The Study of Different Dose Rituximab in the Treatment of ITP

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03258866
• Date of registration: 18/08/2017
• Prospective Registration: No
• Primary sponsor: Shandong University
• Public title: The Study of Different Dose Rituximab in the Treatment of ITP
• Scientific title: The Clinical Randomized Controlled Study of Different Dose Rituximab in the Treatment of Primary Immune Thrombocytopenia
• Date of first enrolment: January 1, 2010
• Target sample size: 62
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03258866
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

China

Contacts

• Name: Ming Hou, Dr
• Affiliation: Shandong University

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Meet the diagnostic criteria for immune thrombocytopenia.

2. Male or female, between the ages of 10 ~ 70 years.

3. Normal glucocorticoid therapy is ineffective or effective but the maintenance dose is
large, without immunosuppressive therapy or immunosuppressive treatment ineffective

4. To show a platelet count < 30×10^9/L, or with bleeding manifestations.

5. Eastern Cooperative Oncology Group(ECOG)performance status = 2

Exclusion Criteria:

1. Current HIV infection or hepatitis B virus or hepatitis C virus infections.

2. Severe medical condition (lung, hepatic or renal disorder) other than ITP. Unstable or
uncontrolled disease or condition related to or impacting cardiac function (e.g.,
unstable angina, congestive heart failure, uncontrolled hypertension or cardiac
arrhythmia)

3. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate
pregnancy during the study period.

4. Have a known diagnosis of other autoimmune diseases, established in the medical
history and laboratory findings with positive results for the determination of
antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct
Coombs test.

5. Patients who are deemed unsuitable for the study by the investigator.



Age minimum: 10 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Purpura, Thrombocytopenic, Idiopathic

Immune Thrombocytopenia

Intervention(s)

Drug: Rituximab

Primary Outcome(s)

Evaluation of platelet response(continuous response rate) [Time Frame: up to 1 year per subject]

Secondary Outcome(s)

therapy associated adverse events [Time Frame: up to 1 year per subject]

Secondary ID(s)

RTX 4v1 in ITP

Source(s) of Monetary Support

Please refer to primary and secondary sponsors