raise study eltrombopag

Clinical Trial on Leukemia: Eltrombopag, Hypomethylating Agent (HMA Study Record Detail Save this study RAISE: Randomized Placebo-Controlled Idiopathic Thrombocytopenic Purpura (ITP) Study With Eltrombopag (RAISE) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. 2015 Oct 24;386(10004):1649-58. doi: 10.1016/S0140-6736(15)61107-2. You have reached the maximum number of saved studies (100). Dysmegakaryopoiesis and Transient Mild Increase in Bone Marrow Blasts 2011 Jan 29;377(9763):382. The first-line therapy is a corticosteroid (prednisolone, methylprednisolone or dexamethasone); while the Intravenous Immunoglobulin (IVIG) can be used in individual cases with or without steroids in cases where immediate platelet count elevation is desired [5]. The ELEVATE study will test whether a drug called 'eltrombopag' works at raising platelet levels in people with chronic liver disease and thrombocytopenia. Hemoglobin: Subjects with hemoglobin levels between 10 g/dL (100 g/L) and the lower limit of normal are eligible for inclusion, if anemia is clearly attributable to ITP (excessive blood loss). U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. A French study [116] showed that Eltrombopag monotherapy in patients who were refractory or relapsed after IST determined a unilinear response in 74% and a multilinear response in 34% of cases. Eltrombopag for management of chronic immune thrombocytopenia (RAISE pseudothrombocytopenia, myelofibrosis). Epub 2011 Dec 20. Subjects must have either initially responded (platelet count > 100,000/L) to a previous ITP therapy or have had a bone marrow examination consistent with ITP within 3 years to rule out myelodysplastic syndromes or other causes of thrombocytopenia. Anemia was the commonest adverse event followed by hepatobiliary dysfunction as measured by deranged AST/ALT or raised bilirubin. Durable and overall platelet responses in patients with chronic idiopathic thrombocytopenic purpura during long-term treatment with oral eltrombopag by splenectomy status: the RAISE study. Review efficacy data from the RAISE study Review safety data from the RAISE study REPEAT4 An open-label, single-arm study that evaluated the efficacy and safety of repeated short courses of REVOLADE for up to 3 cycles of treatment. Daniele Ouellet Not Observed. General The most common side effects reported in ITP patients have included nausea, diarrhea, upper respiratory tract infection, vomiting, increased ALT, myalgia, urinary tract infection, oropharyngeal pain, increased AST, pharyngitis, back pain, influenza, paresthesia, and rash. Curr Med Res Opin. Eltrombopag for management of chronic immune thrombocytopenia (RAISE): a 6-month, randomised, phase 3 study. Kaplan-Meier curve showing the cumulative incidence of relapse following Eltrombopag. . Department of Internal Medicine, Choosing to participate in a study is an important personal decision. REVOLADE eltrombopag 50mg | myHealthbox reported the median time to response as 12 days (9-13 days) and an overall response rate of 88.8% in chronic ITP patients treated with eltrombopag (Table 6) [23]. Epub 2015 Oct 1. Before It is used to treat low platelet count (immune thrombocytopenia) in adults and in children aged 1 year and above who are unresponsive to other medicines. In a study from India, Tripathi et al. National Library of Medicine Efficacy and safety of eltrombopag in Japanese patients with chronic This may help increase your platelet counts . reported that 21% patients discontinued eltrombopag after persistent response, and 51% of evaluable patients continued to have sustained response after six months of drug discontinuation [23]. doi: 10.1016/S2352-3026(15)00114-3. Miller AB, Hoogstraten B, Staquet M, Winkler A. Worcester, Massachusetts, USA, 3 2011 Jan 29;377(9763):382. How I treat idiopathic thrombocytopenic purpura (ITP). Injury, poisoning and procedural complications, Aspartate aminotransferase (AST) increased, Neoplasms benign, malignant and unspecified (incl cysts and polyps), Respiratory, thoracic and mediastinal disorders, Frequency Threshold for Reporting Other Adverse Events, Musculoskeletal and connective tissue disorders. