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

Completed

Conditions: eutropenic stem cell transplantation patients
Infections and Infestations
Bacterial infections

Registration Number: ISRCTN27226314

Lead Sponsor: AM-Pharma B.V. (Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 8

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

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

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 enzyme-linked immunosorbent assay (ELISA) will be measured during and after the study up to two weeks post dosage administration.