Venous ThromboembolismPhase 3NCT01130025
Long-Term Innohep® Treatment Versus a Vitamin K Antagonist (Warfarin) for the Treatment of Venous Thromboembolism (VTE) in Cancer
A Phase 3 study testing Warfarin and Innohep® in people with Venous Thromboembolism, run by LEO Pharma at 1 site in Canada.
Trial summary
The purpose of this study is to assess the efficacy and safety of Innohep® in preventing the recurrence of VTE in patients with active cancer who have had an acute VTE episode. 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?
- Warfarin and Innohep®
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2010to May 2014
- 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
- Patients with a diagnosis of active cancer.
- Symptomatic and objectively confirmed VTE.
- ≥ 18 years of age or above the legal age of consent as per country specific regulations.
- Patients with Eastern Co-operative Oncology Group (ECOG) performance status of 0, 1 or 2.
- Signed informed consent.
Who cannot join
- Life expectancy < 6 months.
- Patients with basal cell carcinoma or non-melanoma skin cancer.
- Creatinine clearance ≤ 20 ml/min.
- Contra-indications to anticoagulation.
- Known hypersensitivity to the investigational product (Innohep®) or the reference product (warfarin).
- History of heparin-induced thrombocytopenia (HIT).
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- Pre-randomisation therapeutic anticoagulant treatment for acute VTE administered for more than 72 hours prior to randomisation.
- Patients unlikely to comply with the protocol.
- Participation in another interventional study.
- Pregnant or breast-feeding women.
- Women of childbearing potential.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Diamond Health Care Centre
Vancouver, British Columbia, BC V5Z 1M9
About this study
Official title: Efficacy and Safety of Long-Term (6 Months) Innohep® Treatment Versus Anticoagulation With a Vitamin K Antagonist (Warfarin) for the Treatment of Acute Venous Thromboembolism in Cancer Patients / IN 0901 INT
The purpose of this study is to assess the efficacy and safety of Innohep® in preventing the recurrence of VTE in patients with active cancer who have had an acute VTE episode.
- Conditions
- Venous Thromboembolism
- Being tested
- Warfarin, Innohep®
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WarfarinDrug
Tablets. Once daily for 6 months (180 days) to maintain therapeutic international normalised ratio (INR) levels in combination with initial (5-10 days) overlapping treatment with Innohep®.
Innohep®Drug
Solution for sub-cutaneous injection, pre-filled syringes. Once daily for 6 months (180 days). 175 anti Xa IU/kg.
| Study group | Role | What they receive |
|---|---|---|
| Innohep® | Experimental | Long-term treatment with Innohep® only. Receives: Drug: Innohep® |
| Warfarin | Active comparator | Oral treatment with warfarin in combination with overlapping initial (5 to 10 days) treatment with Innohep®. Receives: Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite end-point represented by the time in days from randomisation to the first occurrence of VTE
- Symptomatic non-fatal DVTs.
- Symptomatic non-fatal PEs.
- Fatal PE.
- Incidental proximal DVT (popliteal vein or higher).
- Incidental proximal PE (segmental arteries or larger).
Measured: 6 months
Secondary outcomes (1)
Time in days from randomisation to the first occurrence of VTE.
- The 5 individual components of the composite primary efficacy endpoint.
- A composite endpoint of symptomatic DVT and/or PE, including fatal PE.
Safety endpoints will consist of bleeding and overall mortality
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2010 (estimated)
- Study startAug 2010
- Primary completionApr 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Agnes Y. Y. Lee, MD, MSc, FRCPC, Principal investigator, Director of Thrombosis, Division of Hematology, University of British Columbia, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01130025
- Sponsor's protocol ID
- IN 0901 INT
- Other IDs
- 2009-018141-20, 2009
- Status last verified
- Jun 2014
- First submitted
- 24 May 2010
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Kahale LA, Matar CF, Hakoum MB, Tsolakian IG, Yosuico VE, Terrenato I, Sperati F, Barba M, Schunemann H, Akl EA. Anticoagulation for the initial treatment of venous thromboembolism in people with cancer. Cochrane Database Syst Rev. 2021 Dec 8;12(12):CD006649. doi: 10.1002/14651858.CD006649.pub8.
PubMed 34878173Bauersachs R, Lee AYY, Kamphuisen PW, Meyer G, Janas MS, Jarner MF, Khorana AA; CATCH Investigators. Renal Impairment, Recurrent Venous Thromboembolism and Bleeding in Cancer Patients with Acute Venous Thromboembolism-Analysis of the CATCH Study. Thromb Haemost. 2018 May;118(5):914-921. doi: 10.1055/s-0038-1641150. Epub 2018 Apr 4.
PubMed 29618162Lee AYY, Kamphuisen PW, Meyer G, Bauersachs R, Janas MS, Jarner MF, Khorana AA; CATCH Investigators. Tinzaparin vs Warfarin for Treatment of Acute Venous Thromboembolism in Patients With Active Cancer: A Randomized Clinical Trial. JAMA. 2015 Aug 18;314(7):677-686. doi: 10.1001/jama.2015.9243.
