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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00430469
Recruitment Status : Withdrawn (Strategic company decision)
First Posted : February 2, 2007
Last Update Posted : June 30, 2015
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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 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 or disease Intervention/treatment Phase
Fungal Infection Bacterial Infection Drug: human lactoferrin (hLF1-11) Phase 1 Phase 2

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Safety of a 0.5mg Dose of hLF1-11 Given for 10 Consecutive Days to Autologous Haematopoietic Stem Cell Transplant Recipients
Study Start Date : November 2008
Estimated Primary Completion Date : March 2009
Estimated Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: human lactoferrin (hLF1-11)
    intravenous 0.5mg in NaCl-solution
    Other Name: hLF1-11

Primary Outcome Measures :
  1. Safety and tolerability as measured by adverse events, local tolerability, clinical chemistry, haematology, and vital signs [ Time Frame: 28 Days ]

Secondary Outcome Measures :
  1. Monitor for possible formation of hLF 1-11 specific antibodies. [ Time Frame: 28 Days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00430469

UMC St. Radboud
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
Principal Investigator: Peter J Donnelly, PhD UMC St. Radboud Nijmegen

Responsible Party: AM-Pharma Identifier: NCT00430469     History of Changes
Other Study ID Numbers: AMP 02-02; SC13
2006-004012-52 ( EudraCT Number )
First Posted: February 2, 2007    Key Record Dates
Last Update Posted: June 30, 2015
Last Verified: June 2015

Keywords provided by AM-Pharma:
Bone marrow transplant

Additional relevant MeSH terms:
Communicable Diseases
Bacterial Infections
Anti-Infective Agents