Stable Atherothrombotic DiseasePhase 2NCT01499420
A Single Ascending Dose Study Examining the Safety and Pharmacokinetic Profile of Reconstituted High Density Lipoprotein (CSL112) Administered to Patients
A Phase 2 study testing CSL112 (reconstituted high density lipoprotein) in people with Stable Atherothrombotic Disease, run by CSL Limited at 11 sites in United States.
Trial summary
Reconstituted high density lipoprotein used in patients with acute coronary syndrome (ACS) may reduce atherosclerotic plaque burden, thereby reducing the risk of recurrent cardiovascular events. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stable Atherothrombotic Disease
- What is being tested?
- CSL112 (reconstituted high density lipoprotein)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 11 sitesUnited States
- Study dates
- Feb 2012to Mar 2013
- Phase
- Phase 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18 years to 80 years.
- Subjects must have documented evidence of a history of atherosclerotic coronary artery disease/surgical revascularization.
- Subjects on a stable medication regimen.
- Body weight 50 kg or greater at screening.
Who cannot join
- Moderate/severe heart failure or renal impairment.
- Uncontrolled hyperglycemia in subjects with type 1 or type 2 diabetes.
- Receipt of the combination of omeprazole and clopidogrel within 1 month of randomization.
- Subjects whose medical history, condition or medication regimen may interfere with the evaluation of the safety and tolerability of CSL112 (for example significantly altered electrocardiogram (ECG) waveform, hepatobiliary disease, malignancy, thrombocytopenia, etc.)
- Known hypersensitivity to the product components
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Study Site
Auburn, Maine, 04210
Study Site
Baltimore, Maryland, 21215
Study Site
Chula Vista, California, 91911
Study Site
Durham, North Carolina, 27710
Study Site
Jacksonville, Florida, 32209
Study Site
Lexington, Kentucky, 40536
Study Site
Madisonville, Kentucky, 42431
Study Site
Miami, Florida, 33126
Study Site
Petoskey, Michigan, 49770
Study Site
Philadelphia, Pennsylvania, 19104
Study Site
Rapid City, South Dakota, 57701
About this study
Official title: A Phase 2a, Multi-center, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of a Single Intravenous Infusion of CSL112 in Patients With Stable Atherothrombotic Disease
Reconstituted high density lipoprotein used in patients with acute coronary syndrome (ACS) may reduce atherosclerotic plaque burden, thereby reducing the risk of recurrent cardiovascular events. This study is a multi-center, randomized, placebo-controlled, single ascending dose study in patients with stable atherothrombotic disease in whom the safety and pharmacokinetic profile of CSL112 will be assessed.
- Conditions
- Stable Atherothrombotic Disease
- Being tested
- CSL112 (reconstituted high density lipoprotein), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSL112 (reconstituted high density lipoprotein)Biological
Single escalating intravenous doses of CSL112
PlaceboBiological
Single intravenous doses of normal saline (0.9%)
| Study group | Role | What they receive |
|---|---|---|
| CSL112 | Experimental | Not described Receives: Biological: CSL112 (reconstituted high density lipoprotein) |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
The frequency of study product-related adverse events
Measured: 14 days
Clinically significant elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
Number of subjects with clinically significant elevation of ALT or AST
Measured: 14 days
Secondary outcomes (4)
Pharmacokinetic profile of apolipoprotein A-I (apoA-I)
Plasma apoA-I concentration with and without baseline correction
Measured: 9 days
Plasma apoA-I area under the curve (AUC)
Measured: 9 days
Plasma apoA-I Cmax
Measured: 9 days
Plasma apoA-I Tmax
Measured: 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
- Study startFeb 2012
- Primary completionDec 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stable Atherothrombotic DiseaseStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Denise D'Andrea, Study director, CSL Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01499420
- Sponsor's protocol ID
- CSLCT-HDL-10-70a
- Status last verified
- Jan 2014
- First submitted
- 19 Dec 2011
- Last updated
- 6 Feb 2014
- Results posted
- No
Publications
Zheng B, Duffy D, Tricoci P, Kastrissios H, Pfister M, Wright SD, Gille A, Tortorici MA. Pharmacometric analyses to characterize the effect of CSL112 on apolipoprotein A-I and cholesterol efflux capacity in acute myocardial infarction patients. Br J Clin Pharmacol. 2021 Jun;87(6):2558-2571. doi: 10.1111/bcp.14666. Epub 2020 Dec 23.
