Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03673085 | Clinical Study of CN128 in Thalassemia Patients | PHASE1 | COMPLETED | 32 | — | — | Jan 5, 2018 | Dec 17, 2019 | Dec 19, 2019 | 1 | China |
Vital signs checks
Vital signs checks; determine the patient's pulse which is one kind of physiological parameter
Vital signs checks; determine the patient's respiration which is one kind of physiological parameter
Vital signs checks; both systolic and diastolic will be measured
Physical examination
Physical examination
Physical examination
Laboratory test: WBC, RBC, NEUT, BASO, etc.
Laboratory test: colour, appearance, glucose, protein, ketone, bilirubin, leukocyte, blood, and microscopic
Laboratory test: ALT, AST, ALP, LDH, AMS, BUN, ALB, etc.
Laboratory test: Serum iron
Laboratory test: fibrinogen, prothrombin time and corresponding INR, APTT
Laboratory test: heart rate and QTc
Adverse events
Pharmacokinetics parameters
Pharmacokinetics parameters
Pharmacokinetics parameters
Pharmacokinetics parameters
Pharmacokinetics parameters
Pharmacokinetics parameters
Pharmacokinetics parameters: mean residence time
| Arm | Type | Description |
|---|---|---|
| Group 1-1 | EXPERIMENTAL | The dose of CN128 is 2.5 mg/kg bw. |
| Group 1-2 | PLACEBO_COMPARATOR | The dose of placebo is 2.5 mg/kg bw. |
| Group 2-1 | EXPERIMENTAL | The dose of CN128 is 5 mg/kg bw. |
| Group 2-2 | PLACEBO_COMPARATOR | The dose of placebo is 5 mg/kg bw. |
| Group 3-1 | EXPERIMENTAL | The dose of CN128 is 10 mg/kg bw. |
| Group 3-2 | PLACEBO_COMPARATOR | The dose of placebo is 10 mg/kg bw. |
| Group 4-1 | EXPERIMENTAL | The dose of CN128 is 15 mg/kg bw. |
| Group 4-2 | PLACEBO_COMPARATOR | The dose of placebo is 15 mg/kg bw. |
| Group 5-1 | EXPERIMENTAL | The dose of CN128 is 20 mg/kg bw. |
| Group 5-2 | PLACEBO_COMPARATOR | The dose of placebo is 20 mg/kg bw. |
| Group 6-1 | EXPERIMENTAL | The dose of CN128 is 30 mg/kg bw. |
| Group 6-2 | PLACEBO_COMPARATOR | The dose of placebo is 30 mg/kg bw. |
| Group 7-1 | EXPERIMENTAL | The dose of CN128 is 45 mg/kg bw. |
| Group 7-2 | PLACEBO_COMPARATOR | The dose of placebo is 45 mg/kg bw. |
| Group 8-1 | EXPERIMENTAL | The dose of CN128 is 60 mg/kg bw. |
| Group 8-2 | PLACEBO_COMPARATOR | The dose of placebo is 60 mg/kg bw. |
| Name | Type | Description |
|---|---|---|
| CN128 | DRUG | CN128 |
| placebo | OTHER | The tablets without CN128 |
Subject inclusion criteria: * Thalassemia patients with serum ferritin ≥500 μg/L * Patients aged 16 and above * Without blood transfusion within 1 week before admission, with hemoglobin ≥ 80 g/L * Voluntarily participate in the experiment, and the process of obtaining informed consent form meeting ...
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| Vertex Pharmaceuticals Incorporated | VRTX | 3 | PHASE3 | CTX001 |
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| Editas Medicine, Inc. | EDIT | 2 | PHASE1 | EDIT-301 |
| Illumina, Inc. | ILMN | 1 | — | Undisclosed |