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Clinical Trial on Treatment of Intraventricular Hemorrhage

NCT00650858 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2017-12-11

Study results available
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Summary

The specific objective of this trial is to determine the lowest dose and dose frequency possible with the best pharmacokinetic and safety profile and it's ability to remove a blood clot from the ventricular system.

Conditions

  • Intraventricular Hemorrhage

Interventions

DRUG

tissue plasminogen activator, rt-PA (thrombolytic) (Cathflo)

0.3 mg and 1.0 mg of rt-PA (Cathflo) were administered every 12 hours (dose finding) and every 8 hours (dose frequency) via the intraventricular catheter to treat intraventricular hemorrhage.

Sponsors & Collaborators

  • FDA Office of Orphan Products Development

    collaborator FED

  • Genentech, Inc.

    collaborator INDUSTRY

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Daniel F Hanley, MD · Johns Hopkins University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • United States
  • Canada
  • Germany
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

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 NCT00650858 on ClinicalTrials.gov