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Status unknownNCT05677178Updated Jan 10, 2023

Response Prediction in EBV-HLH Using Metabonomics Analysis

An observational study in Hemophagocytic Lymphohistiocytoses, EBV and Metabonomics, sponsored by Beijing Friendship Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-01-10.

Sponsored by Beijing Friendship Hospital · Observational

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 60 Years
Sex
All
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Study summary

Hemophagocytic lymphohistiocytosis (HLH) is a rare, poorly recognized and underdiagnosed syndrome of excessive immune activation, which is rapidly fatal. Epstein-Barr virus (EBV) is a common trigger of HLH, particularly in Asian individuals. We aim to analyze metabolomics and cytokine profiles of patients before and after treatment to explore the metabolomic characteristics of EBV-HLH, and search for pathogenic mechanisms and therapeutic targets.

Read the detailed description

Hemophagocytic lymphohistiocytosis (HLH) is a rare, poorly recognized and underdiagnosed syndrome of excessive immune activation, which is rapidly fatal. Without early intervention, the median survival time is less than 2 months.Epstein-Barr virus (EBV) is a common trigger of HLH, particularly in Asian individuals. We aim to analyze metabolomics and cytokine profiles of patients before and after treatment to explore the metabolomic characteristics of EBV-HLH, and search for pathogenic mechanisms and therapeutic targets.

02

Conditions studied

  • Hemophagocytic Lymphohistiocytoses
  • EBV
  • Metabonomics

Keywords

  • Hemophagocytic Lymphohistiocytoses
  • EBV
  • matabonomics
03

In context

Lymphohistiocytosis, Hemophagocytic

99 studies on the registry are indexed under Lymphohistiocytosis, Hemophagocytic; 36 are open to participants now.

This study's planned enrollment of 30 is below the median of 128 across 29 observational studies indexed under Lymphohistiocytosis, Hemophagocytic.

Browse Lymphohistiocytosis, Hemophagocytic studies →

Lead sponsor

Beijing Friendship Hospital is the lead sponsor of 216 studies on the registry; 95 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who were diagnosed with EBV-HLH in China.

Inclusion criteria

  • Patients who meet HLH-04 diagnostic criteria
  • EBV-DNA viral load in the peripheral blood > 500 copies/mL
  • Informed consent obtained.

Exclusion criteria

Exclusion Criteria:

  • refuse to participate.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
30 participants (estimated)
Target follow-up
2 Months
Patient registry
Yes

Groups and cohorts

  • survival group

    Patients who survived 2 months after treatment.

    Other: observational

  • death group

    Patients who died 2 months after treatment.

    Other: observational

Interventions

  • Otherobservational

    This study is an observational study without any intervention.

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What researchers measure

Primary outcomes

  1. Difference in metabonomics pattern between subgroups

    Compare metabonomics pattern of the survival group with that of the death group, identify potential predictors of outcomes, and establish a survival prediction model in patients with EBV-HLH. Measure metabolite levels.

    Time frame: 2 months

  2. Difference in cytokine pattern between subgroups

    Compare metabonomics and cytokine pattern of the survival group with that of the death group, identify potential predictors of outcomes, and establish a survival prediction model in patients with EBV-HLH. Measure cytokine levels.

    Time frame: 2 months

07

Study locations

1 site
  • Beijing Friendship Hospital, Capital Medical University
    Beijing, Beijing 100050, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05677178
Lead sponsor
Beijing Friendship Hospital
Responsible party
Zhao Wang (Head of the hematology department, Beijing Friendship Hospital) — Principal investigator
First posted
Jan 10, 2023
Start date
Jan 1, 2023 (estimated)
Primary completion
Dec 1, 2024 (estimated)
Completion
Mar 1, 2025 (estimated)
Last update
Jan 10, 2023

Study contacts

Zhao Wang, MD
Contact
wangzhao@ccmu.edu.cn
+861083138303
Zhao Wang, MD
principal investigator · Beijing Friendship Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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