Safety of Human Lactoferrin hLF1-11 for the Treatment of Infectious Complications Among Haematopoietic Stem Cell Transplant Recipients - Full Text View

Sponsored by:	AM-Pharma
Information provided by:	AM-Pharma
ClinicalTrials.gov Identifier:	NCT00430469

Purpose

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.

Condition	Intervention	Phase
Fungal Infection Bacterial Infection	Drug: human lactoferrin (hLF1-11)	Phase I Phase II

MedlinePlus related topics: Bacterial Infections Fungal Infections Molds

Drug Information available for: Lactoferrin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Safety of a 0.5mg Dose of hLF1-11 Given for 10 Consecutive Days to Autologous Haematopoietic Stem Cell Transplant Recipients

Further study details as provided by AM-Pharma:

Primary Outcome Measures:

Safety and tolerability as measured by adverse events, local tolerability, clinical chemistry, haematology, and vital signs [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Monitor for possible formation of hLF 1-11 specific antibodies. [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	8
Study Start Date:	November 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Intervention Details:

intravenous 0.5mg in NaCl-solution

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 comprising the first eleven residues of hLF (further referred to as hLF1-11) was significantly more effective than the full length protein or the peptide representing the second cationic domain. As with other antimicrobial peptides, hLF1-11 shows poor antimicrobial activity under physiological conditions in vitro, but it is highly effective in vivo against infections due to a variety of microorganisms, including Gram negative and Gram positive bacteria and fungi. The objective is to develop hLF1-11 for the treatment of fungal and bacterial infections that develop during neutropenia that results from myeloablative therapy to prepare for a haematopoietic stem cell transplant(HSCT) formerly referred to as bone marrow transplant. Rates of infection and related morbidity are high in this population, making it an attractive target for testing clinically the proof-of-principle that hLF1-11 can provide effective treatment. Subsequently, hLF1-11 will be developed further as a systemic antifungal agent

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00430469

Contacts

Contact: J. Arend, MD

+31 (0)30 228 92 22

J.Arend@AM-Pharma.com

Locations

Netherlands, Gelderland
UMC St. Radboud
Nijmegen, Gelderland, Netherlands, 6500 HB

Sponsors and Collaborators

AM-Pharma

Investigators

Principal Investigator:

Peter J Donnelly, PhD

UMC St. Radboud Nijmegen

More Information

Publications:

Dijkshoorn L, Brouwer CP, Bogaards SJ, Nemec A, van den Broek PJ, Nibbering PH. The synthetic N-terminal peptide of human lactoferrin, hLF(1-11), is highly effective against experimental infection caused by multidrug-resistant Acinetobacter baumannii. Antimicrob Agents Chemother. 2004 Dec;48(12):4919-21.

Nibbering PH, Welling MM, Paulusma-Annema A, Brouwer CP, Lupetti A, Pauwels EK. 99mTc-Labeled UBI 29-41 peptide for monitoring the efficacy of antibacterial agents in mice infected with Staphylococcus aureus. J Nucl Med. 2004 Feb;45(2):321-6.

Responsible Party:	AM-Pharma ( Dr J Arend, MD )
Study ID Numbers:	AMP 02-02; SC13, EudraCT No. 2006-004012-52
Study First Received:	February 1, 2007
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00430469 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by AM-Pharma:

Lactoferrin
hLF
Neutropenia
Myeloablative
Treatment

Fungal
Bacterial
Infections
Bone marrow transplant

Study placed in the following topic categories:

Bacterial Infections
Neutropenia
Mycoses

Additional relevant MeSH terms:

Bacterial Infections
Mycoses
Communicable Diseases
Infection

ClinicalTrials.gov processed this record on May 07, 2009