HealthyPhase 1NCT01542619
A Safety and Pharmacokinetics Study of a Recombinant Fusion Protein Linking Coagulation Factor VIIa With Albumin (rVIIa-FP) in Healthy Male Volunteers
A Phase 1 study testing rVIIa-FP in people with Healthy, run by CSL Behring at 1 site in Germany.
Trial summary
This is a first in man, prospective, single-center, randomized, double-blind, dose-escalation cohort study to investigate tolerability, safety and pharmacokinetics of rVIIa-FP in comparison to placebo. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- rVIIa-FP
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2012to Jul 2012
- Phase
- Phase 1
- 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 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects between 18 and 35 years of age, both inclusive.
- Body weight between 50.0 and 100.0 kg, both inclusive.
- Body mass index (BMI) between 18.0 and 29.9 kg/m2, both inclusive.
- Written informed consent for study participation obtained before undergoing any study specific procedures.
Who cannot join
- Subjects at increased cardiovascular risk.
- Any clinical sign or known history of atherosclerosis or thromboembolic events.
- A subject considered at high risk of thromboembolic events confirmed either from history or by thrombophilia screening test.
- Subjects with significant elevation of cholesterol level.
- Renal dysfunction.
- Overt bleeding.
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- Smokers with positive cotinine test at screening.
- Participation in any other trial investigating a procoagulant within the last six months prior to screening.
- Known or suspected hypersensitivity to the investigational medicinal product (IMP), or to any excipients of the IMP.
- Contraindications to Warfarin (Coumadin®).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo-controlled, Single Center, 5 Cohort Dose Escalation Trial to Investigate Safety and Pharmacokinetics of rVIIa-FP (CSL689) in Comparison to Placebo in Healthy Male Human Volunteers
This is a first in man, prospective, single-center, randomized, double-blind, dose-escalation cohort study to investigate tolerability, safety and pharmacokinetics of rVIIa-FP in comparison to placebo.
- Conditions
- Healthy
- Being tested
- rVIIa-FP, Placebo (0.9% normal saline)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rVIIa-FPBiological
Recombinant VIIa-FP (rVIIa-FP) is a fusion protein linking coagulation factor VIIa with albumin and will be administered by intravenous infusion in escalating doses up to 1000 mcg/kg. Participants will receive pre-treatment with an oral anticoagulant starting 7 days prior to administration of study product and continuing for 7 days after study product has been administered.
Placebo (0.9% normal saline)Biological
Placebo will be administered by intravenous infusion. Participants will receive pre-treatment with an oral anticoagulant starting 7 days prior to administration of placebo and continuing for 7 days after placebo has been administered.
| Study group | Role | What they receive |
|---|---|---|
| rVIIa-FP | Experimental | Not described Receives: Biological: rVIIa-FP |
| Placebo (0.9% normal saline) | Placebo comparator | Not described Receives: Biological: Placebo (0.9% normal saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of related Adverse Events (AEs) to rVIIa-FP.
Measured: 28 days
Number of subjects who develop inhibitors against Factor VII (FVII).
Measured: 28 days
Number of subjects who develop antibodies against rVIIa-FP.
Measured: 28 days
Secondary outcomes (4)
Area under curve to the last sample with quantifiable drug concentration (AUC0-t) of a single dose of rVIIa-FP
Measured: 120 hours
Half- life (t1/2) of a single dose of rVIIa-FP
Measured: 120 hours
Incremental recovery (IR) of rVIIa-FP
Measured: 120 hours
Clearance (Cl) of a single dose of rVIIa-FP
Measured: 120 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionJun 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by CSL BehringThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alex Veldman, M.D., Study director, CSL Behring
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01542619
- Sponsor's protocol ID
- CSL689_1001
- Other IDs
- 2011-004568-32
- Status last verified
- Mar 2013
- First submitted
- 26 Feb 2012
- Last updated
- 21 Apr 2017
- Results posted
- No
Publications
Golor G, Bensen-Kennedy D, Haffner S, Easton R, Jung K, Moises T, Lawo JP, Joch C, Veldman A. Safety and pharmacokinetics of a recombinant fusion protein linking coagulation factor VIIa with albumin in healthy volunteers. J Thromb Haemost. 2013 Nov;11(11):1977-85. doi: 10.1111/jth.12409.
