Hemophagocytic LymphohistiocytosesNCT06047210
Evaluation of IFNγ and Inflammatory Mediators in Patients With Hemophagocytic Lymphohistiocytosis
An observational study of Hemophagocytic Lymphohistiocytoses, run by Swedish Orphan Biovitrum at 1 site in United States.
Trial summary
This observational study is designed to provide a better understanding of the potential use of interferon gamma (IFNγ) and IFNγ-inducible chemokines as markers of HLH disease activity in adults, and the potential of IFNγ to represent a therapeutic target. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemophagocytic Lymphohistiocytoses
- What is being tested?
- Blood Draws Data Collection
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2016to 30 Oct 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Male and female adult (>=18 years old) patients who are diagnosed with HLH and meet the inclusion criteria.
Who may be able to join
- Patients >=18 years old diagnosed with active HLH as established by the treating physician.
- HLH forms of unknown origin or secondary to infections or rheumatologic disorders.
- Should the diagnosis of primary HLH or malignancy become apparent after inclusion, the data collected will be analyzed separately as additional cohorts.
- The patient must have consented to the use of their clinical data for research purposes at the site.
Who cannot join
- Patients with primary HLH (diagnosed by the presence of homozygous mutations in a known HLH causative gene) and secondary HLH due to malignancy are excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: An Observational, Multicenter Study to Evaluate Levels of Interferon Gamma (IFNγ) and Other Inflammatory Mediators in Adult Patients With Hemophagocytic Lymphohistiocytosis (A-HLH)
This observational study is designed to provide a better understanding of the potential use of interferon gamma (IFNγ) and IFNγ-inducible chemokines as markers of HLH disease activity in adults, and the potential of IFNγ to represent a therapeutic target.
Read the detailed description
This is a observational study designed to determine the levels of pro-inflammatory markers in adult patients diagnosed with HLH and to assess the relationship between the biomarkers and disease activity in these patients during the HLH course. Inflammatory markers include IFNγ and IFNγ-induced chemokines C-X-C chemokine ligand 9 and C-X-C chemokine ligand 10.
In addition to the blood samples for the biomarker analysis, relevant information gathered by the treating physician will be collected in a data collection form. Whenever possible, collection of serum samples for biomarker analysis and relevant information should occur at HLH diagnosis, at regular time intervals during the treatment course (not more than once a week) up to resolution of HLH.
Blood samples will also be sent to the study sponsor (NovImmune S.A.) for cytokine testing. Before patient's samples are sent to the sponsor for testing, patient's name and any personal identifying information will be coded to protect participant's privacy.
- Conditions
- Hemophagocytic Lymphohistiocytoses
- Being tested
- Blood Draws Data Collection
- Keywords
- Hemophagocytic Lymphohistiocytosis, Interferon Gamma, IFNγ, Biomarkers, Inflammatory Markers
- Medical subject headings
- Lymphohistiocytosis, Hemophagocytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Draws Data CollectionOther
| Study group | Role | What they receive |
|---|---|---|
| A-HLH Patients | Patients diagnosed with A-HLH. Receives: Other: Blood Draws Data Collection | |
| Malignancy-Associated Hemophagocytic Lymphohistiocytosis (M-HLH) Patients | Patients diagnosed with HLH in the context of a malignancy. Receives: Other: Blood Draws Data Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 10 (CXCL10)
Serum samples was collected at various times after HLH diagnosis to determine the concentration of CXCL10.
Measured: 11 months
Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 9 (CXCL9)
Serum samples was collected at various times after HLH diagnosis to determine the concentration of CXCL9.
Measured: 11 months
Mean Serum Concentration of Inflammatory Biomarker - Interferon Gamma (IFNg)
Serum samples was collected at various times after HLH diagnosis to determine the concentration of IFNg.
Measured: 11 months
Mean Serum Concentration of Inflammatory Biomarker - Interleukin 10 (IL-10)
Serum samples was collected at various times after HLH diagnosis to determine the concentration of IL-10.
Measured: 11 months
Mean Serum Concentration of Inflammatory Biomarker - Interleukin 1 Beta (IL-1B)
Serum samples was collected at various times after HLH diagnosis to determine the concentration of IL-1B.
Measured: 11 months
Mean Serum Concentration of Inflammatory Biomarker - Interleukin 6 (IL-6)
Serum samples was collected at various times after HLH diagnosis to determine the concentration of IL-6.
Measured: 11 months
Mean Serum Concentration of Inflammatory Biomarker - Neopterin
Serum samples was collected at various times after HLH diagnosis to determine the concentration of neopterin.
