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Safety Study of GMA161 in Patients With Idiopathic Thrombocytopenic Purpura (ITP)

NCT00244257 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2015-04-09

No results posted yet for this study

Summary

This study is designed to investigate the safety of a single infusion of GMA161 in patients with idiopathic thrombocytopenic purpura, as well as, the way the drug enters and leaves the body. In addition, throughout the study, platelet counts and other blood cell numbers will be measured. NOTE: A decision was made to terminate this study in June 2008 due to low enrollment.

Conditions

  • Idiopathic Thrombocytopenic Purpura

Interventions

BIOLOGICAL

GMA161

0.1 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples

BIOLOGICAL

GMA161

0.3 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples

BIOLOGICAL

GMA161

0.6 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples

BIOLOGICAL

GMA161

1.0 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples

BIOLOGICAL

GMA161

3.0 mg/kg, IV infusion on Day 0 and monitored for 7 days with collection of blood samples

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Genzyme, a Sanofi Company

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • United States

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 NCT00244257 on ClinicalTrials.gov