Clinical trial · Interventional
Long-Term Innohep® Treatment Versus a Vitamin K Antagonist (Warfarin) for the Treatment of Venous Thromboembolism (VTE) in Cancer
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
NCT01130025CI-TRIAL-00086392completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Venous Thromboembolism | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Innohep® | Drug | — | UNRESOLVED |
| Warfarin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Innohep®
- description
- Long-term treatment with Innohep® only.
- interventionNames
- Drug: Innohep®
- type
- ACTIVE_COMPARATOR
- label
- Warfarin
- description
- Oral treatment with warfarin in combination with overlapping initial (5 to 10 days) treatment with Innohep®.
- interventionNames
- Drug: Warfarin
Primary outcomes (1)
- measure
- Composite end-point represented by the time in days from randomisation to the first occurrence of VTE
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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). * 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.
References
Publications (4)
- DERIVEDKahale 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. PMID 34878173
- DERIVEDBauersachs 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. PMID 29618162
- DERIVEDLee 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. PMID 26284719
- DERIVEDLee 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. PMID 23764005