Immune ThrombocytopeniaPhase 2/3ITPNCT01763658
Oxidant Status and Effect of Antioxidant in Immune Thrombocytopenia
A Phase 2/3 study testing Antox tablets(Mepaco) and drug therapy for ITP in people with Immune Thrombocytopenia, run by Ain Shams University at 1 site in Egypt.
Trial summary
Oxidative stress occurs as a result of increased activity of free radical-producing enzymes, decreased activity of free radical-removing enzymes, and insufficient levels of antioxidants. The most sensitive molecules to oxidation are lipids. 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?
- Antox tablets(Mepaco) and drug therapy for ITP
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2013to Sep 2013
- Phase
- Phase 2/3
- 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
- 1. All patients less than 18 years with primary ITP; at initial presentation with platelet count less than 40 x 109/L attended Ain Shams Hematology clinic Children hospital from January 2013 and followed-up for 6 months.
- 2. For acute ITP, patients will be newly diagnosed (about one month within the diagnosis).
- 3. For chronic (12-24 months) and persistent (3-12 months) ITP patients.
Who cannot join
- Patients' platelet count more than 40 x 109/L.; or above 18 years
- Patients with secondary cause for thrombocytopenia.
- Patients with any there associated chronic illness affecting oxidant status
Trial locations and contacts
1 site in 1 country.
Egypt1 site
hematology clinic ,pediatrics hospital, Ain Shams University hospital Cairo, Egypt
Cairo
Mohsen Saleh Elalfy, professor
Mohsen Saleh Elalfy, professor
About this study
Official title: Evaluation of Oxidant Status in Patients With Immune Thrombocytopenia (ITP) and the Role of an Adjuvant Antioxidant Therapy
Oxidative stress occurs as a result of increased activity of free radical-producing enzymes, decreased activity of free radical-removing enzymes, and insufficient levels of antioxidants. The most sensitive molecules to oxidation are lipids. Loss of cell membrane elasticity, increased cell fragility, and a shortened cellular life span results from oxidation of cell membrane lipids.
Read the detailed description
Free oxygen radicals may have an effect on the structural and functional damage of platelets and plays a role in pathogenesis of thrombocytopenia in both, acute and chronic ITP.
Selenium is an essential mineral found in small amounts in the body. It works as an antioxidant, especially when combined with other antioxidants as vitamin E , A and C. Antioxidants neutralize free radicals and may reduce or even help prevent some of the damage they cause.
aim of this study is to assess oxidant and antioxidant systems initially in patients with acute and chronic immune thrombocytopenia (ITP) and 6 months later.Another aim of the study is to evaluate effect of antioxidant therapy on bleeding score, platelet count and antioxidant status during 6 months follow-up.
- Conditions
- Immune Thrombocytopenia
- Being tested
- Antox tablets(Mepaco), drug therapy for ITP
- Keywords
- ITP, antioxidant therapy, oxidant status
- 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.
Antox tablets(Mepaco)Drug
Also called antioxidant drug
effect of antioxidant on disease outcome
drug therapy for ITPOther
Also called dexamethasone, prednisolone, solumedrol, Anti-D
drugs will be selected according to ASH,2011 guidelines
| Study group | Role | What they receive |
|---|---|---|
| Antioxidant, drug therapy for ITP | Experimental | interventional arm 1 and will receive antioxidant therapy (Antox tablets ( 1 tablet contains : Vit. A 2000 IU, Vit C 90 mg, Vit E 15 mg and selenium yeast 55 ug ) with the therapy selected for ITP tailored according to patient's presentation.For Antox tablets it will be given daily for 6 months. Receives: Drug: Antox tablets(Mepaco); Other: drug therapy for ITP |
| drug therapy for ITP | Active comparator | drug therapy for ITP according to ASH, 2011 guidelines. Receives: Other: drug therapy for ITP |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxidant status in ITP
oxidant and antioxidant systems initially in patients with acute and chronic immune thrombocytopenia (ITP)
Measured: 6 month
Secondary outcomes (1)
antioxidant therapy
antioxidant therapy on bleeding score, platelet count and antioxidant status
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 posted9 Jan 2013 (estimated)
- Study startMar 2013
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohsen Saleh Elalfy, Ain Shams University
- Investigators
- Mohsen S Elalfy, professor, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01763658
- Sponsor's protocol ID
- Antioxident in ITP
- Acronym
- ITP
- Status last verified
- Jan 2013
- First submitted
- 6 Jan 2013
- Last updated
- 9 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oxidant Status in Patients With Immune Thrombocytopenia (ITP) and the Role of an Adjuvant Antioxidant Therapy
- ClinicalTrials.gov ID
- NCT01763658
- Acronym / sponsor ID
- ITP / Antioxident in ITP
- Conditions
- Immune Thrombocytopenia
- Keywords
- ITP, antioxidant therapy, oxidant status
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 9 Jan 2013 (estimated)
- 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.