Measured: 11 months
Mean Serum Concentration of Inflammatory Biomarker - Tumor Necrosis Factor Alpha (TNFa)
Serum samples was collected at various times after HLH diagnosis to determine the concentration of TNFa.
Measured: 11 months
Mean Serum Concentration of Inflammatory Biomarker - Total Human Interferon Gamma (hIFNg)
Serum samples was collected at various times after HLH diagnosis to determine the concentration of hIFNg.
Measured: 11 months
Mean Serum Concentration of Inflammatory Biomarker - Soluble CD163 (sCD163)
Serum samples was collected at various times after HLH diagnosis to determine the concentration of sCD163.
Measured: 11 months
Mean Serum Concentration of Inflammatory Biomarker - Soluble IL-2 Receptor Alpha (sIL2Ra)
Serum samples was collected at various times after HLH diagnosis to determine the concentration of sIL2Ra.
Measured: 11 months
Mean Serum Concentration of White Blood Cells
Blood samples was collected at various times after HLH diagnosis to determine the concentration of white blood cells.
Measured: 11 months
Mean Serum Concentration of Red Blood Cells
Blood samples was collected at various times after HLH diagnosis to determine the concentration of red blood cells.
Measured: 11 months
Mean Serum Concentration of Hemoglobin
Blood samples was collected at various times after HLH diagnosis to determine the concentration of hemoglobin.
Measured: 11 months
Mean Serum Concentration of Hematocrit
Blood samples was collected at various times after HLH diagnosis to determine the concentration of hematocrit.
Measured: 11 months
Mean Serum Concentration of Platelets
Blood samples was collected at various times after HLH diagnosis to determine the concentration of platelets.
Measured: 11 months
Mean Serum Concentration of Neutrophils
Blood samples was collected at various times after HLH diagnosis to determine the concentration of neutrophils.
Measured: 11 months
Mean Serum Concentration of Lymphocytes
Blood samples was collected at various times after HLH diagnosis to determine the concentration of lymphocytes.
Measured: 11 months
Mean Serum Concentration of Monocytes
Blood samples was collected at various times after HLH diagnosis to determine the concentration of monocytes.
Measured: 11 months
Mean Serum Concentration of Eosinophils
Blood samples was collected at various times after HLH diagnosis to determine the concentration of eosinophils.
Measured: 11 months
Mean Serum Concentration of Basophils
Blood samples was collected at various times after HLH diagnosis to determine the concentration of basophils.
Measured: 11 months
Mean Plasma Concentration of D-Dimer
Blood samples was collected at various times after HLH diagnosis to determine the concentration of D-dimer.
Measured: 11 months
Mean Plasma Concentration of Fibrinogen
Blood samples was collected at various times after HLH diagnosis to determine the concentration of fibrinogen.
Measured: 11 months
Mean Activated Partial Thromboplastin Time (aPTT)
Blood samples was collected at various times after HLH diagnosis to determine the aPTT.
Measured: 11 months
Mean Prothrombin Time
Blood samples was collected at various times after HLH diagnosis to determine the prothrombin time.
Measured: 11 months
Mean Serum Concentration of C-Reactive Protein
Blood samples was collected at various times after HLH diagnosis to determine the concentration of c-reactive protein.
Measured: 11 months
Mean Serum Concentration of Ferritin
Blood samples was collected at various times after HLH diagnosis to determine the concentration of ferritin.
Measured: 11 months
Mean Plasma Concentration of Blood Urea Nitrogen
Blood samples was collected at various times after HLH diagnosis to determine the concentration of blood urea nitrogen.
Measured: 11 months
Mean Serum Concentration of Creatinine
Blood samples was collected at various times after HLH diagnosis to determine the concentration of creatinine.
Measured: 11 months
Mean Serum Concentration of Albumin
Blood samples was collected at various times after HLH diagnosis to determine the concentration of albumin.
Measured: 11 months
Mean Serum Concentration of Sodium
Blood samples was collected at various times after HLH diagnosis to determine the concentration of sodium.
Measured: 11 months
Mean Serum Concentration of Fasting Triglycerides
Blood samples was collected at various times after HLH diagnosis to determine the concentration of fasting triglycerides.
Measured: 11 months
Mean Serum Concentration of Total Bilirubin
Blood samples was collected at various times after HLH diagnosis to determine the concentration of total bilirubin.
Measured: 11 months
Mean Serum Concentration of Conjugated Bilirubin
Blood samples was collected at various times after HLH diagnosis to determine the concentration of conjugated bilirubin.
Measured: 11 months
Mean Serum Concentration of Alanine Aminotransferase
Blood samples was collected at various times after HLH diagnosis to determine the concentration of alanine aminotransferase.
