NCT07339345 Prospective Single-Arm Clinical Trial of GO Regimen for HLH.
| NCT ID | NCT07339345 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Beijing Friendship Hospital |
| Condition | Lymphohistiocytosis, Hemophagocytic |
| Study Type | INTERVENTIONAL |
| Enrollment | 28 participants |
| Start Date | 2025-06-27 |
| Primary Completion | 2026-06-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 28 participants in total. It began in 2025-06-27 with a primary completion date of 2026-06-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to investigate the efficacy and safety of Golidocitinib(GO) monotherapy in the treatment of hemophagocytic lymphohistiocytosis.
Eligibility Criteria
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.
Contact & Investigator
zhao Wang
PRINCIPAL INVESTIGATOR
Beijing Friendship Hospital
Frequently Asked Questions
Who can join the NCT07339345 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 70 Years, studying Lymphohistiocytosis, Hemophagocytic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07339345 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07339345 currently recruiting?
Yes, NCT07339345 is actively recruiting participants. Contact the research team at wangjingshi987@126.com for enrollment information.
Where is the NCT07339345 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07339345 clinical trial?
NCT07339345 is sponsored by Beijing Friendship Hospital. The principal investigator is zhao Wang at Beijing Friendship Hospital. The trial plans to enroll 28 participants.