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Romiplostim Treatment of Thrombocytopenia in Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

NCT00614523 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2022-11-07

Study results available
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Summary

The Data Monitoring Committee (DMC) for study 20060198 recommended that all subjects discontinue treatment of study drug and continue to be followed for long term follow-up. Amgen adopted the DMC recommendation.

Conditions

Interventions

DRUG

Placebo

Placebo is supplied in a 5 mL single use glass vial as a sterile, white, preservative-free, lyophilized powder.

BIOLOGICAL

Romiplostim

Romiplostim is supplied in a 5 mL single use glass vial as a sterile, white, preservative-free, lyophilized powder.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-21
Primary Completion
2011-03-31
Completion
2015-11-30

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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 NCT00614523 on ClinicalTrials.gov