PubMed 24112951
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Single Center, 5 Cohort Dose Escalation Trial to Investigate Safety and Pharmacokinetics of rVIIa-FP (CSL689) in Comparison to Placebo in Healthy Male Human Volunteers
- ClinicalTrials.gov ID
- NCT01542619
- Acronym / sponsor ID
- CSL689_1001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 2 Mar 2012 (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.
This is a first in man, prospective, single-center, randomized, double-blind, dose-escalation cohort study to investigate tolerability, safety and pharmacokinetics of rVIIa-FP in comparison to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rVIIa-FP | Experimental | Biological: rVIIa-FP |
| Placebo (0.9% normal saline) | Placebo comparator | Biological: Placebo (0.9% normal saline) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subjects between 18 and 35 years of age, both inclusive.
- Body weight between 50.0 and 100.0 kg, both inclusive.
- Body mass index (BMI) between 18.0 and 29.9 kg/m2, both inclusive.
- Written informed consent for study participation obtained before undergoing any study specific procedures.
Key exclusion criteria (10 listed)
- Subjects at increased cardiovascular risk.
- Any clinical sign or known history of atherosclerosis or thromboembolic events.
- A subject considered at high risk of thromboembolic events confirmed either from history or by thrombophilia screening test.
- Subjects with significant elevation of cholesterol level.
- Renal dysfunction.
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 |
|---|---|---|
| rVIIa-FPRecombinant VIIa-FP (rVIIa-FP) is a fusion protein linking coagulation factor VIIa with albumin and will be administered by intravenous infusion in escalating doses up to 1000 mcg/kg. Participants will receive pre-treatment with an oral anticoagulant starting 7 days prior to administration of study product and continuing for 7 days after study product has been administered. | Biological | rVIIa-FP |
| Placebo (0.9% normal saline)Placebo will be administered by intravenous infusion. Participants will receive pre-treatment with an oral anticoagulant starting 7 days prior to administration of placebo and continuing for 7 days after placebo has been administered. | Biological | Placebo (0.9% normal saline) |
Primary outcome
The frequency of related Adverse Events (AEs) to rVIIa-FP.
Time frame: 28 days
Number of subjects who develop inhibitors against Factor VII (FVII).
Time frame: 28 days
Number of subjects who develop antibodies against rVIIa-FP.
Time frame: 28 days
4 secondary outcomes
Area under curve to the last sample with quantifiable drug concentration (AUC0-t) of a single dose of rVIIa-FP
Time frame: 120 hours
Half- life (t1/2) of a single dose of rVIIa-FP
Time frame: 120 hours
Incremental recovery (IR) of rVIIa-FP
Time frame: 120 hours
Clearance (Cl) of a single dose of rVIIa-FP
Time frame: 120 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 21 Apr 2017.
- Results publication: PubMed 24112951Golor G, Bensen-Kennedy D, Haffner S, Easton R, Jung K, Moises T, Lawo JP, Joch C, Veldman A. Safety and pharmacokinetics of a recombinant fusion protein linking coagulation factor VIIa with albumin in healthy volunteers. J Thromb Haemost. 2013 Nov;11(11):1977-85. doi: 10.1111/jth.12409.
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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.
Alex Veldman, M.D. study director
CSL Behring
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rVIIa-FP in people with Healthy, run by CSL Behring at 1 site in Germany.
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 10 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 21 Apr 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 Germany. 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 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.
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?
The frequency of related Adverse Events (AEs) to rVIIa-FP. (time frame: 28 days). The study lists 3 primary outcomes in all. 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 NCT01542619, which also lists 1 linked publication.
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 21 Apr 2017.