Immune Thrombocytopenia PurpuraPhase 4NCT05861297
Immune Thrombocytopenia Management in Adults
A Phase 4 study testing Dexamethasone, Prednisolone and Azathioprine and Rituximab in people with Immune Thrombocytopenia Purpura, run by Nahda University at 1 site in Egypt.
Trial summary
Immune thrombocytopenia treatment has evolved recently. However, none of treatments have only benefits without drawbacks. This study compares the clinical outcomes and adverse drug patterns of different treatment options. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Immune Thrombocytopenia Purpura
- What is being tested?
- Dexamethasone, Prednisolone and Azathioprine and Rituximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 467 participants
- Where
- 1 siteEgypt
- Study dates
- 5 May 2020to 2 Apr 2024
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion criteria were adult patients aged 18 years or older, diagnosed with primary ITP after excluding secondary causes and with an initial PLTs count of less than 30 ×109/L or with hemorrhage manifestations.
Who cannot join
- Patients with a confirmed secondary ITP diagnoses such as (chemicals induced, systemic lupus erythematosus, immune thyroid diseases, a lymphoproliferative disease, or chronic infection, such as Helicobacter pylori, human immunodeficiency virus (HIV) or hepatitis C virus (HCV); with cardiac, renal, or liver disease; who had received NSAIDs or anti-platelets within one month before the initiation of the enrollment were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
EL-Kasr elineiy
Cairo, 52611
Doaa Mohamed El Demerdash, 01003516382, dr_eldemerdash@kasralainy.edu.eg
Ahmed M. Khalaf, 01204419172, dr.ahmed201176@yahoo.com
About this study
Official title: The Outcomes and Safety of Immunomodulators and Thrombopoietin Receptor Agonists in Primary Immune Thrombocytopenia Egyptian Patients With Hemorrhage Comorbidity
Immune thrombocytopenia treatment has evolved recently. However, none of treatments have only benefits without drawbacks. This study compares the clinical outcomes and adverse drug patterns of different treatment options. Medications which will be assessed during the current study are High Dose-dexamethasone (HD-DXM) (control group), Prednisolone + Azathioprine, Rituximab, Eltrombopag, and Romiplostim.
Read the detailed description
A prospective controlled randomized study was conducted on primary Immune thrombocytopenia patients. The study's main objective is to evaluate the efficacy and adverse events profile of the different therapeutic approaches during Immune thrombocytopenia. Upon the confirmation of the Immune thrombocytopenia diagnosis, all patients immediately initiated the High Dose-dexamethasone as a frontline therapy for Immune thrombocytopenia with a dose of 40 mg/m2 daily for 4 days/week in the first month for one cycle. Then, the recruited patients who fulfilled the inclusion criteria are randomly assigned into one of five groups. Among these patients, the control group received IV pulse (HD-DXM) therapy with 40 mg/m2 daily for 4 successive days in a 28-day cycle to complete the six cycles. The Prednisolone + Azathioprine group received 20 mg of Prednisolone three times daily and 1 mg/kg of oral Azathioprine once daily for two weeks, then tapering the Prednisolone dose through the subsequent weeks (6 weeks). While continuing treatment with Azathioprine for a total of six months. The Rituximab group received 500 mg/m2 intravenously of Rituximab once weekly for one month. The Eltrombopag group received 50 mg of Eltrombopag four hours before or after meals as oral daily doses for 6 months. The Romiplostim group received 3μg/kg sub-cutaneous injection of Romiplostim once a week for 6 months. The first evaluation date of confirmed ITP diagnosis was well-defined as the first index date (baseline). After that, every patient visited the investigational site as the protocol prescribes once weekly to assess and adjust the doses of study medications. The outcome measures were judged at baseline, at the end of treatment (6 months), and after an additional 6-month free treatment period.
- Conditions
- Immune Thrombocytopenia Purpura
- Being tested
- Dexamethasone, Prednisolone and Azathioprine, Rituximab, Eltrombopag, Romiplostim
- Keywords
- Primary Immune Thrombocytopenia, Etrombopag, Dexamethasone, Romiplostim, Rituximab, Autoimmune Disorder
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Patients were initiated with High Dose-Dexamethasone with a dose of 40 mg/m2 daily for four days per week immediately after the diagnosis of ITP for 6 months
Prednisolone and AzathioprineDrug
the second group received 20 mg of Prednisolone three times daily and 1 mg/kg of oral Azathioprine once daily for two weeks, then tapering the Prednisolone dose through the subsequent weeks (6 weeks). While continuing treatment with Azathioprine for a total of six months.