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00370331. Eltrombopag for management of chronic immune thrombocytopenia (RAISE): A 6-month, randomised, phase 3 study Authors: Gregory Cheng The Chinese University of Hong Kong Mansoor Saleh University. Signorovitch J, Brainsky A, Grotzinger KM. Eser A, Toptas T, Kara O, Sezgin A, Noyan-Atalay F, Yilmaz G, Ozgumus T, Pepedil-Tanrikulu F, Kaygusuz-Atagunduz I, Firatli-Tuglular T. Efficacy and safety of eltrombopag in treatment-refractory primary immune thrombocytopenia: a retrospective study. A subject will NOT be eligible for inclusion in this study if any of the following criteria apply: Any clinically relevant abnormality, other than ITP, identified on the screening examination or any other medical condition or circumstance, which in the opinion of the investigator makes the subject unsuitable for participation in the study or suggests another primary diagnosis (e.g., thrombocytopenia is secondary to another disease). The institutional ethics committee approved the study (AHRR IEC44/2020). Subjects treated with concomitant ITP medication (e.g. Eltrombopag is an oral thrombopoietin receptor agonist that stimulates thrombopoiesis and shows higher exposure in East Asian patients than in non-Asian patients. Curr Med Res Opin. Percentage of participants who experienced a reduction in their baseline concomitant ITP medication use, Summary of World Health Organization (WHO) bleeding scores at each nominal visit. Genetic and Rare Diseases Information Center. Eltrombopag | Interactions | BNF | NICE However, contrary to our study, the study published by Mazza et al. Please remove one or more studies before adding more. In addition, total albumin must not be below the lower limit of normal (LLN) by more than 10%. Himachal Pradesh, India, 4 Health-related quality of life (HR-QoL) patient reported outcomes from the motivation and energy inventory-short form (MEI-SF) questionnaire. Revolade (eltrombopag olamine) | Efficacy: Study designs Talk with your doctor and family members or friends about deciding to join a study. In another study from Korea, Kim et al. Scores could range from 0 (worst possible) to 52 (best possible). 2011 Jan 29;377(9763):393-402. doi: 10.1016/S0140-6736(10)60959-2. The birth and rapid growth of the internet has revolutionised many areas of publishing. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Demographic profile and baseline clinical characteristics of the ITP patients who received eltrombopag. Health-related quality of life (HR-QoL) patient reported outcomes from the functional assessment of cancer therapy thrombocytopenia (FACT-Th) questionnaire (six selected items). Epub 2015 Jul 28. Eltrombopag has also been implicated in the development of iron deficiency in children treated for ITP [34]. Revolade (eltrombopag olamine) | Efficacy: ITP 2012 Jan;28(1):79-87. doi: 10.1185/03007995.2011.644849. This also results in a very limited data on efficacy and safety of eltrombopag from the developing countries. Female subjects (or female partners of male subjects) must either be of non-childbearing potential (hysterectomy, bilateral oophorectomy, bilateral tubal ligation or post-menopausal > 1 year), or of childbearing potential and use one of the following highly effective methods of contraception (i.e., Pearl Index <1.0%) from two weeks prior to administration of study medication, throughout the study, and 28 days after completion or premature discontinuation from the study: Two forms of barrier contraception (diaphragm plus spermicide, and for males condom plus spermicide); Male partner is sterile prior to entry into the study and is the only partner of the female; Systemic contraceptives (combined or progesterone only). PROMACTA HELPED IN OTHER WAYS of patients (6 of 45) on PROMACTA (eltrombopag) needed to take rescue medication to raise their platelet levels compared with 50% of patients (11 of 22) on placebo In a second study, 19% (12 of 63) on PROMACTA needed rescue medication versus 24% (7 of 29) on placebo It specifically targets patients with adequate counts ie 50-100,000/uL, not waiting for patients whose counts spontaneously increase to high levels and thus indicate that they are being . Phase II Eltrombopag in Chronic Lymphocytic Leukemia (CLL) Eltrombopag was started at 25 mg once daily dose, to be taken empty stomach in the morning. 62 participants were randomized to the placebo arm, but only 61 took study medication and are analyzed in the Safety Population. Corticosteroids for the treatment of chronic idiopathic thrombocytopenic purpura: patient-perceived burden. Tripathi AK, Shukla A, Mishra S, Yadav YS, Yadav DK. See page 5 for advice on testing of patients on eltrombopag, indicated for platelet . On audit of medical records, patients of ITP receiving eltrombopag were screened for inclusion. corticosteroids or azathioprine) must be receiving a dose that has been stable for at least 4 weeks prior to randomization. Moreover, as we anticipate more frequent use of eltrombopag in future, there is a need to explore the data from the developing world. If a potential subject has no clinical history that would support HIV infection or hepatitis infection, no further laboratory screening is necessary; however, standard medical practice would suggest further evaluation of patients who have risk factors for these infections. Grainger JD, Locatelli F, Chotsampancharoen T, Donyush E, Pongtanakul B, Komvilaisak P, Sosothikul D, Drelichman G, Sirachainan N, Holzhauer S, Lebedev V, Lemons R, Pospisilova D, Ramenghi U, Bussel JB, Bakshi KK, Iyengar M, Chan GW, Chagin KD, Theodore D, Marcello LM, Bailey CK.