Safety of hLF1-11 for the Treatment of Infectious Complications Among HSCT Recipients

• Status: Withdrawn
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The safety and tolerability of hLF 1-11 given in multiple doses 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 or bacterial 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 safe and well tolerated 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:

Recipients will be eligible for inclusions if they satisfy the following conditions:

• Has been admitted for an autologous HSCT after myeloablative therapy with high-dose melphalan;

• Is being managed with a 3 or 4-lumen central venous catheter;

• Is at least 18 years old;

• Has a BMI <30 kg/M2;

• Has no medical reason for not participating

• Has adequate renal function (creatinine < 1.5 x ULN)

• Has adequate liver function (ASAT, ALAT < 2.5 x ULN, bilirubin < 1.5 x ULN);

• If a woman, is functionally post-menopausal

• Has not participated in a study of a new chemical molecular entity in the previous 3 months

• Is able and willing to participate;

• Has provided written informed consent.