| Primary | ORR at 6 Months: Overall Response Rate (ORR) Defined as the Number of Participants Who Met the Criteria of Either Complete Response (CR) or Partial Response (PR) at Week 26 | ORR will be calculated after 6 months of eltrombopag administration by measuring platelet, reticulocyte, neutrophil and transfusion independence. ORR includes Complete Response (CR) and Partial Response (PR) Rate. | Full analysis set; population obtained by excluding subjects: Eltrombopag was never administered to the subject during the study, subject had no baseline data: platelet count, hemoglobin, neutrophil count, and transfusion,subject had no data after the start of rabbit ATG therapy: platelet count, hemoglobin, neutrophil count, and transfusion. | Posted | | Count of Participants | | Participants | | Week 26 | | | | ID | Title | Description |
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| OG000 | Eltrombopag+Rabbit ATG/CsA Arm | Subjects received rabbit ATG diluted by 500 mL of saline or 5% glucose injection at a dose of 2.5 to 3.75 mg per kilogram (kg) per day for 5 days as a slow intravenous infusion over 6 hours. CsA was administered at a dose of 3 mg per kg twice a day from day 0. The dose level was adjusted based on the monitoring of blood level or renal function. Eltrombopag was initiated on day 14 and it could be delayed up to 2 weeks if the subject had infection, serum sickness, or other adverse events. Eltrombopag was administered orally once a day at fasting at an initial dose of 75 mg, and the dose adjusted every 2 weeks according to the platelet count. Eltrombopag and CsA were continued until Week 26. After Week 26, eligible subjects received eltrombopag; and CsA was tapered or maintained as per the investigator's discretion. |
| | | Title | Denominators | Categories |
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| CR+PR | | | | CR | | | | PR | | |
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| Secondary | ORR at 3 Months | ORR will be calculated after 3 months of eltrombopag administration by measuring platelet, reticulocyte, neutrophil and transfusion independence. | Full analysis set; population obtained by excluding subjects: Eltrombopag was never administered to the subject during the study, subject had no baseline data: platelet count, hemoglobin, neutrophil count, and transfusion,subject had no data after the start of rabbit ATG therapy: platelet count, hemoglobin, neutrophil count, and transfusion. | Posted | | Count of Participants | | Participants | | Week 14 | | | | ID | Title | Description |
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| OG000 | Eltrombopag+Rabbit ATG/CsA Arm | Subjects received rabbit ATG diluted by 500 mL of saline or 5% glucose injection at a dose of 2.5 to 3.75 mg per kilogram (kg) per day for 5 days as a slow intravenous infusion over 6 hours. CsA was administered at a dose of 3 mg per kg twice a day from day 0. The dose level was adjusted based on the monitoring of blood level or renal function. Eltrombopag was initiated on day 14 and it could be delayed up to 2 weeks if the subject had infection, serum sickness, or other adverse events. Eltrombopag was administered orally once a day at fasting at an initial dose of 75 mg, and the dose adjusted every 2 weeks according to the platelet count. Eltrombopag and CsA were continued until Week 26. After Week 26, eligible subjects received eltrombopag; and CsA was tapered or maintained as per the investigator's discretion. |
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| Secondary | Complete Response (CR), and Partial Response (PR) Rate at 3 Months | CR and PR will be calculated after 3 months of eltrombopag administration by measuring platelet, reticulocyte, neutrophil and transfusion independence. | Full analysis set; population obtained by excluding subjects: Eltrombopag was never administered to the subject during the study, subject had no baseline data: platelet count, hemoglobin, neutrophil count, and transfusion,subject had no data after the start of rabbit ATG therapy: platelet count, hemoglobin, neutrophil count, and transfusion. | Posted | | Count of Participants | | Participants | | Week 14 | | | | ID | Title | Description |
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| OG000 | Eltrombopag+Rabbit ATG/CsA Arm | Subjects received rabbit ATG diluted by 500 mL of saline or 5% glucose injection at a dose of 2.5 to 3.75 mg per kilogram (kg) per day for 5 days as a slow intravenous infusion over 6 hours. CsA was administered at a dose of 3 mg per kg twice a day from day 0. The dose level was adjusted based on the monitoring of blood level or renal function. Eltrombopag was initiated on day 14 and it could be delayed up to 2 weeks if the subject had infection, serum sickness, or other adverse events. Eltrombopag was administered orally once a day at fasting at an initial dose of 75 mg, and the dose adjusted every 2 weeks according to the platelet count. Eltrombopag and CsA were continued until Week 26. After Week 26, eligible subjects received eltrombopag; and CsA was tapered or maintained as per the investigator's discretion. |
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| Secondary | CR Rate Based on the Criteria Used in NIH 12-H-0150 Study at 6 Months | CR criteria used in NIH 12-H-150 study is as follows: Hemoglobin >10 gram (g)/ deciliter (dL), and Absolute neutrophil count (ANC) >1,000/microliter, and Platelets >100,000/microliter. | Full analysis set; population obtained by excluding subjects: Eltrombopag was never administered to the subject during the study, subject had no baseline data: platelet count, hemoglobin, neutrophil count, and transfusion,subject had no data after the start of rabbit ATG therapy: platelet count, hemoglobin, neutrophil count, and transfusion. | Posted | | Count of Participants | | Participants | | Week 26 | | | | ID | Title | Description |
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| OG000 | Eltrombopag+Rabbit ATG/CsA Arm | Subjects received rabbit ATG diluted by 500 mL of saline or 5% glucose injection at a dose of 2.5 to 3.75 mg per kilogram (kg) per day for 5 days as a slow intravenous infusion over 6 hours. CsA was administered at a dose of 3 mg per kg twice a day from day 0. The dose level was adjusted based on the monitoring of blood level or renal function. Eltrombopag was initiated on day 14 and it could be delayed up to 2 weeks if the subject had infection, serum sickness, or other adverse events. Eltrombopag was administered orally once a day at fasting at an initial dose of 75 mg, and the dose adjusted every 2 weeks according to the platelet count. Eltrombopag and CsA were continued until Week 26. After Week 26, eligible subjects received eltrombopag; and CsA was tapered or maintained as per the investigator's discretion. |
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| Secondary | Changes in Hematology Parameters (Haemoglobin) in the Absence of Platelet Transfusion | The change in hematology values ( haemoglobin) were evaluated. | Full analysis set; population obtained by excluding subjects: Eltrombopag was never administered to the subject during the study, subject had no baseline data: platelet count, hemoglobin, neutrophil count, and transfusion,subject had no data after the start of rabbit ATG therapy: platelet count, hemoglobin, neutrophil count, and transfusion. | Posted | | Mean | Standard Deviation | g/L | | Week 26 and week 104 | | | | ID | Title | Description |
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| OG000 | Eltrombopag+Rabbit ATG/CsA Arm | Subjects received rabbit ATG diluted by 500 mL of saline or 5% glucose injection at a dose of 2.5 to 3.75 mg per kilogram (kg) per day for 5 days as a slow intravenous infusion over 6 hours. CsA was administered at a dose of 3 mg per kg twice a day from day 0. The dose level was adjusted based on the monitoring of blood level or renal function. Eltrombopag was initiated on day 14 and it could be delayed up to 2 weeks if the subject had infection, serum sickness, or other adverse events. Eltrombopag was administered orally once a day at fasting at an initial dose of 75 mg, and the dose adjusted every 2 weeks according to the platelet count. Eltrombopag and CsA were continued until Week 26. After Week 26, eligible subjects received eltrombopag; and CsA was tapered or maintained as per the investigator's discretion. |
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| Secondary | Changes in Hematology Parameters in the Absence of Platelet Transfusion | The change in hematology values from baseline for platelets, neutrophils and reticulocytes were evaluated. | Full analysis set; population obtained by excluding subjects: Eltrombopag was never administered to the subject during the study, subject had no baseline data: platelet count, hemoglobin, neutrophil count, and transfusion,subject had no data after the start of rabbit ATG therapy: platelet count, hemoglobin, neutrophil count, and transfusion. | Posted | | Mean | Standard Deviation | Gi/L | | Week 26 and week 104 | | | | ID | Title | Description |
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| OG000 | Eltrombopag+Rabbit ATG/CsA Arm | Subjects received rabbit ATG diluted by 500 mL of saline or 5% glucose injection at a dose of 2.5 to 3.75 mg per kilogram (kg) per day for 5 days as a slow intravenous infusion over 6 hours. CsA was administered at a dose of 3 mg per kg twice a day from day 0. The dose level was adjusted based on the monitoring of blood level or renal function. Eltrombopag was initiated on day 14 and it could be delayed up to 2 weeks if the subject had infection, serum sickness, or other adverse events. Eltrombopag was administered orally once a day at fasting at an initial dose of 75 mg, and the dose adjusted every 2 weeks according to the platelet count. Eltrombopag and CsA were continued until Week 26. After Week 26, eligible subjects received eltrombopag; and CsA was tapered or maintained as per the investigator's discretion. |
