Trial · NCT00508820
An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With ITP
NCT00508820, Phase 3, Completed, Amgen; results first posted 2012-02-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With ITP. Trials, record NCT00508820. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00508820
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With ITP
- NCT number
- NCT00508820
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 407 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Idiopathic Thrombocytopenic Purpura, Thrombocytopenia, Thrombocytopenic Purpura
- Interventions
- Romiplostim
- First posted
- 2007-07-30
- Last updated
- 2022-11-14
- Results first posted
- 2012-02-13
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adverse Events | Duration of Treatment plus 30 days or End of Study (whichever is later). Approximately 205 weeks. | 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 |
| Secondary | Platelet Response (Definition 1) | Duration of treatment (up to 201 weeks) | Platelet response using definition1 . (a doubling of baseline platelet count and a platelet count of \>=50 x 10\^9/L |
| Secondary | Platelet Response (Definition 2) | Duration of treatment (up to 201 weeks) | Platelet response using definition 2 (a platelet count increase of \>=20 x 109/L from baseline) |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Adverse Events | Duration of Treatment plus 30 days or End of Study (whichever is later). Approximately 205 weeks. | Safety Analysis Set, comprised of all participants who received at least one dose of romiplostim | participants | NUMBER |
| SECONDARY | Platelet Response (Definition 1) | Duration of treatment (up to 201 weeks) | Full Analysis Set, all enrolled participants | Participants | NUMBER |
| SECONDARY | Platelet Response (Definition 2) | Duration of treatment (up to 201 weeks) | Full Analysis Set, all enrolled participants | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Adverse Events | Romiplostim (AMG 531) Cohort 1 | 162 | participants | ||
| Adverse Events | Romiplostim (AMG 531) Cohort 2 | 215 | participants | ||
| Platelet Response (Definition 1) | Romiplostim (AMG 531) Cohort 1 | 156 | Participants | ||
| Platelet Response (Definition 1) | Romiplostim (AMG 531) Cohort 2 | 214 | Participants | ||
| Platelet Response (Definition 2) | Romiplostim (AMG 531) Cohort 1 | 160 | Participants | ||
| Platelet Response (Definition 2) | Romiplostim (AMG 531) Cohort 2 | 220 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Romiplostim (AMG 531) Cohort 1 | 168 | |
| Overall Study | STARTED | Romiplostim (AMG 531) Cohort 2 | 239 | |
| Overall Study | COMPLETED | Romiplostim (AMG 531) Cohort 1 | 113 | |
| Overall Study | COMPLETED | Romiplostim (AMG 531) Cohort 2 | 175 | |
| Overall Study | NOT COMPLETED | Romiplostim (AMG 531) Cohort 1 | 55 | |
| Overall Study | NOT COMPLETED | Romiplostim (AMG 531) Cohort 2 | 64 |
Source ClinicalTrials.gov
Adverse events432
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Romiplostim Cohort 1 | 13 | 168 | |
| other | Anaemia | Blood and lymphatic system disorders | Romiplostim Cohort 2 | 10 | 239 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Romiplostim Cohort 1 | 15 | 168 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Romiplostim Cohort 2 | 11 | 239 | |
| other | Abdominal pain | Gastrointestinal disorders | Romiplostim Cohort 1 | 18 | 168 | |
| other | Abdominal pain | Gastrointestinal disorders | Romiplostim Cohort 2 | 11 | 239 | |
| other | Constipation | Gastrointestinal disorders | Romiplostim Cohort 1 | 20 | 168 | |
| other | Constipation | Gastrointestinal disorders | Romiplostim Cohort 2 | 12 | 239 | |
| other | Diarrhoea | Gastrointestinal disorders | Romiplostim Cohort 1 | 33 | 168 | |
| other | Diarrhoea | Gastrointestinal disorders | Romiplostim Cohort 2 | 24 | 239 |
1 to 10 of 432Source ClinicalTrials.gov
See all 432 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Romiplostim Cohort 1 | ||
| Total, all-cause mortality | Romiplostim Cohort 2 | ||
| Total, other adverse events | Romiplostim Cohort 1 | 155 | 168 |
| Total, other adverse events | Romiplostim Cohort 2 | 188 | 239 |
| Total, serious adverse events | Romiplostim Cohort 1 | 61 | 168 |
| Total, serious adverse events | Romiplostim Cohort 2 | 61 | 239 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26066765 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Romiplostim (AMG 531) Cohort 1 vs Romiplostim (AMG 531) Cohort 2: Adverse Events | Trial comparisons |
| Romiplostim (AMG 531) Cohort 1 vs Romiplostim (AMG 531) Cohort 2: Platelet Response (Definition 2) | Trial comparisons |
| Romiplostim (AMG 531) Cohort 1 vs Romiplostim (AMG 531) Cohort 2: Platelet Response (Definition 1) | Trial comparisons |
| Romiplostim Cohort 1 vs Romiplostim Cohort 2: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00508820
GET https://conductscience.org/api/trials/v1/NCT00508820/events?page=2