Venous ThromboembolismPhase 3SAVE-HIP3NCT00709904
Evaluation of AVE5026 as Compared to Placebo for the Extended Prophylaxis of Venous Thromboembolism in Patients Having Undergone Hip Fracture Surgery
A Phase 3 study testing Open-label Semuloparin sodium and Semuloparin sodium in people with Venous Thromboembolism, run by Sanofi at 16 sites in 16 countries.
Trial summary
The primary objective is to evaluate the efficacy of once daily (QD) subcutaneous (SC) injections of Semuloparin sodium (AVE5026) versus placebo for 3 additional weeks following an initial 7 to 10-day venous thromboprophylaxis with open-label AVE5026 in patients having undergone hip fracture surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Open-label Semuloparin sodium and Semuloparin sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 469 participants
- Where
- 16 sitesin 16 countries
- Study dates
- Jun 2008to Jan 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In the run-in phase:
- Standard surgery for fracture of the upper third of the femur, including femoral head and neck
- In the double-blind phase following the run-in phase:
- Completion of the run-in phase without permanent treatment discontinuation
Who cannot join
- Any major orthopedic surgery within 3 months prior to enrolment;
- Deep vein thrombosis or pulmonary embolism within the last 12 months, or known post-phlebitic syndrome;
- High risk of bleeding;
- Known hypersensitivity to heparins;
- Any contraindication to the performance of venography;
- End stage renal disease or patient on dialysis
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
16 sites in 16 countries.
16 sites in 16 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
About this study
Official title: A Multinational, Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of AVE5026 With Placebo for the Extended Prevention of Venous Thromboembolism in Patients Having Undergone Hip Fracture Surgery
The primary objective is to evaluate the efficacy of once daily (QD) subcutaneous (SC) injections of Semuloparin sodium (AVE5026) versus placebo for 3 additional weeks following an initial 7 to 10-day venous thromboprophylaxis with open-label AVE5026 in patients having undergone hip fracture surgery.
The secondary objective is to evaluate the safety of extended AVE5026 administration.
Read the detailed description
The total duration of observation per participant is 56-63 days from surgery broken down as follows:
- 7 to 10-day initial treatment period with open-label Semuloparin sodium;
- Randomization;
- 19 to 23-day double-blind treatment period with Semuloparin sodium or placebo;
- 30-day follow-up period.
Mandatory bilateral venography of the lower limbs is to be performed between 19 and 24 days after randomization.
- Conditions
- Venous Thromboembolism
- Being tested
- Open-label Semuloparin sodium, Placebo (for Semuloparin sodium), Semuloparin sodium
- Keywords
- venous thromboprophylaxis, primary prevention, orthopedic surgery
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open-label Semuloparin sodiumDrug
Also called AVE5026
0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe
Subcutaneous injection once daily with an initial dose given 8 hours after surgery
Placebo (for Semuloparin sodium)Drug
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 once daily
Semuloparin sodiumDrug
Also called AVE5026
0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe
Subcutaneous injection once daily
| Study group | Role | What they receive |
|---|---|---|
| Semuloparin extension treatment | Experimental | Extension treatment with Semuloparin sodium 20 mg (10 mg if SRI) for 19-23 days following initial treatment with open-label Semuloparin 20 mg (10 mg if SRI) for 7-10 days. Receives: Drug: Open-label Semuloparin sodium; Drug: Semuloparin sodium |
| Placebo extension treatment | Placebo comparator | Extension treatment with placebo (for Semuloparin sodium) for 19-23 days following initial treatment with open-label Semuloparin 20 mg (10 mg if SRI) for 7-10 days Receives: Drug: Open-label Semuloparin sodium; Drug: Placebo (for Semuloparin sodium) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Experience Venous Thromboembolism Events (VTE) or Death From Any Cause During the Extension Treatment Period
VTE include any 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 suspected VTE. All-cause deaths include fatal PE and deaths for other reason than PE.
Measured: From randomization up to 24 days after randomization or the day of mandatory venography, whichever comes first
Secondary outcomes (3)
Percentage of Participants Who Experience "Major" VTE or Death From Any Cause
"Major" VTE include any proximal DVT, symptomatic distal DVT and non-fatal PE as confirmed by the CIAC.
Measured: From randomization up to 24 days after randomization or the day of mandatory venography, whichever comes first
Percentage of Participants Who Experience Clinically Relevant Bleedings During the Extension Treatment Period
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);
"Non-clinically relevant bleeding".
Measured: From 1st study drug injection in the extension treatment period up to 3 days after last study drug injection
Percentage of Participants Who Require the Initiation of Curative Anticoagulant or Thrombolytic Treatment After VTE Assessment During the Extension Treatment Period
Initiation of curative anticoagulant or thrombolytic treatment after VTE assessment is 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.