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| Secondary | Frequency of Platelet and Red Blood Cells (RBC) Transfusions | RBC transfusion dependency defined as at least one RBC transfusion within 8 weeks prior to D1. Platelet or RBC transfusions will be based on physician's subjective judgement. Platelet transfusion will be done if the platelet count is less than 10×10^9/liter (L) with significant bleeding tendency or the platelet count is less than 20×10^9/L with pyrexia. RBC transfusion will be done to keep the hemoglobin concentration at over 7 g/dL or in the presence of clinical symptoms such as dyspnea. | full analysis set, participants who were transfusion dependant | Posted | | Mean | Standard Deviation | mean of transfusions number | | Baseline, Week 26 | | | | ID | Title | Description |
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| OG000 | Eltrombopag+Rabbit ATG/CsA Arm | Subjects received rabbit ATG diluted by 500 mL of saline or 5% glucose injection at a dose of 2.5 to 3.75 mg per kilogram (kg) per day for 5 days as a slow intravenous infusion over 6 hours. CsA was administered at a dose of 3 mg per kg twice a day from day 0. The dose level was adjusted based on the monitoring of blood level or renal function. Eltrombopag was initiated on day 14 and it could be delayed up to 2 weeks if the subject had infection, serum sickness, or other adverse events. Eltrombopag was administered orally once a day at fasting at an initial dose of 75 mg, and the dose adjusted every 2 weeks according to the platelet count. Eltrombopag and CsA were continued until Week 26. After Week 26, eligible subjects received eltrombopag; and CsA was tapered or maintained as per the investigator's discretion. |
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| Secondary | Volume of Platelet and RBC Transfusions | Platelet or RBC transfusions will be based on physician's subjective judgement. Platelet transfusion will be done if the platelet count is less than 10×10^9/L with significant bleeding tendency or the platelet count is less than 20×10^9/L with pyrexia. RBC transfusion will be done to keep the hemoglobin concentration at over 7 g/dL or in the presence of clinical symptoms such as dyspnea. | Full analysis set, patients who were transfusion dependent | Posted | | Mean | Standard Deviation | mL | | Baseline, Week 26 | | | | ID | Title | Description |
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| OG000 | Eltrombopag+Rabbit ATG/CsA Arm | Subjects received rabbit ATG diluted by 500 mL of saline or 5% glucose injection at a dose of 2.5 to 3.75 mg per kilogram (kg) per day for 5 days as a slow intravenous infusion over 6 hours. CsA was administered at a dose of 3 mg per kg twice a day from day 0. The dose level was adjusted based on the monitoring of blood level or renal function. Eltrombopag was initiated on day 14 and it could be delayed up to 2 weeks if the subject had infection, serum sickness, or other adverse events. Eltrombopag was administered orally once a day at fasting at an initial dose of 75 mg, and the dose adjusted every 2 weeks according to the platelet count. Eltrombopag and CsA were continued until Week 26. After Week 26, eligible subjects received eltrombopag; and CsA was tapered or maintained as per the investigator's discretion. |
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| Secondary | The Proportion of Subjects Whose Transfusion Unit (or Volume) Are Decreased or Who Became Transfusion (Platelet, RBC) Independent | The proportions of the subjects for whom the amount of blood transfusion (platelets and RBC) decreased or the proportions of the subjects for whom blood transfusion (platelets and RBC) became unnecessary. Platelet transfusion will be done if the platelet count is less than 10×10^9/L with significant bleeding tendency or the platelet count is less than 20×10^9/L with pyrexia. RBC transfusion will be done to keep the hemoglobin concentration at over 7 g/dL or in the presence of clinical symptoms such as dyspnea. | Full analysis set; population obtained by excluding subjects: Eltrombopag was never administered to the subject during the study, subject had no baseline data: platelet count, hemoglobin, neutrophil count, and transfusion,subject had no data after the start of rabbit ATG therapy: platelet count, hemoglobin, neutrophil count, and transfusion. | Posted | | Count of Participants | | Participants | | Week 26 | | | | ID | Title | Description |
