Helicobacter Pylori Immune Thrombocytopenic Purpura

Immune Thrombocytopenic Purpura Clinical Trial

— HpyloriITP  

Official title:

Efficacy of Helicobacter Pylori Eradication for the 1st Line Treatment of Immune Thrombocytopenic Purpura (ITP) Patients With Moderate Thrombocytopenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01255332
• Other study ID #: C-023
• Status: Recruiting
• Phase: Phase 2
• First received: November 24, 2010
• Last updated: December 6, 2010
• Start date: September 2010
• Est. completion date: August 2012

Study information

• Verified date: November 2010
• Source: Cooperative Study Group A for Hematology
• Contact: Hyo Jung Kim, professor
• Phone: 82-31-380-3859
• Email: hemonc[@]hallym.or.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

We designed a study for evaluate the efficacy of Helicobacter pylori eradication for the 1st line treatment of immune thrombocytopenic purpura (ITP) patients with moderate thrombocytopenia.

If this eradication treatment is revealed effective on ITP patients with more than 30X109/L of platelet, it would be valuable treatment especially for young ITP patients with mild to moderate thrombocytopenia.

Description:

lansoprazole 30mg bid, amoxicillin 1000mg bid and clarithromycin 500mg bid for 7 days. (Jeil Pharm. CO. LTD. will provide lansoprazole.) C13-UBT, at 4 weeks after onset of treatment, to determine eradication

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: August 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• 20~55 years old

• Persistent or chronic ITP patients, defined by international working group ( persistent: between 3 to 12 months from diagnosis, chronic: lasting for more than 12 months)

• 30X109/L = platelet count = 70X109/L

• C13-urea breath test: positive

• no previous ITP treatment

• no previous H. pylori eradication treatment

• Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital

Exclusion Criteria:

• Patients who have any cause of thrombocytopenia such as HIV, HCV infection, lymphoproliferative disease, liver disease, definite SLE, drug, MDS, leukemia

• Uncontrolled hypothyroidism or hyperthyroidism

• Acute active bleeding or infection

• Who taking anti-coagulant or aspirin

• Patients with penicillin allergy

• Patients with side effects of macrolide.

• Patients who taking Mizolastine, Terfenadine, Cisapride, Pimozide, Astemizole, Ergot alkaloid and its derivatives (Ergotamine, Dihydroergotamine), Bepridil, or Atazanavir

• Patients who have known allergy or severe side effect on study drugs

• Pregnant or lactating women

• Clinically relevant hepatic or renal disease (Creatinine clearance = 30mL/min)

• patients who cannot understand informed consent or express his/her condition

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Immune Thrombocytopenic Purpura
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

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	Overall response	Overall response rate at 3 months after treatment	2 years	Yes
Secondary	Eradication rate of H. pylori	We designed a study for evaluate the efficacy of Helicobacter pylori eradication for the 1st line treatment of immune thrombocytopenic purpura (ITP) patients with moderate thrombocytopenia.; Duration of response; Side effect and safety of treatment	2 years	Yes

External Links

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