Status:
WITHDRAWN
Safety of hLF1-11 for the Treatment of Infectious Complications Among HSCT Recipients
Lead Sponsor:
AM-Pharma
Conditions:
Fungal Infection
Bacterial Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 t...
Detailed Description
Human lactoferrin (hLF) is a glycoprotein containing 692 amino acids and found in the saliva, milk, tears, and other body fluids. The peptide representing the first cationic domain, i.e. the peptide c...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00430469
Start Date
November 1 2008
End Date
June 1 2009
Last Update
June 30 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UMC St. Radboud
Nijmegen, Gelderland, Netherlands, 6500 HB