An observational study in Corticosteroid-resistant or Relapsed ITP, sponsored by Peking University People's Hospital. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-06-04.
Sponsored by Peking University People's Hospital · Observational
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.
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.
Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.
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adult ITP patients
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:
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.
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.
Initial response after switching
Rate of response at 4 weeks after switching from rhTPO to avatrombopag or vise versa
Time frame: 4 weeks
Response rate at 12 weeks after switching
Rate of response at 12 weeks after switching from rhTPO to avatrombopag or vise versa
Time frame: 12 weeks
Initial response after switching according to the reasons of switching
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
Time frame: 4 weeks
Rate of response at 12 weeks after switching according to the reasons of switching
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
Time frame: 12 weeks
Time to response
Time to CR or R from switching
Time frame: 4 weeks
Durable response
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.
Time frame: 24 weeks
Incidence of bleeding events
Incidence of clinically significant bleeding as assessed using the world health organization (WHO) bleeding scale
Time frame: 24 weeks
Immune Thrombocytopenia Patient Assessment Questionnaire (ITP-PAQ)
In all participants ,use ITP-PAQ to assess the Health Related Quality of Life(HRQoL) before and after treatment.
Time frame: 24 weeks
Functional Assessment of Chronic Illness Therapy fatigue subscale (FACIT-F)
In all participants ,use FACIT-F to assess the Health Related Quality of Life(HRQoL) before and after treatment.
Time frame: 24 weeks
Safety assessment
Number of Participants with side effects of the drugs
Time frame: 24 weeks
No study locations are listed for this record.
Plan to share: No
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Peking University People's Hospital