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Low-dose Rituximab Regimens in Chinese Adult Patients With Immune Thrombocytopenia (ITP)

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ClinicalTrials.gov Identifier: NCT01719692
Recruitment Status : Completed
First Posted : November 1, 2012
Last Update Posted : May 16, 2017
Sponsor:
Collaborator:
National Natural Science Foundation of China
Information provided by (Responsible Party):
Renchi Yang, Institute of Hematology & Blood Diseases Hospital

Brief Summary:
A comparative study with rituximab (100 mg weekly for 4 weeks and 375mg/m2 for once) shows low dose rituximab may be a useful alternative therapy in patients with ITP.The aim of this study is to compare the efficacy and tolerability of two different regimens of low doses rituximab for the treatment of adult patients with ITP.

Condition or disease Intervention/treatment Phase
Immune Thrombocytopenic Purpura Drug: Rituximab Not Applicable

Detailed Description:
Hundreds of Patients without infection (age 18 to 60 years old) developed Chronic ITP. All patients will be enrolled in this study and will be randomly assigned to receive 100 mg rituximab weekly for 4 weeks (group A) or a single dose of 375 mg/m2 rituximab (group B). After treatment all patients will be followed for two years. During observation platelet count and B lymphocyte will be detected every month.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Multi-center Randomized Controlled Low-dose Rituximab Regimens in Chinese Adult Patients With Immune Thrombocytopenia
Study Start Date : August 2012
Actual Primary Completion Date : October 2015
Actual Study Completion Date : February 2016


Arm Intervention/treatment
Experimental: Rituximab A group
375mg/m2 for once
Drug: Rituximab
Other Name: Trade names Rituxan and MabThera

Active Comparator: Rituximab B group
100mg/week for four weeks
Drug: Rituximab
Other Name: Trade names Rituxan and MabThera




Primary Outcome Measures :
  1. Compare the platelet count between two groups given different doses of Rituximab. [ Time Frame: Patients will be followed for 6 months after Rituximab treatment. ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult chronic ITP, age 18 to 60

Exclusion Criteria:

  • pregnant woman with ITP; liver disease and kidney disease; allergy to rituximab

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01719692


Locations
China, Tianjin
Hospital of Blood disease
Tianjin, Tianjin, China, 300020
Sponsors and Collaborators
Institute of Hematology & Blood Diseases Hospital
National Natural Science Foundation of China
Investigators
Principal Investigator: RENCHI YANG, Dr Hospital of Blood disease

Responsible Party: Renchi Yang, Thrombosis and Hemostasis Center, Institute of Hematology & Blood Diseases Hospital
ClinicalTrials.gov Identifier: NCT01719692     History of Changes
Other Study ID Numbers: low dose rituximab for ITP
First Posted: November 1, 2012    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Thrombocytopenia
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Blood Coagulation Disorders
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents