Clinical trial NCT01958164: Efficacy and Safety of Actilyse 2 mg/ 2 ml in Comparison to Saline Solution in Patients With Central Venous Access Device Occlusion
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Catheter Obstruction
Vascular Access Devices
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-10-09
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion criteria:

* 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;
  * glucose \> 2.8 mmol/l.

Exclusion criteria:

* 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.
* 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.

Primary outcomes:
measure: Proportion of Patients With Restored CVAD Function at 120 Min After Administration of the First Dose of Study Medication
timeFrame: 120 minutes after first drug administration
Secondary outcomes:
measure: Restored CVAD Function 30 Minutes After Administration of Study Medication at Time 0
timeFrame: 30 minutes after first drug administration
measure: Restored CVAD Function 30 Minutes After Administration of the Second Dose of Study Medication Actilyse
timeFrame: 150 minutes after first drug administration
measure: Restored CVAD Function 120 Minutes After Administration of the Second Dose of Study Medication Actilyse
timeFrame: 240 minutes after first drug administration
measure: Percentage of Participants Who Achieved Restored CVAD Function After 1 Dose and 2 Doses, in Patients From the Actilyse Treatment Group.
timeFrame: 0 minutes and 240 minutes
Other outcomes:
Locations:
city: Akhangelsk
country: Russian Federation
facility: 135.323.1 Boehringer Ingelheim Investigational Site
city: Krasnodar
country: Russian Federation
facility: 135.323.2 Boehringer Ingelheim Investigational Site
city: Krasnoyarsk
country: Russian Federation
facility: 135.323.3 Boehringer Ingelheim Investigational Site
city: Samara
country: Russian Federation
facility: 135.323.5 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 135.323.7 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: