Fungal InfectionPhase 1/2NCT00430469
Safety of hLF1-11 for the Treatment of Infectious Complications Among HSCT Recipients
A Phase 1/2 study testing human lactoferrin (hLF1-11) in people with Fungal Infection and Bacterial Infection, run by AM-Pharma at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fungal Infection, Bacterial Infection
- What is being tested?
- human lactoferrin (hLF1-11)
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2008to Jun 2009
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety of a 0.5mg Dose of hLF1-11 Given for 10 Consecutive Days to Autologous Haematopoietic Stem Cell Transplant Recipients
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.
Read the 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
- Conditions
- Fungal Infection, Bacterial Infection
- Being tested
- human lactoferrin (hLF1-11)
- Keywords
- Lactoferrin, hLF, Neutropenia, Myeloablative, Treatment, Fungal, Bacterial, Infections, Bone marrow transplant
- Medical subject headings
- Mycoses, Bacterial Infections, Neutropenia, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human lactoferrin (hLF1-11)Drug
Also called hLF1-11
intravenous 0.5mg in NaCl-solution
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability as measured by adverse events, local tolerability, clinical chemistry, haematology, and vital signs
Measured: 28 Days
Secondary outcomes (1)
Monitor for possible formation of hLF 1-11 specific antibodies.
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2007 (estimated)
- Study startNov 2008
- Primary completionMar 2009 (estimated)
- Study completionJun 2009 (estimated)
Why it stopped: Strategic company decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fungal InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AM-Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter J Donnelly, PhD, Principal investigator, UMC St. Radboud Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00430469
- Sponsor's protocol ID
- AMP 02-02; SC13
- Other IDs
- 2006-004012-52
- Status last verified
- Jun 2015
- First submitted
- 1 Feb 2007
- Last updated
- 30 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15561882Nibbering 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.
PubMed 14960656
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of a 0.5mg Dose of hLF1-11 Given for 10 Consecutive Days to Autologous Haematopoietic Stem Cell Transplant Recipients
- ClinicalTrials.gov ID
- NCT00430469
- Acronym / sponsor ID
- AMP 02-02; SC13
- Conditions
- Fungal Infection, Bacterial Infection
- Keywords
- Lactoferrin, hLF, Neutropenia, Myeloablative, Treatment, Fungal, Bacterial, Infections
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Strategic company decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AM-PharmaIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Mar 2009 (estimated)
- Study completion
- Jun 2009 (estimated)
- First posted
- 2 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| human lactoferrin (hLF1-11)Also: hLF1-11intravenous 0.5mg in NaCl-solution | Drug | – |
Primary outcome
Safety and tolerability as measured by adverse events, local tolerability, clinical chemistry, haematology, and vital signs
Time frame: 28 Days
1 secondary outcome
Monitor for possible formation of hLF 1-11 specific antibodies.
Time frame: 28 Days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2015.
- Background: PubMed 15561882Dijkshoorn 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.
- Background: PubMed 14960656Nibbering 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter J Donnelly, PhD principal investigator
UMC St. Radboud Nijmegen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing human lactoferrin (hLF1-11) in people with Fungal Infection and Bacterial Infection, run by AM-Pharma at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability as measured by adverse events, local tolerability, clinical chemistry, haematology, and vital signs (time frame: 28 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00430469, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2015.