Patients who have received myeloablative treatment resulting in neutropenia and mucosal barrier injury and are therefore susceptible to fungal and bacterial infections.
Conditions
Interventions
Study medication hLF1-11 of 5 mg will be given by intravenous administration. hLF 1-11 will be dissolved in sterile 0.9 % NaCl go a volume of 20 mL to be administered at 1 mL/min over 20 mins.
Sponsors
AM-Pharma B.V
Rumpsterweg 6
3981 AK Bunnik
Tel +31 (0) 30 228 92 22
Fax +31 (0) 30 228 92 20
Eligibility
Inclusion criteria
Inclusion criteria: 1. Admitted for an autologous HSCT after myeloablative therapy with high-dose melfalan; 2. Managed with a 4-lumen central venous catheter; 3. 18 to 45 years of age; 4. BMI < 30; 5. Able and willing to participate; 6. Has provided written informed consent; 7. There is no medical reason for exclusion; 8. Has adequate renal function (creatinine <110 µmol/L (man); <90 µmol/L (woman)); 9. Has adequate liver function (ASAT <40 U; ALAT <45 U; bilirubin <10µmol/L); 10. Has no known allergy to lactoferrin; 11. Has no history of hepatitis and is not HIV seropositive; 12. If a woman, functionally post-menopausal.
Exclusion criteria
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; 3. A clinically relevant history of intolerance or hypersensitivity to the study drug, or its additives and excipients in the intravenous formulation; 4. Evidence of having serum hepatitis or carrying the hepatitis B surface antigen or Hepatitis C antibodies or being HIV positive; 5. Subjects, who in the opinion of the investigator should not, for reasons of safety, participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability as measured by adverse events, local tolerability, clinical chemistry, haematology, and vital signs. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate formation of antibodies, anti-hLF 1-11 (ELISA) will be measured during and after the study up to two weeks post dose. | — |
Contacts
Public ContactB.Th.M. Bierman
AM-Pharma B.V., Rumpsterweg 6
Outcome results
None listed