Helicobacter Pylori Immune Thrombocytopenic Purpura

NCT01255332 | Unknown DMC

• 1 other identifier: C-023
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Immune Thrombocytopenic Purpura

Keywords

ITP

Outcome Measures

Primary Outcomes (1)

• Overall response

  Overall response rate at 3 months after treatment

  2 years

Secondary Outcomes (1)

• Eradication rate of H. pylori

  2 years

Study Arms (1)

C13-urea breath test: positive

lansoprazole 30mg bid, amoxicillin 1000mg bid and clarithromycin 500mg bid for 7 days

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

immune thrombocytopenic purpura

You may qualify if:

• \~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)
• X109/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

You may not qualify if:

• 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

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 Publications (1)

• Kim H, Lee WS, Lee KH, Bae SH, Kim MK, Joo YD, Zang DY, Jo JC, Lee SM, Lee JH, Lee JH, Kim DY, Ryoo HM, Hyun MS, Kim HJ; CoOperative Study Group A for Hematology (COSAH). Efficacy of Helicobacter pylori eradication for the 1st line treatment of immune thrombocytopenia patients with moderate thrombocytopenia. Ann Hematol. 2015 May;94(5):739-46. doi: 10.1007/s00277-014-2268-9. Epub 2014 Dec 13.

  PMID: 25501820 DERIVED

Related Links

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

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Jung-Hee Lee, professor

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

• Hyo Jung Kim, professor

  Department of Internal Medicine, Hallym University Sacred Heart Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyo Jung Kim, professor

CONTACT

82-31-380-3859; hemonc@hallym.or.kr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: November 24, 2010
• First Posted: December 7, 2010
• Study Start: September 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2012
• Last Updated: December 7, 2010

Record last verified: 2010-11

Locations

KR (1)