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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Natural Science Foundation of China
Information provided by (Responsible Party):
Renchi Yang, Institute of Hematology & Blood Diseases Hospital
ClinicalTrials.gov Identifier:
NCT01719692
First received: October 26, 2012
Last updated: October 30, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention
Immune Thrombocytopenic Purpura
 Drug: Rituximab

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Multi-center Randomized Controlled Low-dose Rituximab Regimens in Chinese Adult Patients With Immune Thrombocytopenia

Resource links provided by NLM:

MedlinePlus related topics: Blood Disorders
Drug Information available for: Rituximab
U.S. FDA Resources

Further study details as provided by Institute of Hematology & Blood Diseases Hospital:

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

Estimated Enrollment: 100
Study Start Date: August 2012
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: October 26, 2012
Last Updated: October 30, 2012
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 21, 2013