Trial Outcomes & Findings for A Safety and Efficacy Study of BCD-080 Compared to Clexan for Deep Vein Thrombosis Prophylaxis at Orthopedic Surgeries (NCT NCT02368314)
NCT ID: NCT02368314
Last Updated: 2016-10-24
Results Overview
Frequency of deep vein thrombosis (DVT) (proximal and/or distal; symptomatic or asymptomatic).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
124 participants
Primary outcome timeframe
During the treatment period (14 days)
Results posted on
2016-10-24
Participant Flow
Participant milestones
| Measure |
BCD-080
Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of BCD-080 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery.
Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h).
|
Clexane
Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of Clexane 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery/
Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h).
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
60
|
|
Overall Study
COMPLETED
|
61
|
57
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
BCD-080
Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of BCD-080 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery.
Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h).
|
Clexane
Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of Clexane 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery/
Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Adverse Event
|
1
|
2
|
Baseline Characteristics
A Safety and Efficacy Study of BCD-080 Compared to Clexan for Deep Vein Thrombosis Prophylaxis at Orthopedic Surgeries
Baseline characteristics by cohort
| Measure |
BCD-080
n=64 Participants
Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of BCD-080 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery.
Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h).
|
Clexane
n=59 Participants
Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of Clexane 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery/
Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h).
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.50 years
n=99 Participants
|
60.00 years
n=107 Participants
|
58.00 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: During the treatment period (14 days)Population: Patient who finished the study as per protocol and had contrast venography results for efficacy evaluation.
Frequency of deep vein thrombosis (DVT) (proximal and/or distal; symptomatic or asymptomatic).
Outcome measures
| Measure |
BCD-080
n=59 Participants
Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of BCD-080 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery.
Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h).
|
Clexane
n=54 Participants
Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of Clexane 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery/
Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h).
|
|---|---|---|
|
Frequency of DVT.
|
0 participants
|
2 participants
|
PRIMARY outcome
Timeframe: During the treatment period (14 days)Population: Patient who finished the study as per protocol and had contrast venography results for efficacy evaluation.
Outcome measures
| Measure |
BCD-080
n=59 Participants
Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of BCD-080 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery.
Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h).
|
Clexane
n=54 Participants
Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of Clexane 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery/
Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h).
|
|---|---|---|
|
Frequency of Symptomatic Nonlethal Thromboembolia of the Pulmonary Artery (PATE)
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: During the treatment period (14 days)Population: Patient who finished the study as per protocol and had contrast venography results for efficacy evaluation.
Outcome measures
| Measure |
BCD-080
n=59 Participants
Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of BCD-080 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery.
Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h).
|
Clexane
n=54 Participants
Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of Clexane 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery/
Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h).
|
|---|---|---|
|
Frequency of Venous Thromboembolism Death
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: During the treatment period (14 days) and follow-up period (till 60-th day)Frequency of DTV (proximal and/or distal; symptomatic or asymptomatic)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During the treatment period (14 days) and follow-up period (till 60-th day)Frequency of proximal DVT (symptomatic or asymptomatic)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During the treatment period (14 days) and follow-up period (till 60-th day)Frequency of distal DVT (symptomatic or asymptomatic)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During the treatment period (14 days) and follow-up period (till 60-th day)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During the treatment period (14 days) and follow-up period (till 60-th day)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During the treatment period (14 days) and follow-up period (till 60-th day)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During the treatment period (14 days) and follow-up period (till 60-th day)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During the treatment period (14 days)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During the treatment period (14 days)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During the treatment period (14 days)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During the treatment period (14 days)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During the treatment period (14 days)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During the treatment period (14 days)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During the treatment period (14 days)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During the treatment period (14 days) and follow-up period (till 60-th day)Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During the treatment period (14 days) and follow-up period (till 60-th day)Outcome measures
Outcome data not reported
Adverse Events
BCD-080
Serious events: 2 serious events
Other events: 53 other events
Deaths: 0 deaths
Clexane
Serious events: 5 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BCD-080
n=64 participants at risk
Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of BCD-080 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery.
Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h).
|
Clexane
n=59 participants at risk
Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of Clexane 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery/
Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h).
|
|---|---|---|
|
General disorders
Sepsis
|
1.6%
1/64 • 60 days
|
0.00%
0/59 • 60 days
|
|
Infections and infestations
Infection of surgery wound surface
|
1.6%
1/64 • 60 days
|
3.4%
2/59 • 60 days
|
|
Surgical and medical procedures
Surgery wound dehiscence
|
0.00%
0/64 • 60 days
|
1.7%
1/59 • 60 days
|
|
Musculoskeletal and connective tissue disorders
Large trochanter fracture
|
0.00%
0/64 • 60 days
|
1.7%
1/59 • 60 days
|
|
Surgical and medical procedures
Hemorrhagic discharge from surgical wound
|
0.00%
0/64 • 60 days
|
1.7%
1/59 • 60 days
|
Other adverse events
| Measure |
BCD-080
n=64 participants at risk
Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of BCD-080 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery.
Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h).
|
Clexane
n=59 participants at risk
Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of Clexane 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery/
Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h).
|
|---|---|---|
|
Vascular disorders
Oedema of lower limbs
|
0.00%
0/64 • 60 days
|
5.1%
3/59 • 60 days
|
|
Vascular disorders
Arterial hypertension
|
17.2%
11/64 • 60 days
|
28.8%
17/59 • 60 days
|
|
Blood and lymphatic system disorders
Anemia
|
62.5%
40/64 • 60 days
|
59.3%
35/59 • 60 days
|
|
Hepatobiliary disorders
Elevated gamma glutamyl tranferase
|
10.9%
7/64 • 60 days
|
1.7%
1/59 • 60 days
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.4%
6/64 • 60 days
|
5.1%
3/59 • 60 days
|
|
Blood and lymphatic system disorders
Elevated D-dimer
|
35.9%
23/64 • 60 days
|
66.1%
39/59 • 60 days
|
|
Blood and lymphatic system disorders
Increase of activated partial thromboplastin time
|
7.8%
5/64 • 60 days
|
1.7%
1/59 • 60 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place