Measured: 11 months
Mean Serum Concentration of Aspartate Aminotransferase
Blood samples was collected at various times after HLH diagnosis to determine the concentration of aspartate aminotransferase.
Measured: 11 months
Mean Serum Concentration of Alkaline Phosphatase
Blood samples was collected at various times after HLH diagnosis to determine the concentration of alkaline phosphatase.
Measured: 11 months
Mean Serum Concentration of Lactate Dehydrogenase
Blood samples was collected at various times after HLH diagnosis to determine the concentration of lactate dehydrogenase.
Measured: 11 months
Mean Serum Concentration of Immunoglobulin G (IgG)
Blood samples was collected at various times after HLH diagnosis to determine the concentration of IgG.
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start14 Dec 2016
- Primary completion30 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hemophagocytic LymphohistiocytosesStudies of the same condition, open and under way.
- More trials run by Swedish Orphan BiovitrumThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Orphan Biovitrum
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Brigham and Women's Hospital, Harvard Medical School (HMS and HSDM)
- Responsible party
- Sponsor
- Investigators
- Nancy Berliner, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047210
- Sponsor's protocol ID
- NI-0501-08
- Status last verified
- Apr 2024
- First submitted
- 25 Aug 2023
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Multicenter Study to Evaluate Levels of Interferon Gamma (IFNγ) and Other Inflammatory Mediators in Adult Patients With Hemophagocytic Lymphohistiocytosis (A-HLH)
- ClinicalTrials.gov ID
- NCT06047210
- Acronym / sponsor ID
- NI-0501-08
- Conditions
- Hemophagocytic Lymphohistiocytoses
- Keywords
- Hemophagocytic Lymphohistiocytosis, Interferon Gamma, IFNγ, Biomarkers, Inflammatory Markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Swedish Orphan BiovitrumIndustry (pharma, biotech, devices)
- Collaborators
- Brigham and Women's Hospital, Harvard Medical School (HMS and HSDM)
- Study start
- 14 Dec 2016 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational study is designed to provide a better understanding of the potential use of interferon gamma (IFNγ) and IFNγ-inducible chemokines as markers of HLH disease activity in adults, and the potential of IFNγ to represent a therapeutic target.
Detailed description
This is a observational study designed to determine the levels of pro-inflammatory markers in adult patients diagnosed with HLH and to assess the relationship between the biomarkers and disease activity in these patients during the HLH course. Inflammatory markers include IFNγ and IFNγ-induced chemokines C-X-C chemokine ligand 9 and C-X-C chemokine ligand 10.
In addition to the blood samples for the biomarker analysis, relevant information gathered by the treating physician will be collected in a data collection form. Whenever possible, collection of serum samples for biomarker analysis and relevant information should occur at HLH diagnosis, at regular time intervals during the treatment course (not more than once a week) up to resolution of HLH.
Blood samples will also be sent to the study sponsor (NovImmune S.A.) for cytokine testing. Before patient's samples are sent to the sponsor for testing, patient's name and any personal identifying information will be coded to protect participant's privacy.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A-HLH Patients | – | Other: Blood Draws Data CollectionPatients diagnosed with A-HLH. |
| Malignancy-Associated Hemophagocytic Lymphohistiocytosis (M-HLH) Patients | – | Other: Blood Draws Data CollectionPatients diagnosed with HLH in the context of a malignancy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female adult (>=18 years old) patients who are diagnosed with HLH and meet the inclusion criteria.
Key inclusion criteria (4 listed)
- Patients >=18 years old diagnosed with active HLH as established by the treating physician.
- HLH forms of unknown origin or secondary to infections or rheumatologic disorders.
- Should the diagnosis of primary HLH or malignancy become apparent after inclusion, the data collected will be analyzed separately as additional cohorts.
- The patient must have consented to the use of their clinical data for research purposes at the site.
Key exclusion criteria (1 listed)
- Patients with primary HLH (diagnosed by the presence of homozygous mutations in a known HLH causative gene) and secondary HLH due to malignancy are excluded.
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 |
|---|---|---|
| Blood Draws Data Collection | Other | A-HLH Patients, Malignancy-Associated Hemophagocytic Lymphohistiocytosis (M-HLH) Patients |
Primary outcome
Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 10 (CXCL10)
Time frame: 11 months
Serum samples was collected at various times after HLH diagnosis to determine the concentration of CXCL10.
Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 9 (CXCL9)
Time frame: 11 months
Serum samples was collected at various times after HLH diagnosis to determine the concentration of CXCL9.
Mean Serum Concentration of Inflammatory Biomarker - Interferon Gamma (IFNg)
Time frame: 11 months
Serum samples was collected at various times after HLH diagnosis to determine the concentration of IFNg.
