Neonatal Staphylococcal SepsisPhase 1/2N002NCT00631878
Safety and Pharmacokinetics Study in VLBW Neonates With BSYX-A110
A Phase 1/2 study testing Pagibaximab (formerly BSYX-A110) in people with Neonatal Staphylococcal Sepsis, run by Biosynexus Incorporated at 1 site in United States.
Trial summary
"Phase I/II, Randomized, Double Blind, Placebo Controlled, Dose Escalating, Safety and Pharmacokinetics Study in Very Low Birth Weight Neonates of Four Doses of BSYX-A110 for the Prevention of S. Read more about this study
- Who is it for?
- Ages 3 to 7 days
- Conditions the study is for
- Neonatal Staphylococcal Sepsis
- What is being tested?
- Pagibaximab (formerly BSYX-A110)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2001to Aug 2003
- 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 3 to 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients must meet all of the following criteria at the time of first infusion (Day 0):
- 3-7 days of age, inclusive
- Birth weight of 700-1300 grams
- Survival expected for at least 1 week after infusion
- Inpatient in a Neonatal Intensive Care Unit with intravenous access
- Written informed consent obtained from the parent(s) or guardian
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- Multiple gestations:
- Siblings from multiple gestations may be enrolled if they each meet the entry criteria
- No more than 4 subjects in any birth weight or dose cohort may be siblings
Who cannot join
- Patients may have none of the following at either the first or second dose:
- Clinically overt systemic infection, as determined by history, physical examination, culture or laboratory data. Neonates with known or suspected HIV infection but without other active systemic infection are not excluded.
- Life threatening hemodynamic instability
- Severe congenital anomalies or genetic disorders (especially any predisposing to cardiac decompensation) as determined by history and/or physical examination and including but not limited to:
- Trisomy 13 ii. Trisomy 18 iii. Hypoplastic Left Heart Syndrome iv. Omphalocele v. Gastroschesis vi. Holoprosencephaly
- Known or suspected hepatic or renal insufficiency
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- Persistent seizure disorder
- Immunodeficiency other than due to prematurity
- A history of immune globulin administration prior to first study drug infusion
- Any history, in the infant subject or its mother, of a hypersensitivity or severe vasomotor reaction to immunoglobulin G, or blood products.
- Any of the following laboratory findings
- BUN or creatinine > 1.5 x upper limit of normal for age
- AST (SGOT), ALT (SGPT) or total bilirubin > 1.5 x upper limit of normal age
- Direct bilirubin of > 2.0 mg/dL
- Hemoglobin < 9.0gm/dL
- White Blood Count < 2,000 cells/mm3
- Currently receiving or recently received other investigational agents that could interfere with conduct or results of this study. Each patient receiving other investigational agents will be reviewed by the investigator or his designee with the Sponsor prior to the patient's entry into the study.
- Expectation that the patient will not be able to be followed for the duration of the study.
- Mother with serology positive for hepatitis B surface antigen
- Receipt of Hepatitis B vaccine since birth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I/II Randomized, Double Blind, Placebo Controlled, Dose Escalation, Safety and Pharmacokinetics Study in VLBW Neonates, a Human Chimeric Anti-Staphylococcal Monoclonal Antibody for the Prevention of S. Epidermidis Infection
"Phase I/II, Randomized, Double Blind, Placebo Controlled, Dose Escalating, Safety and Pharmacokinetics Study in Very Low Birth Weight Neonates of Four Doses of BSYX-A110 for the Prevention of S. epidermidis Infection." The purpose of this study is to evaluate the safety and pharmacokinetics of escalating doses of BSYX-A110 administered on Study Days 0 and 14.
Read the detailed description
"Phase I/II, Randomized, Double Blind, Placebo Controlled, Dose Escalating, Safety and Pharmacokinetics Study in Very Low Birth Weight Neonates of Four Doses of BSYX-A110, a Human Chimeric Anti-Staphylococcal Monoclonal Antibody for the Prevention of S. epidermidis Infection" will be the first study of BSYX-A110 in the target population of hospitalized, very low birth weight infants. The purpose of this study is to evaluate the safety and pharmacokinetics of escalating doses of BSYX-A110 administered on Study Days 0 and 14.
This will be a randomized, double blind, placebo controlled, dose escalating study of BSYX-A110 in 48 very low birth weight neonates. The dose levels to be evaluated are 10, 30, 60 and 90 mg/kg. Each dose level will enroll 12 infants who will receive two doses of BSYX-A110 or placebo intravenously at a ratio of 2:1 while hospitalized following birth. Infants will be followed for 8 weeks following the first dose of BSYX-A110 or placebo. The primary objective of this study is to evaluate safety and tolerability. The secondary objective is to analyze the pharmacokinetics of BSYX-A110. Positive cultures obtained during the study period will be recorded and analyzed.
- Conditions
- Neonatal Staphylococcal Sepsis
- Being tested
- Pagibaximab (formerly BSYX-A110)
- Keywords
- Staphylococcal, Monoclonal antibodies, Very Low Birth Weight Infants, Prophylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pagibaximab (formerly BSYX-A110)Drug
Also called BSYX-A110, HU96-110, Pagibaximab
Pagibaximab at 10, 30, 60, 90 mg/kg intravenously at Days 0 and 14.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Pagibaximab (formerly BSYX-A110) |
| 10 mg/kg | Experimental | 10 mg/kg was given on Days 0, 14 Receives: Drug: Pagibaximab (formerly BSYX-A110) |
| 30 mg/kg | Experimental | 30 mg/kg was given on Days 0, 14 Receives: Drug: Pagibaximab (formerly BSYX-A110) |
| 60 mg/kg | Experimental | 60 mg/kg was given on Days 0, 14 Receives: Drug: Pagibaximab (formerly BSYX-A110) |
| 90 mg/kg | Experimental | 90 mg/kg was given on Days 0, 14 Receives: Drug: Pagibaximab (formerly BSYX-A110) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability.
Measured: 0 - 52 days
Secondary outcomes (1)
Evaluate the pharmacokinetics and positive cultures.
Measured: 0 - 52 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2008 (estimated)
- Study startNov 2001
- Primary completionMay 2003
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Staphylococcal SepsisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosynexus Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Investigators
- Leonard Weisman, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00631878
- Sponsor's protocol ID
- MAB-N002
- Acronym
- N002
- Status last verified
- Feb 2008
- First submitted
- 29 Feb 2008
- Last updated
- 10 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Randomized, Double Blind, Placebo Controlled, Dose Escalation, Safety and Pharmacokinetics Study in VLBW Neonates, a Human Chimeric Anti-Staphylococcal Monoclonal Antibody for the Prevention of S. Epidermidis Infection
- ClinicalTrials.gov ID
- NCT00631878
- Acronym / sponsor ID
- N002 / MAB-N002
- Conditions
- Neonatal Staphylococcal Sepsis
- Keywords
- Staphylococcal, Monoclonal antibodies, Very Low Birth Weight Infants, Prophylaxis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Biosynexus IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- Nov 2001
- Primary completion
- May 2003 (actual)
- Study completion
- Aug 2003 (actual)
- First posted
- 10 Mar 2008 (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.
"Phase I/II, Randomized, Double Blind, Placebo Controlled, Dose Escalating, Safety and Pharmacokinetics Study in Very Low Birth Weight Neonates of Four Doses of BSYX-A110 for the Prevention of S. epidermidis Infection." The purpose of this study is to evaluate the safety and pharmacokinetics of escalating doses of BSYX-A110 administered on Study Days 0 and 14.
Detailed description
"Phase I/II, Randomized, Double Blind, Placebo Controlled, Dose Escalating, Safety and Pharmacokinetics Study in Very Low Birth Weight Neonates of Four Doses of BSYX-A110, a Human Chimeric Anti-Staphylococcal Monoclonal Antibody for the Prevention of S. epidermidis Infection" will be the first study of BSYX-A110 in the target population of hospitalized, very low birth weight infants. The purpose of this study is to evaluate the safety and pharmacokinetics of escalating doses of BSYX-A110 administered on Study Days 0 and 14.
This will be a randomized, double blind, placebo controlled, dose escalating study of BSYX-A110 in 48 very low birth weight neonates. The dose levels to be evaluated are 10, 30, 60 and 90 mg/kg. Each dose level will enroll 12 infants who will receive two doses of BSYX-A110 or placebo intravenously at a ratio of 2:1 while hospitalized following birth. Infants will be followed for 8 weeks following the first dose of BSYX-A110 or placebo. The primary objective of this study is to evaluate safety and tolerability. The secondary objective is to analyze the pharmacokinetics of BSYX-A110. Positive cultures obtained during the study period will be recorded and analyzed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Pagibaximab (formerly BSYX-A110) |
| 10 mg/kg | Experimental | Drug: Pagibaximab (formerly BSYX-A110)10 mg/kg was given on Days 0, 14 |
| 30 mg/kg | Experimental | Drug: Pagibaximab (formerly BSYX-A110)30 mg/kg was given on Days 0, 14 |
| 60 mg/kg | Experimental | Drug: Pagibaximab (formerly BSYX-A110)60 mg/kg was given on Days 0, 14 |
| 90 mg/kg | Experimental | Drug: Pagibaximab (formerly BSYX-A110)90 mg/kg was given on Days 0, 14 |
Who may qualify
- Ages
- 3 to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 3-7 days of age, inclusive
- Birth weight of 700-1300 grams
- Survival expected for at least 1 week after infusion
- Inpatient in a Neonatal Intensive Care Unit with intravenous access
- Written informed consent obtained from the parent(s) or guardian
Key exclusion criteria (20 listed)
- Clinically overt systemic infection, as determined by history, physical examination, culture or laboratory data. Neonates with known or suspected HIV infection but without other active systemic infection are not excluded.
- Life threatening hemodynamic instability
- Severe congenital anomalies or genetic disorders (especially any predisposing to cardiac decompensation) as determined by history and/or physical examination and including but not limited to:
- Known or suspected hepatic or renal insufficiency
- Persistent seizure disorder
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 |
|---|---|---|
| Pagibaximab (formerly BSYX-A110)Also: BSYX-A110, HU96-110, PagibaximabPagibaximab at 10, 30, 60, 90 mg/kg intravenously at Days 0 and 14. | Drug | 10 mg/kg, 30 mg/kg, 60 mg/kg, 90 mg/kg, Placebo |
Primary outcome
Safety and tolerability.
Time frame: 0 - 52 days
1 secondary outcome
Evaluate the pharmacokinetics and positive cultures.
Time frame: 0 - 52 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2008.
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.
Leonard Weisman, MD principal investigator
Baylor College of Medicine
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 Pagibaximab (formerly BSYX-A110) in people with Neonatal Staphylococcal Sepsis, run by Biosynexus Incorporated at 1 site in United States.
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 9 inclusion and 20 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: finished, as of the sponsor's last update on 10 Mar 2008. 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 United States. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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. (time frame: 0 - 52 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2008.