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
- Conditions
- Health Condition 1: null- acute venous thromboembolism in patients with active cancer
- Registration Number
- CTRI/2010/091/000598
- Lead Sponsor
- EO Pharma AS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 1000
1.Patients with a diagnosis of active cancer with a histologically or cytologically diagnosed solid tumour or haematological malignancy (evidence of early stage, regional or metastatic disease). Active cancer is defined as:
Patients diagnosed with cancer within the past 6 months, OR Patients with recurrent, advanced or metastatic disease, OR
Patients that have received any treatment for cancer during the previous 6 months, OR
Patients not in complete remission of a chronic haematological malignancy.
2.Symptomatic and objectively confirmed acute proximal lower-limb deep vein thrombosis (DVT) (anatomically including popliteal, femoral [superficial and common] and iliac [external and common]) and/or pulmonary embolism (PE) (located in segmental or larger pulmonary arteries) diagnosed within 72 hours prior to randomisation. Diagnosis of DVT/PE (at randomisation and at recurrence) must be made by appropriate objective imaging.
3. 18 years of age or above the legal age of consent as per country specific regulations.
4.Patients with Eastern Co-operative Oncology Group (ECOG) performance status of 0, 1 or 2 prior to the VTE episode.
5.Signed informed consent.
1.Life expectancy < 6 months.
2.Patients with basal cell carcinoma or non-melanoma skin cancer.
3.Creatinine clearance; 20 ml/min according to the abbreviated Modification of Diet in Renal Disease (aMDRD) formula.
4.Contra-indications to anticoagulation:
a.Active or recent (< 1 month) clinically significant bleeding, including gastrointestinal bleeding or peptic ulcer.
b.History of bleeding disorder or coagulopathy (congenital, acquired or unexplained repeated bleeding episodes).
c.Uncontrolled arterial hypertension (systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg).
d.Recent intracranial haemorrhage (in the last 1 month prior to randomisation) which is at high risk of rebleeding and would prohibit anticoagulant therapy, according to the Investigator's judgment.
e.Recent (in the last 1 month prior to randomisa-tion) brain, spinal or ophthalmic surgery.
f.Thrombocytopenia (platelet count < 50 x 109/ L).
g.Coagulopathy due to liver insufficiency as indicated by a prolonged baseline activated partial thromboplastin time (aPTT) > 1.5 x upper limit of normal (ULN) or equivalent to an aPTT ratio > 1.5 (if not receiving low molecular weight heparin [LMWH] /unfractionated heparin [UFH])
5.Known hypersensitivity to the investigational product (Innohep®) or the reference product (warfarin).
6.History of heparin-induced thrombocytopenia (HIT).
7.Pre-randomisation therapeutic anticoagulant treatment for acute VTE administered for more than 72 hours prior to randomisation.
8.Patients that had been receiving therapeutic anticoagulation at the time of the VTE event (i.e. anticoagulant failure), using any anticoagulant, such as:
a.Parenteral anticoagulants e.g. UFH, LMWH, fondaparinux, bivalirudin or hirudin.
b.Vitamin K antagonists (VKA).
c.New oral anticoagulants, e.g. dabigatran, rivaroxaban.
Note: Chronic treatment with anti-platelet agents such as low dose of aspirin (up to
325 mg/day), clopidogrel or ticlopidine is
allowed).
9.Patients unlikely to comply with the protocol, e.g. inability to return for study visits or inability to receive/administer daily subcutaneous (SC) injection.
10.Participation in another interventional study with active drug treatment or an investigational device.
11.Pregnant or breast-feeding women. Pregnancy status should be checked by serum or urine pregnancy testing prior to inclusion.
12.Women of childbearing potential not protected by an effective contraceptive method (as defined for contra-ception in the Informed Consent Form [ICF]) for the duration of the study.
13.Sexually active fertile men if they, or their partner (being a woman of childbearing potential), is not using effective birth control.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of the study is to assess the efficacy of Innohep® in preventing the recurrence of VTE in patients with active cancer who have had an acute VTE episode.Timepoint: Each scheduled visit (Visit 1 and onwards) and telephone-contacts will include a standardised assessment (standardized questionnaire) of the signs and symptoms of recurrent VTE
- Secondary Outcome Measures
Name Time Method