Anti Phospholipid SyndromeNCT07743242
Autoimmune Hemolytic Anemia and Its Clinical Implication on Antiphospholipid Syndrome
A study testing Hemoglobin and Coombs test in people with Anti Phospholipid Syndrome, run by New Valley University at 1 site in Egypt.
Trial summary
AIHA is a heterogeneous autoimmune cytopenia with variable severity and significant morbidity. APS is defined by thrombosis and/or obstetric morbidity with persistent antiphospholipid antibodies (aPL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anti Phospholipid Syndrome
- What is being tested?
- Hemoglobin and Coombs test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jun 2026to 15 Apr 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥18 years
- Patients with anemia consistant with hemolysis.
- Patient diagnosed with antiphospholipid syndrome.
- Informed consent obtained
Who cannot join
- Age less than 18 years.
- Other causes of anemia than autoimmune hemolysis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
New Valley University
Al Khārjah, Kharga Oasis, 72511
Asmaa N Hussein, MD, 01065161752, asmaanady_1010@med.nvu.edu.eg
About this study
AIHA is a heterogeneous autoimmune cytopenia with variable severity and significant morbidity. APS is defined by thrombosis and/or obstetric morbidity with persistent antiphospholipid antibodies (aPL).
Read the detailed description
AIHA occurs in ~10-12% of APS cohorts and is associated with arterial thrombosis, cardiac valve disease, livedo reticularis, epilepsy/chorea, and a more severe APS phenotype.
APS patients hospitalized with AIHA have markedly higher venous thromboembolism (VTE) risk (OR ≈ 8.6) compared with AIHA without APS.
Hematologic APS (AIHA ± thrombocytopenia) may precede or coexist with thrombotic/obstetric APS, depending on aPL profile.
There is a need to systematically define the clinical implications (thrombosis, organ involvement, outcomes) of AIHA in APS.
- Conditions
- Anti Phospholipid Syndrome
- Being tested
- Hemoglobin, Coombs test
- Keywords
- AIHA
- Medical subject headings
- Antiphospholipid Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemoglobinDiagnostic test
Blood sample
Coombs testDiagnostic test
Blood sample
| Study group | Role | What they receive |
|---|---|---|
| Antiphospholipid syndrome patients with AIHA | Active comparator | AIHA defined by:
* Anemia plus hemolysis (↑LDH, ↑indirect bilirubin, ↓haptoglobin, reticulocytosis) and
* Positive direct anti-globulin (Coombs) test , Drug induced hemolysis or other hereditary/acquired non immune hemolytic anemias. Receives: Diagnostic Test: Hemoglobin; Diagnostic Test: Coombs test |
| Antiphospholipid syndrome patients without AIHA | Active comparator | Patients without hemolysis evidence Receives: Diagnostic Test: Hemoglobin; Diagnostic Test: Coombs test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of thrombotic events in APS patients with AIHA
Measured: baseline
Secondary outcomes (1)
Number of thrombotic events in APS patients aithout AIHA
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start5 Jun 2026
- Primary completion30 Nov 2027 (estimated)
- Study completion15 Apr 2028 (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 Anti Phospholipid SyndromeStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- APS patients will be divided into 2 arms based on the presence of AIHA AIHA defined by: * Anemia plus hemolysis (↑LDH, ↑indirect bilirubin, ↓haptoglobin, reticulocytosis) and * Positive direct anti-globulin (Coombs) test , Drug induced hemolysis or other hereditary/acquired non immune hemolytic anemias. * Active hematologic malignancy causing hemolysis. * Composite incidence of VTE and arterial thrombosis in APS+AIHA vs APS without AIHA. * Frequency of triple aPL positivity in APS+AIHA vs APS-AIHA. * Prevalence of extra criteria manifestations. In hospital mortality, length of stay, and costs in AIHA hospitalizations with vs without APS.
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Nady Hussein, New Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07743242
- Sponsor's protocol ID
- AIHA-APS
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mulder FVM, Evers D, de Haas M, Cruijsen MJ, Bernelot Moens SJ, Barcellini W, Fattizzo B, Vos JMI. Severe autoimmune hemolytic anemia; epidemiology, clinical management, outcomes and knowledge gaps. Front Immunol. 2023 Sep 18;14:1228142. doi: 10.3389/fimmu.2023.1228142. eCollection 2023.
PubMed 37795092Zufferey R, Dull T, Mandel RJ, Bukovsky A, Quiroz D, Naldini L, Trono D. Self-inactivating lentivirus vector for safe and efficient in vivo gene delivery. J Virol. 1998 Dec;72(12):9873-80. doi: 10.1128/JVI.72.12.9873-9880.1998.
PubMed 9811723Erton ZB, Leaf RK, de Andrade D, Clarke A, Tektonidou MG, Pengo V, Sciascia S, Pardos-Gea J, Kello N, Paredes-Ruiz D, Lopez-Pedrera C, Belmont HM, Fortin PR, Ramires de Jesus G, Atsumi T, Zhang Z, Efthymiou M, Branch DW, Pazzola G, Andreoli L, Duarte-Garcia A, Rodriguez-Almaraz E, Petri M, Cervera R, Artim-Esen B, Quintana R, Shi H, Zuo Y, Willis R, Barber MRW, Skeith L, Radin M, Meroni P, Bertolaccini ML, Cohen H, Roubey R, Erkan D. Thrombocytopenia and autoimmune hemolytic anemia in antiphospholipid antibody-positive patients: Descriptive analysis of the AntiPhospholipid syndrome alliance for clinical trials and InternatiOnal networking (APS ACTION) clinical database and repository ("Registry"). Lupus. 2025 May;34(6):617-625. doi: 10.1177/09612033251332258. Epub 2025 Apr 3.