PubMed 33217027Tricoci P, D'Andrea DM, Gurbel PA, Yao Z, Cuchel M, Winston B, Schott R, Weiss R, Blazing MA, Cannon L, Bailey A, Angiolillo DJ, Gille A, Shear CL, Wright SD, Alexander JH. Infusion of Reconstituted High-Density Lipoprotein, CSL112, in Patients With Atherosclerosis: Safety and Pharmacokinetic Results From a Phase 2a Randomized Clinical Trial. J Am Heart Assoc. 2015 Aug 25;4(8):e002171. doi: 10.1161/JAHA.115.002171.
PubMed 26307570
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Multi-center, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of a Single Intravenous Infusion of CSL112 in Patients With Stable Atherothrombotic Disease
- ClinicalTrials.gov ID
- NCT01499420
- Acronym / sponsor ID
- CSLCT-HDL-10-70a
- Conditions
- Stable Atherothrombotic Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- CSL LimitedIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 26 Dec 2011 (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.
Reconstituted high density lipoprotein used in patients with acute coronary syndrome (ACS) may reduce atherosclerotic plaque burden, thereby reducing the risk of recurrent cardiovascular events. This study is a multi-center, randomized, placebo-controlled, single ascending dose study in patients with stable atherothrombotic disease in whom the safety and pharmacokinetic profile of CSL112 will be assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSL112 | Experimental | Biological: CSL112 (reconstituted high density lipoprotein) |
| Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female aged 18 years to 80 years.
- Subjects must have documented evidence of a history of atherosclerotic coronary artery disease/surgical revascularization.
- Subjects on a stable medication regimen.
- Body weight 50 kg or greater at screening.
Key exclusion criteria (5 listed)
- Moderate/severe heart failure or renal impairment.
- Uncontrolled hyperglycemia in subjects with type 1 or type 2 diabetes.
- Receipt of the combination of omeprazole and clopidogrel within 1 month of randomization.
- Subjects whose medical history, condition or medication regimen may interfere with the evaluation of the safety and tolerability of CSL112 (for example significantly altered electrocardiogram (ECG) waveform, hepatobiliary disease, malignancy, thrombocytopenia, etc.)
- Known hypersensitivity to the product components
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 |
|---|---|---|
| CSL112 (reconstituted high density lipoprotein)Single escalating intravenous doses of CSL112 | Biological | CSL112 |
| PlaceboSingle intravenous doses of normal saline (0.9%) | Biological | Placebo |
Primary outcome
Safety
Time frame: 14 days
The frequency of study product-related adverse events
Clinically significant elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
Time frame: 14 days
Number of subjects with clinically significant elevation of ALT or AST
4 secondary outcomes
Pharmacokinetic profile of apolipoprotein A-I (apoA-I)
Time frame: 9 days
Plasma apoA-I area under the curve (AUC)
Time frame: 9 days
Plasma apoA-I Cmax
Time frame: 9 days
Plasma apoA-I Tmax
Time frame: 9 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 6 Feb 2014.
- Derived from this study: PubMed 33217027Zheng B, Duffy D, Tricoci P, Kastrissios H, Pfister M, Wright SD, Gille A, Tortorici MA. Pharmacometric analyses to characterize the effect of CSL112 on apolipoprotein A-I and cholesterol efflux capacity in acute myocardial infarction patients. Br J Clin Pharmacol. 2021 Jun;87(6):2558-2571. doi: 10.1111/bcp.14666. Epub 2020 Dec 23.
- Derived from this study: PubMed 26307570Tricoci P, D'Andrea DM, Gurbel PA, Yao Z, Cuchel M, Winston B, Schott R, Weiss R, Blazing MA, Cannon L, Bailey A, Angiolillo DJ, Gille A, Shear CL, Wright SD, Alexander JH. Infusion of Reconstituted High-Density Lipoprotein, CSL112, in Patients With Atherosclerosis: Safety and Pharmacokinetic Results From a Phase 2a Randomized Clinical Trial. J Am Heart Assoc. 2015 Aug 25;4(8):e002171. doi: 10.1161/JAHA.115.002171.
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.
Dr. Denise D'Andrea study director
CSL Limited
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CSL112 (reconstituted high density lipoprotein) in people with Stable Atherothrombotic Disease, run by CSL Limited at 11 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 4 inclusion and 5 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 6 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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. 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 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 (time frame: 14 days). 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?
On the ClinicalTrials.gov record for NCT01499420, which also lists 2 linked publications.
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 6 Feb 2014.