ITP - Immune ThrombocytopeniaNCT07093606
Eltrombopag Induced Liver Dysfunction During Treatment of Immunethrombocytopenic Purpura
A study testing Eltrombopag in people with ITP - Immune Thrombocytopenia, run by Sohag University at 1 site in Egypt.
Trial summary
this study amis to assess the incidence and severity of liver dysfunction in ITP patients receiving eltrombopag. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ITP - Immune Thrombocytopenia
- What is being tested?
- Eltrombopag
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Jul 2025to 20 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Pre-existing liver disease (e.g., hepatitis, cirrhosis, NAFLD). Concurrent use of hepatotoxic drugs. Patients lost to follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Usama M Abdelaal, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university hospital
Sohag
Magdy M Amin, Professor
About this study
this study amis to assess the incidence and severity of liver dysfunction in ITP patients receiving eltrombopag.
- Conditions
- ITP - Immune Thrombocytopenia
- Being tested
- Eltrombopag
- 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.
EltrombopagDrug
ITP patients will receive Eltrombopag and evulate occurance of liver disordres .
| Study group | Role | What they receive |
|---|---|---|
| this group will receive Eltrombopag tabelts | Experimental | ITP patients in this group receive Eltrombopag then follow up by liver functions test to evulate occurance of liver disorders . Receives: Drug: Eltrombopag |
What is being measured
The primary outcome is the main question the study is designed to answer.
•To assess the incidence and severity of liver dysfunction in ITP patients receiving eltrombopag.
the incidence and severity of liver dysfunction in ITP patients
Measured: 3-6 months after receiving eltombopag
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start14 Jul 2025
- Primary completion20 Jan 2026 (estimated)
- Study completion20 Jan 2026 (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 ITP - Immune ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Sohag 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Adel Alfy, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093606
- Sponsor's protocol ID
- Soh-Med--25-7-4MS
- Status last verified
- Jul 2025
- First submitted
- 23 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bidika E, Fayyaz H, Salib M, Memon AN, Gowda AS, Rallabhandi B, Cancarevic I. Romiplostim and Eltrombopag in Immune Thrombocytopenia as a Second-Line Treatment. Cureus. 2020 Aug 21;12(8):e9920. doi: 10.7759/cureus.9920.
PubMed 32968581Kuter DJ. New thrombopoietic growth factors. Blood. 2007 Jun 1;109(11):4607-16. doi: 10.1182/blood-2006-10-019315. Epub 2007 Feb 8.
PubMed 17289815Ptushkin VV, Vinogradova OY, Pankrashkina MM, Chernikov MV, Arshanskaya EG, Tkachenko NE. Thrombopoietin Receptor Agonists in the Treatment of Chronic Resistant Primary Immune Thrombocytopenia: Efficacy and Safety Data in Real Clinical Practice. Ter Arkh. 2018 Aug 17;90(7):70-76. doi: 10.26442/terarkh201890770-76.
PubMed 30701925
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eltrombopag Induced Liver Dysfunction During Treatment of Immunethrombocytopenic Purpura
- ClinicalTrials.gov ID
- NCT07093606
- Acronym / sponsor ID
- Soh-Med--25-7-4MS
- Conditions
- ITP - Immune Thrombocytopenia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- 20 Jan 2026 (estimated)
- Study completion
- 20 Jan 2026 (estimated)
- First posted
- 30 Jul 2025 (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.
this study amis to assess the incidence and severity of liver dysfunction in ITP patients receiving eltrombopag.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| this group will receive Eltrombopag tabelts | Experimental | Drug: EltrombopagITP patients in this group receive Eltrombopag then follow up by liver functions test to evulate occurance of liver disorders . |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Pre-existing liver disease (e.g., hepatitis, cirrhosis, NAFLD). Concurrent use of hepatotoxic drugs. Patients lost to follow-up.
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 |
|---|---|---|
| EltrombopagITP patients will receive Eltrombopag and evulate occurance of liver disordres . | Drug | this group will receive Eltrombopag tabelts |
Primary outcome
•To assess the incidence and severity of liver dysfunction in ITP patients receiving eltrombopag.
Time frame: 3-6 months after receiving eltombopag
the incidence and severity of liver dysfunction in ITP patients
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Background: PubMed 32968581Bidika E, Fayyaz H, Salib M, Memon AN, Gowda AS, Rallabhandi B, Cancarevic I. Romiplostim and Eltrombopag in Immune Thrombocytopenia as a Second-Line Treatment. Cureus. 2020 Aug 21;12(8):e9920. doi: 10.7759/cureus.9920.
- Background: PubMed 17289815Kuter DJ. New thrombopoietic growth factors. Blood. 2007 Jun 1;109(11):4607-16. doi: 10.1182/blood-2006-10-019315. Epub 2007 Feb 8.
- Background: PubMed 30701925Ptushkin VV, Vinogradova OY, Pankrashkina MM, Chernikov MV, Arshanskaya EG, Tkachenko NE. Thrombopoietin Receptor Agonists in the Treatment of Chronic Resistant Primary Immune Thrombocytopenia: Efficacy and Safety Data in Real Clinical Practice. Ter Arkh. 2018 Aug 17;90(7):70-76. doi: 10.26442/terarkh201890770-76.
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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.
Usama M Abdelaal, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eltrombopag in people with ITP - Immune Thrombocytopenia, run by Sohag 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 0 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: looking for participants now, as of the sponsor's last update on 30 Jul 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter A Alfy, Resident (01274069691, peter.adel.dola@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
•To assess the incidence and severity of liver dysfunction in ITP patients receiving eltrombopag. (time frame: 3-6 months after receiving eltombopag). 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 NCT07093606, 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 30 Jul 2025.