Eltrombopag Combining Rituximab Versus Eltrombopag in the Management of Primary Immune Thrombocytopenia (ITP) in Adults
A Multicenter, Randomized, Open-label Study To Compare The Efficacy And Safety Of Eltrombopag Combining Rituximab With Eltrombopag In Adult ITP Patients
Sponsor: Affiliated Hospital of Nantong University
A observational or N/A phase clinical study on Primary Immune Thrombocytopenia (ITP), this trial is actively recruiting participants. The trial is conducted by Affiliated Hospital of Nantong University and has accumulated 7 data snapshots since 2020. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)The primary objective of this study was to evaluate the efficacy and safety of eltrombopag combining rituximab treating previously treated ITP patients compared to eltrombopag. The secondary objective was to evaluate the efficacy of eltrombopag combining rituximab in ITP patients with positive autoantibody compared to eltrombopag .In addition, health-related quality of life (HRQoL) measure was assessed in all participants.
224 eligible subjects were randomized to either eltrombopag combining rituximab or eltrombopag treatment in 1:1 ratio. 112 enrolled patients are randomly picked up to take eltrombopag combining with rituximab at the indicated dose. 112 enrolled patients are randomly picked up to take eltrombopag at the indicated dose.
The initial dose of eltrombopag administration was an oral 75 mg once daily in all participants .The dose of eltrombopag was adjusted according to the subject platelet count during the period from week 1 to week 24.
Subjects in eltrombopag combining rituximab treatment group received single dose infusion of rituximab 375 mg/m(2) within 14 days after enrollment.
The primary objective of this study was to evaluate the efficacy and safety of eltrombopag combining rituximab treating previously treated ITP patients compared to eltrombopag. The secondary objective was to evaluate the efficacy of eltrombopag combining rituximab in ITP patients with positive autoantibody compared to eltrombopag .In addition, health-related quality of life (HRQoL) measure was assessed in all participants.
224 eligible subjects were randomized to either eltrombopag combining rituximab or eltrombopag treatment in 1:1 ratio. 112 enrolled patients are randomly picked up to take eltrombopag combining with rituximab at the indicated dose. 112 enrolled patients are randomly picked up to take eltrombopag at the indicated dose.
The initial dose of eltrombopag administration was an oral 75 mg once daily in all participants .The dose of eltrombopag was adjusted according to the subject platelet count during the period from week 1 to week 24.
Subjects in eltrombopag combining rituximab treatment group received single dose infusion of rituximab 375 mg/m(2) within 14 days after enrollment.
Status Flow
Change History
7 versions recorded-
May 4, 2026 — Present [daily]
Recruiting
Status: Unknown → Recruiting · Phase: PHASE4 → None
-
Sep 2024 — May 2026 [monthly]
Unknown PHASE4
-
Jul 2024 — Sep 2024 [monthly]
Unknown PHASE4
Status: Unknown Status → Unknown
-
Oct 2023 — Jul 2024 [monthly]
Unknown Status PHASE4
-
Nov 2022 — Oct 2023 [monthly]
Unknown Status PHASE4
Status: Recruiting → Unknown Status
▶ Show 2 earlier versions
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Jan 2021 — Nov 2022 [monthly]
Recruiting PHASE4
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Sep 2020 — Jan 2021 [monthly]
Recruiting PHASE4
First recorded
Aug 2020
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
This multicenter randomized, open-label study aimed to compare the efficacy and safety of eltrombopag combining rituximab with eltrombopag in China adult ITP patients .This study was be conducted in adult ITP patients who had not responded to or had relapsed after previous treatment of ITP, including first line therapy and /or splenectomy.
Contact Information
- Affiliated Hospital of Nantong University
- Henan Cancer Hospital
- Institute of Hematology & Blood Diseases Hospital, China
- The First Affiliated Hospital of Xiamen University
- The Second Affiliated Hospital of Kunming Medical University
- Tianjin Medical University Second Hospital
For direct contact, visit the study record on ClinicalTrials.gov .