Measured: From randomization up to 24 days after randomization or the day of mandatory venography, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 469 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William D. Fisher, MD, Principal investigator, McGill University Health Centre, Montreal, Quebec, CanadaAlexander G. Turpie, MD, Study chair, HHS-General Hospital, Hamilton, Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00709904
- Sponsor's protocol ID
- EFC10636
- Other IDs
- 2007-007947-28
- Acronym
- SAVE-HIP3
- Status last verified
- Jun 2013
- First submitted
- 1 Jul 2008
- Last updated
- 14 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fisher WD, Agnelli G, George DJ, Kakkar AK, Lassen MR, Mismetti P, Mouret P, Turpie AG. Extended venous thromboembolism prophylaxis in patients undergoing hip fracture surgery - the SAVE-HIP3 study. Bone Joint J. 2013 Apr;95-B(4):459-66. doi: 10.1302/0301-620X.95B4.30730.
PubMed 23539696
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational, Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of AVE5026 With Placebo for the Extended Prevention of Venous Thromboembolism in Patients Having Undergone Hip Fracture Surgery
- ClinicalTrials.gov ID
- NCT00709904
- Acronym / sponsor ID
- SAVE-HIP3 / EFC10636
- Conditions
- Venous Thromboembolism
- Keywords
- venous thromboprophylaxis, primary prevention, orthopedic surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 469 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 3 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to evaluate the efficacy of once daily (QD) subcutaneous (SC) injections of Semuloparin sodium (AVE5026) versus placebo for 3 additional weeks following an initial 7 to 10-day venous thromboprophylaxis with open-label AVE5026 in patients having undergone hip fracture surgery.
The secondary objective is to evaluate the safety of extended AVE5026 administration.
Detailed description
The total duration of observation per participant is 56-63 days from surgery broken down as follows:
- 7 to 10-day initial treatment period with open-label Semuloparin sodium;
- Randomization;
- 19 to 23-day double-blind treatment period with Semuloparin sodium or placebo;
- 30-day follow-up period.
Mandatory bilateral venography of the lower limbs is to be performed between 19 and 24 days after randomization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semuloparin extension treatment | Experimental | Drug: Open-label Semuloparin sodium, Drug: Semuloparin sodiumExtension treatment with Semuloparin sodium 20 mg (10 mg if SRI) for 19-23 days following initial treatment with open-label Semuloparin 20 mg (10 mg if SRI) for 7-10 days. |
| Placebo extension treatment | Placebo comparator | Drug: Open-label Semuloparin sodium, Drug: Placebo (for Semuloparin sodium)Extension treatment with placebo (for Semuloparin sodium) for 19-23 days following initial treatment with open-label Semuloparin 20 mg (10 mg if SRI) for 7-10 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- In the run-in phase:
- In the double-blind phase following the run-in phase:
Key exclusion criteria (7 listed)
- Any major orthopedic surgery within 3 months prior to enrolment;
- Deep vein thrombosis or pulmonary embolism within the last 12 months, or known post-phlebitic syndrome;
- High risk of bleeding;
- Known hypersensitivity to heparins;
- Any contraindication to the performance of venography;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open-label Semuloparin sodiumAlso: AVE50260.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe Subcutaneous injection once daily with an initial dose given 8 hours after surgery | Drug | Placebo extension treatment, Semuloparin extension treatment |
| Placebo (for Semuloparin sodium)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 once daily | Drug | Placebo extension treatment |
| Semuloparin sodiumAlso: AVE50260.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe Subcutaneous injection once daily | Drug | Semuloparin extension treatment |
Primary outcome
Percentage of Participants Who Experience Venous Thromboembolism Events (VTE) or Death From Any Cause During the Extension Treatment Period
Time frame: From randomization up to 24 days after randomization or the day of mandatory venography, whichever comes first
VTE include any 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 suspected VTE. All-cause deaths include fatal PE and deaths for other reason than PE.
3 secondary outcomes
Percentage of Participants Who Experience "Major" VTE or Death From Any Cause
Time frame: From randomization up to 24 days after randomization or the day of mandatory venography, whichever comes first
Percentage of Participants Who Experience Clinically Relevant Bleedings During the Extension Treatment Period
Time frame: From 1st study drug injection in the extension treatment period up to 3 days after last study drug injection
Percentage of Participants Who Require the Initiation of Curative Anticoagulant or Thrombolytic Treatment After VTE Assessment During the Extension Treatment Period
Time frame: From randomization up to 24 days after randomization or the day of mandatory venography, whichever comes first
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2013.
- Results publication: PubMed 23539696Fisher WD, Agnelli G, George DJ, Kakkar AK, Lassen MR, Mismetti P, Mouret P, Turpie AG. Extended venous thromboembolism prophylaxis in patients undergoing hip fracture surgery - the SAVE-HIP3 study. Bone Joint J. 2013 Apr;95-B(4):459-66. doi: 10.1302/0301-620X.95B4.30730.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William D. Fisher, MD principal investigator
McGill University Health Centre, Montreal, Quebec, Canada
Alexander G. Turpie, MD study chair
HHS-General Hospital, Hamilton, Ontario, Canada
16 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Open-label Semuloparin sodium and Semuloparin sodium in people with Venous Thromboembolism, run by Sanofi at 16 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Belarus, Canada, Chile, China and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Experience Venous Thromboembolism Events (VTE) or Death From Any Cause During the Extension Treatment Period (time frame: From randomization up to 24 days after randomization or the day of mandatory venography, whichever comes first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00709904, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2013.