Immune Thrombocytopenia Clinical Trial
Official title:
Effects of Helicobacter Pylori Eradication Therapy in Children With Chronic Immune Thrombocytopenic Purpura
Thrombocytopenia refers to a reduction in platelet count to (<150 × 109/L). Immune thrombocytopenic purpura is an acquired autoimmune disorder defined by isolated thrombocytopenia and the exclusion of other causes of thrombocytopenia
Status | Recruiting |
Enrollment | 75 |
Est. completion date | August 30, 2020 |
Est. primary completion date | June 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 18 Years |
Eligibility |
Inclusion Criteria: 1. chronic immune thrombocytopenic purpura patients who still have thrombocytopenia > 12 months 2. age <18 years . 3. diagnosis of immune thrombocytopenic purpura according to American Society of Hematology criteria based on an initial platelet count <100×103/µL . 4. Patients diagnosed as steroid and immunoglobulin resistant chronic immune thrombocytopenic purpura . exclusion criteria: 1. Patients with acute immune thrombocytopenic purpura . . 2. age >18 years. 3. thrombocytopenia was related to autoimmune disorders, drugs, a family history consistent with inherited thrombocytopenia, human immunodeficiency virus infection, hepatitis. 4. previous history of Helicobacter pylori eradication; and history of medication with proton pump inhibitors, H2- receptor antagonists, or antibiotics in the previous 4 weeks. |
Country | Name | City | State |
---|---|---|---|
Egypt | Assiut Medical School | Assiut |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Egypt,
Chey WD, Leontiadis GI, Howden CW, Moss SF. ACG Clinical Guideline: Treatment of Helicobacter pylori Infection. Am J Gastroenterol. 2017 Feb;112(2):212-239. doi: 10.1038/ajg.2016.563. Epub 2017 Jan 10. Erratum in: Am J Gastroenterol. 2018 Jul;113(7):1102. — View Citation
Loffredo G, Marzano MG, Migliorati R, Miele E, Menna F, Poggi V, Staiano A. The relationship between immune thrombocytopenic purpura and Helicobacter pylori infection in children: where is the truth? Eur J Pediatr. 2007 Oct;166(10):1067-8. Epub 2006 Nov 29. — View Citation
Treepongkaruna S, Sirachainan N, Kanjanapongkul S, Winaichatsak A, Sirithorn S, Sumritsopak R, Chuansumrit A. Absence of platelet recovery following Helicobacter pylori eradication in childhood chronic idiopathic thrombocytopenic purpura: a multi-center randomized controlled trial. Pediatr Blood Cancer. 2009 Jul;53(1):72-7. doi: 10.1002/pbc.21991. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | effects of Helicobacter pylori infection eradication on platelet counts of chronic immune thrombocytopenic patients | platelet counts will be measured at the start of the study ,before the starting of the interventions, and after 6 months. platelet response will be classified as: 1-complete response: platelet count> 150 × 109/L , 2-partial response: platelet count : 50-150 × 109/L , no response: platelet count < 50 × 109/L. | 6 months |
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