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

Primary Purpose

Immune Thrombocytopenic Purpura

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Rituximab
Sponsored by
Institute of Hematology & Blood Diseases Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immune Thrombocytopenic Purpura

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult chronic ITP, age 18 to 60

Exclusion Criteria:

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

Sites / Locations

  • Hospital of Blood disease

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rituximab A group

Rituximab B group

Arm Description

375mg/m2 for once

100mg/week for four weeks

Outcomes

Primary Outcome Measures

Compare the platelet count between two groups given different doses of Rituximab.

Secondary Outcome Measures

Full Information

First Posted
October 26, 2012
Last Updated
May 15, 2017
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Collaborators
National Natural Science Foundation of China
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1. Study Identification

Unique Protocol Identification Number
NCT01719692
Brief Title
Low-dose Rituximab Regimens in Chinese Adult Patients With Immune Thrombocytopenia
Acronym
ITP
Official Title
Prospective Multi-center Randomized Controlled Low-dose Rituximab Regimens in Chinese Adult Patients With Immune Thrombocytopenia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Collaborators
National Natural Science Foundation of China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenic Purpura

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rituximab A group
Arm Type
Experimental
Arm Description
375mg/m2 for once
Arm Title
Rituximab B group
Arm Type
Active Comparator
Arm Description
100mg/week for four weeks
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Trade names Rituxan and MabThera
Primary Outcome Measure Information:
Title
Compare the platelet count between two groups given different doses of Rituximab.
Time Frame
Patients will be followed for 6 months after Rituximab treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult chronic ITP, age 18 to 60 Exclusion Criteria: pregnant woman with ITP; liver disease and kidney disease; allergy to rituximab
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
RENCHI YANG, Dr
Organizational Affiliation
Hospital of Blood disease
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of Blood disease
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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