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Safety and efficacy of human lactoferrin hLF1-11 for the treatment of infectious complications among haematopoietic stem cell transplant recipients.


- candidate number2069
- NTR NumberNTR672
- ISRCTNISRCTN27226314
- Date ISRCTN created9-jun-2006
- date ISRCTN requested22-mei-2006
- Date Registered NTR21-apr-2006
- Secondary IDsN/A 
- Public TitleSafety and efficacy of human lactoferrin hLF1-11 for the treatment of infectious complications among haematopoietic stem cell transplant recipients.
- Scientific TitlePart A: Clinical Study Protocol SC12: Safety of a single dose of 5 mg of hLF1-11 given to autologous haematopoietic stem cell transplant recipients.
- ACRONYMAMP 02-01
- hypothesisA 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.
- Healt Condition(s) or Problem(s) studiedStem cell transplantation
- Inclusion criteria1. 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 Ámol/L (man); <90 Ámol/L (woman));
9. Has adequate liver function (ASAT <40 U; ALAT <45 U; bilirubin <10Ámol/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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeintervention
- planned startdate 6-mrt-2006
- planned closingdate31-mei-2006
- Target number of participants8
- InterventionsStudy 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.
- Primary outcomeSafety and tolerability as measured by adverse events, local tolerability, clinical chemistry, haematology, and vital signs.
- Secondary outcomeTo evaluate formation of antibodies, anti-hLF 1-11 (ELISA) will be measured during and after the study up to two weeks post dose.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESM.D. B.Th.M. Bierman
- CONTACT for SCIENTIFIC QUERIESPhD J.P. Donnelly
- Sponsor/Initiator AM-Pharma B.V.
- Funding
(Source(s) of Monetary or Material Support)
AM-Pharma, SenterNovem
- PublicationsN/A
- Brief summaryOpen 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).
- Main changes (audit trail)
- RECORD21-apr-2006 - 18-nov-2008


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