No registrations found.
ID
Source
Brief title
Health condition
Patients who have received myeloablative treatment resulting in neutropenia and mucosal barrier injury and are therefore susceptible to fungal and bacterial infections.
Sponsors and support
Rumpsterweg 6
3981 AK Bunnik
Tel +31 (0) 30 228 92 22
Fax +31 (0) 30 228 92 20
Intervention
Outcome measures
Primary outcome
Safety and tolerability as measured by adverse events, local tolerability, clinical chemistry, haematology, and vital signs.
Secondary outcome
To evaluate formation of antibodies, anti-hLF 1-11 (ELISA) will be measured during and after the study up to two weeks post dose.
Background summary
Open label prospective trial of a single 5 mg dose of hLF1-11 in autologous haematopoietic stem cell transplant (HSCT) recipients. Eight (8) subjects will receive a single intravenous dose of hLF1-11 given in a volume of 20 mL given over 20 min.
Adverse events whether infectious or non-infectious whether reported by the patient spontaneously or by the nursing and medical carers will be recorded according to World Wide Standards as will any abnormalities in clinical chemistry, haematology, urine analysis or vital signs (BP, heart rate and temperature).
Study objective
A peptide representing the first eleven residues of hLF (hLF1-11) was shown to be effective in killing a variety of bacteria in vivo. The objective is to develop hLF1-11 as an effective and safe antibacterial and antifungal for the treatment of infections that develop during the neutropenia resulting from myeloablative therapy to prepare for a haematopoietic stem cell transplant.
Study design
N/A
Intervention
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.
Rumpsterweg 6
B.Th.M. Bierman
Bunnik 3981 AK
The Netherlands
+31 (0)30 2289222
B.Bierman@AM-Pharma.com
Rumpsterweg 6
B.Th.M. Bierman
Bunnik 3981 AK
The Netherlands
+31 (0)30 2289222
B.Bierman@AM-Pharma.com
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL613 |
| NTR-old | NTR672 |
| Other | : N/A |
| ISRCTN | ISRCTN27226314 |