PubMed 40180601
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autoimmune Hemolytic Anemia and Its Clinical Implication on Antiphospholipid Syndrome
- ClinicalTrials.gov ID
- NCT07743242
- Acronym / sponsor ID
- AIHA-APS
- Conditions
- Anti Phospholipid Syndrome
- Keywords
- AIHA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- New Valley UniversityUniversity, hospital or other
- Study start
- 5 Jun 2026 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 15 Apr 2028 (estimated)
- First posted
- 3 Aug 2026 (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.
AIHA is a heterogeneous autoimmune cytopenia with variable severity and significant morbidity. APS is defined by thrombosis and/or obstetric morbidity with persistent antiphospholipid antibodies (aPL).
Detailed description
AIHA occurs in ~10-12% of APS cohorts and is associated with arterial thrombosis, cardiac valve disease, livedo reticularis, epilepsy/chorea, and a more severe APS phenotype.
APS patients hospitalized with AIHA have markedly higher venous thromboembolism (VTE) risk (OR ≈ 8.6) compared with AIHA without APS.
Hematologic APS (AIHA ± thrombocytopenia) may precede or coexist with thrombotic/obstetric APS, depending on aPL profile.
There is a need to systematically define the clinical implications (thrombosis, organ involvement, outcomes) of AIHA in APS.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- APS patients will be divided into 2 arms based on the presence of AIHA AIHA defined by: * Anemia plus hemolysis (↑LDH, ↑indirect bilirubin, ↓haptoglobin, reticulocytosis) and * Positive direct anti-globulin (Coombs) test , Drug induced hemolysis or other hereditary/acquired non immune hemolytic anemias. * Active hematologic malignancy causing hemolysis. * Composite incidence of VTE and arterial thrombosis in APS+AIHA vs APS without AIHA. * Frequency of triple aPL positivity in APS+AIHA vs APS-AIHA. * Prevalence of extra criteria manifestations. In hospital mortality, length of stay, and costs in AIHA hospitalizations with vs without APS.
| Arm | Type | Receives |
|---|---|---|
| Antiphospholipid syndrome patients with AIHA | Active comparator | Diagnostic Test: Hemoglobin, Diagnostic Test: Coombs testAIHA defined by: * Anemia plus hemolysis (↑LDH, ↑indirect bilirubin, ↓haptoglobin, reticulocytosis) and * Positive direct anti-globulin (Coombs) test , Drug induced hemolysis or other hereditary/acquired non immune hemolytic anemias. |
| Antiphospholipid syndrome patients without AIHA | Active comparator | Diagnostic Test: Hemoglobin, Diagnostic Test: Coombs testPatients without hemolysis evidence |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged ≥18 years
- Patients with anemia consistant with hemolysis.
- Patient diagnosed with antiphospholipid syndrome.
- Informed consent obtained
Key exclusion criteria (2 listed)
- Age less than 18 years.
- Other causes of anemia than autoimmune hemolysis.
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 |
|---|---|---|
| HemoglobinBlood sample | Diagnostic test | Antiphospholipid syndrome patients with AIHA, Antiphospholipid syndrome patients without AIHA |
| Coombs testBlood sample | Diagnostic test | Antiphospholipid syndrome patients with AIHA, Antiphospholipid syndrome patients without AIHA |
Primary outcome
Number of thrombotic events in APS patients with AIHA
Time frame: baseline
1 secondary outcome
Number of thrombotic events in APS patients aithout AIHA
Time frame: baseline
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 10 Aug 2026.
- Background: PubMed 37795092Mulder FVM, Evers D, de Haas M, Cruijsen MJ, Bernelot Moens SJ, Barcellini W, Fattizzo B, Vos JMI. Severe autoimmune hemolytic anemia; epidemiology, clinical management, outcomes and knowledge gaps. Front Immunol. 2023 Sep 18;14:1228142. doi: 10.3389/fimmu.2023.1228142. eCollection 2023.
- Background: PubMed 9811723Zufferey R, Dull T, Mandel RJ, Bukovsky A, Quiroz D, Naldini L, Trono D. Self-inactivating lentivirus vector for safe and efficient in vivo gene delivery. J Virol. 1998 Dec;72(12):9873-80. doi: 10.1128/JVI.72.12.9873-9880.1998.
- Background: PubMed 40180601Erton ZB, Leaf RK, de Andrade D, Clarke A, Tektonidou MG, Pengo V, Sciascia S, Pardos-Gea J, Kello N, Paredes-Ruiz D, Lopez-Pedrera C, Belmont HM, Fortin PR, Ramires de Jesus G, Atsumi T, Zhang Z, Efthymiou M, Branch DW, Pazzola G, Andreoli L, Duarte-Garcia A, Rodriguez-Almaraz E, Petri M, Cervera R, Artim-Esen B, Quintana R, Shi H, Zuo Y, Willis R, Barber MRW, Skeith L, Radin M, Meroni P, Bertolaccini ML, Cohen H, Roubey R, Erkan D. Thrombocytopenia and autoimmune hemolytic anemia in antiphospholipid antibody-positive patients: Descriptive analysis of the AntiPhospholipid syndrome alliance for clinical trials and InternatiOnal networking (APS ACTION) clinical database and repository ("Registry"). Lupus. 2025 May;34(6):617-625. doi: 10.1177/09612033251332258. Epub 2025 Apr 3.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemoglobin and Coombs test in people with Anti Phospholipid Syndrome, run by New Valley 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 2 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 10 Aug 2026. 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 Asmaa N Hussein, MD (01065161752, asmaanady_1010@med.nvu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of thrombotic events in APS patients with AIHA (time frame: baseline). 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 NCT07743242, 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 10 Aug 2026.