RituximabDrug
The third group received 500 mg/m2 intravenously of Rituximab once weekly for one month
EltrombopagDrug
The fourth group received 50 mg of Eltrombopag four hours before or after meals as oral daily doses for 6 months
RomiplostimDrug
The fifth group received 3μg/kg subcutaneous injection of Romiplostim once a week for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | The first (control )group includes patients with confirmed diagnosed who received IV pulse (High Dose-Dexamethasone) therapy Receives: Drug: Dexamethasone |
| PSL - AZA group | Experimental | The second group includes patients with confirmed diagnosed who received Prednisolone -Azathioprine therapy Receives: Drug: Prednisolone and Azathioprine |
| The RTX group | Experimental | The third group includes patients with confirmed diagnosed who received Prednisolone -Azathioprine therapy Receives: Drug: Rituximab |
| The ELTRO group | Experimental | The fourth group includes patients with confirmed diagnosed who received E therapy Receives: Drug: Eltrombopag |
| The ROMP group | Experimental | The fifth group includes patients with confirmed diagnosed who received Romiplostim therapy Receives: Drug: Romiplostim |
What is being measured
The primary outcome is the main question the study is designed to answer.
total patients who achieved sustained and overall response
The primary outcomes were the total percentage of patients achieving a sustained response (SR) till the end of the study, complete response (CR), and partial response (PR). CR was characterized by the absence of bleeding and an increase in the platelet count to above 100×109/L after one month of the treatment. SR was defined as achieving CR or partial response (PR) until the end of the study with a 2-fold upsurge from starting point [20, 21]. PR was represented as PLTs count ≥ 30×109/L after one month following therapy, and no response (NR) was defined as platelets < 30×109/L or bleeding
Measured: 18 months
Secondary outcomes (1)
number of patients relapsed and adverse events
The secondary outcome measures were a number of patients relapsed and adverse events (AEs). Relapse was pointed out as PLTs count below 30×109/L or bleeding episodes owing to thrombocytopenia afterward achieving the CR
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start5 May 2020
- Primary completion18 Jan 2024 (estimated)
- Study completion2 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immune Thrombocytopenia PurpuraStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Factorial
- Model description
- comparsion between five groups
- Masking
- None (open label)
- Enrolment
- 467 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nahda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Mostafa Hamed, Nahda University
- Investigators
- Mohamed Hussein Meabed, professor, Study chair, faculty of medicine beni-suef university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861297
- Sponsor's protocol ID
- NahdaV
- Status last verified
- May 2023
- First submitted
- 27 Apr 2023
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hamed EM, Ibrahim ARN, Meabed MH, Khalaf AM, El Demerdash DM, Elgendy MO, Saeed H, Salem HF, Rabea H. Therapeutic Outcomes of High Dose-Dexamethasone versus Prednisolone + Azathioprine, Rituximab, Eltrombopag, and Romiplostim Strategies in Persistent, Chronic, Refractory, and Relapsed Immune Thrombocytopenia Patients. Pharmaceuticals (Basel). 2023 Aug 29;16(9):1215. doi: 10.3390/ph16091215.
PubMed 37765023
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Outcomes and Safety of Immunomodulators and Thrombopoietin Receptor Agonists in Primary Immune Thrombocytopenia Egyptian Patients With Hemorrhage Comorbidity
- ClinicalTrials.gov ID
- NCT05861297
- Acronym / sponsor ID
- NahdaV
- Conditions
- Immune Thrombocytopenia Purpura
- Keywords
- Primary Immune Thrombocytopenia, Etrombopag, Dexamethasone, Romiplostim, Rituximab, Autoimmune Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 467 participants (estimated)
- Lead sponsor
- Nahda UniversityUniversity, hospital or other
- Study start
- 5 May 2020 (actual)
- Primary completion
- 18 Jan 2024 (estimated)
- Study completion
- 2 Apr 2024 (estimated)
- First posted
- 16 May 2023 (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.
Immune thrombocytopenia treatment has evolved recently. However, none of treatments have only benefits without drawbacks. This study compares the clinical outcomes and adverse drug patterns of different treatment options. Medications which will be assessed during the current study are High Dose-dexamethasone (HD-DXM) (control group), Prednisolone + Azathioprine, Rituximab, Eltrombopag, and Romiplostim.
