A multi centre, open label study to evaluate efficacy and safety of 1000 mg of rituximab on day 1 and 15 in patients with idiopathic thrombocytopenic purpura

A multi centre, single arm, open label study to evaluate the efficacy and safety of 1000 mg fixed dose of rituximab on day one and fifteen among patients with chronic or relapsing idiopathic thrombocytopenic purpura

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000297426

Acronym

R-ITP 1000

Enrollment

108

Registered

2007-06-04

Start date

2007-05-16

Completion date

Unknown

Last updated

2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Review efficacy of giving rituximab on day 1 and 15 to see if platelet levels recover and how long a response last. Patients will attend regular visits for the collection of blood samples

Interventions

Only one treatment, rituximab fixed dose of 1000 mg on day 1 and 15 given intravenously (IV).

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Documented diagnosis of Idiopathic Thrombocytopaenic Purpura (ITP) according to the American Society of Haematology (ASH) guidelines: 1. Chronic ITP requiring ongoing corticosteroid and/or immunosuppressive therapy (e.g. dexamethasone, prednisolone, danazol, azathioprine and/or cyclophosphamide) for more than 3 months to maintain platelet count >30x10^9/L. Patients must have a documented platelet count of >30x10^9/L and = 50x10^9/L within 7 days prior to first infusion. OR 2. ITP in relapse (> or = 1) (defined as a platelet count = 30x10^9/L), with first relapse occurring within 12 months of initial diagnosis and second relapse at any time thereafter. Patients must have a documented platelet count = 30x10^9/L and >10x10^9/L within 7 days prior to first infusion.

Exclusion criteria

1. ITP diagnosed less than 6 weeks prior to consent. 2. Prior treatment with rituximab. 3. Multisystem autoimmune disease. 4. Lymphoproliferative disorders. 5. Drug-induced thrombocytopenia. 6. Pregnant or breast-feeding. 7. Human Immunodeficiency Virus (HIV) serology positive. 8. Hepatitis B or Hepatitis C serology positive (unless due to vaccination).

Outcome results