Hemophagocytic Lymphohistiocytosis (HLH)Phase 3isHLH-IVD/IVIgNCT07861776
Efficacy of Short Course of Intravenous Dexamethasone and Intravenous Immunoglobulin Therapy in Infection-Related Secondary Hemophagocytic Lymphohistiocytosis (isHLH)
A Phase 3 study testing Intravenous Immunoglobulin (IVIg) therapy and Intravenous Dexamethasone (IVD) therapy in people with Hemophagocytic Lymphohistiocytosis (HLH) and Secondary Hemophagocytic Lymphohistiocytosis, run by Post Graduate Institute of Medical Education and Research, Chandigarh.
Trial summary
Rationale/Gaps in Existing Knowledge: Therapy of Infection-associated Secondary Hemophagocytic lymphohistiocytosis (sHLH) in adult lacks evidence from randomized trial guiding first-line immunomodulation and current therapeutic practice primarily extrapolated from decades old pediatric HLH protocols and retrospective… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemophagocytic Lymphohistiocytosis (HLH), Secondary Hemophagocytic Lymphohistiocytosis
- What is being tested?
- Intravenous Immunoglobulin (IVIg) therapy and Intravenous Dexamethasone (IVD) therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2026to 30 Sep 2029
- Phase
- Phase 3
- 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
- Age ≥ 18 years
- Gender: Male/female
- h-Score probability ≥ 80%
- Known microbiological etiology
- Mild HLH not responding to infection specific targeted antimicrobial therapy (> 72 hours)
- Mild HLH developing new organ dysfunction
- Moderate to severe HLH with life threatening organ dysfunction
Who cannot join
- Primary (familial) HLH
- Malignancy associated HLH
- HLH associated with autoimmune disease
- EBV associated HLH
- Pregnancy
- Receiving immune modulator therapy within 2 moths
Show all 11Show fewer
- Participants with HIV
- Consent not given
- Known hypersensitivity to IVIG or Dexamethasone
- Chronic liver disease
- Chronic kidney disease
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Randomized Controlled Trial to Evaluate and Compare the Efficacy of Short Course of Intravenous Dexamethasone and Intravenous Immunoglobulin Therapy in Infection-Related Secondary Hemophagocytic Lymphohistiocytosis (sHLH)
Rationale/Gaps in Existing Knowledge: Therapy of Infection-associated Secondary Hemophagocytic lymphohistiocytosis (sHLH) in adult lacks evidence from randomized trial guiding first-line immunomodulation and current therapeutic practice primarily extrapolated from decades old pediatric HLH protocols and retrospective studies. In presence of infection very expensive therapy with intravenous Immunoglobulin (IVIG) is preferred over Dexamethasone, however the comparative efficacy of IVIG and Dexamethasone alone remains undefined, especially in resource-constraints settings. (ii) Novelty: This will be among the first randomized controlled trials in adults with infection-associated sHLH, directly comparing efficacy of IVIG with Dexamethasone. The study uniquely integrates clinical outcomes with economic feasibility in a low-middle income setting. (iii) Objectives: Primary objectives will be to compare the efficacy of intravenous (IV) Dexamethasone and IVIG in achieving clinical remission and recovery of HLH-associated cytokines (IL-1, IL-6, TNF-α, IFN-γ, GM-CSF) and Ferritin level. Secondary objectives include assessment of hematologic recovery, adverse events, and short-term mortality. (iv)Method: In this Randomized controlled open-label, non-inferiority clinical trial participants with sHLH, will be allocated (1:1) to receive either short-course of IV Dexamethasone or IVIG along with infection-directed standard care and will be followed-up for 4 weeks to evaluate predefined clinical outcome and laboratory parameters. (v) Expected Outcome: The study aims to establish whether IV Dexamethasone is non-inferior to IVIG for achieving clinical remission, recovery of HLH-associated cytokines level and reduction of short-term mortality. Results are expected to reform evidence-based, cost-effective therapeutic strategies for infection-associated sHLH and improve access to care in resource-constraint healthcare systems.
