search
Back to results

Safety and Efficacy of TeaRx Xa Factor Direct Inhibitor Versus Enoxaparin as a Venous Thromboembolic Events (VTE) Prevention Following Total Knee Replacement

Primary Purpose

Total Knee Replacement

Status
Completed
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
TeaRx
Enoxaparin
Sponsored by
TeaRx LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Total Knee Replacement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female, age ≥ 18 years;
  • Planned total knee replacement surgery;
  • Signed informed consent form;
  • Willing to comply with the protocol;
  • Willing to use adequate contraception during the trial.

Exclusion Criteria:

  • Surgery for acute fracture 4 weeks before screening; history of septic inflammation in the joint; prosthesis revision or one leg missing
  • History of venous thrombosis of any location or PE
  • History of heparin induced thrombocytopenia or other thrombocytopathy; hemorrhagic diathesis
  • History of evident coagulopathy or in a relative
  • Congenital thrombophilia
  • Bleeding within 6 months of screening; increased risk of bleeding
  • BMI less than 18,5 or more than 40 kg/m2
  • Systolic BP > 180 mmHg and/or diastolic BP > 110 mmHg registered twice within 15-30 minutes
  • Hb ≤ 10.5 g/dL in female or ≤ 11.5 g/dL in male
  • Platelets < 100 000/mm3
  • Clinical significant abnormalities of APTT and/or INR
  • GFR < 30 ml/min/1.73 m2
  • ALT or AST ≥ 2 x ULN or total bilirubin ≥1,5 x ULN

Sites / Locations

  • SHAI "Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan"
  • Federal State Institution "National Medical and Surgical Center n. a. N. I. Pirogov" of the Ministry of Health of the Russian Federation
  • SBEI HPE First Moscow State Medical University n.a. I.M. Sechenov Ministry of Health of the Russian Federation
  • SHI of the city of Moscow City Clinical Hospital n.a. S.P. Botkin
  • FSBI "Nizhny Novgorod Research Institute of Traumatology and Orthopedics" of the Ministry of Health of the Russian Federation
  • SBHI "City Clinical Hospital № 4" of the city of Orenburg
  • St. Petersburg State Institution of Health "City Hospital № 2"
  • SHI of the Yaroslavl Region Emergency care hospital n. a. N. V. Solovyov

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

TeaRx 50 mg

TeaRx 100 mg

TeaRx 150 mg

Enoxaparin

Arm Description

TeaRx: 50 mg per day PO (active 25 mg + placebo 50 mg every 12 hours) during 12 days (±2 days)

TeaRx: 100 mg per day PO (placebo 25 mg + active 50 mg every 12 hours) during 12 days (±2 days)

TeaRx: 150 mg per day PO (active 25 mg + active 50 mg every 12 hours) during 12 days (±2 days)

Enoxaparin 40 mg subcutaneous per day (24 hours interval) during 12 days (±2 days)

Outcomes

Primary Outcome Measures

Incidence of deep venous thrombosis (DVT) (efficacy of the selected TeaRx dose)
Incidence of nonfatal pulmonary embolism (PE) (efficacy of the selected TeaRx dose)
Incidence of symptomatic venous thromboembolic events (DVT, PE) (efficacy of the selected TeaRx dose)
venous thromboembolic events (VTE) caused mortality (efficacy of the selected TeaRx dose)
Non-VTE caused mortality (efficacy of the selected TeaRx dose)
AEs and SAEs from subject complaints, physical examination, vital signs, laboratory results (efficacy of the selected TeaRx dose)

Secondary Outcome Measures

Incidence of bleeding (safety of selected TeaRx dose)
major and clinically relevant non-major bleeding

Full Information

First Posted
February 26, 2017
Last Updated
March 18, 2017
Sponsor
TeaRx LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT03088358
Brief Title
Safety and Efficacy of TeaRx Xa Factor Direct Inhibitor Versus Enoxaparin as a Venous Thromboembolic Events (VTE) Prevention Following Total Knee Replacement
Official Title
A Multicenter, Randomized, Pilot, Dose-Ranging Clinical Study to Evaluate Safety and Efficacy of TeaRx Xa Factor Direct Inhibitor Versus Enoxaparin as a Venous Thromboembolic Events (VTE) Prevention Following Total Knee Replacement
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TeaRx LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate influence of therapy on the following efficacy and safety parameters in different TeaRx dose groups and Enoxaparin group: Total venous thromboembolic events (VTE), which includes confirmed deep venous thrombosis (DVT), nonfatal pulmonary embolism (PE), and total mortality Incidence of DVT (total, proximal, distal) Incidence of nonfatal PE Incidence of symptomatic VTE (DVT, PE) VTE caused mortality Non-VTE caused mortality Incidence of all hemorrhagic complications Incidence of major and clinically relevant non-major bleeding Adverse events (AEs) and serious adverse events (SAEs) from subject complaints, physical examination, vital signs, laboratory results

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Knee Replacement

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TeaRx 50 mg
Arm Type
Experimental
Arm Description
TeaRx: 50 mg per day PO (active 25 mg + placebo 50 mg every 12 hours) during 12 days (±2 days)
Arm Title
TeaRx 100 mg
Arm Type
Experimental
Arm Description
TeaRx: 100 mg per day PO (placebo 25 mg + active 50 mg every 12 hours) during 12 days (±2 days)
Arm Title
TeaRx 150 mg
Arm Type
Experimental
Arm Description
TeaRx: 150 mg per day PO (active 25 mg + active 50 mg every 12 hours) during 12 days (±2 days)
Arm Title
Enoxaparin
Arm Type
Active Comparator
Arm Description
Enoxaparin 40 mg subcutaneous per day (24 hours interval) during 12 days (±2 days)
Intervention Type
Drug
Intervention Name(s)
TeaRx
Other Intervention Name(s)
TeaRxaban
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Other Intervention Name(s)
Clexane ®
Primary Outcome Measure Information:
Title
Incidence of deep venous thrombosis (DVT) (efficacy of the selected TeaRx dose)
Time Frame
6 weeks following total knee replacement
Title
Incidence of nonfatal pulmonary embolism (PE) (efficacy of the selected TeaRx dose)
Time Frame
6 weeks following total knee replacement
Title
Incidence of symptomatic venous thromboembolic events (DVT, PE) (efficacy of the selected TeaRx dose)
Time Frame
6 weeks following total knee replacement
Title
venous thromboembolic events (VTE) caused mortality (efficacy of the selected TeaRx dose)
Time Frame
6 weeks following total knee replacement
Title
Non-VTE caused mortality (efficacy of the selected TeaRx dose)
Time Frame
6 weeks following total knee replacement
Title
AEs and SAEs from subject complaints, physical examination, vital signs, laboratory results (efficacy of the selected TeaRx dose)
Time Frame
6 weeks following total knee replacement
Secondary Outcome Measure Information:
Title
Incidence of bleeding (safety of selected TeaRx dose)
Description
major and clinically relevant non-major bleeding
Time Frame
6 weeks following total knee replacement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female, age ≥ 18 years; Planned total knee replacement surgery; Signed informed consent form; Willing to comply with the protocol; Willing to use adequate contraception during the trial. Exclusion Criteria: Surgery for acute fracture 4 weeks before screening; history of septic inflammation in the joint; prosthesis revision or one leg missing History of venous thrombosis of any location or PE History of heparin induced thrombocytopenia or other thrombocytopathy; hemorrhagic diathesis History of evident coagulopathy or in a relative Congenital thrombophilia Bleeding within 6 months of screening; increased risk of bleeding BMI less than 18,5 or more than 40 kg/m2 Systolic BP > 180 mmHg and/or diastolic BP > 110 mmHg registered twice within 15-30 minutes Hb ≤ 10.5 g/dL in female or ≤ 11.5 g/dL in male Platelets < 100 000/mm3 Clinical significant abnormalities of APTT and/or INR GFR < 30 ml/min/1.73 m2 ALT or AST ≥ 2 x ULN or total bilirubin ≥1,5 x ULN
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mikhail N. Zamyatin, Prof.
Organizational Affiliation
Federal State Institution "National Medical and Surgical Center n. a. N. I. Pirogov" of the Ministry of Health of the Russian Federation
Official's Role
Study Chair
Facility Information:
Facility Name
SHAI "Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan"
City
Kazan
ZIP/Postal Code
420064
Country
Russian Federation
Facility Name
Federal State Institution "National Medical and Surgical Center n. a. N. I. Pirogov" of the Ministry of Health of the Russian Federation
City
Moscow
ZIP/Postal Code
105203
Country
Russian Federation
Facility Name
SBEI HPE First Moscow State Medical University n.a. I.M. Sechenov Ministry of Health of the Russian Federation
City
Moscow
ZIP/Postal Code
119435
Country
Russian Federation
Facility Name
SHI of the city of Moscow City Clinical Hospital n.a. S.P. Botkin
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
FSBI "Nizhny Novgorod Research Institute of Traumatology and Orthopedics" of the Ministry of Health of the Russian Federation
City
Nizhny Novgorod
ZIP/Postal Code
603155
Country
Russian Federation
Facility Name
SBHI "City Clinical Hospital № 4" of the city of Orenburg
City
Orenburg
ZIP/Postal Code
460000
Country
Russian Federation
Facility Name
St. Petersburg State Institution of Health "City Hospital № 2"
City
Saint Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
SHI of the Yaroslavl Region Emergency care hospital n. a. N. V. Solovyov
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Safety and Efficacy of TeaRx Xa Factor Direct Inhibitor Versus Enoxaparin as a Venous Thromboembolic Events (VTE) Prevention Following Total Knee Replacement

We'll reach out to this number within 24 hrs