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

NCT01958164 | Completed Phase 3 Results

• 1 other identifier: 135.323
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 5

Brief 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

Conditions

Catheter Obstruction; Vascular Access Devices

Outcome Measures

Primary Outcomes (1)

• 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).

  120 minutes after first drug administration

Secondary Outcomes (4)

• Restored CVAD Function 30 Minutes After Administration of Study Medication at Time 0

  30 minutes after first drug administration

• Restored CVAD Function 30 Minutes After Administration of the Second Dose of Study Medication Actilyse

  150 minutes after first drug administration

• Restored CVAD Function 120 Minutes After Administration of the Second Dose of Study Medication Actilyse

  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.

  0 minutes and 240 minutes

Study Arms (2)

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.

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.

Drug: Actilyse; Drug: Saline solution

Interventions

Actilyse DRUG

Actilyse 2mg/2ml will be given if the CVAD has not been restored at time 120min.

Saline solution (NaCl 0.9%)

Saline solution DRUG

Instil Saline solution 2 ml into the disfunctional CVAD once at time O only for patients enrolled in Group II

Saline solution (NaCl 0.9%)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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;

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (5)

135.323.1 Boehringer Ingelheim Investigational Site

Akhangelsk, Russia

Location

135.323.2 Boehringer Ingelheim Investigational Site

Krasnodar, Russia

Location

135.323.3 Boehringer Ingelheim Investigational Site

Krasnoyarsk, Russia

Location

135.323.7 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

135.323.5 Boehringer Ingelheim Investigational Site

Samara, Russia

Location

MeSH Terms

Interventions

Tissue Plasminogen Activator; Saline Solution

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

The study was stopped prematurely due to slow recruitment of patients.

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2013
• First Posted: October 9, 2013
• Study Start: September 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 1, 2015
• Results First Posted: May 1, 2015

Record last verified: 2015-04

Locations

RU (5)