Hemophilia ANCT00839202
Activity and Content of Factor VIII (FVIII) in Human Plasma: The Assessment of a Novel Immunoassay
A study testing FVIII immuno-assay in people with Hemophilia A, run by Children's Hospital Los Angeles at 1 site in United States.
Trial summary
A novel immuno-assay is being evaluated for the measurement of Factor VIII. Current procedure measures a rate assay which is subject to much artefact. The hypothesis is that the new assay will give a reading of absolute quantities of FVIII which will provide a more suitable indicator of FVIII content for clotting… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hemophilia A
- What is being tested?
- FVIII immuno-assay
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Feb 2009
- Phase
- Interventional
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults with hemophilia A
- factor VIII less that 2%
- informed consent signed
- absence of an inhibitor
Who cannot join
- history of a high responding inhibitor anemia
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Biochemistry University of Vermont
Burlington, Vermont, 05446
About this study
Official title: Pharmacokinetic (PK) Analysis of a Novel Immunoassay in Hemophilia A
A novel immuno-assay is being evaluated for the measurement of Factor VIII. Current procedure measures a rate assay which is subject to much artefact. The hypothesis is that the new assay will give a reading of absolute quantities of FVIII which will provide a more suitable indicator of FVIII content for clotting factor manufacturers, physicians and patients.
Read the detailed description
Remnant samples collected in a clinical laboratory are assayed with the new procedure and compared with the standard functional activated partial thromboplastin time (APTT) assay. A PK study in seven study subjects with hemophilia A is being carried out using five different commercially licensed factor VIII concentrates and the blood samples drawn for the PK analysis are being measured for FVIII with the novel assay and compared with the standard APTT assay. The concentrates used in the PK studies are also being applied to the two assay systems to determine each product's specific activity.
- Conditions
- Hemophilia A
- Being tested
- FVIII immuno-assay
- Keywords
- factor VIII, hemophilia A, assay
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FVIII immuno-assayOther
There is no intervention. This is a study of the differences in assays.
| Study group | Role | What they receive |
|---|---|---|
| FVIII immuno-assay | Experimental | The study is not designed as a therapeutic evaluation, but an assessment of clotting factor VIII timed responses after the infusion of specified doses of licensed clotting factor VIII concentrates. The purpose of the study is to measure the levels of infused licensed clotting factor VIII by standard assay techniques and comparing these standard assays with an experimental assay. Measurements of possible co-factors that might impact the results were also carried out. Receives: Other: FVIII immuno-assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of Factor VIII in pMols
Measured: 48 hours
Secondary outcomes (1)
The possible role of VWF, factor concentrate type and non-inhibitory antibody presence or absence on the FVIII antigen levels
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2009 (estimated)
- Study startSep 2006
- Primary completionSep 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- University of Vermont
- Responsible party
- Principal investigator, Edward Gomperts, Children's Hospital Los Angeles
- Investigators
- Edward D Gomperts, MD, Principal investigator, Children's Hospital Los AngelesKenneth G Mann, PhD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00839202
- Sponsor's protocol ID
- CCI-06-0069-CR002
- Status last verified
- Jan 2017
- First submitted
- 6 Feb 2009
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic (PK) Analysis of a Novel Immunoassay in Hemophilia A
- ClinicalTrials.gov ID
- NCT00839202
- Acronym / sponsor ID
- CCI-06-0069-CR002
- Conditions
- Hemophilia A
- Keywords
- factor VIII, hemophilia A, assay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Collaborators
- University of Vermont
- Study start
- Sep 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 9 Feb 2009 (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.
A novel immuno-assay is being evaluated for the measurement of Factor VIII. Current procedure measures a rate assay which is subject to much artefact. The hypothesis is that the new assay will give a reading of absolute quantities of FVIII which will provide a more suitable indicator of FVIII content for clotting factor manufacturers, physicians and patients.
Detailed description
Remnant samples collected in a clinical laboratory are assayed with the new procedure and compared with the standard functional activated partial thromboplastin time (APTT) assay. A PK study in seven study subjects with hemophilia A is being carried out using five different commercially licensed factor VIII concentrates and the blood samples drawn for the PK analysis are being measured for FVIII with the novel assay and compared with the standard APTT assay. The concentrates used in the PK studies are also being applied to the two assay systems to determine each product's specific activity.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FVIII immuno-assay | Experimental | Other: FVIII immuno-assayThe study is not designed as a therapeutic evaluation, but an assessment of clotting factor VIII timed responses after the infusion of specified doses of licensed clotting factor VIII concentrates. The purpose of the study is to measure the levels of infused licensed clotting factor VIII by standard assay techniques and comparing these standard assays with an experimental assay. Measurements of possible co-factors that might impact the results were also carried out. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adults with hemophilia A
- factor VIII less that 2%
- informed consent signed
- absence of an inhibitor
Key exclusion criteria (1 listed)
- history of a high responding inhibitor anemia
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 |
|---|---|---|
| FVIII immuno-assayThere is no intervention. This is a study of the differences in assays. | Other | FVIII immuno-assay |
Primary outcome
The level of Factor VIII in pMols
Time frame: 48 hours
1 secondary outcome
The possible role of VWF, factor concentrate type and non-inhibitory antibody presence or absence on the FVIII antigen levels
Time frame: 48 hours
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 1 Feb 2017.
- Individual participant dataSharing planned: No
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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.
Edward D Gomperts, MD principal investigator
Children's Hospital Los Angeles
Kenneth G Mann, PhD principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FVIII immuno-assay in people with Hemophilia A, run by Children's Hospital Los Angeles 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 4 inclusion and 1 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 1 Feb 2017. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
The level of Factor VIII in pMols (time frame: 48 hours). 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 1 Feb 2017.