NCT00305435

Brief Summary

The purpose of the study is to evaluate the efficacy of starting dose of AMG 531 as measured by platelet counts by cohort dose-escalation design.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2006

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

July 5, 2024

Status Verified

July 1, 2024

Enrollment Period

9 months

First QC Date

March 20, 2006

Last Update Submit

July 3, 2024

Conditions

Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

Keywords

AMG 531, ITP, Phase 2, Japanese

Outcome Measures

Primary Outcomes (1)

  • Incidence of all adverse events including evaluation of antibody status

    1 year

Secondary Outcomes (1)

  • Proportion of subjects who achieve a platelet response

    2 weeks

Study Arms (1)

romiplostim (AMG-531)

EXPERIMENTAL
Drug: Romiplostim (AMG-531)

Interventions

Romiplostim (AMG-531)DRUG

Romiplostim (AMG-531)

romiplostim (AMG-531)

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Shirasugi Y, Ando K, Hashino S, Nagasawa T, Kurata Y, Kishimoto Y, Iwato K, Ohtsu T, Berger DP. A phase II, open-label, sequential-cohort, dose-escalation study of romiplostim in Japanese patients with chronic immune thrombocytopenic purpura. Int J Hematol. 2009 Sep;90(2):157-165. doi: 10.1007/s12185-009-0361-y. Epub 2009 Jun 20.

    PMID: 19543952BACKGROUND

Related Links

MeSH Terms

Conditions

Purpura, ThrombocytopenicPurpura, Thrombocytopenic, Idiopathic

Interventions

romiplostim

Condition Hierarchy (Ancestors)

PurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaImmune System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and SymptomsHemorrhagic DisordersAutoimmune Diseases

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2006

First Posted

March 22, 2006

Study Start

February 1, 2006

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

July 5, 2024

Record last verified: 2024-07