Condition category
Infections and Infestations
Date applied
09/06/2006
Date assigned
09/06/2006
Last edited
01/04/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr B.Th.M. Bierman

ORCID ID

Contact details

AM-Pharma B.V.
Rumpsterweg 6
Bunnik
3981 AK
Netherlands
+31 (0)30 2289222
B.Bierman@AM-Pharma.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

AMP 02-01

Study hypothesis

A peptide representing the first eleven residues of hLF (hLF1-11) was shown to be effective in killing a variety of bacteria in vivo. The objective is to develop hLF1-11 as an effective and safe antibacterial and antifungal for the treatment of infections that develop during the neutropenia resulting from myeloablative therapy to prepare for a haematopoietic stem cell transplant.

Ethics approval

Not provided at time of registration

Study design

Non randomised controlled trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Neutropenic stem cell transplantation patients

Intervention

Study medication hLF1-11 of 5 mg will be given by intravenous administration. hLF 1-11 will be dissolved in sterile 0.9 % NaCl to a volume of 20 ml to be administered at 1 ml/min over 20 mins.

Intervention type

Drug

Phase

Not Specified

Drug names

Lactoferrin

Primary outcome measures

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

Secondary outcome measures

To evaluate formation of antibodies, anti-hLF 1-11 enzyme-linked immunosorbent assay (ELISA) will be measured during and after the study up to two weeks post dosage administration.

Overall trial start date

06/03/2006

Overall trial end date

31/05/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Admitted for an autologous hematopoietic stem cell transplantation (HSCT) after myeloablative therapy with high-dose melfalan
2. Managed with a 4-lumen central venous catheter
3. 18 to 45 years of age
4. Body mass index (BMI) <30
5. Able and willing to participate
6. Has provided written informed consent
7. There is no medical reason for exclusion
8. Has adequate renal function (creatinine <110 µmol/l [man]; <90 µmol/l [woman])
9. Has adequate liver function aspartate aminotransferase (ASAT) <40 U; alanine aminotransferase (ALAT) <45 U; bilirubin <10 µmol/l)
10. Has no known allergy to lactoferrin
11. Has no history of hepatitis and is not human immunodeficiency virus (HIV)-seropositive
12. If a woman, functionally post-menopausal

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

8

Participant exclusion criteria

1. A history of, or presence of, significant respiratory, cardiovascular, neurological, haematological, endocrine, gastrointestinal, hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs (as judged clinically relevant by the investigator)
2. 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
3. A clinically relevant history of intolerance or hypersensitivity to the study drug, or its additives and excipients in the intravenous formulation
4. Evidence of having serum hepatitis or carrying the hepatitis B surface antigen or hepatitis C antibodies or being HIV positive
5. Subjects, who in the opinion of the investigator should not, for reasons of safety, participate in the study

Recruitment start date

06/03/2006

Recruitment end date

31/05/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

AM-Pharma B.V.
Bunnik
3981 AK
Netherlands

Sponsor information

Organisation

AM-Pharma B.V. (Netherlands)

Sponsor details

Rumpsterweg 6
Bunnik
3981 AK
Netherlands

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

SenterNovem (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

AM-Pharma B.V. (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes