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To evaluate the efficacy and safety of QL0911 to prevention chemotherapy-induced thrombocytopenia. Thrombocytopenia is a low number of platelets in the blood. Sometimes, thrombocytopenia occurs as a side effect of chemotherapy treatments.
For the phase III study, a double-blind randomized, placebo controlled, parallel-group design will be conducted to evaluate the efficacy and safety of QL0911 . Each subject will be randomly assigned to either Arm A (QL0911) or Arm B (placebo) in 2:1 ratio.The primary objective is to compare the effective rates of the two treatment arms. The study will consist of a screening period of up to 4 weeks, a treatment period of 2 planned cycles of chemotherapy, a follow-up visit of 2 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QL0911 | Experimental | The study in a 2:1 randomization ratio(40 subjects to QL0911). Qilu investigational product (QL0911 or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection. |
|
| Placebo | Placebo Comparator | The study in a 2:1 randomization ratio(20 subjects to Placebo ). Qilu investigational product (QL0911 or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QL0911 | Drug | This study is designed to study QL0911 for the treatment of chemotherapy-induced thrombocytopenia (CIT) in patients receiving chemotherapy for cancer |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who had an efficacy response during the double-blind period | 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Lowest and highest platelet count | 42 days | |
| Bleeding score(Revised WHO grading system) | 42 days | |
| Proportion of patients with platelet count < 50×10^9/L per cycle |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai East Hospital | Shanghai | Shanghai Municipality | 200120 | China |
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| Placebo | Drug | Placebo comparator |
|
| 42 days |