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Open Label Extension Study of AMG 531 in Japanese Subjects With ITP

NCT00440037 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2020-01-21

Study results available
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Summary

The purpose of this study is to assess the safety and efficacy of long term dosing of AMG 531 in thrombocytopenic Japanese subjects with ITP.

It is anticipated that AMG 531 will be a safe and well tolerated in long term treatment and that AMG 531 will effectively raise and maintain platelet counts to a desired therapeutic range, when individual dose adjustments based on platelet counts are permitted.

This study is available to subjects who have completed any previous AMG 531 ITP study in Japan and meet the eligibility criteria of this study.

Conditions

  • Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

Interventions

BIOLOGICAL

AMG 531

AMG 531 will be administered by SC injection once per week from Week 1 (Day 1). The maximum permitted dose of AMG 531 is 10 μg/kg. AMG 531 will be supplied as a sterile, white, preservative-free, lyophilized powder in 5 mL glass vials containing 0.6 mg of protein per vial, and a protein concentration of 0.5 mg/mL when reconstituted with 1.2 mL of sterile water for injection.

Sponsors & Collaborators

  • Kyowa Kirin Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2011-07-31
Completion
2011-09-30

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00440037 on ClinicalTrials.gov