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WithdrawnNCT02137681Updated Apr 20, 2016

A Multicentre Investigation of 2 Cycles Rituximab Compared With Standard Regimen in Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP)

A Phase 3 interventional study of Rituximab in Immune Thrombocytopenia, sponsored by Shandong University. Withdrawn at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-04-20.

Sponsored by Shandong University · Phase 3, Interventional, and Treatment

Why this study was withdrawn
No eligible patient was enrolled.
Phase
Phase 3
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study summary

The project was undertaking by Qilu Hospital, Shandong University and other several well-known hospitals in China. In order to report the efficacy and safety of Rituximab in different frequencies for the treatment of adults with steroid-resistant/relapsed immune thrombocytopenia (ITP).

Read the detailed description

The investigators are undertaking a parallel group, multicentre, randomised controlled trial of 60 refractory ITP adult patients from medical centers in China. One part of the participants are randomly selected to receive rituximab (given intravenously at a dose of 375mg/m(2) weekly for 2 weeks, i.e. Day 1, 8; the others are selected to receive standard rituximab treatment (given intravenously at a dose of 375 mg/m(2) weekly for 4 cycles, i.e. Day 1, 8, 15, 22). Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. In order to report the efficacy and safety of the combination therapy compared to conventional rituximab therapy for the treatment of adults with steroid-resistant/relapsed immune thrombocytopenia (ITP).

02

Conditions studied

  • Immune Thrombocytopenia

Keywords

  • immune thrombocytopenia
  • rituximab
  • efficacy
  • safety
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In context

Thrombocytopenia

697 studies on the registry are indexed under Thrombocytopenia; 153 are open to participants now.

Browse Thrombocytopenia studies →

Lead sponsor

Shandong University is the lead sponsor of 284 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Meet the diagnostic criteria for immune thrombocytopenia.
  2. Untreated hospitalized patients, may be male or female, between the ages of 18 \~ 80 years.
  3. To show a platelet count \<30×10\^9/L, and with bleeding manifestations.
  4. Willing and able to sign written informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
  2. Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit.
  3. Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study.
  4. Current HIV infection or hepatitis B virus or hepatitis C virus infections.
  5. Severe medical condition (lung, hepatic or renal disorder) other than chronic 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)
  6. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
  7. 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.
  8. Patients who are deemed unsuitable for the study by the investigator.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    2 cycles

    2 cycles RTX

    Drug: Rituximab

  • Active comparator
    standard 4 cycles

    standard 4 cycles RTX

    Drug: Rituximab

Interventions

  • DrugRituximab

    Rituximab was given intravenously at a dose of 375mg/m(2) weekly for 2 consecutive weeks (Day 1, 8) in 2 cycles arm; or 4 consecutive weeks (Day 1, 8, 15, 22) in standard 4 cycles arm

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What researchers measure

Primary outcomes

  1. Early Response

    response rate (CR+R) at the 3rd month from the initial injection of RTX. CR is defined as platelet count ≥ 100×10\^9/L, and R is defined as platelet count of \>30 × 10\^9/L with a least a doubling of the baseline value.

    Time frame: 3 months

  2. Duration Response

    response rate (CR+R) at the 12st month from the initial injection of RTX. CR is defined as platelet count ≥ 100×10\^9/L, and R is defined as platelet count of \>30 × 10\^9/L with a least a doubling of the baseline value.

    Time frame: 12 months

Secondary outcomes

  1. Safety

    The type and frequency of therapy associated adverse events

    Time frame: 1 months

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Study locations

1 site
  • Qilu Hospital, Shandong University
    Jinan, Shandong 250012, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02137681
Lead sponsor
Shandong University
Responsible party
Ming Hou (Professor and Director, Shandong University) — Principal investigator
First posted
May 14, 2014
Start date
May 2014
Primary completion
Jan 2015 (estimated)
Completion
Jan 2016 (estimated)
Last update
Apr 20, 2016

Study contacts

Ming Hou, Dr.
principal investigator · Shandong University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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