Trial Outcomes & Findings for Efficacy and Safety of Actilyse 2 mg/ 2 ml in Comparison to Saline Solution in Patients With Central Venous Access Device Occlusion (NCT NCT01958164)

NCT ID: NCT01958164

Last Updated: 2015-05-01

Results Overview

Proportion (percentage) of patients with restored central venous access device (CVAD) function at 120 min after administration of the first dose of study medication (i.e. Actilyse® or saline solution).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 16 participants
• Primary outcome timeframe: 120 minutes after first drug administration
• Results posted on: 2015-05-01

Participant Flow

Participant milestones

Measure	Actilyse Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.	Saline Solution + Actilyse Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.
Overall Study STARTED	6	10
Overall Study COMPLETED	4	5
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Measure	Actilyse Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.	Saline Solution + Actilyse Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.
Overall Study Adverse Event	0	2
Overall Study Lost to Follow-up	2	3

Baseline Characteristics

Efficacy and Safety of Actilyse 2 mg/ 2 ml in Comparison to Saline Solution in Patients With Central Venous Access Device Occlusion

Baseline characteristics by cohort

Measure	Actilyse n=6 Participants Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.	Saline Solution + Actilyse n=10 Participants Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.	Total n=16 Participants Total of all reporting groups
Age, Continuous	56.0 years n=5 Participants	63.9 years n=7 Participants	60.9 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 120 minutes after first drug administration

Population: Full analysis set (FAS) which included all randomised patients who received at least one dose of study medication.

Proportion (percentage) of patients with restored central venous access device (CVAD) function at 120 min after administration of the first dose of study medication (i.e. Actilyse® or saline solution).

Outcome measures

Measure	Actilyse n=6 Participants Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.	Saline Solution + Actilyse n=10 Participants Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.
Proportion of Patients With Restored CVAD Function at 120 Min After Administration of the First Dose of Study Medication	83.3 percentage of participants Interval 35.8 to 99.6	10.0 percentage of participants Interval 0.2 to 44.5

SECONDARY outcome

Timeframe: 30 minutes after first drug administration

Population: Full analysis set (FAS) which included all randomised patients who received at least one dose of study medication.

Percentage of patients with restored CVAD function 30 minutes after administration of study medication at time 0 (i.e. Actilyse® or saline solution)

Outcome measures

Measure	Actilyse n=6 Participants Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.	Saline Solution + Actilyse n=10 Participants Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.
Restored CVAD Function 30 Minutes After Administration of Study Medication at Time 0	66.7 percentage of participants Interval 22.3 to 95.7	0.0 percentage of participants Interval 0.0 to 30.8

SECONDARY outcome

Timeframe: 150 minutes after first drug administration

Population: All patients in the FAS who did not have restored CVAD function 120 minutes after first drug administration

Percentage of patients with restored CVAD function 30 minutes after administration of the second dose of study medication Actilyse (150 minutes after time 0)

Outcome measures

Measure	Actilyse n=1 Participants Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.	Saline Solution + Actilyse n=9 Participants Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.
Restored CVAD Function 30 Minutes After Administration of the Second Dose of Study Medication Actilyse	100.0 percentage of participants Interval 2.5 to 100.0	55.6 percentage of participants Interval 21.2 to 86.3

SECONDARY outcome

Timeframe: 240 minutes after first drug administration

Population: All patients in the FAS who did not have restored CVAD function 120 minutes after first drug administration

Percentage of patients with restored CVAD function 120 minutes after administration of the second dose of study medication Actilyse (240 minutes after time 0)

Outcome measures

Measure	Actilyse n=1 Participants Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.	Saline Solution + Actilyse n=9 Participants Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.
Restored CVAD Function 120 Minutes After Administration of the Second Dose of Study Medication Actilyse	100.0 percentage of participants Interval 2.5 to 100.0	77.8 percentage of participants Interval 39.9 to 97.2

SECONDARY outcome

Timeframe: 0 minutes and 240 minutes

Population: All patients in the FAS who were randomised to the Actilyse treatment group

This endpoint was defined as the number of doses required to achieve restored CVAD function in patients from the actilyse treatment group but was analysed as the percentage of participants who achieved restored CVAD function after 1 dose and 2 doses, in patients from the actilyse treatment group.

Outcome measures

Measure	Actilyse n=6 Participants Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.	Saline Solution + Actilyse Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.
Percentage of Participants Who Achieved Restored CVAD Function After 1 Dose and 2 Doses, in Patients From the Actilyse Treatment Group. After 1 dose of Actilyse	83.3 percentage of participants	—
Percentage of Participants Who Achieved Restored CVAD Function After 1 Dose and 2 Doses, in Patients From the Actilyse Treatment Group. After 2 doses of Actilyse	16.7 percentage of participants	—

Adverse Events

Actilyse

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Saline Solution + Actilyse

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Actilyse n=6 participants at risk Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.	Saline Solution + Actilyse n=10 participants at risk Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.
Vascular disorders Arterial hypertension	16.7% 1/6 • From drug administration until the end of that day	0.00% 0/10 • From drug administration until the end of that day

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

Results disclosure agreements

• Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER