A Study of Switching Avatrombopag and Rh-TPO in ITP
29. maj 2021 opdateret af: Fuhaixia, Peking University People's Hospital
A Prospective Observational Study of Switching Avatrombopag and Rh-TPO in Chinese Adult Patients With Primary Immune Thrombocytopenia
Thrombopoietin receptor agonists (TPO-RAs) represent a highly effective and well-tolerated second-line ITP treatment that provides excellent responses.If there is cross-resistance between 2 drugs for the treatment of adult ITP is still unkonwn.The purpose of this study is to investigate the efficacy and safety of switching avatrombopag and rh-TPO in adults with ITP.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Detaljeret beskrivelse
Thrombopoietin Receptor Agonists (TPO-RAs) are novel treatments for patients with chronic Primary Immune Thrombocytopenia (ITP).
According to the findings of mechanism-based studies, rhTPO competes with endogenous TPO for binding to TPO-R while avatrombopag has an additive effect with endogenous TPO, indicating that the treatment mechanism and side-effect profiles could be somewhat different between these drugs.
If there is cross-resistance between 2 drugs for the treatment of adult ITP is still no answer.
The purpose of this study is to investigate the efficacy and safety of switching avatrombopag and rh-TPO in adults with ITP.This is a non-interventional study.
Patients who fail previous steroids and receive rh-TPO and then switch to avatrombopag or vice versa will be enrolled.
The reason for switch will be recorded.
The efficacy, safety, and patient/physician preference will be assessed and compared between the two agents.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
100
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Haixia Fu, MD
- Telefonnummer: 8610-88324577
- E-mail: fuhaixia_210@163.com
Undersøgelse Kontakt Backup
- Navn: Yun He, MD
- Telefonnummer: 18910504949
- E-mail: heyun04@126.com
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
adult ITP patients
Beskrivelse
Inclusion Criteria:
1.18 years or older 2.Primary ITP 3.Failed initial glucocorticosteroid treatment, 4.Applying rhTPO or Eltrombopag as subsequent treatment 5.Switch from rh-TPO to eltrombopag or vice versa 6.Normal neutrophils 7.Available follow-up at least 6 weeks after switching
Exclusion Criteria:
- HIV positive status, or active infection of HBV or HCV
- Suffering from a serious or progressive disease, which, in the investigator's judgment, put the subject at undue risk for participation in this study (i.e. cancer or pre-cancer, immunocompromised, uncontrolled diabetes, epilepsy, severe cardio-cerebrovascular disease(s) (i.e. stroke, idiopathic aortic stenosis, aneurysm, hypertrophic obstructive cardiomyopathy, ischaemic heart disease, tachyarrhythmias, severe heart failure [classified as NYHA III-IV], severe lung dysfunctions, etc))
- History of thrombosis plus two or more risk factors as defined in Caprini thrombosis risk assessment model
- Lactating or pregnant women, or WOCBP who are unwilling to use highly effective contraceptive measures during the study period
- Abnormal liver and renal functions: AST or ALT or total bilirubin ≥1.5 × ULN, and/or creatinine ≥176.8 μmol/L
- Women of childbearing potential (WOCBP) that are pregnant or wish to become pregnant during the prospective phase of the study.
- Other conditions which the investigator considers inappropriate for enrollment
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Recombinant human thrombopoietin (rh-TPO) group
Patients who fail previous steroids and avatrombopag and then switch to Rh-TPO will be enrolled.
The reason for switch will be recorded.
Patients will be given rh-TPO 300 U/kg once daily for 14 days as initial treatment.
After initial treatment, maintenance therapy were performance.
At initial therapy, rhTPO will be suspended when platelet counts ≥100×10^9 / L. During maintenance therapy, patients with platelet counts >150×10^9 / L will suspend treatment until platelet counts drop to ≤150×10^9 / L. Dosing interval will be prolonged when platelet count is ≥100×10^9 / L to ≤150×10^9 / L. Dose modification is not required when platelet count is ≥30×10^9 / L to <100×10^9 / L. The efficacy, safety, and patient/physician preference will be assessed.
|
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Avatrombopag group
Patients who fail previous steroids and rh-TPO and then switch to avatrombopag will be enrolled.
The reason for switch will be recorded.
Patients will be given avatrombopag 20mg once daily as initiate treatment, and adjust the dosage according to the count of platelets.
The maximum dose of avatrombopag is 40mg daily.Avatrombopag will be terminated any time the platelet counts increased above 250×10^9/L.
Dose adjustment of avatrombopag will be allowed to maintain platelet counts between 30×10^9/L and 150×10^9/L.
The efficacy, safety, and patient/physician preference will be assessed.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Initial response after switching
Tidsramme: 4 weeks
|
Rate of response at 4 weeks after switching from rhTPO to avatrombopag or vise versa
|
4 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Response rate at 12 weeks after switching
Tidsramme: 12 weeks
|
Rate of response at 12 weeks after switching from rhTPO to avatrombopag or vise versa
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12 weeks
|
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Initial response after switching according to the reasons of switching
Tidsramme: 4 weeks
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Rate of response at 1 month after switching according to the reasons of switching,such as lack of efficacy, Platelet count fluctuations, development of adverse events,patient's or doctor's preference
|
4 weeks
|
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Rate of response at 12 weeks after switching according to the reasons of switching
Tidsramme: 12 weeks
|
Rate of response at 12 weeks after switching according to the reasons of switching,such as lack of efficacy, Platelet count fluctuations, development of adverse events,patient's or doctor's preference
|
12 weeks
|
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Time to response
Tidsramme: 4 weeks
|
Time to CR or R from switching
|
4 weeks
|
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Durable response
Tidsramme: 24 weeks
|
The maintenance of platelet count ≥ 30 x 10^9/L, at least 2-fold increase of the baseline count, the absence of bleeding, and no need for rescue medication at the 24 weeks follow-up.
|
24 weeks
|
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Incidence of bleeding events
Tidsramme: 24 weeks
|
Incidence of clinically significant bleeding as assessed using the world health organization (WHO) bleeding scale
|
24 weeks
|
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Immune Thrombocytopenia Patient Assessment Questionnaire (ITP-PAQ)
Tidsramme: 24 weeks
|
In all participants ,use ITP-PAQ to assess the Health Related Quality of Life(HRQoL) before and after treatment.
|
24 weeks
|
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Functional Assessment of Chronic Illness Therapy fatigue subscale (FACIT-F)
Tidsramme: 24 weeks
|
In all participants ,use FACIT-F to assess the Health Related Quality of Life(HRQoL) before and after treatment.
|
24 weeks
|
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Safety assessment
Tidsramme: 24 weeks
|
Number of Participants with side effects of the drugs
|
24 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Haixia Fu, MD, Peking University People's Hospital
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Kuter DJ. The biology of thrombopoietin and thrombopoietin receptor agonists. Int J Hematol. 2013 Jul;98(1):10-23. doi: 10.1007/s12185-013-1382-0. Epub 2013 Jul 3.
- Wormann B. Clinical indications for thrombopoietin and thrombopoietin-receptor agonists. Transfus Med Hemother. 2013 Oct;40(5):319-25. doi: 10.1159/000355006. Epub 2013 Sep 11.
- Neunert C, Terrell DR, Arnold DM, Buchanan G, Cines DB, Cooper N, Cuker A, Despotovic JM, George JN, Grace RF, Kuhne T, Kuter DJ, Lim W, McCrae KR, Pruitt B, Shimanek H, Vesely SK. American Society of Hematology 2019 guidelines for immune thrombocytopenia. Blood Adv. 2019 Dec 10;3(23):3829-3866. doi: 10.1182/bloodadvances.2019000966. Erratum In: Blood Adv. 2020 Jan 28;4(2):252.
- Liu XG, Bai XC, Chen FP, Cheng YF, Dai KS, Fang MY, Feng JM, Gong YP, Guo T, Guo XH, Han Y, Hong LJ, Hu Y, Hua BL, Huang RB, Li Y, Peng J, Shu MM, Sun J, Sun PY, Sun YQ, Wang CS, Wang SJ, Wang XM, Wu CM, Wu WM, Yan ZY, Yang FE, Yang LH, Yang RC, Yang TH, Ye X, Zhang GS, Zhang L, Zheng CC, Zhou H, Zhou M, Zhou RF, Zhou ZP, Zhu HL, Zhu TN, Hou M. Chinese guidelines for treatment of adult primary immune thrombocytopenia. Int J Hematol. 2018 Jun;107(6):615-623. doi: 10.1007/s12185-018-2445-z. Epub 2018 Apr 4.
- Provan D, Arnold DM, Bussel JB, Chong BH, Cooper N, Gernsheimer T, Ghanima W, Godeau B, Gonzalez-Lopez TJ, Grainger J, Hou M, Kruse C, McDonald V, Michel M, Newland AC, Pavord S, Rodeghiero F, Scully M, Tomiyama Y, Wong RS, Zaja F, Kuter DJ. Updated international consensus report on the investigation and management of primary immune thrombocytopenia. Blood Adv. 2019 Nov 26;3(22):3780-3817. doi: 10.1182/bloodadvances.2019000812.
- Bussel JB. Avatrombopag. Br J Haematol. 2018 Nov;183(3):342-343. doi: 10.1111/bjh.15568. Epub 2018 Oct 23. No abstract available.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
20. juni 2021
Primær færdiggørelse (Forventet)
31. december 2022
Studieafslutning (Forventet)
31. december 2023
Datoer for studieregistrering
Først indsendt
29. maj 2021
Først indsendt, der opfyldte QC-kriterier
29. maj 2021
Først opslået (Faktiske)
4. juni 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. juni 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. maj 2021
Sidst verificeret
1. maj 2021
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- ITP-SWITCH1
Plan for individuelle deltagerdata (IPD)
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