QL0911 for the Treatment of Cancer Treatment-Induced Thrombocytopenia
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorQilu Pharmaceutical Co., Ltd.
About this trial
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 criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- QL0911
- QL0911 plus Placebo
- Placebo
Treatment groups
235 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov