent ITP, as well as the potential for treatment-free responses following discontinuation, romiplostim might help to avoid the need for subsequent treatment.
  • ||||||||||  Doptelet (avatrombopag) / SOBI
    [VIRTUAL] Clinical Experience with Avatrombopag () -  May 26, 2021 - Abstract #EASLILC2021EASL_ILC_1584;    
    Additionally, given the durable responses observed in patients with newly diagnosed/persistent ITP, as well as the potential for treatment-free responses following discontinuation, romiplostim might help to avoid the need for subsequent treatment. Sponsored By Sobi
  • ||||||||||  Zarzio (filgrastim biosimilar) / Novartis
    [VIRTUAL] LENGTH OF THROMBOPOIETIN RECEPTOR AGONIST (TPO-RA) TREATMENT AND PERSISTENCE IN IMMUNE THROMBOCYTOPENIA (ITP): REAL WORLD UNITED STATES CLAIMS ANALYSES () -  May 13, 2021 - Abstract #EHA2021EHA_1938;    
    Avatrombopag (AVA), a TPO-RA which was FDA approved in 2019, also recently received EMA approval for adults suffering with chronic ITP...Aims To understand length of therapy (LOT) and persistence (PER) of treatment in adult ITP patients in US, treated with an FDA-approved TPO-RA (AVA, eltrombopag (ELT) or romiplostim (ROMI)...Claims data using matched methodologies were utilized to calculate LOT and PER for each TPO-RA, however due to AVA’s commercial availability occurring in July 2019, slightly different time frames were evaluated. Also, different sources of data capture were necessary due to lack of a consistent source.
  • ||||||||||  Doptelet (avatrombopag) / SOBI
    [VIRTUAL] DURABILITY OF PLATELET COUNT RESPONSE IN PATIENTS TREATED WITH AVATROMBOPAG FOR IMMUNE THROMBOCYTOPENIA (ITP): POST-HOC RESULTS FROM THE PHASE 3 CORE AND OPEN-LABEL EXTENSION STUDY () -  May 13, 2021 - Abstract #EHA2021EHA_1935;    
    P3
    Thrombopoietin receptor agonists (TPO-RAs) have become widely utilized as second-line treatments, and the 2019 ASH guidelines recommend their use over rituximab to achieve a durable response...Pts maintained their initial response on average for 83.5% (median 100%) of their remaining time in the study for LOR-4wk and for 79.3% (median 100%) in the LOR-2vis analyses (Table 1). Conclusion These data suggest that the initial response to AVA is durable, with up to 62% of Pts never experiencing a LOR in the core or extension, and stable with Pts maintaining a response on average for up to 84% of the time despite the planned objective of reducing concomitant medications and required AVA starting dose in the extension.
  • ||||||||||  [VIRTUAL] A MULTICENTER U.S. STUDY OF AVATROMBOPAG SWITCH THERAPY FOLLOWING PRIOR ELTROMBOPAG OR ROMIPLOSTIM () -  May 13, 2021 - Abstract #EHA2021EHA_1931;    
    AVA Discontinuation: 7 patients (16%) discontinued AVA, including 2 patients (4%) for adverse events (headache, portal vein thrombosis), 1 (2%) for lack of response, 1 for patient preference, 1 for achievement of remission, 1 for transition to rituximab to treat concomitant hemolytic anemia (patient with Evans syndrome), and 1 due to lack of the medication on a formulary. Conclusion In a heavily pretreated chronic ITP population, AVA was effective following therapy with ROMI/ELT, with high response rates even in patients with inadequate response to a prior TPO-RA.
  • ||||||||||  Mulpleta (lusutrombopag) / Shionogi, Doptelet (avatrombopag) / SOBI
    Clinical, Review, Journal:  Thrombocytopenia and Hemostatic Changes in Acute and Chronic Liver Disease: Pathophysiology, Clinical and Laboratory Features, and Management. (Pubmed Central) -  May 1, 2021   
    Two newly licensed oral thrombopoietin mimetics/receptor agonists, avatrombopag and lusutrombopag, are now available for targeted treatment of thrombocytopenia in patients with advanced liver disease, who are undergoing invasive procedures. This review summarizes recent advances in the understanding of defective but at low level rebalanced hemostasis in stable cirrhosis, discusses clinical consequences and persistent controversial issues related to the inherent bleeding risk, and is focused on a risk-adapted management of thrombocytopenia in patients with chronic liver disease, including a restrictive transfusion regimen.
  • ||||||||||  Doptelet (avatrombopag) / SOBI
    Journal:  An evaluation of avatrombopag for the treatment of thrombocytopenia. (Pubmed Central) -  Apr 28, 2021   
    In periprocedural thrombocytopenia in patients with CLD, avatrombopag is comparable to lusutrombopag, another TPO-RA. Finally, the results of the study of avatrombopag in CIT are eagerly awaited, as there are no currently approved medications for this indication in the US.
  • ||||||||||  danazol oral / Generic mfg.
    Review, Journal:  Thrombopoietin receptor agonist for treatment of immune thrombocytopenia in pregnancy: a narrative review. (Pubmed Central) -  Apr 7, 2021   
    Cytotoxic chemotherapy (vincristine, cyclophosphamide), danazol, and mycophenolate are contraindicated in pregnant women...Current evidence on the use of TPO-RAs in pregnant women with ITP is limited. In this narrative review, we will examine the preclinical and the clinical literature regarding the use of TPO-RAs in the management of ITP in pregnancy and their effect on neonates with NMITP.
  • ||||||||||  Doptelet (avatrombopag) / SOBI
    New P2/3 trial:  Avatrombopag-1: Avatrombopag Usage in NSAA (clinicaltrials.gov) -  Jan 28, 2021   
    P2/3,  N=40, Not yet recruiting, 
  • ||||||||||  Doptelet (avatrombopag) / SOBI
    Enrollment change, Trial completion date, Trial withdrawal, Trial primary completion date:  Avatrombopag for Thrombocytopenia in People With Cancer (clinicaltrials.gov) -  Dec 8, 2020   
    P2,  N=0, Withdrawn, 
    This algorithm provides guidance for the management of severe thrombocytopenia to reduce bleeding risks in patients with chronic liver disease undergoing elective procedures, while reducing requirement for platelet transfusion. N=20 --> 0 | Trial completion date: May 2022 --> Dec 2020 | Recruiting --> Withdrawn | Trial primary completion date: May 2022 --> Dec 2020
  • ||||||||||  Doptelet (avatrombopag) / SOBI, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    [VIRTUAL] Characterization of Thromboembolic Events Occurring during the Avatrombopag Immune Thrombocytopenia (ITP) Clinical Development Program (Poster Hall (Virtual Meeting)) -  Nov 5, 2020 - Abstract #ASH2020ASH_1809;    
    The TPO-RAs eltrombopag (ELT) and romiplostim (ROMI) have been utilized in patients with ITP for over a decade, whereas avatrombopag (AVA) was more recently approved in June, 2019...Analyses of other TPO-RAs and TEEs have led to similar conclusions regarding a lack of relationship between platelet count and drug dose (Ghanima, 2018). Clinicians should carefully monitor PC and assess the risk for thromboembolism in each individual patient treated with a TPO-RA.
  • ||||||||||  Doptelet (avatrombopag) / SOBI, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    [VIRTUAL] Consistent Efficacy Demonstrated By Avatrombopag in Immune Thrombocytopenia (ITP) Regardless of the Number of Lines of Prior ITP Treatment (Poster Hall (Virtual Meeting)) -  Nov 5, 2020 - Abstract #ASH2020ASH_1799;    
    The TPO-RAs eltrombopag (ELT) and romiplostim (ROMI) have well understood efficacy profiles, but ELT has an FDA boxed safety warning for hepatotoxicity, necessitating hepatic function monitoring...Conclusions : In this Phase 3 study, the number of prior ITP treatments a patient had received did not seem to definitively predict PC response to AVA, though on some measures the group receiving <3 fared slightly better. These data suggest that AVA efficacy is relatively consistent, even if a patient has received multiple prior ITP therapies before AVA initiation.