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The primary objective of this study is to evaluate the safety and tolerability of romiplostim in thrombocytopenic patients with ITP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Romiplostim 0.2 µg/kg | Experimental | Participants received 0.2 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts. |
|
| Part A: Romiplostim 0.5 µg/kg | Experimental | Participants received 0.5 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts. |
|
| Part A: Romiplostim 1.0 µg/kg | Experimental | Participants received 1.0 µg/kg romiplostim subcutaneously on day 1 and on day 15 or 22 depending on platelet counts. |
|
| Part A: Romiplostim 3 µg/kg | Experimental | Participants received 3.0 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts. |
|
| Part A: Romiplostim 6 µg/kg | Experimental | Participants received 6.0 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Romiplostim | Drug | Administered by subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | From first dose of study drug through 8 weeks (Part A) or 6 weeks (Part B) after last dose of study drug; 78 days | |
| Number of Participants With Anti-romiplostim or Anti-endogenous Thrombopoietin Neutralizing Antibodies | The development of antibodies to romiplostim or to endogenous thrombopoietin (eTPO) was assessed using a neutralizing bioassay. Participants positive for neutralizing antibodies at any of the assessments during the study are reported. | Assessed on day 29 (Part A only), day 43 (Part B only), and day 78 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieved Targeted Therapeutic Platelet Level in Part A | Targeted therapeutic platelet level was defined as a doubling of baseline platelet counts and between 50 to 450 x 10⁹ cells/L. Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders. | After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78) |
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Inclusion Criteria:
Diagnosis of ITP according to American Society of Hematology (ASH) guidelines at least 3 months before enrollment
Have completed at least 1 prior treatment for ITP
Two (including day -2) of the 3 platelet counts taken during the screening and pre-treatment periods must have fulfilled the following:
Eastern Cooperative Oncology Group performance status of 0 to 2
Serum creatinine concentration ≤ 2 mg/dL (≤ 176.8 µmol/L)
Adequate liver function, as evidenced by a serum bilirubin ≤ 1.5 times the laboratory normal range
Hemoglobin greater than 10.0 g/dL
Written informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28411254 | Background | Cines DB, Wasser J, Rodeghiero F, Chong BH, Steurer M, Provan D, Lyons R, Garcia-Chavez J, Carpenter N, Wang X, Eisen M. Safety and efficacy of romiplostim in splenectomized and nonsplenectomized patients with primary immune thrombocytopenia. Haematologica. 2017 Aug;102(8):1342-1351. doi: 10.3324/haematol.2016.161968. Epub 2017 Apr 14. | |
| 17050891 |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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In Part A participants were sequentially assigned to escalating dose cohorts. In Part B, participants were randomized to each dose cohort; within each cohort 2 of 10 participants were randomly assigned to receive placebo. The 6.0 µg/kg dose cohort was discontinued in protocol amendment 4.
This study consisted of 2 parts. Part A (conducted from July 1, 2002 to October 13, 2003) was an open-label, dose-escalation trial with sequential cohorts of participants.
Part B (conducted from October 6, 2003 to June 17, 2004) was a double-blind, placebo-controlled, parallel design study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A: Romiplostim 0.2 µg/kg | Participants received 0.2 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts |
| FG001 | Part A: Romiplostim 0.5 µg/kg | Participants received 0.5 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. |
| FG002 | Part A: Romiplostim 1.0 µg/kg | Participants received 1.0 µg/kg romiplostim on day 1 and on day 15 or 22 depending on platelet counts. |
| FG003 | Part A: Romiplostim 3 µg/kg | Participants received 3.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. |
| FG004 | Part A: Romiplostim 6 µg/kg | Participants received 6.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. |
| FG005 | Part A: Romiplostim 10 µg/kg | Participants received 10.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. |
| FG006 | Part B: Placebo | Participants received placebo by subcutaneous injection once a week for 6 weeks. |
| FG007 | Part B: Romiplostim 1.0 µg/kg | Participants received 1.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. |
| FG008 | Part B: Romiplostim 3.0 µg/kg | Participants received 3.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. |
| FG009 | Part B: Romiplostim 6.0 µg/kg | Participants received 6.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A: Romiplostim 0.2 µg/kg | Participants received 0.2 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts |
| BG001 | Part A: Romiplostim 0.5 µg/kg | Participants received 0.5 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Part A and Part B were analyzed separately; no overall total was calculated. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events | All treated participants | Posted | Count of Participants | Participants | From first dose of study drug through 8 weeks (Part A) or 6 weeks (Part B) after last dose of study drug; 78 days |
|
From first dose of study drug through 8 weeks (Part A) or 6 weeks (Part B) after last dose of study drug; 78 days.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A: Romiplostim 0.2 µg/kg | Participants received 0.2 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 7.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 7.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
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| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| C488777 | romiplostim |
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Part A was a sequential cohort dose escalation study. Part B was a randomized, placebo-controlled parallel group study.
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| Part A: Romiplostim 10 µg/kg |
| Experimental |
Participants received 10.0 µg/kg romiplostim subcutaneously on day 1 and day 15 or 22, depending on platelet counts. |
|
| Part B: Placebo | Placebo Comparator | Participants received placebo subcutaneously once a week for 6 weeks. |
|
| Part B: Romiplostim 1.0 µg/kg | Experimental | Participants received 1.0 µg/kg subcutaneously once a week for 6 weeks. |
|
| Part B: Romiplostim 3.0 µg/kg | Experimental | Participants received 3.0 µg/kg subcutaneously once a week for 6 weeks. |
|
| Part B: Romiplostim 6.0 µg/kg | Experimental | Participants received 6.0 µg/kg subcutaneously once a week for 6 weeks. |
|
|
| Placebo | Drug | Administered by subcutaneous injection |
|
| Number of Participants With an Increase in Platelet Count of ≥ 20 x 10⁹ Cells/L Over Baseline in Part A | Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders. | After first dose (day 1 to day 15 or 22), and after second dose (day 15 or 22 to day 78) |
| Number of Participants With a Peak Platelet Count ≥ 100 x 10⁹ Cells/L in Part A | Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders. | After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78) |
| Number of Participants With a Peak Platelet Count of > 450 x 10⁹ Cells/L in Part A | Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders. | After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78) |
| Peak Platelet Count After Each Dose in Part A | Platelet count data after the use of rescue medication were not included. | After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78) |
| Change From Baseline in Peak Platelet Count After Each Dose in Part A | Platelet count data after the use of rescue medication were not included. | Baseline and after first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78) |
| Time to Peak Platelet Count After Each Dose in Part A | Platelet count data after the use of rescue medication were not included. | After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78) |
| Duration Within the Targeted Therapeutic Platelet Range In Part A | Targeted therapeutic platelet level was defined as a platelet count that was double the baseline level and ≥ 50 and ≤ 450 × 10⁹ cells/L. Platelet count data after the use of rescue medication were not included. | After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78) |
| Percentage of Participants Who Achieved Targeted Therapeutic Platelet Level In Part B | Targeted therapeutic platelet level was defined as a doubling of baseline platelet counts and within the range of greater than or equal to 50 x 10⁹ cells/L and less than or equal to 450 x 10⁹ cells/L. Platelet count data after use of rescue medication were not included in the analysis. | Day 1 to day 78 |
| Percentage of Participants With an Increase in Platelet Count of ≥ 20 x 10⁹ Cells/L Over Baseline in Part B | Platelet count data after administration of rescue medication were not included in the analysis. Participants with no platelet count data were considered non-responders. | Day 1 to day 78 |
| Percentage of Participants With a Peak Platelet Count of ≥ 100 x 10⁹ Cells/L in Part B | Platelet count data after administration of rescue medication were not included in the analysis. Participants with no platelet count data were considered non-responders. | Day 1 to day 78 |
| Percentage of Participants With a Peak Platelet Count of > 450 x 10⁹ Cells/L in Part B | Platelet count data after administration of rescue medication were not included in the analysis. Participants with no platelet count data were considered non-responders. | Day 1 to day 78 |
| Percentage of Participants With a Peak Platelet Count of > 500 x 10⁹ Cells/L in Part B | Platelet count data after administration of rescue medication were not included in the analysis. Participants with no platelet count data were considered non-responders. | Day 1 to day 78 |
| Peak Platelet Count in Part B | Platelet count data after administration of rescue medication were not included in the analysis. | Day 1 to day 78 |
| Change From Baseline in Peak Platelet Count in Part B | Platelet count data after administration of rescue medication were not included in the analysis. | Baseline and day 1 to day 78 |
| Time to Peak Platelet Count in Part B | Platelet count data after administration of rescue medication were not included in the analysis. Time to peak platelet count was analyzed using the Kaplan-Meier method. | Day 1 to day 78 |
| Duration Within the Targeted Therapeutic Platelet Range in Part B | Targeted therapeutic platelet level was defined as a doubling of baseline platelet counts and within the range of greater than or equal to 50 × 10⁹ cells/L and less than or equal to 450 × 10⁹ cells/L. Platelet count data after administration of rescue medication were not included in the analysis. | Day 1 to day 78 |
| Bussel JB, Kuter DJ, George JN, McMillan R, Aledort LM, Conklin GT, Lichtin AE, Lyons RM, Nieva J, Wasser JS, Wiznitzer I, Kelly R, Chen CF, Nichol JL. AMG 531, a thrombopoiesis-stimulating protein, for chronic ITP. N Engl J Med. 2006 Oct 19;355(16):1672-81. doi: 10.1056/NEJMoa054626. |
| To access clinical trial results information click on this link | View source |
| FDA-approved Drug Labeling | View source |
| BG002 | Part A: Romiplostim 1.0 µg/kg | Participants received 1.0 µg/kg romiplostim on day 1 and on day 15 or 22 depending on platelet counts. |
| BG003 | Part A: Romiplostim 3 µg/kg | Participants received 3.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. |
| BG004 | Part A: Romiplostim 6 µg/kg | Participants received 6.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. |
| BG005 | Part A: Romiplostim 10 µg/kg | Participants received 10.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. |
| BG006 | Part B: Placebo | Participants received placebo by subcutaneous injection once a week for 6 weeks. |
| BG007 | Part B: Romiplostim 1.0 µg/kg | Participants received 1.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. |
| BG008 | Part B: Romiplostim 3.0 µg/kg | Participants received 3.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. |
| BG009 | Part B: Romiplostim 6.0 µg/kg | Participants received 6.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. |
| BG010 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Plateleet Count | Part A and Part B were analyzed separately; no overall total was calculated. | Mean | Standard Deviation | 1 × 10⁹ cells/L |
|
Participants received 1.0 µg/kg romiplostim on day 1 and on day 15 or 22 depending on platelet counts. |
| OG003 | Part A: Romiplostim 3 µg/kg | Participants received 3.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. |
| OG004 | Part A: Romiplostim 6 µg/kg | Participants received 6.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. |
| OG005 | Part A: Romiplostim 10 µg/kg | Participants received 10.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. |
| OG006 | Part B: Placebo | Participants received placebo by subcutaneous injection once a week for 6 weeks. |
| OG007 | Part B: Romiplostim 1.0 µg/kg | Participants received 1.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. |
| OG008 | Part B: Romiplostim 3.0 µg/kg | Participants received 3.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. |
| OG009 | Part B: Romiplostim 6.0 µg/kg | Participants received 6.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. |
|
|
| Primary | Number of Participants With Anti-romiplostim or Anti-endogenous Thrombopoietin Neutralizing Antibodies | The development of antibodies to romiplostim or to endogenous thrombopoietin (eTPO) was assessed using a neutralizing bioassay. Participants positive for neutralizing antibodies at any of the assessments during the study are reported. | All treated participants | Posted | Count of Participants | Participants | Assessed on day 29 (Part A only), day 43 (Part B only), and day 78 |
|
|
|
| Secondary | Number of Participants Who Achieved Targeted Therapeutic Platelet Level in Part A | Targeted therapeutic platelet level was defined as a doubling of baseline platelet counts and between 50 to 450 x 10⁹ cells/L. Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders. | Participants enrolled in Part A who received each dose of romiplostim. | Posted | Count of Participants | Participants | After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78) |
|
|
|
| Secondary | Number of Participants With an Increase in Platelet Count of ≥ 20 x 10⁹ Cells/L Over Baseline in Part A | Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders. | Participants enrolled in Part A who received each dose of romiplostim | Posted | Count of Participants | Participants | After first dose (day 1 to day 15 or 22), and after second dose (day 15 or 22 to day 78) |
|
|
|
| Secondary | Number of Participants With a Peak Platelet Count ≥ 100 x 10⁹ Cells/L in Part A | Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders. | Participants enrolled in Part A who received each dose of romiplostim | Posted | Count of Participants | Participants | After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78) |
|
|
|
| Secondary | Number of Participants With a Peak Platelet Count of > 450 x 10⁹ Cells/L in Part A | Platelet count data after the use of rescue medication were not included; participants with no platelet count data were considered non-responders. | Participants enrolled in Part A who received each dose of romiplostim | Posted | Count of Participants | Participants | After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78) |
|
|
|
| Secondary | Peak Platelet Count After Each Dose in Part A | Platelet count data after the use of rescue medication were not included. | Participants enrolled in Part A who received each dose of romiplostim and with a platelet count of ≥ 50 × 10⁹ cells/L and a doubling of the baseline platelet count, in the absence of rescue medication. | Posted | Mean | Standard Deviation | 1 × 10⁹ cells/L | After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78) |
|
|
|
| Secondary | Change From Baseline in Peak Platelet Count After Each Dose in Part A | Platelet count data after the use of rescue medication were not included. | Participants enrolled in Part A who received each dose of romiplostim and with a platelet count of ≥ 50 × 10⁹ cells/L and a doubling of the baseline platelet count, in the absence of rescue medication. | Posted | Mean | Standard Deviation | 1 × 10⁹ cells/L | Baseline and after first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78) |
|
|
|
| Secondary | Time to Peak Platelet Count After Each Dose in Part A | Platelet count data after the use of rescue medication were not included. | Participants enrolled in Part A who received each dose of romiplostim and with a platelet count of ≥ 50 × 10⁹ cells/L and a doubling of the baseline platelet count, in the absence of rescue medication. | Posted | Median | Full Range | days | After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78) |
|
|
|
| Secondary | Duration Within the Targeted Therapeutic Platelet Range In Part A | Targeted therapeutic platelet level was defined as a platelet count that was double the baseline level and ≥ 50 and ≤ 450 × 10⁹ cells/L. Platelet count data after the use of rescue medication were not included. | Participants enrolled in Part A who received each dose of romiplostim and with a platelet count ≥ 50 × 10⁹ cells/L and ≤ 450 × 10⁹ cells/L and a doubling of the baseline platelet count, in the absence of rescue medication. | Posted | Mean | Standard Deviation | days | After first dose (day 1 to day 15 or 22) and after second dose (day 15 or 22 to day 78) |
|
|
|
| Secondary | Percentage of Participants Who Achieved Targeted Therapeutic Platelet Level In Part B | Targeted therapeutic platelet level was defined as a doubling of baseline platelet counts and within the range of greater than or equal to 50 x 10⁹ cells/L and less than or equal to 450 x 10⁹ cells/L. Platelet count data after use of rescue medication were not included in the analysis. | Participants randomized in Part B who received at least 1 dose of study drug. | Posted | Number | percentage of participants | Day 1 to day 78 |
|
|
|
| Secondary | Percentage of Participants With an Increase in Platelet Count of ≥ 20 x 10⁹ Cells/L Over Baseline in Part B | Platelet count data after administration of rescue medication were not included in the analysis. Participants with no platelet count data were considered non-responders. | Participants randomized in Part B who received at least 1 dose of study drug. | Posted | Number | percentage of participants | Day 1 to day 78 |
|
|
|
| Secondary | Percentage of Participants With a Peak Platelet Count of ≥ 100 x 10⁹ Cells/L in Part B | Platelet count data after administration of rescue medication were not included in the analysis. Participants with no platelet count data were considered non-responders. | Participants randomized in Part B who received at least 1 dose of study drug. | Posted | Number | percentage of participants | Day 1 to day 78 |
|
|
|
| Secondary | Percentage of Participants With a Peak Platelet Count of > 450 x 10⁹ Cells/L in Part B | Platelet count data after administration of rescue medication were not included in the analysis. Participants with no platelet count data were considered non-responders. | Participants randomized in Part B who received at least 1 dose of study drug. | Posted | Number | percentage of participants | Day 1 to day 78 |
|
|
|
| Secondary | Percentage of Participants With a Peak Platelet Count of > 500 x 10⁹ Cells/L in Part B | Platelet count data after administration of rescue medication were not included in the analysis. Participants with no platelet count data were considered non-responders. | Participants randomized in Part B who received at least 1 dose of study drug. | Posted | Number | percentage of participants | Day 1 to day 78 |
|
|
|
| Secondary | Peak Platelet Count in Part B | Platelet count data after administration of rescue medication were not included in the analysis. | Participants randomized in Part B who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | 1 × 10⁹ cells/L | Day 1 to day 78 |
|
|
|
| Secondary | Change From Baseline in Peak Platelet Count in Part B | Platelet count data after administration of rescue medication were not included in the analysis. | Participants randomized in Part B who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | 1 × 10⁹ cells/L | Baseline and day 1 to day 78 |
|
|
|
| Secondary | Time to Peak Platelet Count in Part B | Platelet count data after administration of rescue medication were not included in the analysis. Time to peak platelet count was analyzed using the Kaplan-Meier method. | Participants randomized in Part B who received at least 1 dose of study drug. | Posted | Median | Inter-Quartile Range | days | Day 1 to day 78 |
|
|
|
| Secondary | Duration Within the Targeted Therapeutic Platelet Range in Part B | Targeted therapeutic platelet level was defined as a doubling of baseline platelet counts and within the range of greater than or equal to 50 × 10⁹ cells/L and less than or equal to 450 × 10⁹ cells/L. Platelet count data after administration of rescue medication were not included in the analysis. | Participants randomized in Part B who received at least 1 dose of study drug and achieved a targeted therapeutic platelet level. | Posted | Median | Full Range | weeks | Day 1 to day 78 |
|
|
|
| 2 |
| 4 |
| 4 |
| 4 |
| EG001 | Part A: Romiplostim 0.5 µg/kg | Participants received 0.5 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | 0 | 4 | 4 | 4 |
| EG002 | Part A: Romiplostim 1.0 µg/kg | Participants received 1.0 µg/kg romiplostim on day 1 and on day 15 or 22 depending on platelet counts. | 0 | 4 | 4 | 4 |
| EG003 | Part A: Romiplostim 3 µg/kg | Participants received 3.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | 0 | 4 | 4 | 4 |
| EG004 | Part A: Romiplostim 6 µg/kg | Participants received 6.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | 0 | 4 | 4 | 4 |
| EG005 | Part A: Romiplostim 10 µg/kg | Participants received 10.0 µg/kg romiplostim on day 1 and day 15 or 22, depending on platelet counts. | 1 | 4 | 4 | 4 |
| EG006 | Part B: Placebo | Participants received placebo by subcutaneous injection once a week for 6 weeks. | 2 | 4 | 4 | 4 |
| EG007 | Part B: Romiplostim 1.0 µg/kg | Participants received 1.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. | 0 | 8 | 8 | 8 |
| EG008 | Part B: Romiplostim 3.0 µg/kg | Participants received 3.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. | 1 | 8 | 8 | 8 |
| EG009 | Part B: Romiplostim 6.0 µg/kg | Participants received 6.0 µg/kg romiplostim by subcutaneous injection once a week for 6 weeks. | 0 | 1 | 1 | 1 |
| Vertigo | Ear and labyrinth disorders | MedDRA 7.1 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 7.1 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 7.1 | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 7.1 | Systematic Assessment |
|
| Idiopathic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 7.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 7.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 7.1 | Systematic Assessment |
|
| Ear haemorrhage | Ear and labyrinth disorders | MedDRA 7.1 | Systematic Assessment |
|
| Eye haemorrhage | Eye disorders | MedDRA 7.1 | Systematic Assessment |
|
| Retinal haemorrhage | Eye disorders | MedDRA 7.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 7.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Faeces discoloured | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Loose stools | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Oesophageal spasm | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Oral mucosal blistering | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Oral mucosal petechiae | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Tongue haemorrhage | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Fibrosis | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Venipuncture site bruise | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 7.1 | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 7.1 | Systematic Assessment |
|
| Eye injury | Injury, poisoning and procedural complications | MedDRA 7.1 | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 7.1 | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 7.1 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 7.1 | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA 7.1 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 7.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 7.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Muscle cramp | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
|
| Sinus headache | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 7.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 7.1 | Systematic Assessment |
|
| Depressed mood | Psychiatric disorders | MedDRA 7.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 7.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 7.1 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 7.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 7.1 | Systematic Assessment |
|
| Ejaculation disorder | Reproductive system and breast disorders | MedDRA 7.1 | Systematic Assessment |
|
| Menstruation irregular | Reproductive system and breast disorders | MedDRA 7.1 | Systematic Assessment |
|
| Premenstrual syndrome | Reproductive system and breast disorders | MedDRA 7.1 | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 7.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Lipohypertrophy | Skin and subcutaneous tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Nail bed bleeding | Skin and subcutaneous tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Rash scaly | Skin and subcutaneous tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 7.1 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 7.1 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 7.1 | Systematic Assessment |
|
| Petechiae | Vascular disorders | MedDRA 7.1 | Systematic Assessment |
|
| Varicose vein | Vascular disorders | MedDRA 7.1 | Systematic Assessment |
|
| Vascular insufficiency | Vascular disorders | MedDRA 7.1 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 7.1 | Systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA 7.1 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| D006425 |
| Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
|
| Male |
|
| Black |
|
| Hispanic |
|
|
| Anti-eTPO neutralizing antibodies |
|
|
| After second dose |
|
|
| After both doses |
|
|
|
| After second dose |
|
|
| After both doses |
|
|
|
| After second dose |
|
|
| After both doses |
|
|
|
| After second dose |
|
|
| After both doses |
|
|
|
| After second dose |
|
|
|
| After second dose |
|
|
|
| After second dose |
|
|
|
| After second dose |
|
|