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Efficacy and Safety of Activase (Ateplase) vs Placebo in Complicated Pleural Effusions (CPE)/Empyemas

NCT00468104 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2012-04-30

Study results available
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Summary

The purpose of this study is to document the efficacy and safety of intrapleural instillation of Activase vs Placebo in the management of complicated pleural effusions and empyemas

Conditions

  • Pleural Effusion Associated With Pulmonary Infection
  • Bacterial Pleural Effusion Other Than Tuberculosis

Interventions

DRUG

Alteplase

25 Mg of Alteplase in 100 cc of normal saline was instilled intrapeurally for daily for three days

DRUG

Placebo

Placebo in 100 cc of normal saline was instilled intrapleurally daily for three days

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Midwest Pulmonary and Critical Care

    lead OTHER

Principal Investigators

  • George Thommi, MD · Midwest Pulmonary and Critical Care, PC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2008-10-31
Completion
2009-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00468104 on ClinicalTrials.gov