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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 22, 2014