Deep Vein ThrombosisPhase 4NCT00277394
Innohep® in Elderly Patients With Impaired Renal Function Treated for Acute Deep Vein Thrombosis
A Phase 4 study testing innohep® and Heparin in people with Deep Vein Thrombosis, run by LEO Pharma at 9 sites in 9 countries.
Trial summary
The objective of the study is to compare the safety of innohep® and Unfractionated Heparin (UFH) in terms of clinically relevant bleedings in elderly patients with impaired renal function for initial treatment of acute Deep Venous Thrombosis (DVT). Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Deep Vein Thrombosis
- What is being tested?
- innohep® and Heparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 541 participants
- Where
- 9 sitesin 9 countries
- Study dates
- Dec 2005to Jul 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients with a symptomatic and objectively confirmed Venous Thromboembolism (VTE) (lower limb deep venous thrombosis (DVT) or pulmonary embolus (PE)) with mandatory presences of objectively confirmed and treatment requiring DVT, i.e. symptomatic and objectively confirmed distal DVT or objectively confirmed, symptomatic or asymptomatic proximal DVT (confirmation of DVT should be performed by ultrasonography or venography within 48 hous prior to randomisation)
- Patients with an indication for DVT treatment with SC Low Molecular Weight Heparin (LMWH) or Unfractionated Heparin (UFH) followed by Oral Anticoagulant (OAC) for at least 90 days
- Hospitalized patients who, during SC anticoagulant treatment, will be followed, as specified in the protocol, on a daily basis either in the hospital or in an out-patient setting
- Patients at or above 75 years with a creatinine clearance less than or equal to 60 mL/min calculated according to the Cockcroft-Gault formula
- Patients at or above 70 years with a creatinine clearance less than or equal to 30 mL/min calculated according to the Cockcroft-Gault formula
Who cannot join
- Patients receiving high dose (i.e. equivalent to a dose recommended for treatment of DVT) of UFH or LMWH or thrombolytic agents within the last 4 weeks except for UFH/LMWH during the last 36 hours prior to randomisation
- Patients on oral anticoagulant treatment (vitamin K-antagonists) at or within last 1 week prior to randomisation
- Patients with a symptomatic venous thromboembolism (VTE) requiring thrombolytic therapy or invasive intervention
- End stage renal disease patients requiring dialysis
- Surgery within 2 weeks prior to randomisation or planned surgery, epidural anaesthesia and/or spinal anaesthesia during the SC anticoagulant treatment period
- Planned use of acetylsalicylic acid in doses above 300 mg/day, NSAID or Dextran 40 at randomisation and during the SC anticoagulant treatment period
Show all 14Show fewer
- Patients with a current overt bleeding or known haemorrhage condition (e.g. active G.I. ulcer)
- Patients with a platelet count < 100 x 10 9/L
- Patients with a known history of heparin-induced thrombocytopenia
- Patients with known severe hepatic insufficiency manifested as international normalized ratio (INR) greater than or equal to 1.5
- Patients with uncontrolled severe hypertension i.e. a systolic blood pressure > 220 mm Hg or diastolic blood pressure > 120 mm Hg during at least 2 measurements within 24 hours prior to randomisation
- Patients with ischaemic stroke at or within last 1 week prior to randomisation
- Patients with a known haemorrhagic stroke within 3 months prior to randomisation
- Patients with known bacterial endocarditis within 3 months prior to randomisation
Trial locations and contacts
9 sites in 9 countries.
9 sites in 9 countries
Serbia1 site
Clinical Center Serbia, Institute of Cardiovascular diseases & Centre for Vascular Surgery-Belgrade
Belgrade, 11000
Spain1 site
Service of Geriatry, Hospital Universitario Clínico San Carlos
Madrid, 28040
About this study
Official title: Safety Profile of Innohep Versus Subcutaneous Unfractionated Heparin in Elderly Patients With Impaired Renal Function Treated for Acute Deep Vein Thrombosis
The objective of the study is to compare the safety of innohep® and Unfractionated Heparin (UFH) in terms of clinically relevant bleedings in elderly patients with impaired renal function for initial treatment of acute Deep Venous Thrombosis (DVT).
The primary response criterion is the percentage of patients with clinically relevant bleeding events prior to day 90 +/- 5.
- Conditions
- Deep Vein Thrombosis
- Being tested
- innohep®, Heparin
- Keywords
- Acute, symptomatic and objectively confirmed DVT
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
innohep®Drug
175 anti-Xa IU/kg administered subcutaneously (SC) once daily
HeparinDrug
Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.
