Catheter ObstructionPhase 3NCT01958164

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

A Phase 3 study testing Actilyse and Saline solution in people with Catheter Obstruction and Vascular Access Devices, run by Boehringer Ingelheim at 5 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a multicentre, open-label, randomised, phase III study designed to evaluate the efficacy and safety of Actilyse 2 mg/2 ml in the restoration of function of CVAD Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Catheter Obstruction, Vascular Access Devices
What is being tested?: Actilyse and Saline solution
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 16 participants
Where: 5 sitesRussia
Study dates: Sep 2013to Apr 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and female patients between 18 and 80 years, who signed a written informed consent
Patients with central venous access device occlusion, which occurred within 24-h before randomisation, where central venous access device is indicated for any of the following: fluid maintenance, chemotherapy, intravenous feeding, haemodialysis, long-term administration of antibiotics or other medication
Patients with central venous access device occlusion occurred within 24-h before randomisation. Central venous access device is defined by inability to withdraw at least 3 ml of blood from the central venous access device. If multiple lumens are occluded, investigators are to choose and treat only one lumen for the study.
Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice and the local legislation. Acceptable level of the following laboratory parameters:
hemoglobin ≥ 80 g/L;
total white blood cell count ≥ 2.0 x109/L;

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platelets ≥ 50.0 x109/L;
fibrinogen ≥0.5 x lower limit of normal;
international normalized ratio <2 x upper limit of normal;
activated partial thromboplastin time <2 x upper limit of normal;
total protein ≥ 35 g/l;
alanine transaminase <20 x upper limit of normal;
aspartate transaminase <20 x upper limit of normal;
total bilirubin <10 x upper limit of normal;
creatinine <6 x upper limit of normal;
glucose > 2.8 mmol/l.

Who cannot join

Any clinical evidence of mechanical or non-thrombotic occlusion
High risk for bleeding events
High risk for embolic complications
Any condition for which bleeding constitutes a significant hazard or would be particularly difficult to manage
Administration of any fibrinolytic agent within 48 hours before start of study treatment
Patients who have had any of the following within the previous 48 hours before start of study treatment:

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surgery
obstetrical delivery
percutaneous biopsy of viscera or deep tissues
puncture of non-compressible vessels
active internal bleeding
Patients who have thrombocytopenia, other hemostatic defects (including those secondary to severe hepatic or renal disease).
Pregnancy and lactation.
Previously known positive results from infectious serology for Human Immunodeficiency Virus (HIV) or hepatitis B surface antigen (HBsAg), or hepatitis C virus.
Known hypersensitivity to alteplase or gentamicin, or any excipient of Actilyse - Body weight <30 kg.
Administration of any fibrinolytic agent within 48 hours before start of study treatment.
Participation in another investigational trial within 30 days prior to the Screening Visit.
Concomitant treatment with angiotensin-converting-enzyme inhibitors.
Impossibility to infuse fluids at the volume necessary to infuse study drug (2 ml) into the central venous access device.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Russia5 sites

135.323.1 Boehringer Ingelheim Investigational Site
Akhangelsk
135.323.2 Boehringer Ingelheim Investigational Site
Krasnodar
135.323.3 Boehringer Ingelheim Investigational Site
Krasnoyarsk
135.323.7 Boehringer Ingelheim Investigational Site
Saint Petersburg
135.323.5 Boehringer Ingelheim Investigational Site
Samara

Other trials in Russia

About this study

Official title: A Multicenter, Open-label, Randomised, Clinical Trial to Compare the Efficacy and Safety of Actilyse 2 mg/ 2 ml Versus Saline Solution in Restoring Function of an Occluded Central Venous Access Device

This is a multicentre, open-label, randomised, phase III study designed to evaluate the efficacy and safety of Actilyse 2 mg/2 ml in the restoration of function of CVAD

Conditions: Catheter Obstruction, Vascular Access Devices
Being tested: Actilyse, Saline solution

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ActilyseDrug
Actilyse 2mg/2ml will be given if the CVAD has not been restored at time 120min.
Saline solutionDrug
Instil Saline solution 2 ml into the disfunctional CVAD once at time O only for patients enrolled in Group II
ActilyseDrug
Instil Actilyse 2 mg/ 2 ml into the dysfunctional CVAD at time O.
ActilyseDrug
Second dose of Actilyse 2mg/2ml will be given if CVAD has not been restored at time 120min.

Study groups in NCT01958164
Study group	Role	What they receive
Actilyse 2 mg/2 ml	Experimental	First dose of Actilyse 2mg/2ml will be given at time 0. Second dose will be given at 120 if CVAD function has not been restored. Receives: Drug: Actilyse
Saline solution (NaCl 0.9%)	Sham comparator	Saline solution will be given at time 0. First dose of Actilyse 2mg/2ml will be given to patients if CVAD function has not been restored. Receives: Drug: Actilyse; Drug: Saline solution

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Patients With Restored CVAD Function at 120 Min After Administration of the First 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).
Measured: 120 minutes after first drug administration

Secondary outcomes (4)

Restored CVAD Function 30 Minutes After Administration of Study Medication at Time 0
Percentage of patients with restored CVAD function 30 minutes after administration of study medication at time 0 (i.e. Actilyse® or saline solution)
Measured: 30 minutes after first drug administration
Restored CVAD Function 30 Minutes After Administration of the Second Dose of Study Medication Actilyse
Percentage of patients with restored CVAD function 30 minutes after administration of the second dose of study medication Actilyse (150 minutes after time 0)
Measured: 150 minutes after first drug administration
Restored CVAD Function 120 Minutes After Administration of the Second Dose of Study Medication Actilyse
Percentage of patients with restored CVAD function 120 minutes after administration of the second dose of study medication Actilyse (240 minutes after time 0)
Measured: 240 minutes after first drug administration
Percentage of Participants Who Achieved Restored CVAD Function After 1 Dose and 2 Doses, in Patients From 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.
Measured: 0 minutes and 240 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2013Apr 2014

First posted9 Oct 2013 (estimated)
Study startSep 2013
Primary completionApr 2014
Study completionApr 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Catheter ObstructionStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01958164
Sponsor's protocol ID: 135.323
Status last verified: Apr 2015
First submitted: 1 Oct 2013
Last updated: 1 May 2015
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Catheter Obstruction trials

Study at a glance

From the registry record, last updated by the sponsor on 1 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Open-label, Randomised, Clinical Trial to Compare the Efficacy and Safety of Actilyse 2 mg/ 2 ml Versus Saline Solution in Restoring Function of an Occluded Central Venous Access Device
ClinicalTrials.gov ID: NCT01958164
Acronym / sponsor ID: 135.323
Conditions: Catheter Obstruction, Vascular Access Devices
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Sep 2013
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 9 Oct 2013 (estimated)
Results: Posted 1 May 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a multicentre, open-label, randomised, phase III study designed to evaluate the efficacy and safety of Actilyse 2 mg/2 ml in the restoration of function of CVAD

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Actilyse 2 mg/2 ml	Experimental	Drug: ActilyseFirst dose of Actilyse 2mg/2ml will be given at time 0. Second dose will be given at 120 if CVAD function has not been restored.
Saline solution (NaCl 0.9%)	Sham comparator	Drug: Actilyse, Drug: Saline solutionSaline solution will be given at time 0. First dose of Actilyse 2mg/2ml will be given to patients if CVAD function has not been restored.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Male and female patients between 18 and 80 years, who signed a written informed consent
Patients with central venous access device occlusion, which occurred within 24-h before randomisation, where central venous access device is indicated for any of the following: fluid maintenance, chemotherapy, intravenous feeding, haemodialysis, long-term administration of antibiotics or other medication
Patients with central venous access device occlusion occurred within 24-h before randomisation. Central venous access device is defined by inability to withdraw at least 3 ml of blood from the central venous access device. If multiple lumens are occluded, investigators are to choose and treat only one lumen for the study.
Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice and the local legislation. Acceptable level of the following laboratory parameters:

Key exclusion criteria (19 listed)

Any clinical evidence of mechanical or non-thrombotic occlusion
High risk for bleeding events
High risk for embolic complications
Any condition for which bleeding constitutes a significant hazard or would be particularly difficult to manage
Administration of any fibrinolytic agent within 48 hours before start of study treatment

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ActilyseActilyse 2mg/2ml will be given if the CVAD has not been restored at time 120min.	Drug	Saline solution (NaCl 0.9%)
Saline solutionInstil Saline solution 2 ml into the disfunctional CVAD once at time O only for patients enrolled in Group II	Drug	Saline solution (NaCl 0.9%)
ActilyseInstil Actilyse 2 mg/ 2 ml into the dysfunctional CVAD at time O.	Drug	Actilyse 2 mg/2 ml
ActilyseSecond dose of Actilyse 2mg/2ml will be given if CVAD has not been restored at time 120min.	Drug	Actilyse 2 mg/2 ml

Primary outcome

Proportion of Patients With Restored CVAD Function at 120 Min After Administration of the First Dose of Study Medication
Time frame: 120 minutes after first drug administration
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).

4 secondary outcomes

Restored CVAD Function 30 Minutes After Administration of Study Medication at Time 0
Time frame: 30 minutes after first drug administration
Restored CVAD Function 30 Minutes After Administration of the Second Dose of Study Medication Actilyse
Time frame: 150 minutes after first drug administration
Restored CVAD Function 120 Minutes After Administration of the Second Dose of Study Medication Actilyse
Time frame: 240 minutes after first drug administration
Percentage of Participants Who Achieved Restored CVAD Function After 1 Dose and 2 Doses, in Patients From the Actilyse Treatment Group.
Time frame: 0 minutes and 240 minutes

Results and safety

Results posted to the registry on 1 May 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Actilyse	6	4
Saline Solution + Actilyse	10	5

Primary outcome: Proportion of Patients With Restored CVAD Function at 120 Min After Administration of the First Dose of Study Medication

Time frame: 120 minutes after first drug administration. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Actilyse n = 6	Saline Solution + Actilyse n = 10
Value	83.3 (35.8 to 99.6)	10.0 (0.2 to 44.5)

Actilyse vs Saline Solution + Actilyse: Mean Difference (Net): 73.3 (95% CI 23.3 to 89.3)

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

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From drug administration until the end of that day. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Actilyse	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
Saline Solution + Actilyse	0 of 10 (0%)	0 of 10 (0%)	Not reported

Limitations and caveats (from the sponsor): The study was stopped prematurely due to slow recruitment of patients.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Catheter Obstruction

Recruiting
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Recruiting
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Ischemic Stroke
Active, not recruiting
Compassionate-Use of 4% T-EDTA Lock Solution for Central Venous Lines of Pediatric PN Patients
Central Line Complication, Central Line-associated Bloodstream Infection (CLABSI)
Active, not recruiting
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Acute Ischemic Stroke
Not yet recruitingPhase 4
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Actilyse and Saline solution in people with Catheter Obstruction and Vascular Access Devices, run by Boehringer Ingelheim at 5 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Patients With Restored CVAD Function at 120 Min After Administration of the First Dose of Study Medication (time frame: 120 minutes after first drug administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01958164.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2015.