A Study of Switching Avatrombopag and Rh-TPO in ITP

NCT04913597 | Unknown

• 1 other identifier: ITP-SWITCH1
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Corticosteroid-resistant or Relapsed ITP

Keywords

Immune Thrombocytopenia; Recombinant human thrombopoietin; avatrombopag; switching

Outcome Measures

Primary Outcomes (1)

• Initial response after switching

  Rate of response at 4 weeks after switching from rhTPO to avatrombopag or vise versa

  4 weeks

Secondary Outcomes (9)

• Response rate at 12 weeks after switching

  12 weeks

• Initial response after switching according to the reasons of switching

  4 weeks

• Rate of response at 12 weeks after switching according to the reasons of switching

  12 weeks

• Time to response

  4 weeks

• Durable response

  24 weeks

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

adult ITP patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University People's Hospital: lead

Related Publications (6)

• 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.

  PMID: 31794604 BACKGROUND

• 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.

  PMID: 29619624 BACKGROUND

• 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.

  PMID: 31770441 BACKGROUND

• 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.

  PMID: 24273485 BACKGROUND

• Bussel JB. Avatrombopag. Br J Haematol. 2018 Nov;183(3):342-343. doi: 10.1111/bjh.15568. Epub 2018 Oct 23. No abstract available.

  PMID: 30351482 BACKGROUND

• 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.

  PMID: 23821332 BACKGROUND

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Haixia Fu, MD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haixia Fu, MD

CONTACT

8610-88324577; fuhaixia_210@163.com

Yun He, MD

CONTACT

18910504949; heyun04@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: May 29, 2021
• First Posted: June 4, 2021
• Study Start: June 20, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: June 4, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share