Septic ShockPhase 2ALBUMIMNCT05645887
Human Albumin Treatment in Adult Septic Shock. A Study Evaluating Immune Response and Organ Failure.
A Phase 2 study testing Human albumin and Saline solution in people with Septic Shock, run by Albimmune SL.
Trial summary
The goal of this phase 2, multicenter, randomized, controlled study is to evaluate the effect of albumin treatment on B cell and other immune cell gene exptression in adults with septic shock. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Septic Shock
- What is being tested?
- Human albumin and Saline solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to 23 May 2024
- Phase
- Phase 2
- 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 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 18 years and <85 years of age.
- Community-acquired pneumonia, urinary, skin or biliary infection.
- Treatment with antibiotics at least one course in the first 6 hours of suspected infection.
- Meets Septic Shock criteria defined by the presence of sepsis with persistent hypotension despite initial adequate volume resuscitation requiring vasopressors for more than 4h to maintain MAP>65 mmHg and having a serum lactate level > 2mmol/L (18mg/L).
- SOFA score ≥ 5 points.
- Albumin plasma level <35g/L.
- Lymphocytes count < 1,100 cel/mL.
- Admitted to ICU or IMU
Who cannot join
- Septic shock lasting for more than 24h.
- ECMO or hemoadsortion therapy.
- Contraindications to receive albumin.
- Nosocomial or healthcare-associated infections (surgical intervention or hospitalization within 30 days prior to diagnosis of sepsis).
- Chronic Renal Failure (KIDGO stage 3-5) or dialysis.
- Liver cirrhosis.
Show all 16Show fewer
- A known malignancy that is progressing or has required active treatment within the past 3 months.
- Patient with end-stage disease (unrelated to sepsis) defined as patients who prior to the current hospitalization are expected to live < 6 months (as assessed by the study physician).
- Known New York Heart Association (NYHA) class II to IV heart failure or unstable angina, acute coronary disease or myocardial infarction within 6 months prior to diagnosis of sepsis.
- Known immunocompromised state, including human immunodeficiency virus infection, or medication known to be immunosuppressive.
- Participation in an interventional investigational study within 30 days prior to diagnosis of sepsis.
- Likely to be non-compliant or uncooperative during the study (e.g. substance abuse, uncontrolled psychiatric disorder or any chronic condition that may interfere with the study).
- Albumin administration within the last 14 days.
- Subjects with severe neurological or severe head trauma disorders.
- Pregnant and/or breast-feeding woman.
- Patients who cannot provide prior informed consent and when there is documented evidence that the patient has no legal surrogate decision marker and it appears unlikely that the patient will regain consciousness or sufficient ability to provide delayed informed consent.
About this study
The goal of this phase 2, multicenter, randomized, controlled study is to evaluate the effect of albumin treatment on B cell and other immune cell gene exptression in adults with septic shock.
- Conditions
- Septic Shock
- Being tested
- Human albumin, Saline solution
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human albuminDrug
Human albumin from day 0 to 7 if serum albumin concentrations <35g/l.
Saline solutionOther
Saline solution from day 0 to day 7.
| Study group | Role | What they receive |
|---|---|---|
| Human Albumim (20%, 300mL, 60gr) in 180 min IV | Experimental | Further doses of albumin (60g/l) will be administered daily from day 0 to day 7 in patients with serum albumin concentrations <35 g/L. Receives: Drug: Human albumin |
| Saline solution 0,9% (500mL) in 180 min IV | Placebo comparator | Saline solution will be given from day 0 to day 7. Receives: Other: Saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
1.1 Evaluate B cell response to albumin treatment
Measured by the Immunology Complex (Discovery Study).
Measured: at day 0
1.2 Evaluate B cell response to albumin treatment
Measured by the Immunology Complex (Discovery Study).
Measured: at day 1
1.3 Evaluate B cell response to albumin treatment
Measured by the Immunology Complex (Discovery Study).
Measured: at day 3
1.4 Evaluate B cell response to albumin treatment
Measured by the Immunology Complex (Discovery Study).
Measured: at day 7
1.5 Evaluate B cell response to albumin treatment
Measured by the Immunology Complex (Discovery Study).
Measured: at day 14
1.6 Evaluate other immune cell response to albumin treatment
Measured by the Immunology Complex (Discovery Study).
