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

Thrombocytopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01162941
• Other study ID #: C-019
• Status: Recruiting
• Phase: Phase 2
• First received: July 14, 2010
• Last updated: July 14, 2010
• Start date: February 2010
• Est. completion date: January 2012

Study information

• Verified date: July 2010
• Source: Cooperative Study Group A for Hematology
• Contact: Sung-Hwa Bae, professor
• Phone: 82-53-650-4388
• Email: sunghwa[@]cu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Proportion who would avoid splenectomy at 6 months of follow up

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: January 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia
• Thrombocytosis

Intervention

Other:
• 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)

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul	Asanbyeongwon-gil, songpa-gu

Sponsors (1)

Lead Sponsor	Collaborator
Cooperative Study Group A for Hematology

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion who would avoid splenectomy at 6 months of follow up	Proportion who would avoid splenectomy at 6 months of follow up	2years	Yes
Secondary	SR,IR	Sustained response (platelet count that remained above 30X109/L or 2 folds of initial platelet count at 6 months of follow up) Initial response (an increase in the platelet count of at least 10X109/L or a platelet count of more than 30X109/L by day 7 after the initiation of treatment) Changes of platelet counts Safety of treatment Response rate of HP infected patients Decrement of steroid dose Predictors of response	2years	Yes

External Links

•   Efficacy of Helicobacter pylori eradication, anti-D and danazol combination in steroid dependant or refractory immune thrombocytopenia (ITP)