Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Central Catheters

This study has been completed.
Sponsor:
Information provided by:
ARCA Biopharma, Inc.
ClinicalTrials.gov Identifier:
NCT00346424
First received: June 28, 2006
Last updated: August 12, 2008
Last verified: August 2008
  Purpose

The purpose of the study is to compare the safety and effectiveness of alfimeprase to a placebo in restoring function of occluded central catheters.


Condition Intervention Phase
Thrombosis
Venous Thrombosis
Drug: Alfimeprase
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase 3, Multicenter, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Alfimeprase in Subjects With Occluded Central Venous Access Devices

Resource links provided by NLM:


Further study details as provided by ARCA Biopharma, Inc.:

Primary Outcome Measures:
  • Catheter function restoration at fifteen minutes after initial instillation of study drug. [ Time Frame: 15 minutes ]

Secondary Outcome Measures:
  • Catheter function restoration at 30 minutes after initial instillation of study drug. [ Time Frame: 30 minutes ]
  • Catheter function restoration at 30 minutes after second dose instillation of study drug if patency was not restored after first dose. [ Time Frame: additional 30 minutes ]

Enrollment: 300
Study Start Date: September 2005
Study Completion Date: December 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Detailed Description:

Primary Outcomes: The ability to withdraw at least 3 ml of blood and infuse more at least 5 mL of sterile saline through the occluded catheter lumen at 15 minutes after receiving initial instillation of study drug.

Secondary Outcomes:

The ability to withdraw at least 3 mL of blood and infuse at least 5 mL of sterile saline through the occluded catheter lumen at 30 minutes following a single instillation of study drug and at 30 minutes following a second instillation of study drug if patency is not restored within 30 minutes of the first instillation.

Safety:

  • Adverse events
  • Major bleeding events
  • Change in laboratory values.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must give written informed consent
  • Unable to withdraw 3 mL of blood from a central venous access device
  • Hemodynamically stable
  • Available for follow-up assessments

Exclusion Criteria:

  • Inability to infuse at least 2 mL of saline through the catheter
  • Catheter placed less than 48 hours prior to detection of occlusion
  • Catheter used for hemodialysis of pheresis
  • Less than 18 years of age
  • Evidence of mechanical or nonthrombotic occlusion
  • Receipt of any thrombolytic agent within 24 hours of randomization
  • In the opinion of the investigator, subject is at "high risk" for bleeding events of embolic complications, or has a condition for which bleeding constitutes a significant hazard
  • Increased risk for drug extravasation
  • Pregnant, lactating, or actively menstruating women and women of child-bearing potential who are not using adequate contraceptive precautions (e.g. intrauterine device, oral contraceptives, barrier methods, or other contraception deemed adequate by the investigator)
  • Known right-to-left cardiac shunt, patent foramen ovale, or atrial/ventricular septal defect
  • Participation in any other study of an investigational device, medication, biologic, or other agent within 30 days before enrollment and until the 30-day follow up visit
  • Any other subject feature that in the opinion of the investigator should preclude study participation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00346424

Locations
United States, Oregon
Corvallis Clinic
Corvallis, Oregon, United States, 97330
Sponsors and Collaborators
ARCA Biopharma, Inc.
Investigators
Study Director: Steven Deitcher, M.D. ARCA Biopharma, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00346424     History of Changes
Other Study ID Numbers: HA006
Study First Received: June 28, 2006
Last Updated: August 12, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by ARCA Biopharma, Inc.:
occluded central catheter
central venous access devices dysfunction
withdrawal occlusion
Thrombosis
Venous thrombosis

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thromboembolism

ClinicalTrials.gov processed this record on April 15, 2014