Estudio multicéntrico, abierto, de un solo grupo, de larga duración (52 semanas) sobre la inyección de dalteparina sódica (FRAGMIN®) para conocer la seguridad y eficacia en pacientes con cáncer y tromboembolia venosa sintomática
- Conditions
- Tromboembolia venosa en pacientes con cáncerMedDRA version: 9.1Level: LLTClassification code 10049909Term: Venous thromboembolism prophylaxis
- Registration Number
- EUCTR2008-005236-32-ES
- Lead Sponsor
- Eisai Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 338
1.Age range: subjects must be ? 18 years of age.
2.Male and female subjects will be eligible for enrollment.
3.Females should be either of non-childbearing potential as a result of surgery, radiational therapy, menopause (one year post onset), or of childbearing potential and willing to adhere to an acceptable method of contraception
4.Subjects must be newly diagnosed, symptomatic proximal deep-vein thrombosis of the lower extremity, pulmonary embolism, or both.
5.Subjects must have active malignancy defined as a diagnosis of cancer (excluding basal cell or squamous cell carcinoma of the skin) within six months before enrollment, having received any treatment for cancer within the previous six months, or having documented recurrent or metastatic cancer.
6. Prior to enrollment, subjects must not have received therapeutic doses of anticoagulant therapy (including LMWH) for > 48 hours (or > 4 doses within 48 hours). Subjects must not have received unfractionated heparin within 4 hours prior to enrollment.
7.ECOG performance status of 0, 1 or 2.
8.Subjects must have a life expectancy of > 6 months.
9.Subjects must have a platelet count of > 75,000 mm3.
10.The subject must not be on any oral anticoagulant therapy for concomitant diseases.
11.Subjects must have no active or serious bleeding episodes within two weeks prior to study entry.
12.Subjects must be able to comply with scheduled follow-ups.
13.Subjects must give written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.Subjects who have a high risk of serious bleeding (e.g. recent neurosurgery, history of intracranial hemorrhage, acute gastroduodenal ulcer, etc.).
2.Subjects who are on hemodialysis.
3.Subjects who have a prior placement of a greenfield filter or other device to prevent embolization of DVTs.
4.Subjects with a known contraindication to the use of heparin (e.g. heparin-induced thrombocytopenia).
5.Subjects with a known hypersensitivity to heparin, dalteparin, other LMWHs or pork products.
6.Subjects who are currently participating in another clinical trial involving anticoagulation therapy (with the exception of aspirin), participating in a clinical trial involving anticoagulation therapy (with the exception of aspirin) in the 30 days prior to study entry, or who is actively using any investigational drugs/treatments 30 days prior to study entry involving anticoagulation therapy (with the exception of aspirin x 3).
7.Subject is pregnant or breast feeding.
8.Subjects with uncontrolled hypertension characterized by a sustained systolic pressure > 170 mmHg and/or diastolic pressure > 100 mmHg.
9.Subjects with a serious concomitant systemic disorder (for example, active infection including HIV or cardiac disease) that in the opinion of the investigator, would compromise the subject?s ability to complete the study.
10.Any condition that makes the subject unsuitable in the opinion of the investigator.
11.Subjects with acute leukemia.
12.Subjects with a genetic predisposition to clotting.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method