Safety and efficacy of human lactoferrin hLF1-11 for the treatment of infectious complications among haematopoietic stem cell transplant recipients.
Completed
- Conditions
- Patients who have received myeloablative treatment resulting in neutropenia and mucosal barrier injury and are therefore susceptible to fungal and bacterial infections.
- Registration Number
- NL-OMON20231
- Lead Sponsor
- AM-Pharma B.VRumpsterweg 6 3981 AK Bunnik Tel +31 (0) 30 228 92 22 Fax +31 (0) 30 228 92 20
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
Inclusion Criteria
1. Admitted for an autologous HSCT after myeloablative therapy with high-dose melfalan;
2. Managed with a 4-lumen central venous catheter;
Exclusion Criteria
1. A history of, or presence of, significant respiratory, cardiovascular, neurological, haematological, endocrine, gastro intestinal, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs (as judged clinically relevant by the investigator);
2. Participation in a study with a new chemical entity or new molecular entity 3 months before or participation in a study with a registered drug less than 5 times of the half life of the registered drug before entering the study;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tolerability as measured by adverse events, local tolerability, clinical chemistry, haematology, and vital signs.
- Secondary Outcome Measures
Name Time Method To evaluate formation of antibodies, anti-hLF 1-11 (ELISA) will be measured during and after the study up to two weeks post dose.