Safety of a Single Dose of 5 mg of hLF1-11 Given to Autologous Haematopoietic Stem Cell Transplant Recipients

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The safety and tolerability of hLF 1-11 has to be established first in HSCT recipients who are at risk of developing, but have not yet developed, infectious complications due to invasive fungal disease. These patients are different from healthy volunteers because they have received myeloablative treatment which not only arrests haematopoiesis resulting in neutropenia but also induces mucosal barrier injury both of which predispose to infections which typically occur during the week after transplant. It is therefore essential to know that hLF 1-11 is when given during neutropenia and mucosal barrier injury before infections ensue

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AM-Pharma
• Treatments: Lactoferrin

Criteria

Inclusion Criteria:

• admitted for an autologous HSCT after myeloablative therapy with high-dose melfalan

• managed with a 4-lumen central venous catheter

• BMI <30

• able and willing to participate

• has provided written informed consent

• there is no medical reason for exclusion

• has adequate renal function (creatinine <110 µmol/L (man); <90 µmol/L (woman))

• has adequate liver function (ASAT <40 U; ALAT <45 U; bilirubin <10µmol/L)

• has no known allergy to lactoferrin

• has no history of hepatitis and is not HIV seropositive

• if a woman, functionally post-menopausal

Exclusion Criteria:

• A history of, or presence of, significant respiratory, cardiovascular, neurological, haematological, endocrine, gastrointestinal, 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).

• 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.

• A clinically relevant history of intolerance or hypersensitivity to the study drug, or its additives and excipients in the intravenous formulation.

• Evidence of having serum hepatitis or carrying the hepatitis B surface antigen or Hepatitis C antibodies or being HIV positive.

• Subjects, who in the opinion of the investigator should not, for reasons of safety, participate in the study.