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An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With ITP
Phase 3 trial testing Romiplostim in Idiopathic Thrombocytopenic Purpura in 407 participants. Completed in 1 March 2011.
| Lead sponsor | Amgen |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 407 |
| Start date | 1 February 2005 |
| Primary completion | 1 January 2011 |
| Estimated completion | 1 March 2011 |
Amgen — full company profile →
18 and older, any sex, with Idiopathic Thrombocytopenic Purpura or Thrombocytopenia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
One or more occurences of one or more adverse events within the participant during the study. Participants with more than one event were only counted once
| Group | Value | 95% CI |
|---|---|---|
| Romiplostim (AMG 531) Cohort 1 | 162 | |
| Romiplostim (AMG 531) Cohort 2 | 215 |
Platelet response using definition1 . (a doubling of baseline platelet count and a platelet count of \>=50 x 10\^9/L
| Group | Value | 95% CI |
|---|---|---|
| Romiplostim (AMG 531) Cohort 1 | 156 | |
| Romiplostim (AMG 531) Cohort 2 | 214 |
Platelet response using definition 2 (a platelet count increase of \>=20 x 109/L from baseline)
| Group | Value | 95% CI |
|---|---|---|
| Romiplostim (AMG 531) Cohort 1 | 160 | |
| Romiplostim (AMG 531) Cohort 2 | 220 |
Time frame: Average duration: cohort 1 52 wks; cohort 2 42 wks.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Romiplostim Cohort 1 | Romiplostim Cohort 2 |
|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | — | — |
| Pneumonia | Infections and infestations | — | — |
| Idiopathic thrombocytopenic purpura | Blood and lymphatic system disorders | — | — |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | — | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — | — |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | — | — |
| Purpura | Skin and subcutaneous tissue disorders | — | — |
| Deep vein thrombosis | Vascular disorders | — | — |
| Haemorrhage | Vascular disorders | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Peritonitis | Gastrointestinal disorders | — | — |
| Rectal haemorrhage | Gastrointestinal disorders | — | — |
| Chest pain | General disorders | — | — |
| Pyrexia | General disorders | — | — |
| Portal vein thrombosis | Hepatobiliary disorders | — | — |
| Lower respiratory tract infection | Infections and infestations | — | — |
| Sepsis | Infections and infestations | — | — |
| Viral infection | Infections and infestations | — | — |
| Contusion | Injury, poisoning and procedural complications | — | — |
| Traumatic haematoma | Injury, poisoning and procedural complications | — | — |
| Platelet count decreased | Investigations | — | — |
| Reaction | System | Romiplostim Cohort 1 | Romiplostim Cohort 2 |
|---|---|---|---|
| Headache | Nervous system disorders | — | — |
| Fatigue | General disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Contusion | Injury, poisoning and procedural complications | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Nasopharyngitis | Infections and infestations | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Petechiae | Skin and subcutaneous tissue disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Influenza | Infections and infestations | — | — |
| Oedema peripheral | General disorders | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Pyrexia | General disorders | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Asthenia | General disorders | — | — |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Haematoma | Vascular disorders | — | — |
| Pain | General disorders | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Bone pain | Musculoskeletal and connective tissue disorders | — | — |
| Paraesthesia | Nervous system disorders | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — |
| Mouth haemorrhage | Gastrointestinal disorders | — | — |
| Viral infection | Infections and infestations | — | — |
| Muscle spasms | Musculoskeletal and connective tissue disorders | — | — |
| Gingival bleeding | Gastrointestinal disorders | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Hypertension | Vascular disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
Most-reported serious reactions: Thrombocytopenia, Pneumonia, Idiopathic thrombocytopenic purpura, Gastrointestinal haemorrhage, Epistaxis, Pulmonary embolism, Abdominal pain, Nausea.
Data from ClinicalTrials.gov NCT00508820 adverse events section.
This protocol will provide open label romiplostim to adult thrombocytopenic subjects. Romiplostim will be administered by subcutaneous injection once per week. Dose adjustment will be based on platelet counts, and will be allowed throughout the duration of the study. Rescue therapies are allowed at any time during the study. Reductions in concurrent ITP therapies may occur at any time when platelet counts are \> 50,000.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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