Safety and efficacy of human lactoferrin hLF1-11 for the treatment of infectious complications among haematopoietic stem cell transplant recipients
| ISRCTN | ISRCTN27226314 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27226314 |
| Secondary identifying numbers | N/A |
- Submission date
- 09/06/2006
- Registration date
- 09/06/2006
- Last edited
- 01/04/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr B.Th.M. Bierman
Scientific
Scientific
AM-Pharma B.V.
Rumpsterweg 6
Bunnik
3981 AK
Netherlands
| Phone | +31 (0)30 2289222 |
|---|---|
| B.Bierman@AM-Pharma.com |
Study information
| Study design | Non randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | AMP 02-01 |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Lactoferrin |
| Primary outcome measure | 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 study start date | 06/03/2006 |
| Completion date | 31/05/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 8 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 06/03/2006 |
| Date of final enrolment | 31/05/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
AM-Pharma B.V.
Bunnik
3981 AK
Netherlands
3981 AK
Netherlands
Sponsor information
AM-Pharma B.V. (Netherlands)
Industry
Industry
Rumpsterweg 6
Bunnik
3981 AK
Netherlands
"ROR" |
https://ror.org/02bpbnv34 |
|---|
Funders
Funder type
Industry
SenterNovem (Netherlands)
No information available
AM-Pharma B.V. (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