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| OG000 | Eltrombopag+Rabbit ATG/CsA Arm | Subjects received rabbit ATG diluted by 500 mL of saline or 5% glucose injection at a dose of 2.5 to 3.75 mg per kilogram (kg) per day for 5 days as a slow intravenous infusion over 6 hours. CsA was administered at a dose of 3 mg per kg twice a day from day 0. The dose level was adjusted based on the monitoring of blood level or renal function. Eltrombopag was initiated on day 14 and it could be delayed up to 2 weeks if the subject had infection, serum sickness, or other adverse events. Eltrombopag was administered orally once a day at fasting at an initial dose of 75 mg, and the dose adjusted every 2 weeks according to the platelet count. Eltrombopag and CsA were continued until Week 26. After Week 26, eligible subjects received eltrombopag; and CsA was tapered or maintained as per the investigator's discretion. |
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| Secondary | Duration of Hospitalization | Duration of hospitalization is the time period from the administration of ATG up to discharge. | Full analysis set; population obtained by excluding subjects: Eltrombopag was never administered to the subject during the study, subject had no baseline data: platelet count, hemoglobin, neutrophil count, and transfusion,subject had no data after the start of rabbit ATG therapy: platelet count, hemoglobin, neutrophil count, and transfusion. | Posted | | Median | Full Range | days | | Week 26 | | | | ID | Title | Description |
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| OG000 | Eltrombopag+Rabbit ATG/CsA Arm | Subjects received rabbit ATG diluted by 500 mL of saline or 5% glucose injection at a dose of 2.5 to 3.75 mg per kilogram (kg) per day for 5 days as a slow intravenous infusion over 6 hours. CsA was administered at a dose of 3 mg per kg twice a day from day 0. The dose level was adjusted based on the monitoring of blood level or renal function. Eltrombopag was initiated on day 14 and it could be delayed up to 2 weeks if the subject had infection, serum sickness, or other adverse events. Eltrombopag was administered orally once a day at fasting at an initial dose of 75 mg, and the dose adjusted every 2 weeks according to the platelet count. Eltrombopag and CsA were continued until Week 26. After Week 26, eligible subjects received eltrombopag; and CsA was tapered or maintained as per the investigator's discretion. |
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| Secondary | Time to Onset of CR and PR | The time to onset of CR and PR will be determined by measuring platelet, reticulocyte, neutrophil and transfusion independence. | Full analysis set; population obtained by excluding subjects: Eltrombopag was never administered to the subject during the study, subject had no baseline data: platelet count, hemoglobin, neutrophil count, and transfusion,subject had no data after the start of rabbit ATG therapy: platelet count, hemoglobin, neutrophil count, and transfusion. | Posted | | Median | Full Range | months | | Week 26 | | | | ID | Title | Description |
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| OG000 | Eltrombopag+Rabbit ATG/CsA Arm | Subjects received rabbit ATG diluted by 500 mL of saline or 5% glucose injection at a dose of 2.5 to 3.75 mg per kilogram (kg) per day for 5 days as a slow intravenous infusion over 6 hours. CsA was administered at a dose of 3 mg per kg twice a day from day 0. The dose level was adjusted based on the monitoring of blood level or renal function. Eltrombopag was initiated on day 14 and it could be delayed up to 2 weeks if the subject had infection, serum sickness, or other adverse events. Eltrombopag was administered orally once a day at fasting at an initial dose of 75 mg, and the dose adjusted every 2 weeks according to the platelet count. Eltrombopag and CsA were continued until Week 26. After Week 26, eligible subjects received eltrombopag; and CsA was tapered or maintained as per the investigator's discretion. |
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| Secondary | Duration of CR or PR | Duration for CR or PR will be determined by measuring platelet, reticulocyte, neutrophil and transfusion independence. | Number of participants who responded to treatment (7 out of the 10 participants) | Posted | | Median | Full Range | months | | Week 104 | | | | ID | Title | Description |
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| OG000 | Eltrombopag+Rabbit ATG/CsA Arm | Subjects received rabbit ATG diluted by 500 mL of saline or 5% glucose injection at a dose of 2.5 to 3.75 mg per kilogram (kg) per day for 5 days as a slow intravenous infusion over 6 hours. CsA was administered at a dose of 3 mg per kg twice a day from day 0. The dose level was adjusted based on the monitoring of blood level or renal function. Eltrombopag was initiated on day 14 and it could be delayed up to 2 weeks if the subject had infection, serum sickness, or other adverse events. Eltrombopag was administered orally once a day at fasting at an initial dose of 75 mg, and the dose adjusted every 2 weeks according to the platelet count. Eltrombopag and CsA were continued until Week 26. After Week 26, eligible subjects received eltrombopag; and CsA was tapered or maintained as per the investigator's discretion. |
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| Secondary | Degree of Exposure to Eltrombopag : Average Daily Dose | | safety population:The safety population consisted of all subjects who received at least one dose of eltrombopag. | Posted | | Mean | Standard Deviation | mg/day | | Week 104 | | | | ID | Title | Description |
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| OG000 | Eltrombopag+Rabbit ATG/CsA Arm | Subjects received rabbit ATG diluted by 500 mL of saline or 5% glucose injection at a dose of 2.5 to 3.75 mg per kilogram (kg) per day for 5 days as a slow intravenous infusion over 6 hours. CsA was administered at a dose of 3 mg per kg twice a day from day 0. The dose level was adjusted based on the monitoring of blood level or renal function. Eltrombopag was initiated on day 14 and it could be delayed up to 2 weeks if the subject had infection, serum sickness, or other adverse events. Eltrombopag was administered orally once a day at fasting at an initial dose of 75 mg, and the dose adjusted every 2 weeks according to the platelet count. Eltrombopag and CsA were continued until Week 26. After Week 26, eligible subjects received eltrombopag; and CsA was tapered or maintained as per the investigator's discretion. |
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| Secondary | Degree of Exposure to Eltrombopag : Cumulative Dose | The cumulative dose of drug administered to the subject will be calculated. | safety population:The safety population consisted of all subjects who received at least one dose of eltrombopag. | Posted | | Mean | Standard Deviation | mg | | Week 104 | | | | ID | Title | Description |
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| OG000 | Eltrombopag+Rabbit ATG/CsA Arm | Subjects received rabbit ATG diluted by 500 mL of saline or 5% glucose injection at a dose of 2.5 to 3.75 mg per kilogram (kg) per day for 5 days as a slow intravenous infusion over 6 hours. CsA was administered at a dose of 3 mg per kg twice a day from day 0. The dose level was adjusted based on the monitoring of blood level or renal function. Eltrombopag was initiated on day 14 and it could be delayed up to 2 weeks if the subject had infection, serum sickness, or other adverse events. Eltrombopag was administered orally once a day at fasting at an initial dose of 75 mg, and the dose adjusted every 2 weeks according to the platelet count. Eltrombopag and CsA were continued until Week 26. After Week 26, eligible subjects received eltrombopag; and CsA was tapered or maintained as per the investigator's discretion. |
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| Secondary | Degree of Exposure to Eltrombopag : Days on Study | | safety population:The safety population consisted of all subjects who received at least one dose of eltrombopag. | Posted | | Mean | Standard Deviation | days | | Week 104 | | | | ID | Title | Description |
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| OG000 | Eltrombopag+Rabbit ATG/CsA Arm | Subjects received rabbit ATG diluted by 500 mL of saline or 5% glucose injection at a dose of 2.5 to 3.75 mg per kilogram (kg) per day for 5 days as a slow intravenous infusion over 6 hours. CsA was administered at a dose of 3 mg per kg twice a day from day 0. The dose level was adjusted based on the monitoring of blood level or renal function. Eltrombopag was initiated on day 14 and it could be delayed up to 2 weeks if the subject had infection, serum sickness, or other adverse events. Eltrombopag was administered orally once a day at fasting at an initial dose of 75 mg, and the dose adjusted every 2 weeks according to the platelet count. Eltrombopag and CsA were continued until Week 26. After Week 26, eligible subjects received eltrombopag; and CsA was tapered or maintained as per the investigator's discretion. |
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| Secondary | Number of Participants With Adverse Events | Adverse events will be collected from the start of study treatment until the approval. | safety population:The safety population consisted of all subjects who received at least one dose of eltrombopag. | Posted | | Count of Participants | | Participants | | though study completion , approximately 2 years | | | | ID | Title | Description |
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| OG000 | Eltrombopag+Rabbit ATG/CsA Arm | Subjects received rabbit ATG diluted by 500 mL of saline or 5% glucose injection at a dose of 2.5 to 3.75 mg per kilogram (kg) per day for 5 days as a slow intravenous infusion over 6 hours. CsA was administered at a dose of 3 mg per kg twice a day from day 0. The dose level was adjusted based on the monitoring of blood level or renal function. Eltrombopag was initiated on day 14 and it could be delayed up to 2 weeks if the subject had infection, serum sickness, or other adverse events. Eltrombopag was administered orally once a day at fasting at an initial dose of 75 mg, and the dose adjusted every 2 weeks according to the platelet count. Eltrombopag and CsA were continued until Week 26. After Week 26, eligible subjects received eltrombopag; and CsA was tapered or maintained as per the investigator's discretion. |
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| Secondary | Vital Signs (Blood Pressure) as a Measure of Safety and Tolerability | Vital sign measurements : blood pressure | safety set:The safety population consisted of all subjects who received at least one dose of eltrombopag. | Posted | | Mean | Standard Deviation | mmHg | | baseline and Week 26 | | | | ID | Title | Description |
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| OG000 | Eltrombopag+Rabbit ATG/CsA Arm | Subjects received rabbit ATG diluted by 500 mL of saline or 5% glucose injection at a dose of 2.5 to 3.75 mg per kilogram (kg) per day for 5 days as a slow intravenous infusion over 6 hours. CsA was administered at a dose of 3 mg per kg twice a day from day 0. The dose level was adjusted based on the monitoring of blood level or renal function. Eltrombopag was initiated on day 14 and it could be delayed up to 2 weeks if the subject had infection, serum sickness, or other adverse events. Eltrombopag was administered orally once a day at fasting at an initial dose of 75 mg, and the dose adjusted every 2 weeks according to the platelet count. Eltrombopag and CsA were continued until Week 26. After Week 26, eligible subjects received eltrombopag; and CsA was tapered or maintained as per the investigator's discretion. |
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| Secondary | 12-lead Electrocardiogram (ECG) as Measure of Safety and Tolerability | Triplicate 12-lead ECGs will be obtained at designated time points during the study using an ECG machine that calculates the heart rate and measures PR, QRS, QT, and QT interval corrected by Fridericia formula (QTcF) intervals. | safety population: The safety population consisted of all subjects who received at least one dose of eltrombopag. | Posted | | Count of Participants | | Participants | | Baseline, Week 26 | | | | ID | Title | Description |
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| OG000 | Eltrombopag+Rabbit ATG/CsA Arm | Subjects received rabbit ATG diluted by 500 mL of saline or 5% glucose injection at a dose of 2.5 to 3.75 mg per kilogram (kg) per day for 5 days as a slow intravenous infusion over 6 hours. CsA was administered at a dose of 3 mg per kg twice a day from day 0. The dose level was adjusted based on the monitoring of blood level or renal function. Eltrombopag was initiated on day 14 and it could be delayed up to 2 weeks if the subject had infection, serum sickness, or other adverse events. Eltrombopag was administered orally once a day at fasting at an initial dose of 75 mg, and the dose adjusted every 2 weeks according to the platelet count. Eltrombopag and CsA were continued until Week 26. After Week 26, eligible subjects received eltrombopag; and CsA was tapered or maintained as per the investigator's discretion. |
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| Secondary | The Trough Concentrations of Eltrombopag Following Repeat Doses of at 75 mg, 50 mg and 25 mg | Blood samples will be collected after repeat (14 days) doses of eltrombopag 75, 50, 25 mg to determine the plasma eltrombopag concentration prior to the next dose. | pharmacokinetic population:The PK population was defined as all subjects whose PK samples were collected and measured. | Posted | | Mean | Standard Deviation | ng/mL | | day 15 | | | | ID | Title | Description |
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| OG000 | Eltrombopag+Rabbit ATG/CsA Arm | Subjects received rabbit ATG diluted by 500 mL of saline or 5% glucose injection at a dose of 2.5 to 3.75 mg per kilogram (kg) per day for 5 days as a slow intravenous infusion over 6 hours. CsA was administered at a dose of 3 mg per kg twice a day from day 0. The dose level was adjusted based on the monitoring of blood level or renal function. Eltrombopag was initiated on day 14 and it could be delayed up to 2 weeks if the subject had infection, serum sickness, or other adverse events. Eltrombopag was administered orally once a day at fasting at an initial dose of 75 mg, and the dose adjusted every 2 weeks according to the platelet count. Eltrombopag and CsA were continued until Week 26. After Week 26, eligible subjects received eltrombopag; and CsA was tapered or maintained as per the investigator's discretion. |
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| Secondary | The Concentration After 4 Hours of Dose of Eltrombopag 75 mg | Blood sample will be collected at 4 hours after repeat (14 days) dose of eltrombopag 75 mg | pharmacokinetic population: The PK population was defined as all subjects whose PK samples were collected and measured. | Posted | | Mean | Standard Deviation | ng/mL | | day 15 | | | | ID | Title | Description |
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| OG000 | Eltrombopag+Rabbit ATG/CsA Arm | Subjects received rabbit ATG diluted by 500 mL of saline or 5% glucose injection at a dose of 2.5 to 3.75 mg per kilogram (kg) per day for 5 days as a slow intravenous infusion over 6 hours. CsA was administered at a dose of 3 mg per kg twice a day from day 0. The dose level was adjusted based on the monitoring of blood level or renal function. Eltrombopag was initiated on day 14 and it could be delayed up to 2 weeks if the subject had infection, serum sickness, or other adverse events. Eltrombopag was administered orally once a day at fasting at an initial dose of 75 mg, and the dose adjusted every 2 weeks according to the platelet count. Eltrombopag and CsA were continued until Week 26. After Week 26, eligible subjects received eltrombopag; and CsA was tapered or maintained as per the investigator's discretion. |
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| Secondary | Composite of Laboratory Parameters Assessment as a Safety Measure (Haemoglobin and Albumin). | The laboratory test values (haemoglobin and albumin) were calculated at each time point of evaluation. | safety set:The safety population consisted of all subjects who received at least one dose of eltrombopag. | Posted | | Mean | Standard Deviation | g/L | | Baseline, Week 26 | | | | ID | Title | Description |
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| OG000 | Eltrombopag+Rabbit ATG/CsA Arm | Subjects received rabbit ATG diluted by 500 mL of saline or 5% glucose injection at a dose of 2.5 to 3.75 mg per kilogram (kg) per day for 5 days as a slow intravenous infusion over 6 hours. CsA was administered at a dose of 3 mg per kg twice a day from day 0. The dose level was adjusted based on the monitoring of blood level or renal function. Eltrombopag was initiated on day 14 and it could be delayed up to 2 weeks if the subject had infection, serum sickness, or other adverse events. Eltrombopag was administered orally once a day at fasting at an initial dose of 75 mg, and the dose adjusted every 2 weeks according to the platelet count. Eltrombopag and CsA were continued until Week 26. After Week 26, eligible subjects received eltrombopag; and CsA was tapered or maintained as per the investigator's discretion. |
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| Secondary | Composite of Laboratory Parameters Assessment as a Safety Measure (Lymphocytes and Neutrophils). | The laboratory test values (lymphocytes and neutrophils) were calculated at each time point of evaluation. | safety set:The safety population consisted of all subjects who received at least one dose of eltrombopag. | Posted | | Mean | Standard Deviation | Gi/L | | Baseline, Week 26 | | | | ID | Title | Description |
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| OG000 | Eltrombopag+Rabbit ATG/CsA Arm | Subjects received rabbit ATG diluted by 500 mL of saline or 5% glucose injection at a dose of 2.5 to 3.75 mg per kilogram (kg) per day for 5 days as a slow intravenous infusion over 6 hours. CsA was administered at a dose of 3 mg per kg twice a day from day 0. The dose level was adjusted based on the monitoring of blood level or renal function. Eltrombopag was initiated on day 14 and it could be delayed up to 2 weeks if the subject had infection, serum sickness, or other adverse events. Eltrombopag was administered orally once a day at fasting at an initial dose of 75 mg, and the dose adjusted every 2 weeks according to the platelet count. Eltrombopag and CsA were continued until Week 26. After Week 26, eligible subjects received eltrombopag; and CsA was tapered or maintained as per the investigator's discretion. |
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| Secondary | Composite of Laboratory Parameters Assessment as a Safety Measure (Alcaline Phosphatase and Aspartate Amino Transferase) . | The laboratory test values (Alcaline Phosphatase and Aspartate Amino Transferase) were calculated at each time point of evaluation. | safety set:The safety population consisted of all subjects who received at least one dose of eltrombopag. | Posted | | Mean | Standard Deviation | IU/L | | Baseline, Week 26 | | | | ID | Title | Description |