- Being tested
- Intravenous Immunoglobulin (IVIg) therapy, Intravenous Dexamethasone (IVD) therapy, Targeted antimicrobial therapy & standard care
- Keywords
- Hemophagocytic lymphohistiocytosis (HLH), Dexamethasone, Intravenous Immunoglobulin (IVIg), Infection associated secondary HLH (isHLH)
- Medical subject headings
- Lymphohistiocytosis, Hemophagocytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Immunoglobulin (IVIg) therapyDrug
Injection IVIg (400 mg/kg Body weight) over an hour IV infusion X 5 days (total cumulative dose 2g/kg).
Intravenous Dexamethasone (IVD) therapyDrug
Injection Dexamethasone (10mg/m2) in 100 ml 0.9% normal saline (NS) over half an hour IV infusion X 3 days
Targeted antimicrobial therapy & standard careDrug
Infection specific targeted antimicrobial therapy along with standard medical care
| Study group | Role | What they receive |
|---|---|---|
| IVIg | Active comparator | Will receive intravenous Immunoglobulin (IVIg) therapy Receives: Drug: Intravenous Immunoglobulin (IVIg) therapy; Drug: Targeted antimicrobial therapy & standard care |
| IVD | Experimental | Will receive intravenous Dexamethasone (IVD) Receives: Drug: Intravenous Dexamethasone (IVD) therapy; Drug: Targeted antimicrobial therapy & standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission
Number of participants become persistently asymptomatic without fever for ≥72 hours with h-Score probability <80% and without any HLH-related new organ dysfunction at 1 week and 4 weeks of the IVIG/IVD intervention
Measured: 4 weeks
The recovery of HLH-associated cytokines
Number of participants having reduction of HLH-associated cytokines (IL-1, IL-6, TNF-α, IFN-γ, GM-CSF) and Ferritin level from the pre-intervention baseline at 1 week and 4 weeks of the IVIG/IVD intervention
Measured: 4 weeks
Secondary outcomes (4)
Recovery of the hematological parameters
Number of participants with recovery or normalization of the hematological parameters (hemoglobin, total leukocyte count, and platelet count)
Measured: 4 weeks
Adverse events/ adverse drug reactions
Number of incidence of any adverse events and adverse drug reactions
Measured: 4 weeks
Duration of hospital stay
Number of days of hospital admission
Measured: 4 weeks
Incidence of relapse of HLH: Recurrence of HLH after achieving clinical remission
Number of participants having recurrence of HLH after achieving clinical remission
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophagocytic Lymphohistiocytosis (HLH)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled open-label clinical trial
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Collaborators
- Indian Council of Medical Research
- Responsible party
- Principal investigator, Deba Prasad Dhibar, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Deba Prasad Dhibar, MD, Principal investigator, Post Graduate Institute of Medical Education and Research, Chandigarh, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861776
- Sponsor's protocol ID
- PGI/IEC/2026/SPL-1447
- Acronym
- isHLH-IVD/IVIg
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All the reasonable data requests should be submitted to the principal investigator (DPD) for consideration.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Evaluate and Compare the Efficacy of Short Course of Intravenous Dexamethasone and Intravenous Immunoglobulin Therapy in Infection-Related Secondary Hemophagocytic Lymphohistiocytosis (sHLH)
- ClinicalTrials.gov ID
- NCT07861776
- Acronym / sponsor ID
- isHLH-IVD/IVIg / PGI/IEC/2026/SPL-1447
- Keywords
- Hemophagocytic lymphohistiocytosis (HLH), Dexamethasone, Intravenous Immunoglobulin (IVIg), Infection associated secondary HLH (isHLH)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Collaborators
- Indian Council of Medical Research
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 6 Oct 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.
