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Trial record 2 of 6 for:    "Thrombocytopenic Purpura, Autoimmune" | "Amoxicillin"

Effects of Helicobacter Pylori Eradication in Children With Chronic Immune Thrombocytopenic Purpura

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ClinicalTrials.gov Identifier: NCT03172676
Recruitment Status : Not yet recruiting
First Posted : June 1, 2017
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
Mary Makram Kamel, Assiut University

Tracking Information
First Submitted Date  ICMJE May 26, 2017
First Posted Date  ICMJE June 1, 2017
Last Update Posted Date February 1, 2018
Estimated Study Start Date  ICMJE December 1, 2018
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2017)
effects of Helicobacter pylori infection eradication on platelet counts of chronic immune thrombocytopenic patients [ Time Frame: 6 months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03172676 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Helicobacter Pylori Eradication in Children With Chronic Immune Thrombocytopenic Purpura
Official Title  ICMJE Effects of Helicobacter Pylori Eradication Therapy in Children With Chronic Immune Thrombocytopenic Purpura
Brief Summary 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
Detailed Description Helicobacter pylori was recently demonstrated as an etiological factor in immune thrombocytopenic purpura in some prospective studies, with reports of platelet numbers increasing in these patients after Helicobacter pylori eradication treatment.However, other studies have shown a negative result after eradication treatment of Helicobacter pylori infection in patients with chronic immune thrombocytopenic purpura, leading to controversy.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Immune Thrombocytopenia
Intervention  ICMJE
  • Drug: Amoxicillin 50 mg/kg/day in 2 divided doses for 14 days.
    chronic immune thrombocytopenic purpura patients who will be diagnosed positive for helicobacter pylori infection will receive Amoxicillin for 14 days.
  • Drug: Clarithromycin 15 mg/kg/day in 2 divided doses for 14 days.
    chronic immune thrombocytopenic purpura patients who will be diagnosed positive for helicobacter pylori infection will receive Clarithromycin for 14 days.
  • Drug: Proton pump inhibitor 1 mg/kg/day in 2 divided doses 1 month
    chronic immune thrombocytopenic purpura patients who will be diagnosed positive for helicobacter pylori infection will receive proton pump inhibitor for 1 month.
Study Arms  ICMJE
  • No Intervention: Helicobacter pylori negative patients
    chronic immune thrombocytopenic purpura patients who will be diagnosed negative for Helicobacter pylori infection using detection of Helicobacter pylori antigen in stool of these patients.
  • Active Comparator: Helicobacter pylori positive patients with intervention
    chronic immune thrombocytopenic purpura patients who will be diagnosed positive for Helicobacter pylori infection using detection of Helicobacter pylori antigen in stool of these patients will receive treatment of Helicobacter pylori: Amoxicillin for 14 days, Clarithromycin for 14 days and Proton pump inhibitor for one month).
    Interventions:
    • Drug: Amoxicillin 50 mg/kg/day in 2 divided doses for 14 days.
    • Drug: Clarithromycin 15 mg/kg/day in 2 divided doses for 14 days.
    • Drug: Proton pump inhibitor 1 mg/kg/day in 2 divided doses 1 month
  • No Intervention: Helicobacter pylori positive patients without intervention
    chronic immune thrombocytopenic purpura patients who will be diagnosed positive for Helicobacter pylori infection using detection of Helicobacter pylori antigen in stool of these patients will not receive treatment of Helicobacter pylori during the study,these patient group will receive treatment of Helicobacter pylori after the end of the study
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 30, 2017)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2019
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Fahim Mohamed, MD 00201002500073 fahim.osman@med.au.edu.eg
Contact: Mervat Amin, MD 00201142606221 mamuosif2002@gmail.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03172676
Other Study ID Numbers  ICMJE ITPHP
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Mary Makram Kamel, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assiut University
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP