Trial · NCT00415532

Romiplostim (AMG 531) Versus Medical Standard of Care for Immune (Idiopathic) Thrombocytopenic Purpura

NCT00415532, Phase 3, Completed, Amgen; results first posted 2013-07-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Romiplostim (AMG 531) Versus Medical Standard of Care for Immune (Idiopathic) Thrombocytopenic Purpura. Trials, record NCT00415532. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00415532

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Romiplostim (AMG 531) Versus Medical Standard of Care for Immune (Idiopathic) Thrombocytopenic Purpura
NCT number: NCT00415532
Status: Completed
Phases: Phase 3
Enrollment: 234 participants, actual
Lead sponsor: Amgen
Conditions: Idiopathic Thrombocytopenic Purpura, Thrombocytopenia, Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP), Thrombocytopenic Purpura
Interventions: Medical Standard of Care for ITP, Romiplostim
First posted: 2006-12-25
Last updated: 2022-11-08
Results first posted: 2013-07-08

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Splenectomy During 52-Week Treatment Period	52 weeks	Occurrence of a splenectomy. Participants who discontinued study during the treatment period prior to reporting a splenectomy were considered as having had a splenectomy.
Primary	Number of Participants With Treatment Failure During 52-Week Treatment Period	52 weeks	Treatment failure was defined by platelet counts ≤ 20 x 10\^9/L for 4 consecutive weeks at the highest recommended dose and schedule, a major bleeding event, or change in therapy due to an intolerable side effect or bleeding symptom.
Secondary	Time to Splenectomy	52 weeks	Time to splenectomy in days calculated from date of randomization to date of splenectomy, or censored at date of end of treatment visit if no splenectomy was done during treatment period.
Secondary	Percentage of Participants With Platelet Response	Weeks 1-8, and Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Platelet response was defined as platelet counts \> 50 x 10\^9/L, measured at each study visit (excluding those within 8 weeks of prior rescue medication use) up to the time of splenectomy or the end of initial treatment period, whichever occurred first.
Secondary	Change in ITP-PAQ Physical Health Domain of Symptoms	Baseline and 52 weeks	Change from Baseline in the Immune Thrombocytopenic Purpura (ITP) Patient Assessment Questionnaire (PAQ) physical health domain of symptoms. This domain has a range of 0 to 100, with higher scores indicating a better health-related quality of life. Model included fixed effects of baseline assessment, geographic region, treatment group, assessment week, splenectomy status and treatment group-by-assessment week interaction. Treatment group and splenectomy status are time-varying covariates.
Secondary	Change in ITP-PAQ Physical Health Domain of Fatigue	Baseline and 52 weeks	Change from Baseline in the Immune Thrombocytopenic Purpura (ITP) Patient Assessment Questionnaire (PAQ) physical health domain of fatigue. This domain has a range of 0 to 100, with higher scores indicating a better health-related quality of life. Model included fixed effects of baseline assessment, geographic region, treatment group, assessment week, splenectomy status and treatment group-by-assessment week interaction. Treatment group and splenectomy status are time-varying covariates.
Secondary	Change in ITP-PAQ Physical Health Domain of Bother	Baseline and 52 weeks	Change from Baseline in the Immune Thrombocytopenic Purpura (ITP) Patient Assessment Questionnaire (PAQ) physical health domain of bother. This domain has a range of 0 to 100, with higher scores indicating a better health-related quality of life. Model included fixed effects of baseline assessment, geographic region, treatment group, assessment week, splenectomy status and treatment group-by-assessment week interaction. Treatment group and splenectomy status are time-varying covariates.
Secondary	Change in ITP-PAQ Physical Health Domain of Activity	Baseline and 52 weeks	Change from Baseline in the Immune Thrombocytopenic Purpura (ITP) Patient Assessment Questionnaire (PAQ) physical health domain of activity. This domain has a range of 0 to 100, with higher scores indicating a better health-related quality of life. Model included fixed effects of baseline assessment, geographic region, treatment group, assessment week, splenectomy status and treatment group-by-assessment week interaction. Treatment group and splenectomy status are time-varying covariates.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Splenectomy During 52-Week Treatment Period	52 weeks	The Full Analysis set includes all randomized patients.	Participants	NUMBER
PRIMARY	Number of Participants With Treatment Failure During 52-Week Treatment Period	52 weeks	Full analysis set. Participants who discontinued study during treatment period prior to experiencing treatment failure were considered as having had treatment failure.	Participants	NUMBER
SECONDARY	Time to Splenectomy	52 weeks	Full analysis set	days	MEDIAN
SECONDARY	Percentage of Participants With Platelet Response	Weeks 1-8, and Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52	Full analysis set. N indicates the number of participants with available data at each time point.	percentage of participants	NUMBER
SECONDARY	Change in ITP-PAQ Physical Health Domain of Symptoms	Baseline and 52 weeks	Full analysis set	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change in ITP-PAQ Physical Health Domain of Fatigue	Baseline and 52 weeks	Full analysis set.	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change in ITP-PAQ Physical Health Domain of Bother	Baseline and 52 weeks	Full analysis set	Units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change in ITP-PAQ Physical Health Domain of Activity	Baseline and 52 weeks	Full analysis set	Units on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group56

