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Clinical Trials in China / NCT07339345
Recruiting Phase 2/3

Prospective Single-Arm Clinical Trial of GO Regimen for HLH.

NCT07339345 · tracked via the Priya Life Science China tracker
Sponsor
Beijing Friendship Hospital
Phase
Phase 2/3
Started
2025-06-27
Last updated
2026-01-14

Condition(s) studied

Lymphohistiocytosis, Hemophagocytic

Investigational drug(s) / intervention(s)

Golidocitinib →

Golidocitinib: Administer the GO regimen to HLH patients who meet the inclusion criteria, specifically Golicitinib 150 mg once daily.

Study summary

This study aims to investigate the efficacy and safety of Golidocitinib(GO) monotherapy in the treatment of hemophagocytic lymphohistiocytosis.

Eligibility

Sex
ALL
Min age
14 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: 1. Researchers evaluate patients with newly diagnosed or refractory/relapsed HLH disease. 2. Definite diagnosis of HLH: molecular diagnosis consistent with pHLH, or at least 5 of the 8 criteria in the HLH-2004 diagnostic criteria. 3. Patients who are currently unsuitable or unable to undergo allo-HSCT. 4. Researchers estimate that the expected survival period exceeds one month. 5. Patients must be at least 14 years of age and no older than 70 years of age, with no gender restrictions. 6. Before the study began, TB was ≤10 times the upper limit of normal; Cr was ≤1.5 times the normal value. 7. Serum HIV antigen or antibody negative。 8. HCV antibody negative, or HCV antibody positive but HCV RNA negative. 9. .HBsAg and HBcAb are both negative. If either of the above is positive, peripheral blood hepatitis B virus DNA titer testing is required, with a titer of less than 1×10³ copies/ml. 10. Echocardiography showed LVEF ≥ 50%. 11. Women of childbearing age must be confirmed as not pregnant by a pregnancy test and must be willing to use effective contraception during the study period and for at least 12 months after the last dose; all male participants must use contraception during the study period and for at least 3 months after the last dose. Exclusion Criteria: 1. Heart function above grade II(including II) (NYHA). 2. Pregnancy or lactating Women and reproductive-age patients who refused to use appropriate contraceptive measures during this trial. 3. Individuals who are allergic to GO or have a severe allergic constitution. 4. Active bleeding of the internal organs. 5. uncontrollable infection. 6. Severe mental illness. 7. History of non-melanoma skin cancer. 8. Unable to comply during the trial and/or follow-up phase. Participate in other clinical research at the same time.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
beijing Friendship Hospital, Capital Medical University Beijing Beijing Municipality Recruiting

More Beijing Friendship Hospital trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07339345 on ClinicalTrials.gov ↗ ← All trials in China