Measured: at day 0
1.7 Evaluate other immune cell response to albumin treatment
Measured by the Immunology Complex (Discovery Study).
Measured: at day 1
1.8 Evaluate other immune cell response to albumin treatment
Measured by the Immunology Complex (Discovery Study).
Measured: at day 3
1.9 Evaluate other immune cell response to albumin treatment
Measured by the Immunology Complex (Discovery Study).
Measured: at day 7
1.10 Evaluate other immune cell response to albumin treatment
Measured by the Immunology Complex (Discovery Study).
Measured: at day 14
Secondary outcomes (47)
1.1. Identify additional biomarkers of the immune response to albumin treatment.
Measured by the IGCGS score.
Measured: at day 0, 1, 3, 7 and 14.
1.2.1 Evaluate the functionality of antibody-secreting B cells.
Measurated by B cell function.
Measured: at day 0, 1, 3, 7 and 14.
1.2.2 Evaluate the functionality of antibody-secreting B cells.
Measurated by serum immunoglobilin levels (g/L).
Measured: at day 0, 1, 3, 7 and 14.
1.2.3 Evaluate the functionality of antibody-secreting B cells.
Measurated by glycosylation.
Measured: at day 0, 1, 3, 7 and 14.
1.2.4 Evaluate the functionality of antibody-secreting B cells.
Measurated by blood immunophenotyping.
Measured: at day 0, 1, 3, 7 and 14.
2.1To further investigate the mechanisms of albumin treatment on the immune system.
Measurated by assessment of whole blood RNA sequencing.
Measured: at day 0, 1, 3, 7 and 14.
2.2 To further investigate the mechanisms of albumin treatment on the immune system.
Measurated by assessment of single-cell RNA sequencing.
Measured: at day 0, 1, 3, 7 and 14.
2.3 To further investigate the mechanisms of albumin treatment on the immune system.
Measurated by assessment of CITE-seq.
Measured: at day 0, 1, 3, 7 and 14.
2.4 To further investigate the mechanisms of albumin treatment on the immune system.
Measurated by assessment of immunophenotyping of B cells by high-dimensional spectral flow cytometry.
Measured: at day 0, 1, 3, 7 and 14.
3. Evaluate whether albumin activates B cells at the mucosal interface.
Measurated by assessment of circulating levels of immunoglobulins and glycosylated immunoglobulins.
Measured: at day 0, 3, 7 and 14.
4.1. Evaluate the effect of albumin treatment on systemic inflammation.
Measurated by plasma cytokines: IL-1β, IL-1ra, IL-6, IL-7, IL-8, IL-10, IL-17, TNF-α, TNFr1, IFN-γ, MCP-1, MCP-3, RAGE.
Measured: at day 0, 1, 3, 7 and 14.
4.2.1 Evaluate kidney.
Measurated by sCr (mg/dL).
Measured: at day 0, 1, 3, 7 and 14.
4.2.2 Evaluate kidney.
Measurated by urine output.
Measured: at day 0, 1, 3, 7 and 14.
4.2.3 Evaluate kidney.
Measurated by balance fluid.
Measured: at day 0, 1, 3, 7 and 14.
4.2.4 Evaluate kidney.
Measurated by KDIGO stage 2-3.
Measured: at day 0, 1, 3, 7 and 14.
4.2.5 Evaluate kidney.
Measurated by TIMP-2.
Measured: at day 0, 1, 3, 7 and 14.
4.2.6 Evaluate kidney.
Measurated by IGFBP 7.
Measured: at day 0, 1, 3, 7 and 14.
4.3.1 To explore the effect of albumin on gut mucosa immunoglobulins.
Measurated by composition of bacterial communities bound to IgA.
Measured: at day 0, 3, 7 and 14.
4.3.2 To explore the effect of albumin on gut mucosa immunoglobulins.
Measurated by composition of whole fecal bacteria.
Measured: at day 0, 3, 7 and 14.
4.3.3 To explore the effect of albumin on gut mucosa immunoglobulins.
Measurated by antibody-binding profile of microbes.
Measured: at day 0, 3, 7 and 14.
4.3.4 To explore the effect of albumin on gut mucosa immunoglobulins.
Measurated by bacterial reactivity of peripheral blood antibodies.
Measured: at day 0, 3, 7 and 14.
5.1 Evaluate the effect of albumin on endothelial and glycocalix function.
Measurated by angiopoeitin 1.