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Participants With Splenectomy During 52-Week Treatment Period	Standard of Care	Had splenectomy	28		Participants
Number of Participants With Splenectomy During 52-Week Treatment Period	Romiplostim	Had splenectomy	14		Participants
Number of Participants With Splenectomy During 52-Week Treatment Period	Standard of Care	Did not have splenectomy	49		Participants
Number of Participants With Splenectomy During 52-Week Treatment Period	Romiplostim	Did not have splenectomy	143		Participants
Number of Participants With Treatment Failure During 52-Week Treatment Period	Standard of Care	Had treatment failure	23		Participants
Number of Participants With Treatment Failure During 52-Week Treatment Period	Romiplostim	Had treatment failure	18		Participants
Number of Participants With Treatment Failure During 52-Week Treatment Period	Standard of Care	Did not have treatment failure	54		Participants
Number of Participants With Treatment Failure During 52-Week Treatment Period	Romiplostim	Did not have treatment failure	139		Participants
Time to Splenectomy	Standard of Care		NA	95% Confidence Interval NA to NA	days
Time to Splenectomy	Romiplostim		NA	95% Confidence Interval NA to NA	days

1 to 10 of 56Source ClinicalTrials.gov

See all 56 results by group

Participant flow16

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Treatment Period	STARTED	Standard of Care	77
Treatment Period	STARTED	Romiplostim	157
Treatment Period	Received Treatment	Standard of Care	75
Treatment Period	Received Treatment	Romiplostim	154
Treatment Period	Switched to Romiplostim Group	Standard of Care	2
Treatment Period	Switched to Romiplostim Group	Romiplostim	0
Treatment Period	COMPLETED	Standard of Care	60
Treatment Period	COMPLETED	Romiplostim	142
Treatment Period	NOT COMPLETED	Standard of Care	17
Treatment Period	NOT COMPLETED	Romiplostim	15

1 to 10 of 16Source ClinicalTrials.gov

See all 16 participant flow

Adverse events284

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
other	Anaemia	Blood and lymphatic system disorders	Standard of Care	4	73
other	Anaemia	Blood and lymphatic system disorders	AMG 531	6	156
other	Vertigo	Ear and labyrinth disorders	Standard of Care	1	73
other	Vertigo	Ear and labyrinth disorders	AMG 531	9	156
other	Abdominal pain	Gastrointestinal disorders	Standard of Care	2	73
other	Abdominal pain	Gastrointestinal disorders	AMG 531	8	156
other	Abdominal pain upper	Gastrointestinal disorders	Standard of Care	6	73
other	Abdominal pain upper	Gastrointestinal disorders	AMG 531	4	156
other	Constipation	Gastrointestinal disorders	Standard of Care	6	73
other	Constipation	Gastrointestinal disorders	AMG 531	16	156

1 to 10 of 284Source ClinicalTrials.gov

See all 284 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Standard of Care
Total, all-cause mortality	AMG 531
Total, other adverse events	Standard of Care	60	73
Total, other adverse events	AMG 531	136	156
Total, serious adverse events	Standard of Care	28	73
Total, serious adverse events	AMG 531	36	156

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21067381	BACKGROUND	PubMed
22460421	BACKGROUND	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 comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
AMG 531 vs Standard of Care: serious adverse events

Source 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00415532

GET https://conductscience.org/api/trials/v1/NCT00415532/results?page=2

API reference For AI assistants