A Phase 3 interventional study of Semuloparin Sodium and Enoxaparin sodium in Venous Thromboembolism, sponsored by Sanofi. Completed at 270 sites in 39 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-12-16.
Sponsored by Sanofi · Phase 3, Interventional, and Prevention
The primary objective is to compare the efficacy and safety of once daily (q.d.) subcutaneous (s.c.) injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of Enoxaparin for the prevention of Venous Thromboembolic Events (VTE) in patients undergoing major abdominal surgery.
The secondary objectives are to evaluate the safety of Semuloparin sodium (AVE5026) and to document Semuloparin sodium (AVE5026) exposure in this population.
Randomization has to take place prior to the surgery.
The total duration of observation per participant is 35-42 days from surgery broken down as follows:
Mandatory bilateral venography of the lower limbs has to be performed between 7 to 11 days after surgery.
818 studies on the registry are indexed under Thromboembolism; 98 are open to participants now.
This study's enrollment of 4,413 is above the median of 196 across 436 interventional studies indexed under Thromboembolism.
Browse Thromboembolism studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patient \<60 years of age had to have one of the following additional risk factors for VTE:
Exclusion Criteria:
The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Semuloparin sodium 20 mg (10 mg if Severe Renal Impairment \[SRI\]) once daily for 7-10 days with an initial dose given 8 hours after surgery (placebo for Enoxaparin sodium prior to surgery according to local standard for Enoxaparin and 12 hours after surgery to maintain the blind)
Drug: Semuloparin Sodium · Drug: Placebo
Enoxaparin sodium 40 mg (20 mg if Severe Renal Impairment \[SRI\]) once daily for 7-10 days with an initial dose given prior to or 12 hours after surgery according to local standard for Enoxaparin sodium (placebo for Semuloparin sodium 8 hours after surgery to maintain the blind)
Drug: Enoxaparin sodium · Drug: Placebo
0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe Subcutaneous injection
Also known as: AVE5026
0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe Subcutaneous injection
Also known as: Lovenox®
0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml prefilled syringe strictly identical in appearance containing the same volume but without active component Subcutaneous injection
Percentage of Participants Who Experience Venous Thromboembolism Event (VTE) or All-cause Death
VTE includes any proximal or distal Deep Vein Thrombosis (DVT) (symptomatic or not) and non-fatal Pulmonary Embolism (PE) as confirmed by a Central Independent Adjudication Committee (CIAC) after review of mandatory bilateral venograms and diagnostic tests for VTE. All-cause deaths includes fatal PE and deaths for other reason than PE.
Time frame: From randomization up to 10 days after surgery or the day of mandatory venography, whichever comes first
Percentage of Participants Who Experience "major" VTE or All-cause Death
"major" VTE includes any proximal DVT, symptomatic distal DVT and non-fatal Pulmonary Embolism (PE) as as confirmed by the CIAC.
Time frame: From randomization up to 10 days after surgery or the day of mandatory venography, whichever comes first
Percentage of Participants Who Experience Clinically Relevant Bleedings ("major" and "clinically relevant non-major" bleedings )
Bleedings are centrally and blindly reviewed by the CIAC and classified as: * "major" (fatal, in a critical area/organ, causing a post-operative drop in hemoglobin ≥2 g/dL or requiring post-operative transfusion ≥2 units of blood, leading to an invasive diagnostic or therapeutic intervention, or associated with circulatory decompensation); * "clinically relevant non-major" (skin hematoma or epistaxis requiring surgical/medical intervention/treatment, macroscopic hematuria, or overt bleeding requiring specific attention by health care professional); * "Nonclinically relevant bleeding".
Time frame: From 1st study drug injection up to 3 days after last study drug injection
Percentage of Participants requiring the initiation of curative anticoagulant or thrombolytic treatment after VTE assessment
Initiation of curative anticoagulant or thrombolytic treatment after VTE assessment was defined from investigator's answer to the question "was the subject treated for VTE?" asked after the diagnostic tests for suspected VTE and after the mandatory venography.
Time frame: From randomization up to 10 days after surgery or the day of mandatory venography, whichever comes first
Number of Deaths on Treatment
All deaths are centrally and blindly reviewed by the CIAC and classified as fatal PE, fatal bleeding, cardiovascular death or other based on relevant documentation (e.g. autopsy report).
Time frame: From 1st study drug injection up to 3 days after last study drug injection
Platelets Count: Percentage of Participants With Potentially Clinically Significant Abnormalities (PCSA)
PCSA are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review. Thresholds for platelet counts are defined as \<100 Giga/L.
Time frame: From 1st study drug injection up to 3 days after last study drug injection
Liver Function: Percentage of Participants With Potentially Clinically Significant Abnormalities (PCSA)
Thresholds are defined as follows: * Alanine Aminotransferase (ALT) \>3 Upper Normal Limit (ULN); * Total Bilirubin (TB) \>2 ULN; * ALT \>3 ULN and TB \>2 ULN; Cases with ALT \>3 ULN and TB \>2 ULN (not necessarily concomitant) are evaluated by a blinded independent adjudicator to determine if they met Hy's law criteria.
Time frame: From 1st study drug injection up to 3 days after last study drug injection
Trough Plasma Concentration of Semuloparin Sodium (AVE5026)
Trough Plasma Concentration \[Ctrough\] is defined as plasma concentrations obtained just before study drug injection (i.e.24h±2h after study drug injection). Lower Limit Of Quantification (LLOQ) is defined as 0,348 μgEq/mL. Concentrations below LLOQ are replaced by half of LLOQ for the calculation.
Time frame: 0.5-1 and 2-4 hours after Day 1 first post-operative injection, 6-8 and 10-16 hours after Day 4 injection, and just before the last injection
Showing the first 100 of 270 sites across 39 countries.
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sanofi