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

NCT ID: NCT01162941

Last Updated: 2010-07-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2012-01-31

Brief Summary

Proportion who would avoid splenectomy at 6 months of follow up

Detailed 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.

Conditions

Thrombocytopenia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Steroid refractory ITP

Intervention Type: OTHER

a platelet count less than 20X109/L despite of treatment with full dose of steroid (prednisolone 1mg/kg for at least 4 weeks)

Interventions

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)

Intervention Type: OTHER

Other Intervention Names

prednisolone 1mg/kg

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cooperative Study Group A for Hematology

NETWORK

Sponsor Role: lead

Responsible Party

Cooperative Study Group A for Hematology

Principal Investigators

Jung-Hee Lee, professor

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan Medical Center

Seoul, Asanbyeongwon-gil, Songpa-gu, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Sung-Hwa Bae, professor

Role: CONTACT

sunghwa@cu.ac.kr

82-53-650-4388

Facility Contacts

Yae-Eun Jang, nurse

Role: primary

redpin75@paran.com

82-2-3010-6378

Related Links

http://www.google.co.kr

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

Other Identifiers

C-019

Identifier Type: -

Identifier Source: org_study_id