Measured: at day 0, 1, 3, 7 and 14.
5.2 Evaluate the effect of albumin on endothelial and glycocalix function.
Measurated by angiopoeitin 2.
Measured: at day 0, 1, 3, 7 and 14.
5.3 Evaluate the effect of albumin on endothelial and glycocalix function.
Measurated by MR-proADM.
Measured: at day 0, 1, 3, 7 and 14.
5.4 Evaluate the effect of albumin on endothelial and glycocalix function.
Measurated by Selectin.
Measured: at day 0, 1, 3, 7 and 14.
5.5 Evaluate the effect of albumin on endothelial and glycocalix function.
Measurated by VCAM-1.
Measured: at day 0, 1, 3, 7 and 14.
5.6 Evaluate the effect of albumin on endothelial and glycocalix function.
Measurated by ICAM-1.
Measured: at day 0, 1, 3, 7 and 14.
5.7 Evaluate the effect of albumin on endothelial and glycocalix function.
Measurated by endothelin-1.
Measured: at day 0, 1, 3, 7 and 14.
5.8 Evaluate the effect of albumin on endothelial and glycocalix function.
Measurated by thrombomodulin.
Measured: at day 0, 1, 3, 7 and 14.
5.9 Evaluate the effect of albumin on endothelial and glycocalix function.
Measurated by syndecan 1-4.
Measured: at day 0, 1, 3, 7 and 14.
5.10 Evaluate the effect of albumin on endothelial and glycocalix function.
Measurated by prot C (mg/L).
Measured: at day 0, 1, 3, 7 and 14.
5.11 Evaluate the effect of albumin on endothelial and glycocalix function.
Measurated by heparan sulfate.
Measured: at day 0, 1, 3, 7 and 14.
5.12 Evaluate the effect of albumin on endothelial and glycocalix function.
Measurated by VEGF.
Measured: at day 0, 1, 3, 7 and 14.
5.13 Evaluate the effect of albumin on endothelial and glycocalix function.
Measurated by sphingosine-1-phosphate (S1P).
Measured: at day 0, 1, 3, 7 and 14.
5.14 Evaluate the effect of albumin on endothelial and glycocalix function.
Measurated by PAI-1.
Measured: at day 0, 1, 3, 7 and 14.
6.1 Time on vasopressors.
Measurated by time on vasopressors.
Measured: 14 days
6.2 Time on mechanical ventilation.
Measurated by time on mechanical ventilation.
Measured: 14 days
6.3 Time on renal replacement.
Measurated by time on renal replacement.
Measured: 14 days
7. Proportion of patients with secondary infections.
Measurated by the number of patients with secondary infections.
Measured: 90 days
8.1. Proportion of patients dead at 28 and 90 days.
Measurated by the number of patients dead at 28 and 90 days.
Measured: 90 days
8.2. Proportion of patients re-admitted to ICU at 28 days.
Measurated by the number of re-admitted to UCI at 28 days.
Measured: 28 days
8.3. Proportion of re-hospitalized patients at 28 days.
Measurated by the number of re-hospitalized patients at 28 days.
Measured: 28 days
8.4.1 Evaluate the sequential SOFA score.
Measurated by SOFA score.
Measured: at day 0, 1, 3, 7 and 14.
8.4.2 Evaluate the sequential APACHE II score.
Measurated by APACHE II score.
Measured: at day 0, 1, 3, 7 and 14.
8.4.3 Evaluate the sequential TISS-28 score.
Measurated by TISS-28 score.
Measured: at day 0, 1, 3, 7 and 14.
9. Evaluate quality of life (QoL) at day 90.
Measurated by the EQ-5D-5L questionnaire.
Measured: At day 0 and 90
10. Proportion of participants with any AEs related to albumin treatment, SAEs and SUSARs.
Measured by the number of AE, SAEs and SUSARS presented by the participants.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study startFeb 2024 (estimated)
- Primary completion23 May 2024
- Study completion23 May 2024
Why it stopped: Internal reorganisations and lack of funding by the sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albimmune SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645887
- Sponsor's protocol ID
- 2022-001949-20
- Acronym
- ALBUMIM
- Status last verified
- Jul 2023
- First submitted
- 22 Nov 2022
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Albumin Treatment in Adult Septic Shock. A Study Evaluating Immune Response and Organ Failure.
- ClinicalTrials.gov ID
- NCT05645887
- Acronym / sponsor ID
- ALBUMIM / 2022-001949-20
- Conditions
- Septic Shock
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Internal reorganisations and lack of funding by the sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Albimmune SLIndustry (pharma, biotech, devices)
- Study start
- Feb 2024 (estimated)
- Primary completion
- 23 May 2024 (actual)
- Study completion
- 23 May 2024 (actual)
- First posted
- 12 Dec 2022 (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.
The goal of this phase 2, multicenter, randomized, controlled study is to evaluate the effect of albumin treatment on B cell and other immune cell gene exptression in adults with septic shock.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Human Albumim (20%, 300mL, 60gr) in 180 min IV | Experimental | Drug: Human albuminFurther doses of albumin (60g/l) will be administered daily from day 0 to day 7 in patients with serum albumin concentrations <35 g/L. |
| Saline solution 0,9% (500mL) in 180 min IV | Placebo comparator | Other: Saline solutionSaline solution will be given from day 0 to day 7. |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female ≥ 18 years and <85 years of age.
- Community-acquired pneumonia, urinary, skin or biliary infection.
- Treatment with antibiotics at least one course in the first 6 hours of suspected infection.
- Meets Septic Shock criteria defined by the presence of sepsis with persistent hypotension despite initial adequate volume resuscitation requiring vasopressors for more than 4h to maintain MAP>65 mmHg and having a serum lactate level > 2mmol/L (18mg/L).
- SOFA score ≥ 5 points.
Key exclusion criteria (16 listed)
- Septic shock lasting for more than 24h.
- ECMO or hemoadsortion therapy.
- Contraindications to receive albumin.
- Nosocomial or healthcare-associated infections (surgical intervention or hospitalization within 30 days prior to diagnosis of sepsis).
- Chronic Renal Failure (KIDGO stage 3-5) or dialysis.
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 |
|---|---|---|
| Human albuminHuman albumin from day 0 to 7 if serum albumin concentrations <35g/l. | Drug | Human Albumim (20%, 300mL, 60gr) in 180 min IV |
| Saline solutionSaline solution from day 0 to day 7. | Other | Saline solution 0,9% (500mL) in 180 min IV |
Primary outcome
1.1 Evaluate B cell response to albumin treatment
Time frame: at day 0
Measured by the Immunology Complex (Discovery Study).
1.2 Evaluate B cell response to albumin treatment
Time frame: at day 1
Measured by the Immunology Complex (Discovery Study).
1.3 Evaluate B cell response to albumin treatment
Time frame: at day 3
Measured by the Immunology Complex (Discovery Study).
1.4 Evaluate B cell response to albumin treatment
Time frame: at day 7
Measured by the Immunology Complex (Discovery Study).
1.5 Evaluate B cell response to albumin treatment
Time frame: at day 14
Measured by the Immunology Complex (Discovery Study).
1.6 Evaluate other immune cell response to albumin treatment
Time frame: at day 0
Measured by the Immunology Complex (Discovery Study).
1.7 Evaluate other immune cell response to albumin treatment
Time frame: at day 1
Measured by the Immunology Complex (Discovery Study).
1.8 Evaluate other immune cell response to albumin treatment
Time frame: at day 3
Measured by the Immunology Complex (Discovery Study).
1.9 Evaluate other immune cell response to albumin treatment
Time frame: at day 7
Measured by the Immunology Complex (Discovery Study).
1.10 Evaluate other immune cell response to albumin treatment
Time frame: at day 14
Measured by the Immunology Complex (Discovery Study).
47 secondary outcomes
1.1. Identify additional biomarkers of the immune response to albumin treatment.
Time frame: at day 0, 1, 3, 7 and 14.
1.2.1 Evaluate the functionality of antibody-secreting B cells.
Time frame: at day 0, 1, 3, 7 and 14.
1.2.2 Evaluate the functionality of antibody-secreting B cells.
Time frame: at day 0, 1, 3, 7 and 14.
1.2.3 Evaluate the functionality of antibody-secreting B cells.
Time frame: at day 0, 1, 3, 7 and 14.
1.2.4 Evaluate the functionality of antibody-secreting B cells.
Time frame: at day 0, 1, 3, 7 and 14.
2.1To further investigate the mechanisms of albumin treatment on the immune system.
Time frame: at day 0, 1, 3, 7 and 14.
