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

RecruitingPhase 2, Phase 3Ages 14 Years - 70 YearsAllBeijing Friendship Hospital
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In plain words

What the trial is, and whether it could suit you

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

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๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค10 times the upper limit of normal; Cr was โ‰ค1.5 times the normal value. 7. Serum HIV antigen or antibody negativeใ€‚ 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 1ร—10ยณ copies/ml. 10. Echocardiography showed LVEF โ‰ฅ 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.
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What it tests

  • Golidocitinib
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Where

1 site
beijing Friendship Hospital, Capital Medical University
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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