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The Study of Different Dose Rituximab in the Treatment of ITP

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ClinicalTrials.gov Identifier: NCT03258866
Recruitment Status : Completed
First Posted : August 23, 2017
Last Update Posted : August 23, 2017
Sponsor:
Information provided by (Responsible Party):
Ming Hou, Shandong University

Tracking Information
First Submitted Date  ICMJE August 18, 2017
First Posted Date  ICMJE August 23, 2017
Last Update Posted Date August 23, 2017
Actual Study Start Date  ICMJE January 1, 2010
Actual Primary Completion Date December 31, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2017)
Evaluation of platelet response(continuous response rate) [ Time Frame: up to 1 year per subject ]
Complete Response:a sustained (≥ 3 months) platelet count≥100×10^9/L;response: a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia;No response (NR): platelet count < 30 × 10^9/L or a less than two fold increase in platelet count from baseline or the presence of bleeding. Platelet count must be measured on two occasions more than a day apart.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2017)
therapy associated adverse events [ Time Frame: up to 1 year per subject ]
The number and frequency of therapy associated adverse events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Study of Different Dose Rituximab in the Treatment of ITP
Official Title  ICMJE The Clinical Randomized Controlled Study of Different Dose Rituximab in the Treatment of Primary Immune Thrombocytopenia
Brief Summary The project was undertaking by Qilu Hospital of Shandong University in China. In order to compare the efficacy, safety and response duration of different dose of rituximab in patients primary immune thrombocytopenia(pITP).
Detailed Description 62 patients with pITP who had failed to respond to glucocorticosteroids were randomly divided into 2 groups: group A(n = 32) and group B(n = 30). In group A, Rituximab was given with a fixed dose of 100 mg administered as an intravenous infusion weekly (on day 1, 8, 15 and 22). In group B, Rituximab was given with a single dose of 375mg/m2. The clinical effect, onset time, duration of efficacy and adverse reactions were observed to compare the efficacy and safety of two different plans.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Purpura, Thrombocytopenic, Idiopathic
  • Immune Thrombocytopenia
Intervention  ICMJE
  • Drug: Rituximab
    given with a fixed dose of 100 mg administered as an intravenous infusion weekly (on day 1, 8, 15 and 22)
    Other Name: Mabthera
  • Drug: Rituximab
    given with a single dose of 375mg/m2
    Other Name: Mabthera
Study Arms  ICMJE
  • Experimental: group A
    In group A, Rituximab was given with a fixed dose of 100 mg administered as an intravenous infusion weekly (on day 1, 8, 15 and 22).
    Intervention: Drug: Rituximab
  • Experimental: group B
    In group B, Rituximab was given with a single dose of 375mg/m2
    Intervention: Drug: Rituximab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 22, 2017)
62
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2016
Actual Primary Completion Date December 31, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03258866
Other Study ID Numbers  ICMJE RTX 4v1 in ITP
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ming Hou, Shandong University
Study Sponsor  ICMJE Shandong University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ming Hou, Dr Shandong University
PRS Account Shandong University
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP