Central venous access device occlusion
Conditions
Interventions
Product Name: Alfimeprase
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Alfimeprase
CAS Number: 259074-76-5
Concentration unit: mg/ml milligram(s)/millilitre
Concentrati
Sponsors
Nuvelo, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following criteria will be eligible for enrollment: a) The subject (or legally acceptable representative) must give written informed consent b) Unable to withdraw 3 mL of blood from a central venous access device c) Hemodynamically stable d) Available for follow-up assessments Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria are not eligible for enrollment: a) Inability to infuse at least 2 mL of saline through the catheter b) Catheter placed < 48 hours prior to detection of occlusion c) Catheter used for hemodialysis or pheresis d) < 18 years of age e) Evidence of mechanical or nonthrombotic occlusion f) Receipt of any thrombolytic agent within 24 hours of randomization g) In the opinion of the investigator, subject is at “high risk” for bleeding events or embolic complications, or has a condition for which bleeding constitutes a significant hazard h) Increased risk for drug extravasation i) 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) j) Known right-to-left cardiac shunt, patent foramen ovale, or atrial/ventricular septal defect k) Participation in any other study of an investigational device, medication, biologic, or other agent within the 30 days before enrollment and until the 30-day follow up visit l) Any other subject feature that in the opinion of the investigator should preclude study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of alfimeprase compared with placebo as measured by the proportion of subjects with re-establishment of a functional central venous access device 15 minutes following the initial instillation of study drug.;Secondary Objective: Evaluate the efficacy of alfimeprase compared with placebo: - The proportion of subjects with re-establishment of a functional central venous access device 30 minutes following the initial instillation of study drug. - The cumulative proportion of subjects with re-establishment of a functional central venous access device 30 minutes following the instillation of one or two doses of study drug Evaluate the safety of alfimeprase compared with placebo: - Adverse event rate during the study period (time from initial instillation of study drug until 120 minutes following the final instillation of study drug) - Serious adverse event rate during the study period (time from initial instillation of study drug until 120 minutes following the final instillation of study drug) - Major bleeding event rate during the study period (time from initial instillation of study drug until 120 minutes following the final instillation of study drug) ;Primary end point(s): The primary efficacy endpoint is the proportion of subjects with re-establishment of a functional central venous access device 15 minutes following the initial instillation of study drug. The proportion of catheters with restored function following instillations of study drug will be compared between the treatment groups using a ?2 test. | — |
Countries
Belgium, Czech Republic
Outcome results
None listed