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Safety and Efficacy of Tissue Plasminogen Activator (tPA) in Neonates and Infants

NCT00265005 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-04-04

No results posted yet for this study

Summary

The purpose of this study is to determine if alteplase is effective in dissolving a clot in a catheter in a large vein (central venous line or PICC line) or artery in infants less than 6 months of age.

Conditions

Interventions

DRUG

alteplase

Iv administration of 1 mg/ml up to two times and 2 mg/ml if needed.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • University of Louisville

    lead OTHER

Principal Investigators

  • Janice E Sullivan, MD · University of Louisville

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
28 Weeks
Max Age
66 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2009-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00265005 on ClinicalTrials.gov