Safety of a Single Dose of 5 mg of hLF1-11 Given to Autologous Haematopoietic Stem Cell Transplant Recipients

NCT00509938 | Completed Phase 1 DMC

• 3 other identifiers: AMP 02-01SC12IS 044096
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The safety and tolerability of hLF 1-11 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 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 when given during neutropenia and mucosal barrier injury before infections ensue

Conditions

Hematopoietic Stem Cell Transplantation; Bacterial Infections and Mycoses

Keywords

immunocompromized; hLF1-11; antimicrobial; peptide; lactoferrin

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability by recording the vital signs, clinical chemistry, local tolerability and adverse events during the study

  28 Days

Secondary Outcomes (1)

• formation of antibodies anti-hLF 1-11 during the study.

  28 Days

Study Arms (1)

1

EXPERIMENTAL

5mg hLF1-11, single dose iv

Drug: human lactoferrin peptide 1-11

Interventions

human lactoferrin peptide 1-11 DRUG

Each subject will receive a single intravenous dose of hLF1-11 given in a volume of 20mL given over 20 minutes i.e. 1mL/per minute.

1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• admitted for an autologous HSCT after myeloablative therapy with high-dose melfalan
• managed with a 4-lumen central venous catheter
• BMI \<30
• able and willing to participate
• has provided written informed consent
• has adequate renal function (creatinine \<110 µmol/L (man); \<90 µmol/L (woman))
• has adequate liver function (ASAT \<40 U; ALAT \<45 U; bilirubin \<10µmol/L)
• has no known allergy to lactoferrin
• has no history of hepatitis and is not HIV seropositive
• if a woman, functionally post-menopausal

You may not qualify if:

• A history of, or presence of, significant respiratory, cardiovascular, neurological, haematological, endocrine, gastrointestinal, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs (as judged clinically relevant by the investigator).
• Participation in a study with a new chemical entity or new molecular entity 3 months before or participation in a study with a registered drug less than 5 times of the half life of the registered drug before entering the study.
• A clinically relevant history of intolerance or hypersensitivity to the study drug, or its additives and excipients in the intravenous formulation.
• Evidence of having serum hepatitis or carrying the hepatitis B surface antigen or Hepatitis C antibodies or being HIV positive.
• Subjects, who in the opinion of the investigator should not, for reasons of safety, participate in the study.

Sponsors & Collaborators

• AM-Pharma: lead

Study Sites (1)

UMC St. Radboud

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

Related Publications (1)

• Velden WJ, van Iersel TM, Blijlevens NM, Donnelly JP. Safety and tolerability of the antimicrobial peptide human lactoferrin 1-11 (hLF1-11). BMC Med. 2009 Sep 8;7:44. doi: 10.1186/1741-7015-7-44.

  PMID: 19735580 DERIVED

MeSH Terms

Conditions

Bacterial Infections and Mycoses

Interventions

lactoferrin (1-11), human

Condition Hierarchy (Ancestors)

Infections

Study Officials

• J.P. Donnelly, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 31, 2007
• First Posted: August 1, 2007
• Study Start: March 1, 2006
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: October 17, 2008

Record last verified: 2008-10

Locations

NL (1)