Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Open Label Extension Study of Romiplostim (AMG 531) in Thrombocytopenic Patients With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00116688
Recruitment Status : Completed
First Posted : July 1, 2005
Results First Posted : April 6, 2011
Last Update Posted : December 18, 2013
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Thrombocytopenia
Idiopathic Thrombocytopenic Purpura
Intervention Biological: Romiplostim
Enrollment 313
Recruitment Details Participants were enrolled from 2 August 2004 through 15 April 2009
Pre-assignment Details  
Arm/Group Title Romiplostim in Adults Romiplostim in Pediatric Population
Hide Arm/Group Description Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg. Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
Period Title: Overall Study
Started 292 21
Received Study Medication 291 20
Completed 200 17
Not Completed 92 4
Reason Not Completed
Protocol deviation             1             0
Noncompliance             3             1
Adverse Event             11             0
Withdrawal by Subject             26             2
Requirement for alternative therapy             11             1
Physician Decision             7             0
Lost to Follow-up             3             0
Death             15             0
Protocol-specified criteria             3             0
Pregnancy             1             0
Other             11             0
Arm/Group Title Romiplostim in Adults Romiplostim in Pediatric Population Total
Hide Arm/Group Description Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg. Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts. Total of all reporting groups
Overall Number of Baseline Participants 292 21 313
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 292 participants 21 participants 313 participants
54.2  (16.9) 10.2  (5.1) 51.3  (19.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 292 participants 21 participants 313 participants
Female
184
  63.0%
6
  28.6%
190
  60.7%
Male
108
  37.0%
15
  71.4%
123
  39.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 292 participants 21 participants 313 participants
Black or African American 13 3 16
White or Caucasian 246 13 259
Hispanic or Latino 21 4 25
Asian 9 0 9
Japanese 1 0 1
American Indian or Alaska Native 1 0 1
Native Hawaiian or Other Pacific Islander 1 0 1
Other 0 1 1
1.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description Participants with one or more occurrences of one or more adverse events up to 8 weeks after the end of treatment. Participants with more than one event were only counted once.
Time Frame Duration of treatment plus 8 weeks (up to 285 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set, composed of all participants who received at least one dose of romiplostim
Arm/Group Title Romiplostim in Adults Romiplostim in Pediatric Population
Hide Arm/Group Description:
Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
Overall Number of Participants Analyzed 291 20
Measure Type: Number
Unit of Measure: Participants
284 19
2.Secondary Outcome
Title Number of Participants With a Platelet Response
Hide Description Platelet response was defined as having a platelet count of ≥ 50 x 10^9/L at any time on study, excluding platelet counts within 8 weeks after receiving any rescue medications.
Time Frame Duration of treatment (up to 277 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim
Arm/Group Title Romiplostim in Adults Romiplostim in Pediatric Population
Hide Arm/Group Description:
Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
Overall Number of Participants Analyzed 291 20
Measure Type: Number
Unit of Measure: Participants
275 20
3.Secondary Outcome
Title Number of Participants With a Reduction or Discontinuation of Concurrent ITP Therapies
Hide Description The number of participants with a reduction or discontinuation of concurrent immune (idiopathic) thrombocytopenic purpura (ITP) therapies (corticosteroids, danazol, azathioprine) during the study.
Time Frame Duration of treatment (up to 277 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim and with baseline concurrent ITP therapy.
Arm/Group Title Romiplostim in Adults Romiplostim in Pediatric Population
Hide Arm/Group Description:
Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
Overall Number of Participants Analyzed 37 2
Measure Type: Number
Unit of Measure: Participants
30 1
4.Secondary Outcome
Title Change From Baseline in ITP Patient Assessment Questionnaire
Hide Description The ITP Patient Assessment Questionnaire (ITP-PAQ) assesses ITP-specific health-related quality of life (HRQOL). This questionnaire assesses ITP specific health-related quality of life (HRQOL). The questionnaire consists of 44 items and has six domains: These domains assess the impact of ITP on Physical Health, Mental Health, Work, Social Activity, Women's Health and Overall QOL. The impact of ITP on Physical Health consists of four sub-scales, which evaluate ITP related Symptoms, Fatigue, Bother and Activity. The impact of ITP on Mental Health consists of two sub-scales, which evaluate Psychological distress and Fear in a population with ITP. Items are scored from 0-100 with higher scores indicating better HRQOL.
Time Frame Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with available data. Patient reported outcomes were only analyzed in adult participants.
Arm/Group Title Romiplostim in Adults
Hide Arm/Group Description:
Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
Overall Number of Participants Analyzed 292
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Physical Health Symptoms (N=209) 4.20  (13.15)
Physical Health Fatigue (N=208) 3.99  (16.00)
Physical Health Bother (N=204) 6.43  (17.39)
Physical Health Activity (N=208) 5.23  (21.08)
Emotional Health Psychological (N=208) 4.01  (15.81)
Emotional Health Fear (N=209) 3.48  (12.59)
Overall Quality of Life (N=210) 8.32  (19.65)
Social Quality of Life (N=209) 3.89  (13.41)
Women's Reproductive Health (N=71) 4.51  (16.35)
Work Quality of Life (N=75) 2.78  (14.54)
5.Secondary Outcome
Title Change From Baseline in Short Form 36 (SF-36)
Hide Description The SF-36 is a widely used generic health-related quality of life measure. It has 36 questions with 8 domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health. Items are scored from 0 to 100 with higher scores indicating better health status.
Time Frame Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with available data. Patient reported outcomes were only analyzed in adult participants.
Arm/Group Title Romiplostim in Adults
Hide Arm/Group Description:
Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
Overall Number of Participants Analyzed 292
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Physical Functioning (N=206) 1.38  (6.34)
Role-Physical (N=208) 2.03  (8.89)
Bodily Pain (N=206) 0.94  (7.99)
General Health Perception (N=208) 1.31  (7.03)
Vitality (N=208) 1.68  (7.47)
Social Functioning (N=208) 0.52  (8.21)
Role-Emotional (N=205) 1.75  (12.22)
Mental Health Index (N=208) 0.91  (7.45)
Physical Component Summary (N=200) 1.49  (6.51)
Mental Component Summary (N=200) 1.06  (8.80)
6.Secondary Outcome
Title Change From Baseline in Euroqol-5D (EQ-5D) Index Score
Hide Description The EQ-5D is a patient-completed, multidimensional measure of health related quality of life. The instrument is applicable to a wide range of health conditions and treatments and results in a single index score and a visual analog scale (VAS) score. The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension comprises three levels (no problems, some/moderate problems, extreme problems). A unique EQ-5D health state is defined by combining one level from each of the five dimensions. EQ-5D index values range from -0.59 to 1.00. Higher EQ-5D Index scores represent better health status.
Time Frame Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with available data. Patient reported outcomes were only analyzed in adult participants.
Arm/Group Title Romiplostim in Adults
Hide Arm/Group Description:
Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
Overall Number of Participants Analyzed 154
Mean (Standard Deviation)
Unit of Measure: scores on a scale
0.03  (0.16)
7.Secondary Outcome
Title Change From Baseline in Euroqol-5D (EQ-5D) Visual Analogue Scale (VAS)
Hide Description The EQ-5D is a patient-completed, multidimensional measure of health related quality of life. The EQ-5D VAS records the respondent's self-rated health status on a vertical graduated (0-100) visual analogue scale. Higher EQ-5D VAS scores represent better health status.
Time Frame Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with available data. Patient reported outcomes were only analyzed in adult participants.
Arm/Group Title Romiplostim in Adults
Hide Arm/Group Description:
Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
Overall Number of Participants Analyzed 150
Mean (Standard Deviation)
Unit of Measure: scores on a scale
6.05  (14.85)
8.Secondary Outcome
Title Patient Global Assessment
Hide Description The Patient Global Assessment is two questions which assess the overall health-related quality of life (HRQOL) and symptoms of the patient. Each item is answered on a 15-point Likert scale ranging from 'A very great deal worse' (1) to 'A very great deal better' (15). A higher score indicates that quality of life or symptoms have improved.
Time Frame Week 1 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with available data. Patient reported outcomes were only analyzed in adult participants.
Arm/Group Title Romiplostim in Adults
Hide Arm/Group Description:
Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
Overall Number of Participants Analyzed 292
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1 (N=271) 7.61  (2.02)
Week 48 (N=216) 8.18  (1.78)
Time Frame For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks
Adverse Event Reporting Description The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.
 
Arm/Group Title Romiplostim in Adults Romiplostim in Pediatric Population
Hide Arm/Group Description Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg. Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
All-Cause Mortality
Romiplostim in Adults Romiplostim in Pediatric Population
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Romiplostim in Adults Romiplostim in Pediatric Population
Affected / at Risk (%) Affected / at Risk (%)
Total   117/291 (40.21%)   2/20 (10.00%) 
Blood and lymphatic system disorders     
Anaemia  1  3/291 (1.03%)  0/20 (0.00%) 
Bicytopenia  1  1/291 (0.34%)  0/20 (0.00%) 
Bone marrow disorder  1  4/291 (1.37%)  0/20 (0.00%) 
Bone marrow reticulin fibrosis  1  1/291 (0.34%)  0/20 (0.00%) 
Evans syndrome  1  1/291 (0.34%)  0/20 (0.00%) 
Haemolytic anaemia  1  1/291 (0.34%)  0/20 (0.00%) 
Idiopathic thrombocytopenic purpura  1  7/291 (2.41%)  1/20 (5.00%) 
Leukocytosis  1  1/291 (0.34%)  0/20 (0.00%) 
Neutropenia  1  1/291 (0.34%)  0/20 (0.00%) 
Thrombocytopenia  1  23/291 (7.90%)  0/20 (0.00%) 
Cardiac disorders     
Acute myocardial infarction  1  3/291 (1.03%)  0/20 (0.00%) 
Angina unstable  1  2/291 (0.69%)  0/20 (0.00%) 
Atrial fibrillation  1  3/291 (1.03%)  0/20 (0.00%) 
Cardiac arrest  1  1/291 (0.34%)  0/20 (0.00%) 
Cardiac failure  1  4/291 (1.37%)  0/20 (0.00%) 
Cardiac failure congestive  1  5/291 (1.72%)  0/20 (0.00%) 
Cardiac tamponade  1  1/291 (0.34%)  0/20 (0.00%) 
Coronary artery disease  1  2/291 (0.69%)  0/20 (0.00%) 
Myocardial infarction  1  5/291 (1.72%)  0/20 (0.00%) 
Pericardial haemorrhage  1  1/291 (0.34%)  0/20 (0.00%) 
Trifascicular block  1  1/291 (0.34%)  0/20 (0.00%) 
Congenital, familial and genetic disorders     
Atrial septal defect  1  1/291 (0.34%)  0/20 (0.00%) 
Ear and labyrinth disorders     
Vertigo  1  2/291 (0.69%)  0/20 (0.00%) 
Vestibular disorder  1  1/291 (0.34%)  0/20 (0.00%) 
Eye disorders     
Blindness  1  1/291 (0.34%)  0/20 (0.00%) 
Conjunctival haemorrhage  1  1/291 (0.34%)  0/20 (0.00%) 
Papilloedema  1  1/291 (0.34%)  0/20 (0.00%) 
Gastrointestinal disorders     
Abdominal distension  1  1/291 (0.34%)  0/20 (0.00%) 
Abdominal pain  1  2/291 (0.69%)  0/20 (0.00%) 
Abdominal pain lower  1  1/291 (0.34%)  0/20 (0.00%) 
Abdominal pain upper  1  1/291 (0.34%)  0/20 (0.00%) 
Anal fistula  1  1/291 (0.34%)  0/20 (0.00%) 
Ascites  1  1/291 (0.34%)  0/20 (0.00%) 
Colitis  1  2/291 (0.69%)  0/20 (0.00%) 
Colitis ischaemic  1  1/291 (0.34%)  0/20 (0.00%) 
Diarrhoea  1  1/291 (0.34%)  0/20 (0.00%) 
Dyspepsia  1  1/291 (0.34%)  0/20 (0.00%) 
Femoral hernia  1  1/291 (0.34%)  0/20 (0.00%) 
Gastrointestinal haemorrhage  1  4/291 (1.37%)  0/20 (0.00%) 
Gingival bleeding  1  2/291 (0.69%)  0/20 (0.00%) 
Haematemesis  1  1/291 (0.34%)  0/20 (0.00%) 
Irritable bowel syndrome  1  1/291 (0.34%)  0/20 (0.00%) 
Mouth cyst  1  1/291 (0.34%)  0/20 (0.00%) 
Mouth haemorrhage  1  1/291 (0.34%)  0/20 (0.00%) 
Mouth ulceration  1  1/291 (0.34%)  0/20 (0.00%) 
Nausea  1  1/291 (0.34%)  0/20 (0.00%) 
Periodontitis  1  1/291 (0.34%)  0/20 (0.00%) 
Rectal haemorrhage  1  2/291 (0.69%)  0/20 (0.00%) 
Small intestinal obstruction  1  1/291 (0.34%)  0/20 (0.00%) 
Tooth impacted  1  1/291 (0.34%)  0/20 (0.00%) 
Tooth loss  1  1/291 (0.34%)  0/20 (0.00%) 
Upper gastrointestinal haemorrhage  1  1/291 (0.34%)  0/20 (0.00%) 
Vomiting  1  1/291 (0.34%)  0/20 (0.00%) 
General disorders     
Adverse drug reaction  1  1/291 (0.34%)  0/20 (0.00%) 
Asthenia  1  1/291 (0.34%)  0/20 (0.00%) 
Chest pain  1  3/291 (1.03%)  0/20 (0.00%) 
Death  1  1/291 (0.34%)  0/20 (0.00%) 
Fatigue  1  1/291 (0.34%)  0/20 (0.00%) 
Generalised oedema  1  1/291 (0.34%)  0/20 (0.00%) 
Hernia  1  1/291 (0.34%)  0/20 (0.00%) 
Hernia obstructive  1  2/291 (0.69%)  0/20 (0.00%) 
Hernia pain  1  1/291 (0.34%)  0/20 (0.00%) 
Hyperpyrexia  1  1/291 (0.34%)  0/20 (0.00%) 
Mechanical complication of implant  1  1/291 (0.34%)  0/20 (0.00%) 
Oedema peripheral  1  1/291 (0.34%)  0/20 (0.00%) 
Pyrexia  1  4/291 (1.37%)  0/20 (0.00%) 
Hepatobiliary disorders     
Biliary colic  1  1/291 (0.34%)  0/20 (0.00%) 
Cholecystitis  1  2/291 (0.69%)  0/20 (0.00%) 
Cholecystitis acute  1  1/291 (0.34%)  0/20 (0.00%) 
Cholelithiasis  1  3/291 (1.03%)  0/20 (0.00%) 
Hepatic failure  1  2/291 (0.69%)  0/20 (0.00%) 
Hepatic steatosis  1  1/291 (0.34%)  0/20 (0.00%) 
Hepatitis  1  1/291 (0.34%)  0/20 (0.00%) 
Portal vein thrombosis  1  1/291 (0.34%)  0/20 (0.00%) 
Infections and infestations     
Anal abscess  1  1/291 (0.34%)  0/20 (0.00%) 
Appendicitis  1  2/291 (0.69%)  0/20 (0.00%) 
Bacteraemia  1  1/291 (0.34%)  0/20 (0.00%) 
Bronchitis  1  3/291 (1.03%)  0/20 (0.00%) 
Candidiasis  1  1/291 (0.34%)  0/20 (0.00%) 
Catheter bacteraemia  1  1/291 (0.34%)  0/20 (0.00%) 
Catheter related infection  1  2/291 (0.69%)  0/20 (0.00%) 
Cellulitis  1  3/291 (1.03%)  0/20 (0.00%) 
Device related infection  1  1/291 (0.34%)  0/20 (0.00%) 
Epiglottitis  1  1/291 (0.34%)  0/20 (0.00%) 
Gastroenteritis  1  1/291 (0.34%)  0/20 (0.00%) 
Haematoma infection  1  1/291 (0.34%)  0/20 (0.00%) 
Influenza  1  0/291 (0.00%)  1/20 (5.00%) 
Klebsiella sepsis  1  1/291 (0.34%)  0/20 (0.00%) 
Localised infection  1  1/291 (0.34%)  0/20 (0.00%) 
Meningitis listeria  1  1/291 (0.34%)  0/20 (0.00%) 
Nasopharyngitis  1  1/291 (0.34%)  0/20 (0.00%) 
Parotitis  1  1/291 (0.34%)  0/20 (0.00%) 
Pharyngitis streptococcal  1  0/291 (0.00%)  1/20 (5.00%) 
Pneumococcal sepsis  1  1/291 (0.34%)  0/20 (0.00%) 
Pneumonia  1  8/291 (2.75%)  0/20 (0.00%) 
Pneumonia streptococcal  1  1/291 (0.34%)  0/20 (0.00%) 
Post procedural cellulitis  1  1/291 (0.34%)  0/20 (0.00%) 
Progressive multifocal leukoencephalopathy  1  1/291 (0.34%)  0/20 (0.00%) 
Sepsis  1  1/291 (0.34%)  0/20 (0.00%) 
Thrombophlebitis septic  1  1/291 (0.34%)  0/20 (0.00%) 
Tooth abscess  1  1/291 (0.34%)  0/20 (0.00%) 
Urosepsis  1  2/291 (0.69%)  0/20 (0.00%) 
Injury, poisoning and procedural complications     
Arteriovenous fistula site complication  1  1/291 (0.34%)  0/20 (0.00%) 
Contusion  1  1/291 (0.34%)  0/20 (0.00%) 
Fractured sacrum  1  1/291 (0.34%)  0/20 (0.00%) 
Head injury  1  1/291 (0.34%)  0/20 (0.00%) 
Hip fracture  1  2/291 (0.69%)  0/20 (0.00%) 
Humerus fracture  1  1/291 (0.34%)  0/20 (0.00%) 
Incisional hernia  1  1/291 (0.34%)  0/20 (0.00%) 
Medical device complication  1  1/291 (0.34%)  0/20 (0.00%) 
Meniscus lesion  1  1/291 (0.34%)  0/20 (0.00%) 
Pelvic fracture  1  1/291 (0.34%)  0/20 (0.00%) 
Subdural haemorrhage  1  1/291 (0.34%)  0/20 (0.00%) 
Upper limb fracture  1  1/291 (0.34%)  0/20 (0.00%) 
Wound  1  1/291 (0.34%)  0/20 (0.00%) 
Investigations     
Megakaryocytes increased  1  1/291 (0.34%)  0/20 (0.00%) 
Platelet count decreased  1  3/291 (1.03%)  0/20 (0.00%) 
Platelet count increased  1  2/291 (0.69%)  0/20 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  1/291 (0.34%)  0/20 (0.00%) 
Dehydration  1  4/291 (1.37%)  0/20 (0.00%) 
Hyperkalaemia  1  2/291 (0.69%)  0/20 (0.00%) 
Hypokalaemia  1  1/291 (0.34%)  0/20 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthritis  1  1/291 (0.34%)  0/20 (0.00%) 
Intervertebral disc protrusion  1  1/291 (0.34%)  0/20 (0.00%) 
Osteoarthritis  1  3/291 (1.03%)  0/20 (0.00%) 
Osteonecrosis  1  1/291 (0.34%)  0/20 (0.00%) 
Pain in extremity  1  1/291 (0.34%)  0/20 (0.00%) 
Rhabdomyolysis  1  1/291 (0.34%)  0/20 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer  1  1/291 (0.34%)  0/20 (0.00%) 
Chronic lymphocytic leukaemia  1  1/291 (0.34%)  0/20 (0.00%) 
Colon cancer recurrent  1  1/291 (0.34%)  0/20 (0.00%) 
Hepatic neoplasm malignant  1  2/291 (0.69%)  0/20 (0.00%) 
Lung neoplasm malignant  1  1/291 (0.34%)  0/20 (0.00%) 
Lymphoma  1  1/291 (0.34%)  0/20 (0.00%) 
Metastases to central nervous system  1  1/291 (0.34%)  0/20 (0.00%) 
Multiple myeloma  1  1/291 (0.34%)  0/20 (0.00%) 
Myelofibrosis  1  1/291 (0.34%)  0/20 (0.00%) 
Neoplasm of orbit  1  1/291 (0.34%)  0/20 (0.00%) 
Renal cell carcinoma  1  1/291 (0.34%)  0/20 (0.00%) 
Transitional cell carcinoma  1  1/291 (0.34%)  0/20 (0.00%) 
Nervous system disorders     
Cerebrovascular accident  1  2/291 (0.69%)  0/20 (0.00%) 
Complex regional pain syndrome  1  1/291 (0.34%)  0/20 (0.00%) 
Convulsion  1  2/291 (0.69%)  0/20 (0.00%) 
Headache  1  1/291 (0.34%)  0/20 (0.00%) 
Intracranial aneurysm  1  1/291 (0.34%)  0/20 (0.00%) 
Loss of consciousness  1  1/291 (0.34%)  0/20 (0.00%) 
Migraine  1  1/291 (0.34%)  0/20 (0.00%) 
Multiple sclerosis relapse  1  1/291 (0.34%)  0/20 (0.00%) 
Presyncope  1  1/291 (0.34%)  0/20 (0.00%) 
Syncope  1  2/291 (0.69%)  0/20 (0.00%) 
Transient ischaemic attack  1  2/291 (0.69%)  0/20 (0.00%) 
Transverse sinus thrombosis  1  1/291 (0.34%)  0/20 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous  1  1/291 (0.34%)  0/20 (0.00%) 
Psychiatric disorders     
Agitation  1  1/291 (0.34%)  0/20 (0.00%) 
Anxiety  1  2/291 (0.69%)  0/20 (0.00%) 
Confusional state  1  1/291 (0.34%)  0/20 (0.00%) 
Mental status changes  1  2/291 (0.69%)  0/20 (0.00%) 
Suicidal ideation  1  1/291 (0.34%)  0/20 (0.00%) 
Renal and urinary disorders     
Renal failure  1  3/291 (1.03%)  0/20 (0.00%) 
Renal failure acute  1  2/291 (0.69%)  0/20 (0.00%) 
Renal failure chronic  1  1/291 (0.34%)  0/20 (0.00%) 
Urinary bladder polyp  1  1/291 (0.34%)  0/20 (0.00%) 
Urinary retention  1  1/291 (0.34%)  0/20 (0.00%) 
Reproductive system and breast disorders     
Menorrhagia  1  1/291 (0.34%)  0/20 (0.00%) 
Metrorrhagia  1  1/291 (0.34%)  0/20 (0.00%) 
Ovarian cyst  1  1/291 (0.34%)  0/20 (0.00%) 
Vaginal haemorrhage  1  2/291 (0.69%)  0/20 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema  1  1/291 (0.34%)  0/20 (0.00%) 
Asthma  1  1/291 (0.34%)  0/20 (0.00%) 
Cough  1  1/291 (0.34%)  0/20 (0.00%) 
Dyspnoea  1  4/291 (1.37%)  0/20 (0.00%) 
Epistaxis  1  3/291 (1.03%)  1/20 (5.00%) 
Haemoptysis  1  1/291 (0.34%)  0/20 (0.00%) 
Pleuritic pain  1  1/291 (0.34%)  0/20 (0.00%) 
Pulmonary embolism  1  1/291 (0.34%)  0/20 (0.00%) 
Pulmonary haemorrhage  1  1/291 (0.34%)  0/20 (0.00%) 
Respiratory arrest  1  1/291 (0.34%)  0/20 (0.00%) 
Respiratory failure  1  2/291 (0.69%)  0/20 (0.00%) 
Skin and subcutaneous tissue disorders     
Blister  1  1/291 (0.34%)  0/20 (0.00%) 
Ecchymosis  1  1/291 (0.34%)  0/20 (0.00%) 
Petechiae  1  2/291 (0.69%)  0/20 (0.00%) 
Psoriasis  1  1/291 (0.34%)  0/20 (0.00%) 
Purpura  1  1/291 (0.34%)  0/20 (0.00%) 
Rash  1  2/291 (0.69%)  0/20 (0.00%) 
Systemic lupus erythematosus rash  1  1/291 (0.34%)  0/20 (0.00%) 
Urticaria  1  1/291 (0.34%)  0/20 (0.00%) 
Surgical and medical procedures     
Cholecystectomy  1  1/291 (0.34%)  0/20 (0.00%) 
Elective surgery  1  1/291 (0.34%)  0/20 (0.00%) 
Knee arthroplasty  1  2/291 (0.69%)  0/20 (0.00%) 
Plastic surgery  1  1/291 (0.34%)  0/20 (0.00%) 
Skin cosmetic procedure  1  1/291 (0.34%)  0/20 (0.00%) 
Stent placement  1  1/291 (0.34%)  0/20 (0.00%) 
Vascular disorders     
Aortic aneurysm  1  1/291 (0.34%)  0/20 (0.00%) 
Deep vein thrombosis  1  2/291 (0.69%)  0/20 (0.00%) 
Femoral arterial stenosis  1  1/291 (0.34%)  0/20 (0.00%) 
Haematoma  1  1/291 (0.34%)  0/20 (0.00%) 
Haemorrhage  1  1/291 (0.34%)  0/20 (0.00%) 
Phlebitis  1  1/291 (0.34%)  0/20 (0.00%) 
Subgaleal haematoma  1  1/291 (0.34%)  0/20 (0.00%) 
Thrombosis  1  1/291 (0.34%)  0/20 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Romiplostim in Adults Romiplostim in Pediatric Population
Affected / at Risk (%) Affected / at Risk (%)
Total   270/291 (92.78%)   18/20 (90.00%) 
Blood and lymphatic system disorders     
Anaemia  1  17/291 (5.84%)  1/20 (5.00%) 
Idiopathic thrombocytopenic purpura  1  29/291 (9.97%)  2/20 (10.00%) 
Gastrointestinal disorders     
Abdominal discomfort  1  17/291 (5.84%)  1/20 (5.00%) 
Abdominal pain  1  33/291 (11.34%)  3/20 (15.00%) 
Abdominal pain upper  1  21/291 (7.22%)  4/20 (20.00%) 
Constipation  1  26/291 (8.93%)  1/20 (5.00%) 
Diarrhoea  1  72/291 (24.74%)  2/20 (10.00%) 
Dyspepsia  1  19/291 (6.53%)  0/20 (0.00%) 
Gingival bleeding  1  43/291 (14.78%)  5/20 (25.00%) 
Mouth haemorrhage  1  21/291 (7.22%)  4/20 (20.00%) 
Mouth ulceration  1  4/291 (1.37%)  2/20 (10.00%) 
Nausea  1  69/291 (23.71%)  4/20 (20.00%) 
Toothache  1  17/291 (5.84%)  1/20 (5.00%) 
Vomiting  1  46/291 (15.81%)  7/20 (35.00%) 
General disorders     
Asthenia  1  22/291 (7.56%)  0/20 (0.00%) 
Chest pain  1  16/291 (5.50%)  1/20 (5.00%) 
Chills  1  12/291 (4.12%)  2/20 (10.00%) 
Fatigue  1  93/291 (31.96%)  7/20 (35.00%) 
Injection site haematoma  1  15/291 (5.15%)  0/20 (0.00%) 
Oedema peripheral  1  41/291 (14.09%)  0/20 (0.00%) 
Pain  1  32/291 (11.00%)  4/20 (20.00%) 
Pyrexia  1  36/291 (12.37%)  9/20 (45.00%) 
Immune system disorders     
Seasonal allergy  1  16/291 (5.50%)  1/20 (5.00%) 
Infections and infestations     
Bronchitis  1  22/291 (7.56%)  1/20 (5.00%) 
Ear infection  1  11/291 (3.78%)  2/20 (10.00%) 
Gastroenteritis  1  13/291 (4.47%)  2/20 (10.00%) 
Influenza  1  23/291 (7.90%)  0/20 (0.00%) 
Nasopharyngitis  1  100/291 (34.36%)  5/20 (25.00%) 
Sinusitis  1  38/291 (13.06%)  1/20 (5.00%) 
Upper respiratory tract infection  1  76/291 (26.12%)  10/20 (50.00%) 
Urinary tract infection  1  36/291 (12.37%)  0/20 (0.00%) 
Viral infection  1  5/291 (1.72%)  2/20 (10.00%) 
Viral upper respiratory tract infection  1  7/291 (2.41%)  3/20 (15.00%) 
Injury, poisoning and procedural complications     
Animal bite  1  3/291 (1.03%)  2/20 (10.00%) 
Arthropod bite  1  6/291 (2.06%)  2/20 (10.00%) 
Contusion  1  88/291 (30.24%)  8/20 (40.00%) 
Excoriation  1  10/291 (3.44%)  3/20 (15.00%) 
Fall  1  19/291 (6.53%)  0/20 (0.00%) 
Joint sprain  1  11/291 (3.78%)  2/20 (10.00%) 
Procedural pain  1  17/291 (5.84%)  2/20 (10.00%) 
Skin laceration  1  18/291 (6.19%)  0/20 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  69/291 (23.71%)  5/20 (25.00%) 
Back pain  1  54/291 (18.56%)  1/20 (5.00%) 
Joint swelling  1  16/291 (5.50%)  0/20 (0.00%) 
Muscle spasms  1  28/291 (9.62%)  1/20 (5.00%) 
Musculoskeletal pain  1  29/291 (9.97%)  1/20 (5.00%) 
Myalgia  1  35/291 (12.03%)  3/20 (15.00%) 
Pain in extremity  1  55/291 (18.90%)  2/20 (10.00%) 
Nervous system disorders     
Dizziness  1  51/291 (17.53%)  2/20 (10.00%) 
Headache  1  109/291 (37.46%)  9/20 (45.00%) 
Migraine  1  15/291 (5.15%)  1/20 (5.00%) 
Paraesthesia  1  28/291 (9.62%)  0/20 (0.00%) 
Psychiatric disorders     
Anxiety  1  21/291 (7.22%)  0/20 (0.00%) 
Depression  1  19/291 (6.53%)  0/20 (0.00%) 
Insomnia  1  41/291 (14.09%)  0/20 (0.00%) 
Renal and urinary disorders     
Dysuria  1  15/291 (5.15%)  0/20 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  70/291 (24.05%)  9/20 (45.00%) 
Dyspnoea  1  22/291 (7.56%)  2/20 (10.00%) 
Epistaxis  1  73/291 (25.09%)  5/20 (25.00%) 
Nasal congestion  1  30/291 (10.31%)  6/20 (30.00%) 
Oropharyngeal blistering  1  20/291 (6.87%)  0/20 (0.00%) 
Oropharyngeal pain  1  50/291 (17.18%)  6/20 (30.00%) 
Rhinorrhoea  1  26/291 (8.93%)  5/20 (25.00%) 
Skin and subcutaneous tissue disorders     
Blood blister  1  19/291 (6.53%)  0/20 (0.00%) 
Ecchymosis  1  25/291 (8.59%)  1/20 (5.00%) 
Petechiae  1  53/291 (18.21%)  9/20 (45.00%) 
Pruritus  1  23/291 (7.90%)  0/20 (0.00%) 
Rash  1  44/291 (15.12%)  5/20 (25.00%) 
Scab  1  0/291 (0.00%)  2/20 (10.00%) 
Skin lesion  1  18/291 (6.19%)  1/20 (5.00%) 
Vascular disorders     
Haematoma  1  37/291 (12.71%)  1/20 (5.00%) 
Hypertension  1  17/291 (5.84%)  0/20 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
Publications:
Terrell D, George J, Bussel J, Lyons R, Pullarkat V, Redner R, Nie, Selleslag D, Nie K, Woodard P.Home administration of romiplostim by patients with chronic immune thrombocytopenia (ITP).Journal-001500;
Terrell D, George J, Bussel J, Lyons R, Pullarkat V, Redner R, Nie, Selleslag D, Nie K, Woodard P.Home administration of romiplostim by patients with chronic immune thrombocytopenia (ITP).Journal-001752;
Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00116688    
Other Study ID Numbers: 20030213
First Submitted: June 30, 2005
First Posted: July 1, 2005
Results First Submitted: March 4, 2011
Results First Posted: April 6, 2011
Last Update Posted: December 18, 2013