| Study group | Role | What they receive |
|---|---|---|
| innohep® | Experimental | innohep® 175 anti-Xa IU/kg once daily Receives: Drug: innohep® |
| Heparin | Active comparator | Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily. Receives: Drug: Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Clinically Relevant Bleeding Events
Measured: prior to day 90 +/- 5
Secondary outcomes (2)
Number of Patients With Recurrence of Venous Thromboembolism
Measured: prior to day 90 +/- 5
Number of Patients With Major Bleeding Events
Measured: prior to day 90 +/- 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2006 (estimated)
- Study startDec 2005
- Primary completionMay 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 541 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alain Leizorovicz, MD, Principal investigator, Faculté de Médecine Laënnec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00277394
- Sponsor's protocol ID
- IN 0401 INT
- Status last verified
- Feb 2019
- First submitted
- 13 Jan 2006
- Last updated
- 6 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Leizorovicz A, Siguret V, Mottier D; Innohep(R) in Renal Insufficiency Study Steering Committee; Leizorovicz A, Siguret V, Mottier D, Clonier F, Janas M, Stinson J, Townshend G, Maddalena M. Safety profile of tinzaparin versus subcutaneous unfractionated heparin in elderly patients with impaired renal function treated for acute deep vein thrombosis: the Innohep(R) in Renal Insufficiency Study (IRIS). Thromb Res. 2011 Jul;128(1):27-34. doi: 10.1016/j.thromres.2011.03.002. Epub 2011 Apr 7.
PubMed 21477846
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Profile of Innohep Versus Subcutaneous Unfractionated Heparin in Elderly Patients With Impaired Renal Function Treated for Acute Deep Vein Thrombosis
- ClinicalTrials.gov ID
- NCT00277394
- Acronym / sponsor ID
- IN 0401 INT
- Conditions
- Deep Vein Thrombosis
- Keywords
- Acute, symptomatic and objectively confirmed DVT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 541 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- May 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 16 Jan 2006 (estimated)
- Results
- Posted 21 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to compare the safety of innohep® and Unfractionated Heparin (UFH) in terms of clinically relevant bleedings in elderly patients with impaired renal function for initial treatment of acute Deep Venous Thrombosis (DVT).
The primary response criterion is the percentage of patients with clinically relevant bleeding events prior to day 90 +/- 5.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| innohep® | Experimental | Drug: innohep®innohep® 175 anti-Xa IU/kg once daily |
| Heparin | Active comparator | Drug: HeparinHeparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Patients with a symptomatic and objectively confirmed Venous Thromboembolism (VTE) (lower limb deep venous thrombosis (DVT) or pulmonary embolus (PE)) with mandatory presences of objectively confirmed and treatment requiring DVT, i.e. symptomatic and objectively confirmed distal DVT or objectively confirmed, symptomatic or asymptomatic proximal DVT (confirmation of DVT should be performed by ultrasonography or venography within 48 hous prior to randomisation)
- Patients with an indication for DVT treatment with SC Low Molecular Weight Heparin (LMWH) or Unfractionated Heparin (UFH) followed by Oral Anticoagulant (OAC) for at least 90 days
- Hospitalized patients who, during SC anticoagulant treatment, will be followed, as specified in the protocol, on a daily basis either in the hospital or in an out-patient setting
- Patients at or above 75 years with a creatinine clearance less than or equal to 60 mL/min calculated according to the Cockcroft-Gault formula
- Patients at or above 70 years with a creatinine clearance less than or equal to 30 mL/min calculated according to the Cockcroft-Gault formula
Key exclusion criteria (14 listed)
- Patients receiving high dose (i.e. equivalent to a dose recommended for treatment of DVT) of UFH or LMWH or thrombolytic agents within the last 4 weeks except for UFH/LMWH during the last 36 hours prior to randomisation
- Patients on oral anticoagulant treatment (vitamin K-antagonists) at or within last 1 week prior to randomisation
- Patients with a symptomatic venous thromboembolism (VTE) requiring thrombolytic therapy or invasive intervention
- End stage renal disease patients requiring dialysis
- Surgery within 2 weeks prior to randomisation or planned surgery, epidural anaesthesia and/or spinal anaesthesia during the SC anticoagulant treatment period
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 |
|---|---|---|
| innohep®175 anti-Xa IU/kg administered subcutaneously (SC) once daily | Drug | innohep® |
| HeparinHeparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily. | Drug | Heparin |
Primary outcome
Number of Patients With Clinically Relevant Bleeding Events
Time frame: prior to day 90 +/- 5
2 secondary outcomes
Number of Patients With Recurrence of Venous Thromboembolism
Time frame: prior to day 90 +/- 5
Number of Patients With Major Bleeding Events
Time frame: prior to day 90 +/- 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21477846Leizorovicz A, Siguret V, Mottier D; Innohep(R) in Renal Insufficiency Study Steering Committee; Leizorovicz A, Siguret V, Mottier D, Clonier F, Janas M, Stinson J, Townshend G, Maddalena M. Safety profile of tinzaparin versus subcutaneous unfractionated heparin in elderly patients with impaired renal function treated for acute deep vein thrombosis: the Innohep(R) in Renal Insufficiency Study (IRIS). Thromb Res. 2011 Jul;128(1):27-34. doi: 10.1016/j.thromres.2011.03.002. Epub 2011 Apr 7.
- Clinical Trials at LEO PharmaLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Alain Leizorovicz, MD principal investigator
Faculté de Médecine Laënnec
9 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing innohep® and Heparin in people with Deep Vein Thrombosis, run by LEO Pharma at 9 sites in 9 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 5 inclusion and 14 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 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Bulgaria, Croatia, Czechia, France, Germany and 4 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients With Clinically Relevant Bleeding Events (time frame: prior to day 90 +/- 5). 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 NCT00277394, 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 6 Mar 2025.