Contact information
Type
Scientific
Primary contact
Dr B.Th.M. Bierman
ORCID ID
Contact details
AM-Pharma B.V.
Rumpsterweg 6
Bunnik
3981 AK
Netherlands
+31 (0)30 2289222
B.Bierman@AM-Pharma.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
AMP 02-01
Study hypothesis
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.
Ethics approval
Not provided at time of registration
Study design
Non randomised controlled trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Neutropenic stem cell transplantation patients
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 to a volume of 20 ml to be administered at 1 ml/min over 20 mins.
Intervention type
Drug
Phase
Not Specified
Drug names
Lactoferrin
Primary outcome measure
Safety and tolerability as measured by adverse events, local tolerability, clinical chemistry, haematology, and vital signs.
Secondary outcome measures
To evaluate formation of antibodies, anti-hLF 1-11 enzyme-linked immunosorbent assay (ELISA) will be measured during and after the study up to two weeks post dosage administration.
Overall trial start date
06/03/2006
Overall trial end date
31/05/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Admitted for an autologous hematopoietic stem cell transplantation (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. Body mass index (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 aspartate aminotransferase (ASAT) <40 U; alanine aminotransferase (ALAT) <45 U; bilirubin <10 µmol/l)
10. Has no known allergy to lactoferrin
11. Has no history of hepatitis and is not human immunodeficiency virus (HIV)-seropositive
12. If a woman, functionally post-menopausal
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
8
Participant exclusion criteria
1. A history of, or presence of, significant respiratory, cardiovascular, neurological, haematological, endocrine, gastrointestinal, hepatic or renal disease or any 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
Recruitment start date
06/03/2006
Recruitment end date
31/05/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
AM-Pharma B.V.
Bunnik
3981 AK
Netherlands
Funders
Funder type
Industry
Funder name
SenterNovem (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
AM-Pharma B.V. (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list