Efficacy of Helicobacter Pylori Eradication, Anti-D and Danazol Combination in Steroid Dependant or Refractory Immune Thrombocytopenia (ITP)

Cooperative Study Group A for Hematology

Status and phase: Unknown; Phase 2

Conditions: Thrombocytopenia

Treatments: Other: Steroid refractory ITP

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01162941

C-019

Details and patient eligibility

About

Proportion who would avoid splenectomy at 6 months of follow up

Full description

1. If urea breath test (+); omeprazole 20mg bid, amoxicillin 1000mg bid and clarithromycin 500mg bid for 1 week.

   Second line Helicobacter pylori eradication will be permitted after failure of first line treatment.

2. Anti-D Anti-Ro 50 μg/kg IV for 2 days (D1, 2)

3. Danazol maintenance (from D1): Danazol will be continued at least 3 months. The dose of danazol can be reduced according to the adverse effects, especially in premenopausal women.

Enrollment: 38 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1.ITP is defined by

  • (a) a true thrombocytopenia on blood smear, (b) adequate megakaryopoiesis on bone marrow examination, (c) the absence of clinically apparent associated conditions or cause of thrombocytopenia

• 2.Steroid dependant ITP: more than 10 mg of prednisolone per day is required to maintain a platelet count above 20X109/L (minimum follow up duration: 3 months after diagnosis)

• 3.Steroid refractory ITP: a platelet count less than 20X109/L despite of treatment with full dose of steroid (prednisolone 1mg/kg for at least 4 weeks)

• 4.18 years old or more

Exclusion criteria

• 1.Patients who have a cause of thrombocytopenia such as HIV infection, lymphoproliferative disease, liver disease, definite SLE or drug
• 2.Pregnancy
• 3.Splectomized patients
• 4.Rh- blood type
• 5.Hemoglobin < 10g/dL
• 6.Known hypersensitivity to immunoglobulins
• 7.A positive direct antiglobulin test
• 8.Clinically relevant hepatic or renal disease

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

38 participants in 1 patient group

Steroid dependant ITP

Experimental group

Description:

more than 10 mg of prednisolone per day is required to maintain a platelet count above 20X109/L (minimum follow up duration: 3 months after diagnosis)

Treatment:

Other: Steroid refractory ITP