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

NCT00430469 | Withdrawn Phase 1 DMC

• 2 other identifiers: AMP 02-02; SC132006-004012-52
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Fungal Infection; Bacterial Infection

Keywords

Lactoferrin; hLF; Neutropenia; Myeloablative; Treatment; Fungal; Bacterial; Infections; Bone marrow transplant

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability as measured by adverse events, local tolerability, clinical chemistry, haematology, and vital signs

  28 Days

Secondary Outcomes (1)

• Monitor for possible formation of hLF 1-11 specific antibodies.

  28 Days

Interventions

human lactoferrin (hLF1-11) DRUG

intravenous 0.5mg in NaCl-solution

Also known as: hLF1-11

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• AM-Pharma: lead

Study Sites (1)

UMC St. Radboud

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

Related Publications (2)

• 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. doi: 10.1128/AAC.48.12.4919-4921.2004.

  PMID: 15561882 BACKGROUND

• 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.

  PMID: 14960656 BACKGROUND

MeSH Terms

Conditions

Mycoses; Bacterial Infections; Neutropenia; Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Officials

• Peter J Donnelly, PhD

  UMC St. Radboud Nijmegen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2007
• First Posted: February 2, 2007
• Study Start: November 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: June 1, 2009
• Last Updated: June 30, 2015

Record last verified: 2015-06

Locations

NL (1)