Immune ThrombocytopeniaPhase 4NCT03172676
Effects of Helicobacter Pylori Eradication in Children With Chronic Immune Thrombocytopenic Purpura
A Phase 4 study testing Amoxicillin 50 mg/kg/day in 2 divided doses for 14 days., Clarithromycin 15 mg/kg/day in 2 divided doses for 14 days. and Proton pump inhibitor 1 mg/kg/day in 2 divided doses 1 month in people with Immune Thrombocytopenia, run by Assiut University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Immune Thrombocytopenia
- What is being tested?
- Amoxicillin 50 mg/kg/day in 2 divided doses for 14 days., Clarithromycin 15 mg/kg/day in 2 divided doses for 14 days. and Proton pump inhibitor 1 mg/kg/day in 2 divided doses 1 month
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 30 Aug 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- chronic immune thrombocytopenic purpura patients who still have thrombocytopenia > 12 months
- age <18 years .
- diagnosis of immune thrombocytopenic purpura according to American Society of Hematology criteria based on an initial platelet count <100×103/μL .
- Patients diagnosed as steroid and immunoglobulin resistant chronic immune thrombocytopenic purpura .
Who cannot join
- Patients with acute immune thrombocytopenic purpura . .
- age >18 years.
- thrombocytopenia was related to autoimmune disorders, drugs, a family history consistent with inherited thrombocytopenia, human immunodeficiency virus infection, hepatitis.
- previous history of Helicobacter pylori eradication; and history of medication with proton pump inhibitors, H2- receptor antagonists, or antibiotics in the previous 4 weeks.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut Medical School
Asyut, 71511
mary makram, MA, 020012018964133, marymakram142@yahoo.com
About this study
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
Read the 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.
- Conditions
- Immune Thrombocytopenia
- Being tested
- Amoxicillin 50 mg/kg/day in 2 divided doses for 14 days., Clarithromycin 15 mg/kg/day in 2 divided doses for 14 days., Proton pump inhibitor 1 mg/kg/day in 2 divided doses 1 month
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin 50 mg/kg/day in 2 divided doses for 14 days.Drug
chronic immune thrombocytopenic purpura patients who will be diagnosed positive for helicobacter pylori infection will receive Amoxicillin for 14 days.
Clarithromycin 15 mg/kg/day in 2 divided doses for 14 days.Drug
chronic immune thrombocytopenic purpura patients who will be diagnosed positive for helicobacter pylori infection will receive Clarithromycin for 14 days.
Proton pump inhibitor 1 mg/kg/day in 2 divided doses 1 monthDrug
chronic immune thrombocytopenic purpura patients who will be diagnosed positive for helicobacter pylori infection will receive proton pump inhibitor for 1 month.
| Study group | Role | What they receive |
|---|---|---|
| Helicobacter pylori negative patients | No intervention | 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. |
| Helicobacter pylori positive patients with intervention | Active comparator | 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). Receives: 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 |
| Helicobacter pylori positive patients without intervention | No 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start1 Jan 2020
- Primary completion1 Jun 2020 (estimated)
- Study completion30 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Immune ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Makram Kamel, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03172676
- Sponsor's protocol ID
- ITPHP
- Status last verified
- Dec 2019
- First submitted
- 26 May 2017
- Last updated
- 3 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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. doi: 10.1007/s00431-006-0344-4. Epub 2006 Nov 29. No abstract available.
PubMed 17136353Chey 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.
PubMed 28071659Treepongkaruna 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.
PubMed 19301380
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Helicobacter Pylori Eradication Therapy in Children With Chronic Immune Thrombocytopenic Purpura
- ClinicalTrials.gov ID
- NCT03172676
- Acronym / sponsor ID
- ITPHP
- Conditions
- Immune Thrombocytopenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 30 Aug 2020 (estimated)
- First posted
- 1 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Helicobacter pylori negative patients | No intervention | –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. |
| Helicobacter pylori positive patients with intervention | Active comparator | 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 monthchronic 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). |
| Helicobacter pylori positive patients without intervention | No 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 |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- chronic immune thrombocytopenic purpura patients who still have thrombocytopenia > 12 months
- age <18 years .
- diagnosis of immune thrombocytopenic purpura according to American Society of Hematology criteria based on an initial platelet count <100×103/μL .
- Patients diagnosed as steroid and immunoglobulin resistant chronic immune thrombocytopenic purpura .
Key exclusion criteria (4 listed)
- Patients with acute immune thrombocytopenic purpura . .
- age >18 years.
- thrombocytopenia was related to autoimmune disorders, drugs, a family history consistent with inherited thrombocytopenia, human immunodeficiency virus infection, hepatitis.
- previous history of Helicobacter pylori eradication; and history of medication with proton pump inhibitors, H2- receptor antagonists, or antibiotics in the previous 4 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Helicobacter pylori positive patients with intervention |
| 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 | Helicobacter pylori positive patients with intervention |
| Proton pump inhibitor 1 mg/kg/day in 2 divided doses 1 monthchronic immune thrombocytopenic purpura patients who will be diagnosed positive for helicobacter pylori infection will receive proton pump inhibitor for 1 month. | Drug | Helicobacter pylori positive patients with intervention |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
- Background: PubMed 17136353Loffredo 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. doi: 10.1007/s00431-006-0344-4. Epub 2006 Nov 29. No abstract available.
- Background: PubMed 28071659Chey 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.
- Background: PubMed 19301380Treepongkaruna 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amoxicillin 50 mg/kg/day in 2 divided doses for 14 days., Clarithromycin 15 mg/kg/day in 2 divided doses for 14 days. and Proton pump inhibitor 1 mg/kg/day in 2 divided doses 1 month in people with Immune Thrombocytopenia, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fahim Mohamed, MD (00201002500073, fahim.osman@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effects of Helicobacter pylori infection eradication on platelet counts of chronic immune thrombocytopenic patients (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03172676, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2020.