Completed PHASE1/PHASE2 INTERVENTIONAL 2-arm NCT00515203

Safety and Efficacy Study of Romiplostim (AMG 531) to Treat ITP in Pediatric Subjects

A Randomized, Double-Blind, Placebo-controlled Phase 1/2 Study to Determine the Safety and Efficacy of Romiplostim (AMG 531) in Thrombocytopenic Pediatric Subjects With Chronic Immune (Idiopathic) Thrombocytopenic Purpura

Sponsor: Amgen

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

Interventions AMG 531 Placebo

Updated 7 times since 2017 Last updated: Jul 18, 2014 Started: Jul 31, 2007 Primary completion: Mar 31, 2009 Completion: Aug 31, 2009

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1/PHASE2 clinical study on Idiopathic Thrombocytopenic Purpura and Thrombocytopenia in Pediatric Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP), this trial is completed. The trial is conducted by Amgen and has accumulated 7 data snapshots since 2007. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

7 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1/PHASE2
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1/PHASE2

Phase: PHASE1_PHASE2 → PHASE1/PHASE2
Jan 2023 — Jul 2024 [monthly]

Completed PHASE1_PHASE2
Dec 2022 — Jan 2023 [monthly]

Completed PHASE1_PHASE2
Jan 2021 — Dec 2022 [monthly]

Completed PHASE1_PHASE2

▶ Show 2 earlier versions

Jun 2018 — Jan 2021 [monthly]

Completed PHASE1_PHASE2
Jan 2017 — Jun 2018 [monthly]

Completed PHASE1_PHASE2

First recorded

Jul 2007

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Amgen

Data source: Amgen

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

No location information available.