Hereditary Angioedema Types I and IIPhase 1NCT01760343
A Study to Evaluate the Safety and Pharmacokinetics of Two Formulations of C1-esterase Inhibitor
A Phase 1 study testing Berinert and CSL830 in people with Hereditary Angioedema Types I and II, run by CSL Behring at 1 site in Germany.
Trial summary
A new formulation of Berinert (CSL830) is being investigated for the management of hereditary angioedema (HAE). The main aim of the study is to assess the safety of a single 1500 IU dose of the new formulation of Berinert. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hereditary Angioedema Types I and II
- What is being tested?
- Berinert and CSL830
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2013to Mar 2013
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects without clinically significant medical conditions or laboratory abnormalities
- Male or female subjects aged 18 to 45 years inclusive, at the time of informed consent
- Non-smokers
- Body mass index of 18.0 to 29.0 kg/m2 inclusive
Who cannot join
- Previous history of clinically significant arterial or venous thrombosis, current history of a clinically significant pro-thrombotic risk, or a clinically significant abnormality on laboratory thrombotic screen at the screening visit.
- Known or suspected hypersensitivity to the investigational medicinal product (IMP), or to any excipients of the IMP.
- Female subjects who started taking or changed dose of any hormonal contraceptive regimen or hormone replacement therapy (ie, estrogen/progesterone containing products) within 3 months before the screening visit.
- Alcohol, drug, or medication abuse within one year before the study.
- Female subjects of childbearing potential (eg, not post-menopausal) either not using, or not willing to use, a medically reliable method of contraception for the entire duration of the study, or have a vasectomized partner, or not sexually abstinent for the entire duration of the study, or not surgically sterile.
- Participation in another clinical study (or use of another IMP) within 30 days (or 5 times the half-life, whichever is longer) before, or during, the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Single-center, Cross-over Study to Evaluate the Safety, Bioavailability and Pharmacokinetics of Two Formulations of C1-esterase Inhibitor Administered Intravenously
A new formulation of Berinert (CSL830) is being investigated for the management of hereditary angioedema (HAE). The main aim of the study is to assess the safety of a single 1500 IU dose of the new formulation of Berinert. This study will also look at the pharmacokinetics of CSL830 relative to Berinert currently on the market.
- Conditions
- Hereditary Angioedema Types I and II
- Being tested
- Berinert, CSL830
- Medical subject headings
- Hereditary Angioedema Types I and II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BerinertBiological
Berinert is a plasma-derived C1 esterase inhibitor (human), supplied as a freeze-dried powder for reconstitution.
CSL830Biological
CSL830 is a formulation of Berinert.
| Study group | Role | What they receive |
|---|---|---|
| Berinert, then CSL830 | Experimental | A single intravenous dose of Berinert at 1500 units (1500 IU), followed by a single intravenous dose of CSL830 at 1500 IU. Receives: Biological: Berinert; Biological: CSL830 |
| CSL830, then Berinert | Experimental | A single intravenous dose of CSL830 at 1500 IU, followed by a single intravenous dose of Berinert at 1500 IU. Receives: Biological: Berinert; Biological: CSL830 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs) within 24 hours of CSL830 infusion
Measured: From the start of infusion to 24 hours after the end of infusion
Secondary outcomes (3)
Incidence of adverse events (AEs) within 10 days of the CSL830 infusion
Measured: From the start of infusion to 10 days after the infusion
Relative bioavailability of CSL830 versus Berinert - Cmax
Relative bioavailability in terms of maximum concentration (Cmax) of CSL830 versus Berinert
Measured: 240 hours
Relative bioavailability of CSL830 versus Berinert - AUC
Relative bioavailability in terms of area under the curve from timepoint 0 to infinity (AUC0-∞) of CSL830 versus Berinert
Measured: 240 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary Angioedema Types I and IIStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Program Director, Study director, CSL Behring
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01760343
- Sponsor's protocol ID
- CSL830_1001
- Other IDs
- 2012-002429-31
- Status last verified
- Apr 2013
- First submitted
- 24 Dec 2012
- Last updated
- 5 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Single-center, Cross-over Study to Evaluate the Safety, Bioavailability and Pharmacokinetics of Two Formulations of C1-esterase Inhibitor Administered Intravenously
- ClinicalTrials.gov ID
- NCT01760343
- Acronym / sponsor ID
- CSL830_1001
- Conditions
- Hereditary Angioedema Types I and II
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 4 Jan 2013 (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 new formulation of Berinert (CSL830) is being investigated for the management of hereditary angioedema (HAE). The main aim of the study is to assess the safety of a single 1500 IU dose of the new formulation of Berinert. This study will also look at the pharmacokinetics of CSL830 relative to Berinert currently on the market.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Berinert, then CSL830 | Experimental | Biological: Berinert, Biological: CSL830A single intravenous dose of Berinert at 1500 units (1500 IU), followed by a single intravenous dose of CSL830 at 1500 IU. |
| CSL830, then Berinert | Experimental | Biological: Berinert, Biological: CSL830A single intravenous dose of CSL830 at 1500 IU, followed by a single intravenous dose of Berinert at 1500 IU. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy subjects without clinically significant medical conditions or laboratory abnormalities
- Male or female subjects aged 18 to 45 years inclusive, at the time of informed consent
- Non-smokers
- Body mass index of 18.0 to 29.0 kg/m2 inclusive
Key exclusion criteria (6 listed)
- Previous history of clinically significant arterial or venous thrombosis, current history of a clinically significant pro-thrombotic risk, or a clinically significant abnormality on laboratory thrombotic screen at the screening visit.
- Known or suspected hypersensitivity to the investigational medicinal product (IMP), or to any excipients of the IMP.
- Female subjects who started taking or changed dose of any hormonal contraceptive regimen or hormone replacement therapy (ie, estrogen/progesterone containing products) within 3 months before the screening visit.
- Alcohol, drug, or medication abuse within one year before the study.
- Female subjects of childbearing potential (eg, not post-menopausal) either not using, or not willing to use, a medically reliable method of contraception for the entire duration of the study, or have a vasectomized partner, or not sexually abstinent for the entire duration of the study, or not surgically sterile.
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 |
|---|---|---|
| BerinertBerinert is a plasma-derived C1 esterase inhibitor (human), supplied as a freeze-dried powder for reconstitution. | Biological | Berinert, then CSL830, CSL830, then Berinert |
| CSL830CSL830 is a formulation of Berinert. | Biological | Berinert, then CSL830, CSL830, then Berinert |
Primary outcome
Incidence of adverse events (AEs) within 24 hours of CSL830 infusion
Time frame: From the start of infusion to 24 hours after the end of infusion
3 secondary outcomes
Incidence of adverse events (AEs) within 10 days of the CSL830 infusion
Time frame: From the start of infusion to 10 days after the infusion
Relative bioavailability of CSL830 versus Berinert - Cmax
Time frame: 240 hours
Relative bioavailability of CSL830 versus Berinert - AUC
Time frame: 240 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 5 Apr 2013.
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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.
Global Clinical Program Director 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 Berinert and CSL830 in people with Hereditary Angioedema Types I and II, 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 6 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 5 Apr 2013. 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. 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?
Incidence of adverse events (AEs) within 24 hours of CSL830 infusion (time frame: From the start of infusion to 24 hours after the end of infusion). 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 5 Apr 2013.