Rationale/Gaps in Existing Knowledge: Therapy of Infection-associated Secondary Hemophagocytic lymphohistiocytosis (sHLH) in adult lacks evidence from randomized trial guiding first-line immunomodulation and current therapeutic practice primarily extrapolated from decades old pediatric HLH protocols and retrospective studies. In presence of infection very expensive therapy with intravenous Immunoglobulin (IVIG) is preferred over Dexamethasone, however the comparative efficacy of IVIG and Dexamethasone alone remains undefined, especially in resource-constraints settings. (ii) Novelty: This will be among the first randomized controlled trials in adults with infection-associated sHLH, directly comparing efficacy of IVIG with Dexamethasone. The study uniquely integrates clinical outcomes with economic feasibility in a low-middle income setting. (iii) Objectives: Primary objectives will be to compare the efficacy of intravenous (IV) Dexamethasone and IVIG in achieving clinical remission and recovery of HLH-associated cytokines (IL-1, IL-6, TNF-α, IFN-γ, GM-CSF) and Ferritin level. Secondary objectives include assessment of hematologic recovery, adverse events, and short-term mortality. (iv)Method: In this Randomized controlled open-label, non-inferiority clinical trial participants with sHLH, will be allocated (1:1) to receive either short-course of IV Dexamethasone or IVIG along with infection-directed standard care and will be followed-up for 4 weeks to evaluate predefined clinical outcome and laboratory parameters. (v) Expected Outcome: The study aims to establish whether IV Dexamethasone is non-inferior to IVIG for achieving clinical remission, recovery of HLH-associated cytokines level and reduction of short-term mortality. Results are expected to reform evidence-based, cost-effective therapeutic strategies for infection-associated sHLH and improve access to care in resource-constraint healthcare systems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled open-label clinical trial
| Arm | Type | Receives |
|---|---|---|
| IVIg | Active comparator | Drug: Intravenous Immunoglobulin (IVIg) therapy, Drug: Targeted antimicrobial therapy & standard careWill receive intravenous Immunoglobulin (IVIg) therapy |
| IVD | Experimental | Drug: Intravenous Dexamethasone (IVD) therapy, Drug: Targeted antimicrobial therapy & standard careWill receive intravenous Dexamethasone (IVD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Gender: Male/female
- h-Score probability ≥ 80%
- Known microbiological etiology
- Mild HLH not responding to infection specific targeted antimicrobial therapy (> 72 hours)
Key exclusion criteria (11 listed)
- Primary (familial) HLH
- Malignancy associated HLH
- HLH associated with autoimmune disease
- EBV associated HLH
- Pregnancy
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 |
|---|---|---|
| Intravenous Immunoglobulin (IVIg) therapyInjection IVIg (400 mg/kg Body weight) over an hour IV infusion X 5 days (total cumulative dose 2g/kg). | Drug | IVIg |
| Intravenous Dexamethasone (IVD) therapyInjection Dexamethasone (10mg/m2) in 100 ml 0.9% normal saline (NS) over half an hour IV infusion X 3 days | Drug | IVD |
| Targeted antimicrobial therapy & standard careInfection specific targeted antimicrobial therapy along with standard medical care | Drug | IVD, IVIg |
Primary outcome
Clinical remission
Time frame: 4 weeks
Number of participants become persistently asymptomatic without fever for ≥72 hours with h-Score probability <80% and without any HLH-related new organ dysfunction at 1 week and 4 weeks of the IVIG/IVD intervention
The recovery of HLH-associated cytokines
Time frame: 4 weeks
Number of participants having reduction of HLH-associated cytokines (IL-1, IL-6, TNF-α, IFN-γ, GM-CSF) and Ferritin level from the pre-intervention baseline at 1 week and 4 weeks of the IVIG/IVD intervention
4 secondary outcomes
Recovery of the hematological parameters
Time frame: 4 weeks
Adverse events/ adverse drug reactions
Time frame: 4 weeks
Duration of hospital stay
Time frame: 4 weeks
Incidence of relapse of HLH: Recurrence of HLH after achieving clinical remission
Time frame: 4 weeks
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 6 Oct 2026.
- Individual participant dataSharing planned: No. All the reasonable data requests should be submitted to the principal investigator (DPD) for consideration.
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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.
Deba Prasad Dhibar, MD principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh, India
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intravenous Immunoglobulin (IVIg) therapy and Intravenous Dexamethasone (IVD) therapy in people with Hemophagocytic Lymphohistiocytosis (HLH) and Secondary Hemophagocytic Lymphohistiocytosis, run by Post Graduate Institute of Medical Education and Research, Chandigarh.
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 7 inclusion and 11 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: opening soon, as of the sponsor's last update on 6 Oct 2026. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Deba Prasad Dhibar, MD (+911722756670, drdeba_prasad@yahoo.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission (time frame: 4 weeks). The study lists 2 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 6 Oct 2026.