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

NCT01162941 | Unknown Phase 2

• 1 other identifier: C-019
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Proportion who would avoid splenectomy at 6 months of follow up

Conditions

Thrombocytopenia

Keywords

ITP

Outcome Measures

Primary Outcomes (1)

• Proportion who would avoid splenectomy at 6 months of follow up

  Proportion who would avoid splenectomy at 6 months of follow up

  2years

Secondary Outcomes (1)

• SR,IR

  2years

Study Arms (1)

Steroid dependant ITP

EXPERIMENTAL

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

Interventions

Steroid refractory ITP OTHER

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

Also known as: prednisolone 1mg/kg

Steroid dependant ITP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)
• 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)
• years old or more

You may not qualify if:

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

Sponsors & Collaborators

• Cooperative Study Group A for Hematology: lead

Study Sites (1)

Asan Medical Center

Seoul, Asanbyeongwon-gil, Songpa-gu, 138-736, South Korea

RECRUITING

Related Links

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

MeSH Terms

Conditions

Thrombocytopenia

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Jung-Hee Lee, professor

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sung-Hwa Bae, professor

CONTACT

82-53-650-4388; sunghwa@cu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: July 14, 2010
• First Posted: July 15, 2010
• Study Start: February 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: January 1, 2012
• Last Updated: July 15, 2010

Record last verified: 2010-07

Locations

KR (1)