PubMed 26284719Lee AY, Bauersachs R, Janas MS, Jarner MF, Kamphuisen PW, Meyer G, Khorana AA; CATCH Investigators. CATCH: a randomised clinical trial comparing long-term tinzaparin versus warfarin for treatment of acute venous thromboembolism in cancer patients. BMC Cancer. 2013 Jun 13;13:284. doi: 10.1186/1471-2407-13-284.
PubMed 23764005
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Long-Term (6 Months) Innohep® Treatment Versus Anticoagulation With a Vitamin K Antagonist (Warfarin) for the Treatment of Acute Venous Thromboembolism in Cancer Patients / IN 0901 INT
- ClinicalTrials.gov ID
- NCT01130025
- Acronym / sponsor ID
- IN 0901 INT
- Conditions
- Venous Thromboembolism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 25 May 2010 (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 purpose of this study is to assess the efficacy and safety of Innohep® in preventing the recurrence of VTE in patients with active cancer who have had an acute VTE episode.
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®Long-term treatment with Innohep® only. |
| Warfarin | Active comparator | Drug: WarfarinOral treatment with warfarin in combination with overlapping initial (5 to 10 days) treatment with Innohep®. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with a diagnosis of active cancer.
- Symptomatic and objectively confirmed VTE.
- ≥ 18 years of age or above the legal age of consent as per country specific regulations.
- Patients with Eastern Co-operative Oncology Group (ECOG) performance status of 0, 1 or 2.
- Signed informed consent.
Key exclusion criteria (11 listed)
- Life expectancy < 6 months.
- Patients with basal cell carcinoma or non-melanoma skin cancer.
- Creatinine clearance ≤ 20 ml/min.
- Contra-indications to anticoagulation.
- Known hypersensitivity to the investigational product (Innohep®) or the reference product (warfarin).
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 |
|---|---|---|
| WarfarinTablets. Once daily for 6 months (180 days) to maintain therapeutic international normalised ratio (INR) levels in combination with initial (5-10 days) overlapping treatment with Innohep®. | Drug | Warfarin |
| Innohep®Solution for sub-cutaneous injection, pre-filled syringes. Once daily for 6 months (180 days). 175 anti Xa IU/kg. | Drug | Innohep® |
Primary outcome
Composite end-point represented by the time in days from randomisation to the first occurrence of VTE
Time frame: 6 months
* Symptomatic non-fatal DVTs. * Symptomatic non-fatal PEs. * Fatal PE. * Incidental proximal DVT (popliteal vein or higher). * Incidental proximal PE (segmental arteries or larger).
1 secondary outcome
Time in days from randomisation to the first occurrence of VTE.
Time frame: 6 months
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 24 Feb 2025.
- Derived from this study: PubMed 34878173Kahale LA, Matar CF, Hakoum MB, Tsolakian IG, Yosuico VE, Terrenato I, Sperati F, Barba M, Schunemann H, Akl EA. Anticoagulation for the initial treatment of venous thromboembolism in people with cancer. Cochrane Database Syst Rev. 2021 Dec 8;12(12):CD006649. doi: 10.1002/14651858.CD006649.pub8.
- Derived from this study: PubMed 29618162Bauersachs R, Lee AYY, Kamphuisen PW, Meyer G, Janas MS, Jarner MF, Khorana AA; CATCH Investigators. Renal Impairment, Recurrent Venous Thromboembolism and Bleeding in Cancer Patients with Acute Venous Thromboembolism-Analysis of the CATCH Study. Thromb Haemost. 2018 May;118(5):914-921. doi: 10.1055/s-0038-1641150. Epub 2018 Apr 4.
- Derived from this study: PubMed 26284719Lee AYY, Kamphuisen PW, Meyer G, Bauersachs R, Janas MS, Jarner MF, Khorana AA; CATCH Investigators. Tinzaparin vs Warfarin for Treatment of Acute Venous Thromboembolism in Patients With Active Cancer: A Randomized Clinical Trial. JAMA. 2015 Aug 18;314(7):677-686. doi: 10.1001/jama.2015.9243.
- Derived from this study: PubMed 23764005Lee AY, Bauersachs R, Janas MS, Jarner MF, Kamphuisen PW, Meyer G, Khorana AA; CATCH Investigators. CATCH: a randomised clinical trial comparing long-term tinzaparin versus warfarin for treatment of acute venous thromboembolism in cancer patients. BMC Cancer. 2013 Jun 13;13:284. doi: 10.1186/1471-2407-13-284.
- 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.
Agnes Y. Y. Lee, MD, MSc, FRCPC principal investigator
Director of Thrombosis, Division of Hematology, University of British Columbia, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Warfarin and Innohep® in people with Venous Thromboembolism, run by LEO Pharma at 1 site in Canada.
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 11 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 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 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?
Composite end-point represented by the time in days from randomisation to the first occurrence of VTE (time frame: 6 months). 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 NCT01130025, which also lists 4 linked publications.
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 24 Feb 2025.