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Phase II Study of Orelabrutinib in Combination With Romiplostim N01 in Patients With Primary Immune Thrombocytopenia (ITP) Who Have Received At Least One Prior Line of Therapy

NCT07400250 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-02-10

No results posted yet for this study

Summary

To evaluate whether orelabrutinib combined with romiplostim N01 can improve the quality of remission, increase the probability of successful drug withdrawal, and prolong the time to treatment failure in patients with primary immune thrombocytopenia (ITP) who have received at least one line of prior therapy.

Conditions

  • Primary Immune Thrombocytopenia (ITP)

Interventions

DRUG

Orelabrutinib

Orelabrutinib will be given as 50mg per day orally, week 1-24

DRUG

Romiplostim N01

Core Treatment Phase Recommended starting dose: 3 μg/kg subcutaneously once weekly. Monitor platelet count (PLT) and symptoms weekly for dose adjustment, max 10 μg/kg/week. Therapeutic target: Maintain PLT within the range of 50-200×10⁹/L. 1. PLT \< 50×10⁹/L: Increase by 1-3 μg/kg/week to max dose. Discontinue study if PLT remains \< 50×10⁹/L after 28d of max dose. 2. 50-200×10⁹/L: Maintain the minimum effective dose to reduce bleeding risk. 3. 200-400×10⁹/L: Decrease by 1-3 μg/kg/week. Discontinue if PLT ≥200×10⁹/L at 250 μg/week; resume when PLT \<50×10⁹/L (extend interval if needed). 4. PLT \>400×10⁹/L: Suspend; resume at 1-3 μg/kg lower dose when PLT \<200×10⁹/L (weekly monitoring). Tapering Phase For maintenance dose \>3 μg/kg/week: Taper by 1-3 μg/kg/week to ≤3 μg/kg (250 μg/week), then extend intervals (weekly→every 10 days→every 2 weeks). 1. PLT \<30×10⁹/L: Maintain current dose. 2. Two consecutive PLT \<30×10⁹/L: Discontinue study.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Tienan Zhu, M.D. · Peking Union Medical College Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2026-10-01
Completion
2028-10-01

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07400250 on ClinicalTrials.gov