2.2 To further investigate the mechanisms of albumin treatment on the immune system.
Time frame: at day 0, 1, 3, 7 and 14.
2.3 To further investigate the mechanisms of albumin treatment on the immune system.
Time frame: at day 0, 1, 3, 7 and 14.
2.4 To further investigate the mechanisms of albumin treatment on the immune system.
Time frame: at day 0, 1, 3, 7 and 14.
3. Evaluate whether albumin activates B cells at the mucosal interface.
Time frame: at day 0, 3, 7 and 14.
4.1. Evaluate the effect of albumin treatment on systemic inflammation.
Time frame: at day 0, 1, 3, 7 and 14.
4.2.1 Evaluate kidney.
Time frame: at day 0, 1, 3, 7 and 14.
4.2.2 Evaluate kidney.
Time frame: at day 0, 1, 3, 7 and 14.
4.2.3 Evaluate kidney.
Time frame: at day 0, 1, 3, 7 and 14.
4.2.4 Evaluate kidney.
Time frame: at day 0, 1, 3, 7 and 14.
4.2.5 Evaluate kidney.
Time frame: at day 0, 1, 3, 7 and 14.
4.2.6 Evaluate kidney.
Time frame: at day 0, 1, 3, 7 and 14.
4.3.1 To explore the effect of albumin on gut mucosa immunoglobulins.
Time frame: at day 0, 3, 7 and 14.
4.3.2 To explore the effect of albumin on gut mucosa immunoglobulins.
Time frame: at day 0, 3, 7 and 14.
4.3.3 To explore the effect of albumin on gut mucosa immunoglobulins.
Time frame: at day 0, 3, 7 and 14.
4.3.4 To explore the effect of albumin on gut mucosa immunoglobulins.
Time frame: at day 0, 3, 7 and 14.
5.1 Evaluate the effect of albumin on endothelial and glycocalix function.
Time frame: at day 0, 1, 3, 7 and 14.
5.2 Evaluate the effect of albumin on endothelial and glycocalix function.
Time frame: at day 0, 1, 3, 7 and 14.
5.3 Evaluate the effect of albumin on endothelial and glycocalix function.
Time frame: at day 0, 1, 3, 7 and 14.
5.4 Evaluate the effect of albumin on endothelial and glycocalix function.
Time frame: at day 0, 1, 3, 7 and 14.
5.5 Evaluate the effect of albumin on endothelial and glycocalix function.
Time frame: at day 0, 1, 3, 7 and 14.
5.6 Evaluate the effect of albumin on endothelial and glycocalix function.
Time frame: at day 0, 1, 3, 7 and 14.
5.7 Evaluate the effect of albumin on endothelial and glycocalix function.
Time frame: at day 0, 1, 3, 7 and 14.
5.8 Evaluate the effect of albumin on endothelial and glycocalix function.
Time frame: at day 0, 1, 3, 7 and 14.
5.9 Evaluate the effect of albumin on endothelial and glycocalix function.
Time frame: at day 0, 1, 3, 7 and 14.
5.10 Evaluate the effect of albumin on endothelial and glycocalix function.
Time frame: at day 0, 1, 3, 7 and 14.
5.11 Evaluate the effect of albumin on endothelial and glycocalix function.
Time frame: at day 0, 1, 3, 7 and 14.
5.12 Evaluate the effect of albumin on endothelial and glycocalix function.
Time frame: at day 0, 1, 3, 7 and 14.
5.13 Evaluate the effect of albumin on endothelial and glycocalix function.
Time frame: at day 0, 1, 3, 7 and 14.
5.14 Evaluate the effect of albumin on endothelial and glycocalix function.
Time frame: at day 0, 1, 3, 7 and 14.
6.1 Time on vasopressors.
Time frame: 14 days
6.2 Time on mechanical ventilation.
Time frame: 14 days
6.3 Time on renal replacement.
Time frame: 14 days
7. Proportion of patients with secondary infections.
Time frame: 90 days
8.1. Proportion of patients dead at 28 and 90 days.
Time frame: 90 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
Related trials for Septic Shock
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Human albumin and Saline solution in people with Septic Shock, run by Albimmune SL.
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 8 inclusion and 16 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: withdrawn, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1.1 Evaluate B cell response to albumin treatment (time frame: at day 0). The study lists 10 primary outcomes in all. 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 31 Jul 2024.