Oxidative stress occurs as a result of increased activity of free radical-producing enzymes, decreased activity of free radical-removing enzymes, and insufficient levels of antioxidants. The most sensitive molecules to oxidation are lipids. Loss of cell membrane elasticity, increased cell fragility, and a shortened cellular life span results from oxidation of cell membrane lipids.
Detailed description
Free oxygen radicals may have an effect on the structural and functional damage of platelets and plays a role in pathogenesis of thrombocytopenia in both, acute and chronic ITP.
Selenium is an essential mineral found in small amounts in the body. It works as an antioxidant, especially when combined with other antioxidants as vitamin E , A and C. Antioxidants neutralize free radicals and may reduce or even help prevent some of the damage they cause.
aim of this study is to assess oxidant and antioxidant systems initially in patients with acute and chronic immune thrombocytopenia (ITP) and 6 months later.Another aim of the study is to evaluate effect of antioxidant therapy on bleeding score, platelet count and antioxidant status during 6 months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antioxidant, drug therapy for ITP | Experimental | Drug: Antox tablets(Mepaco), Other: drug therapy for ITPinterventional arm 1 and will receive antioxidant therapy (Antox tablets ( 1 tablet contains : Vit. A 2000 IU, Vit C 90 mg, Vit E 15 mg and selenium yeast 55 ug ) with the therapy selected for ITP tailored according to patient's presentation.For Antox tablets it will be given daily for 6 months. |
| drug therapy for ITP | Active comparator | Other: drug therapy for ITPdrug therapy for ITP according to ASH, 2011 guidelines. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 1. All patients less than 18 years with primary ITP; at initial presentation with platelet count less than 40 x 109/L attended Ain Shams Hematology clinic Children hospital from January 2013 and followed-up for 6 months.
- 2. For acute ITP, patients will be newly diagnosed (about one month within the diagnosis).
- 3. For chronic (12-24 months) and persistent (3-12 months) ITP patients.
Key exclusion criteria (3 listed)
- Patients' platelet count more than 40 x 109/L.; or above 18 years
- Patients with secondary cause for thrombocytopenia.
- Patients with any there associated chronic illness affecting oxidant status
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 |
|---|---|---|
| Antox tablets(Mepaco)Also: antioxidant drugeffect of antioxidant on disease outcome | Drug | Antioxidant, drug therapy for ITP |
| drug therapy for ITPAlso: dexamethasone, prednisolone, solumedrol, Anti-Ddrugs will be selected according to ASH,2011 guidelines | Other | Antioxidant, drug therapy for ITP, drug therapy for ITP |
Primary outcome
oxidant status in ITP
Time frame: 6 month
oxidant and antioxidant systems initially in patients with acute and chronic immune thrombocytopenia (ITP)
1 secondary outcome
antioxidant therapy
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2013.
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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.
Mohsen S Elalfy, professor principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Antox tablets(Mepaco) and drug therapy for ITP in people with Immune Thrombocytopenia, run by Ain Shams 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 3 inclusion and 3 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 9 Jan 2013. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 yasmine I Elhenawy, lecturer (0104084038, dr_yasmi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oxidant status in ITP (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2013.