Mean Serum Concentration of Inflammatory Biomarker - Interleukin 10 (IL-10)
Time frame: 11 months
Serum samples was collected at various times after HLH diagnosis to determine the concentration of IL-10.
Mean Serum Concentration of Inflammatory Biomarker - Interleukin 1 Beta (IL-1B)
Time frame: 11 months
Serum samples was collected at various times after HLH diagnosis to determine the concentration of IL-1B.
Mean Serum Concentration of Inflammatory Biomarker - Interleukin 6 (IL-6)
Time frame: 11 months
Serum samples was collected at various times after HLH diagnosis to determine the concentration of IL-6.
Mean Serum Concentration of Inflammatory Biomarker - Neopterin
Time frame: 11 months
Serum samples was collected at various times after HLH diagnosis to determine the concentration of neopterin.
Mean Serum Concentration of Inflammatory Biomarker - Tumor Necrosis Factor Alpha (TNFa)
Time frame: 11 months
Serum samples was collected at various times after HLH diagnosis to determine the concentration of TNFa.
Mean Serum Concentration of Inflammatory Biomarker - Total Human Interferon Gamma (hIFNg)
Time frame: 11 months
Serum samples was collected at various times after HLH diagnosis to determine the concentration of hIFNg.
Mean Serum Concentration of Inflammatory Biomarker - Soluble CD163 (sCD163)
Time frame: 11 months
Serum samples was collected at various times after HLH diagnosis to determine the concentration of sCD163.
Mean Serum Concentration of Inflammatory Biomarker - Soluble IL-2 Receptor Alpha (sIL2Ra)
Time frame: 11 months
Serum samples was collected at various times after HLH diagnosis to determine the concentration of sIL2Ra.
Mean Serum Concentration of White Blood Cells
Time frame: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of white blood cells.
Mean Serum Concentration of Red Blood Cells
Time frame: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of red blood cells.
Mean Serum Concentration of Hemoglobin
Time frame: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of hemoglobin.
Mean Serum Concentration of Hematocrit
Time frame: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of hematocrit.
Mean Serum Concentration of Platelets
Time frame: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of platelets.
Mean Serum Concentration of Neutrophils
Time frame: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of neutrophils.
Mean Serum Concentration of Lymphocytes
Time frame: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of lymphocytes.
Mean Serum Concentration of Monocytes
Time frame: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of monocytes.
Mean Serum Concentration of Eosinophils
Time frame: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of eosinophils.
Mean Serum Concentration of Basophils
Time frame: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of basophils.
Mean Plasma Concentration of D-Dimer
Time frame: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of D-dimer.
Mean Plasma Concentration of Fibrinogen
Time frame: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of fibrinogen.
Mean Activated Partial Thromboplastin Time (aPTT)
Time frame: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the aPTT.
Mean Prothrombin Time
Time frame: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the prothrombin time.
Mean Serum Concentration of C-Reactive Protein
Time frame: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of c-reactive protein.
Mean Serum Concentration of Ferritin
Time frame: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of ferritin.
Mean Plasma Concentration of Blood Urea Nitrogen
Time frame: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of blood urea nitrogen.
Mean Serum Concentration of Creatinine
Time frame: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of creatinine.
Mean Serum Concentration of Albumin
Time frame: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of albumin.
Mean Serum Concentration of Sodium
Time frame: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of sodium.
Mean Serum Concentration of Fasting Triglycerides
Time frame: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of fasting triglycerides.
Mean Serum Concentration of Total Bilirubin
Time frame: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of total bilirubin.
Mean Serum Concentration of Conjugated Bilirubin
Time frame: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of conjugated bilirubin.
Mean Serum Concentration of Alanine Aminotransferase
Time frame: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of alanine aminotransferase.
Mean Serum Concentration of Aspartate Aminotransferase
Time frame: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of aspartate aminotransferase.
Mean Serum Concentration of Alkaline Phosphatase
Time frame: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of alkaline phosphatase.
Mean Serum Concentration of Lactate Dehydrogenase
Time frame: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of lactate dehydrogenase.
Mean Serum Concentration of Immunoglobulin G (IgG)
Time frame: 11 months
Blood samples was collected at various times after HLH diagnosis to determine the concentration of IgG.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Brigham and Women's HospitalLink provided by the sponsor.
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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.
Nancy Berliner, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophagocytic Lymphohistiocytoses, run by Swedish Orphan Biovitrum at 1 site in United States.
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 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: finished, as of the sponsor's last update on 19 Sep 2024. 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 United States. 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?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 10 (CXCL10) (time frame: 11 months). The study lists 39 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 19 Sep 2024; AzTrials last refreshed its copy on 8 Nov 2026.