| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Thromboembolism (VTE) in patients with active cancer |
|
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 9.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10043566 |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| 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. |
|
| E.2.2 | Secondary objectives of the trial |
• Assess the safety of long-term Innohep.
• Identify clinical risk factors for recurrent VTE and major bleeding.
• Assess overall mortality at 6 months.
• Identify the possible role of coagulation parameters to predict recurrent VTE or prognosis.
• Assess incidence and severity of post-thrombotic syndrome (PTS).
• Assess health-related quality of life (QoL).
• Assess healthcare resource utilisation. |
|
| E.2.3 | Trial contains a sub-study | Yes |
| E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
ALTRI SOTTOSTUDI: ricerca su biomarkers per studi sulla coagulazione
|
|
| E.3 | Principal inclusion criteria |
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 (see Section 10.7.3.4).
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. |
|
| E.4 | Principal exclusion criteria |
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 (see Appendix V).
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 test-ing 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 us-ing effective birth control. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| Efficacy endpoints (i.e. recurrent lower limb DVTs, and PEs in segmental or larger pulmonary arteries) and major safety endpoints (i.e. bleedings, HIT events and causes of death) |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 94 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
| E.8.7 | Trial has a data monitoring committee | Yes |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
| Leo potrebbe decidere di interrompere prematuramente lo studio nel caso che l`arruolamento sia talmente basso da non prevedere un completamento in tempi ragionevoli |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 2 |
| E.8.9.1 | In the Member State concerned months | 0 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 2 |
| E.8.9.2 | In all countries concerned by the trial months | 6 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
Print