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| OG000 | Eltrombopag+Rabbit ATG/CsA Arm | Subjects received rabbit ATG diluted by 500 mL of saline or 5% glucose injection at a dose of 2.5 to 3.75 mg per kilogram (kg) per day for 5 days as a slow intravenous infusion over 6 hours. CsA was administered at a dose of 3 mg per kg twice a day from day 0. The dose level was adjusted based on the monitoring of blood level or renal function. Eltrombopag was initiated on day 14 and it could be delayed up to 2 weeks if the subject had infection, serum sickness, or other adverse events. Eltrombopag was administered orally once a day at fasting at an initial dose of 75 mg, and the dose adjusted every 2 weeks according to the platelet count. Eltrombopag and CsA were continued until Week 26. After Week 26, eligible subjects received eltrombopag; and CsA was tapered or maintained as per the investigator's discretion. |
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| Secondary | Composite of Laboratory Parameters Assessment as a Safety Measure. | The laboratory test values (hematological /biochemical examinations) were calculated at each time point of evaluation. | safety set:The safety population consisted of all subjects who received at least one dose of eltrombopag. | Posted | | Mean | Standard Deviation | umol/L | | Baseline, Week 26 | | | | ID | Title | Description |
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| OG000 | Eltrombopag+Rabbit ATG/CsA Arm | Subjects received rabbit ATG diluted by 500 mL of saline or 5% glucose injection at a dose of 2.5 to 3.75 mg per kilogram (kg) per day for 5 days as a slow intravenous infusion over 6 hours. CsA was administered at a dose of 3 mg per kg twice a day from day 0. The dose level was adjusted based on the monitoring of blood level or renal function. Eltrombopag was initiated on day 14 and it could be delayed up to 2 weeks if the subject had infection, serum sickness, or other adverse events. Eltrombopag was administered orally once a day at fasting at an initial dose of 75 mg, and the dose adjusted every 2 weeks according to the platelet count. Eltrombopag and CsA were continued until Week 26. After Week 26, eligible subjects received eltrombopag; and CsA was tapered or maintained as per the investigator's discretion. |
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| Secondary | Vital Signs (Temperature) as a Measure of Safety and Tolerability | Vital sign measurements : temperature | safety set:The safety population consisted of all subjects who received at least one dose of eltrombopag. | Posted | | Mean | Standard Deviation | °C | | baseline and Week 26 | | | | ID | Title | Description |
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| OG000 | Eltrombopag+Rabbit ATG/CsA Arm | Subjects received rabbit ATG diluted by 500 mL of saline or 5% glucose injection at a dose of 2.5 to 3.75 mg per kilogram (kg) per day for 5 days as a slow intravenous infusion over 6 hours. CsA was administered at a dose of 3 mg per kg twice a day from day 0. The dose level was adjusted based on the monitoring of blood level or renal function. Eltrombopag was initiated on day 14 and it could be delayed up to 2 weeks if the subject had infection, serum sickness, or other adverse events. Eltrombopag was administered orally once a day at fasting at an initial dose of 75 mg, and the dose adjusted every 2 weeks according to the platelet count. Eltrombopag and CsA were continued until Week 26. After Week 26, eligible subjects received eltrombopag; and CsA was tapered or maintained as per the investigator's discretion. |
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| Secondary | Vital Signs (Pulse Rate) as a Measure of Safety and Tolerability | Vital sign measurements : pulse rate. | safety set:The safety population consisted of all subjects who received at least one dose of eltrombopag. | Posted | | Mean | Standard Deviation | beats/min | | baseline and Week 26 | | | | ID | Title | Description |
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| OG000 | Eltrombopag+Rabbit ATG/CsA Arm | Subjects received rabbit ATG diluted by 500 mL of saline or 5% glucose injection at a dose of 2.5 to 3.75 mg per kilogram (kg) per day for 5 days as a slow intravenous infusion over 6 hours. CsA was administered at a dose of 3 mg per kg twice a day from day 0. The dose level was adjusted based on the monitoring of blood level or renal function. Eltrombopag was initiated on day 14 and it could be delayed up to 2 weeks if the subject had infection, serum sickness, or other adverse events. Eltrombopag was administered orally once a day at fasting at an initial dose of 75 mg, and the dose adjusted every 2 weeks according to the platelet count. Eltrombopag and CsA were continued until Week 26. After Week 26, eligible subjects received eltrombopag; and CsA was tapered or maintained as per the investigator's discretion. |
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