Open randomized study to evaluate the efficacy of i.v. iron support (ferrum gluconate, 125 mg i.v. infusion weekly for 6 weeks) in primary solid tumour patients (breast, lung, colon-rectum and gynecological) treated with darbepoetin alfa (150 mcg once weekly subcutaneous for 12 weeks)for neoplastic chemotherapy related anaemia.
- Conditions
- Treatment of the anaemia in adult patients affected by non mieloid-tumours receiving chemotherapy.MedDRA version: 6.1Level: SOCClassification code 10029104
- Registration Number
- EUCTR2004-002176-42-IT
- Lead Sponsor
- DOMPE' BIOTEC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 420
Inclusion Criteria
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
Exclusion Criteria
Not provided
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