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

Sponsor:	Cooperative Study Group A for Hematology
Information provided by:	Cooperative Study Group A for Hematology
ClinicalTrials.gov Identifier:	NCT01162941

Purpose

Proportion who would avoid splenectomy at 6 months of follow up

Condition	Intervention	Phase
Thrombocytopenia	Other: Steroid refractory ITP	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Efficacy of Helicobacter Pylori Eradication, Anti-D and Danazol Combination in Steroid Dependant or Refractory Immune Thrombocytopenia (ITP)

Resource links provided by NLM:

Genetics Home Reference related topics: MYH9-related disorder

Drug Information available for: Prednisolone Prednisolone acetate Methylprednisolone acetate Methylprednisolone Prednisolone Sodium Phosphate Prednisolone phosphate Methylprednisolone Sodium Succinate Danazol

U.S. FDA Resources

Further study details as provided by Cooperative Study Group A for Hematology:

Primary Outcome Measures:

Proportion who would avoid splenectomy at 6 months of follow up [ Time Frame: 2years ] [ Designated as safety issue: Yes ]
Proportion who would avoid splenectomy at 6 months of follow up

Secondary Outcome Measures:

SR,IR [ Time Frame: 2years ] [ Designated as safety issue: Yes ]
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

Estimated Enrollment:	38
Study Start Date:	February 2010
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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)	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) Other Name: prednisolone 1mg/kg

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01162941

Contacts

Contact: Sung-Hwa Bae, professor

82-53-650-4388

sunghwa@cu.ac.kr

Locations

Korea, Republic of
Asan Medical Center	Recruiting
Seoul, Asanbyeongwon-gil, songpa-gu, Korea, Republic of, 138-736
Contact: Yae-Eun Jang, nurse 82-2-3010-6378 redpin75@paran.com

Sponsors and Collaborators

Cooperative Study Group A for Hematology

Investigators

Principal Investigator:

Jung-Hee Lee, professor

Asan Medical Center

More Information

Additional Information:

Efficacy of Helicobacter pylori eradication, anti-D and danazol combination in steroid dependant or refractory immune thrombocytopenia (ITP) This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	COSAH, Cooperative Study Group A for Hematology
ClinicalTrials.gov Identifier:	NCT01162941 History of Changes
Other Study ID Numbers:	C-019
Study First Received:	July 14, 2010
Last Updated:	July 14, 2010
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Cooperative Study Group A for Hematology:

ITP

Additional relevant MeSH terms:

Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids

Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on May 24, 2012