Detailed description
A prospective controlled randomized study was conducted on primary Immune thrombocytopenia patients. The study's main objective is to evaluate the efficacy and adverse events profile of the different therapeutic approaches during Immune thrombocytopenia. Upon the confirmation of the Immune thrombocytopenia diagnosis, all patients immediately initiated the High Dose-dexamethasone as a frontline therapy for Immune thrombocytopenia with a dose of 40 mg/m2 daily for 4 days/week in the first month for one cycle. Then, the recruited patients who fulfilled the inclusion criteria are randomly assigned into one of five groups. Among these patients, the control group received IV pulse (HD-DXM) therapy with 40 mg/m2 daily for 4 successive days in a 28-day cycle to complete the six cycles. The Prednisolone + Azathioprine group received 20 mg of Prednisolone three times daily and 1 mg/kg of oral Azathioprine once daily for two weeks, then tapering the Prednisolone dose through the subsequent weeks (6 weeks). While continuing treatment with Azathioprine for a total of six months. The Rituximab group received 500 mg/m2 intravenously of Rituximab once weekly for one month. The Eltrombopag group received 50 mg of Eltrombopag four hours before or after meals as oral daily doses for 6 months. The Romiplostim group received 3μg/kg sub-cutaneous injection of Romiplostim once a week for 6 months. The first evaluation date of confirmed ITP diagnosis was well-defined as the first index date (baseline). After that, every patient visited the investigational site as the protocol prescribes once weekly to assess and adjust the doses of study medications. The outcome measures were judged at baseline, at the end of treatment (6 months), and after an additional 6-month free treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- comparsion between five groups
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: DexamethasoneThe first (control )group includes patients with confirmed diagnosed who received IV pulse (High Dose-Dexamethasone) therapy |
| PSL - AZA group | Experimental | Drug: Prednisolone and AzathioprineThe second group includes patients with confirmed diagnosed who received Prednisolone -Azathioprine therapy |
| The RTX group | Experimental | Drug: RituximabThe third group includes patients with confirmed diagnosed who received Prednisolone -Azathioprine therapy |
| The ELTRO group | Experimental | Drug: EltrombopagThe fourth group includes patients with confirmed diagnosed who received E therapy |
| The ROMP group | Experimental | Drug: RomiplostimThe fifth group includes patients with confirmed diagnosed who received Romiplostim therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria were adult patients aged 18 years or older, diagnosed with primary ITP after excluding secondary causes and with an initial PLTs count of less than 30 ×109/L or with hemorrhage manifestations.
Key exclusion criteria (1 listed)
- Patients with a confirmed secondary ITP diagnoses such as (chemicals induced, systemic lupus erythematosus, immune thyroid diseases, a lymphoproliferative disease, or chronic infection, such as Helicobacter pylori, human immunodeficiency virus (HIV) or hepatitis C virus (HCV); with cardiac, renal, or liver disease; who had received NSAIDs or anti-platelets within one month before the initiation of the enrollment were excluded from the study.
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 |
|---|---|---|
| DexamethasonePatients were initiated with High Dose-Dexamethasone with a dose of 40 mg/m2 daily for four days per week immediately after the diagnosis of ITP for 6 months | Drug | Control group |
| Prednisolone and Azathioprinethe second group received 20 mg of Prednisolone three times daily and 1 mg/kg of oral Azathioprine once daily for two weeks, then tapering the Prednisolone dose through the subsequent weeks (6 weeks). While continuing treatment with Azathioprine for a total of six months. | Drug | PSL - AZA group |
| RituximabThe third group received 500 mg/m2 intravenously of Rituximab once weekly for one month | Drug | The RTX group |
| EltrombopagThe fourth group received 50 mg of Eltrombopag four hours before or after meals as oral daily doses for 6 months | Drug | The ELTRO group |
| RomiplostimThe fifth group received 3μg/kg subcutaneous injection of Romiplostim once a week for 6 months | Drug | The ROMP group |
Primary outcome
total patients who achieved sustained and overall response
Time frame: 18 months
The primary outcomes were the total percentage of patients achieving a sustained response (SR) till the end of the study, complete response (CR), and partial response (PR). CR was characterized by the absence of bleeding and an increase in the platelet count to above 100×109/L after one month of the treatment. SR was defined as achieving CR or partial response (PR) until the end of the study with a 2-fold upsurge from starting point [20, 21]. PR was represented as PLTs count ≥ 30×109/L after one month following therapy, and no response (NR) was defined as platelets < 30×109/L or bleeding
1 secondary outcome
number of patients relapsed and adverse events
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Derived from this study: PubMed 37765023Hamed EM, Ibrahim ARN, Meabed MH, Khalaf AM, El Demerdash DM, Elgendy MO, Saeed H, Salem HF, Rabea H. Therapeutic Outcomes of High Dose-Dexamethasone versus Prednisolone + Azathioprine, Rituximab, Eltrombopag, and Romiplostim Strategies in Persistent, Chronic, Refractory, and Relapsed Immune Thrombocytopenia Patients. Pharmaceuticals (Basel). 2023 Aug 29;16(9):1215. doi: 10.3390/ph16091215.
- Individual participant dataSharing planned: No
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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.
Mohamed Hussein Meabed, professor study chair
faculty of medicine beni-suef university
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 Dexamethasone, Prednisolone and Azathioprine and Rituximab in people with Immune Thrombocytopenia Purpura, run by Nahda 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 1 inclusion and 1 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 16 May 2023. 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 Eman Mostafa Hamed, master (01019834193, eman.hamed@nub.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total patients who achieved sustained and overall response (time frame: 18 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 NCT05861297, which also lists 1 linked publication.
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 16 May 2023.