CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 60 target
Drug / intervention
Obinutuzumab Injection [Gazyva]drug
Likely dose
Obinutuzumab Injection [Gazyva] 1000mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06094881
NCT06094881Phase 2RecruitingUpdate OverdueUpdated 16mo ago · Completion was 7mo ago
Enrollment Stalled
Update Overdue
CompareCT.gov

A Prospective, One-arm and Open Clinical Study to Assess Safety and Efficacy of Anti-Human CD20 Monoclonal Antibody Obinutuzumab in the Treatment of Pediatric Primary Immune Thrombocytopenia

Institute of Hematology & Blood Diseases Hospital, China·interventional·Posted Oct 23, 2023·Updated Feb 24, 2025

In Brief

A Phase 2 clinical trial evaluating Obinutuzumab Injection [Gazyva] for Immune Thrombocytopenia and Treatment. Currently recruiting, targeting 60 participants across 1 site.

Signals

Enrollment appears stalled

Detailed Summary

To evaluate the safety and efficacy of Obinutuzumab in the treatment of pediatric primary immune thrombocytopenia in patients who have not responded adequately or relapsed after first-line glucocorticoid treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsImmune Thrombocytopenia, Treatment
CountriesChina
Collaborators--

Timeline

Phase 2Recruiting
202420252026
First PostedOct 23, 2023
Enrollment StartDec 1, 2023
Primary CompletionNov 1, 2025
Study CompletionNov 1, 2026
TodayJul 1, 2026
Enrollment to primary: 1.9 yearsPosted 2.7 years ago

Interventions

Obinutuzumab Injection [Gazyva]drug

intravenous Obinutuzumab administration This study adopts a prospective, single arm, open design method. 60 subjects were enrolled in the study and were treated with CD20 monoclonal antibody (Obinutuzumab: 1000mg) for once. The first stage is the main research stage (d1-w12), which is the core treatment period. The subjects will receive intravenous infusion of 1000mg Obinutuzumab for once to observe the safety and efficacy during treatment. The second stage (w12-w48) is the stage of withdrawal from the visit, mainly to observe the safety and continuous efficacy of Obinutuzumab after treatment.