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QL0911 for the Treatment of Cancer Treatment-Induced Thrombocytopenia
RECRUITINGPhase 2/3Sponsored by Qilu Pharmaceutical Co., Ltd.
Actively Recruiting
PhasePhase 2/3
SponsorQilu Pharmaceutical Co., Ltd.
Started2024-10-22
Est. completion2026-07
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06456528
Summary
To evaluate the efficacy and safety of QL0911 in cancer treatment-induced thrombocytopenia. Thrombocytopenia is a low number of platelets in the blood. Sometimes, thrombocytopenia is a side effect of cancer treatment.
Eligibility
Age: 18 Years – 75 YearsHealthy volunteers accepted
Inclusion Criteria: * Men and women, 18-75 years of age; * Histopathological or cytological examination confirmed cancer , chemotherapy cycle of 21 days; * Participant experienced thrombocytopenia and chemotherapy delay; * ECOG performance status 0-1; * The estimated survival time at screening is ≥12 weeks, and the current chemotherapy regimen can be accepted for at least 2 cycles. Exclusion Criteria: * Participant has any history of hematologic diseases other than chemotherapy-induced thrombocytopenia; * Participant has serious bleeding symptoms; * History of allergy to the study drug; * Patients with hepatitis C antibody positive and detection of HCV-RNA exceeding the upper limit, patients with hepatitis B surface antigen positive and detection of HBV-DNA exceeding the upper limit, patients with severe cirrhosis, HIV antibody positive and syphilis antibody positive; * Pregnant or lactating women; * Participant has received any experimental therapy within 28 days prior to screening * Other conditions that may affect participant's safety or trial evaluations per investigator's discretion
Conditions2
CancerCancer Treatment Induced Thrombocytopenia
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Actively Recruiting
PhasePhase 2/3
SponsorQilu Pharmaceutical Co., Ltd.
Started2024-10-22
Est. completion2026-07
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06456528