Hereditary AngioedemaPhase 1NCT00432510
Pharmacokinetics of C1 Esterase Inhibitor in Hereditary Angioedema Subjects
A Phase 1 study testing C1 esterase inhibitor [human] (C1INH-nf) in people with Hereditary Angioedema, run by Shire at 6 sites in United States.
Trial summary
The study objective was to describe the pharmacokinetics (PK) of one or two doses of C1 esterase inhibitor (C1INH-nf) in hereditary angioedema (HAE) subjects who were not experiencing an HAE attack. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hereditary Angioedema
- What is being tested?
- C1 esterase inhibitor [human] (C1INH-nf)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 6 sitesUnited States
- Study dates
- 9 Oct 2006to 28 Feb 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enrolled in LEVP2005-1 (current or in the past)
Who cannot join
- C1 inhibitor infusion within the last 7 days
- Signs of any HAE attack
- HAE attack within 7 days before actual infusion of C1INH-nf
- Change in the dosage of androgens in the last 14 days before the study
- Use of antifibrinolytics in the last 7 days before the study
- Change in oral conceptive medication in the last two months before the study
Show all 14Show fewer
- History of clinically relevant antibody development to C1 inhibitor
- Use of oral anticoagulant medication in the last 14 days
- Use of heparin within the last two days prior to the study
- History of allergic reaction to C1 inhibitor or other blood products
- Current participation (or within the past 90 days) in any investigational drug study other than those sponsored by Lev Pharmaceuticals
- Pregnancy or lactation
- B-cell malignancy
- Any clinically significant medical condition, such as renal failure, that in the opinion of the investigator would interfere with the subject's ability to participate in the study
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Family Allergy and Asthma Center
Atlanta, Georgia, 30342
AARA Research Center
Dallas, Texas, 75231
Penn State University
Hershey, Pennsylvania, 17033
University of California, San Diego
San Diego, California, 92093-0732
Allergy and Asthma Clinical Research, Inc.
Walnut Creek, California, 94598
Institute for Asthma and Allergy
Wheaton, Maryland, 20902
About this study
Official title: Protocol LEVP2006-5: Pharmacokinetics of C1INH-nf in Hereditary Angioedema Subjects
The study objective was to describe the pharmacokinetics (PK) of one or two doses of C1 esterase inhibitor (C1INH-nf) in hereditary angioedema (HAE) subjects who were not experiencing an HAE attack.
- Conditions
- Hereditary Angioedema
- Being tested
- C1 esterase inhibitor [human] (C1INH-nf)
- Keywords
- Hereditary angioedema, C1 esterase inhibitor (human)
- Medical subject headings
- Angioedemas, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C1 esterase inhibitor [human] (C1INH-nf)Drug
| Study group | Role | What they receive |
|---|---|---|
| Single Dose | Experimental | 1,000 Units (U) of C1INH-nf administered intravenously (IV). Receives: Drug: C1 esterase inhibitor [human] (C1INH-nf) |
| First Dose Followed by Second Dose | Experimental | 1,000 U of C1INH-nf administered IV, followed by a second 1,000 U dose 60 minutes later. Receives: Drug: C1 esterase inhibitor [human] (C1INH-nf) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK will be analyzed by means of incremental recovery, in vivo half-life, area under the curve, clearance, and mean residence time.
Measured: 1 week
C1 inhibitor (functional and antigenic) and C4 antigen serum levels will be measured at a United States Clinical Laboratory Improvement Amendments-certified laboratory and the research division of Sanquin Blood Supply Foundation.
Measured: 1 week
Secondary outcomes (3)
Number and severity of adverse events.
Measured: 3 months
Change in clinical laboratory safety parameters from pre- to post-infusion.
Measured: 3 months
Change in vital signs from pre- to post-infusion.
Measured: 30 minutes (Single Dose), 90 minutes (First Dose Followed by Second Dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2007 (estimated)
- Study start9 Oct 2006
- Primary completion28 Feb 2007
- Study completion28 Feb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary AngioedemaStudies 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00432510
- Sponsor's protocol ID
- LEVP2006-5
- Status last verified
- May 2021
- First submitted
- 7 Feb 2007
- Last updated
- 3 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol LEVP2006-5: Pharmacokinetics of C1INH-nf in Hereditary Angioedema Subjects
- ClinicalTrials.gov ID
- NCT00432510
- Acronym / sponsor ID
- LEVP2006-5
- Conditions
- Hereditary Angioedema
- Keywords
- Hereditary angioedema, C1 esterase inhibitor (human)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2006 (actual)
- Primary completion
- 28 Feb 2007 (actual)
- Study completion
- 28 Feb 2007 (actual)
- First posted
- 8 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 study objective was to describe the pharmacokinetics (PK) of one or two doses of C1 esterase inhibitor (C1INH-nf) in hereditary angioedema (HAE) subjects who were not experiencing an HAE attack.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Dose | Experimental | Drug: C1 esterase inhibitor [human] (C1INH-nf)1,000 Units (U) of C1INH-nf administered intravenously (IV). |
| First Dose Followed by Second Dose | Experimental | Drug: C1 esterase inhibitor [human] (C1INH-nf)1,000 U of C1INH-nf administered IV, followed by a second 1,000 U dose 60 minutes later. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Enrolled in LEVP2005-1 (current or in the past)
Key exclusion criteria (14 listed)
- C1 inhibitor infusion within the last 7 days
- Signs of any HAE attack
- HAE attack within 7 days before actual infusion of C1INH-nf
- Change in the dosage of androgens in the last 14 days before the study
- Use of antifibrinolytics in the last 7 days before the study
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 |
|---|---|---|
| C1 esterase inhibitor [human] (C1INH-nf) | Drug | First Dose Followed by Second Dose, Single Dose |
Primary outcome
PK will be analyzed by means of incremental recovery, in vivo half-life, area under the curve, clearance, and mean residence time.
Time frame: 1 week
C1 inhibitor (functional and antigenic) and C4 antigen serum levels will be measured at a United States Clinical Laboratory Improvement Amendments-certified laboratory and the research division of Sanquin Blood Supply Foundation.
Time frame: 1 week
3 secondary outcomes
Number and severity of adverse events.
Time frame: 3 months
Change in clinical laboratory safety parameters from pre- to post-infusion.
Time frame: 3 months
Change in vital signs from pre- to post-infusion.
Time frame: 30 minutes (Single Dose), 90 minutes (First Dose Followed by Second Dose)
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 3 Jun 2021.
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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.
Study Director study director
Takeda
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing C1 esterase inhibitor [human] (C1INH-nf) in people with Hereditary Angioedema, run by Shire at 6 sites 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 1 inclusion and 14 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 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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.
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?
PK will be analyzed by means of incremental recovery, in vivo half-life, area under the curve, clearance, and mean residence time. (time frame: 1 week). The study lists 2 primary outcomes in all. 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 3 Jun 2021.