NCT01499420

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 26, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

February 6, 2014

Status Verified

January 1, 2014

Enrollment Period

10 months

First QC Date

December 19, 2011

Last Update Submit

January 8, 2014

Conditions

Stable Atherothrombotic Disease

Outcome Measures

Primary Outcomes (2)

  • Safety

    The frequency of study product-related adverse events

    14 days

  • Clinically significant elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST)

    Number of subjects with clinically significant elevation of ALT or AST

    14 days

Secondary Outcomes (4)

  • Pharmacokinetic profile of apolipoprotein A-I (apoA-I)

    9 days

  • Plasma apoA-I area under the curve (AUC)

    9 days

  • Plasma apoA-I Cmax

    9 days

  • Plasma apoA-I Tmax

    9 days

Study Arms (2)

CSL112

EXPERIMENTAL
Biological: CSL112 (reconstituted high density lipoprotein)

Placebo

PLACEBO COMPARATOR
Biological: Placebo

Interventions

CSL112 (reconstituted high density lipoprotein)BIOLOGICAL

Single escalating intravenous doses of CSL112

CSL112
PlaceboBIOLOGICAL

Single intravenous doses of normal saline (0.9%)

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Study Site

Chula Vista, California, 91911, United States

Location

Study Site

Jacksonville, Florida, 32209, United States

Location

Study Site

Miami, Florida, 33126, United States

Location

Study Site

Lexington, Kentucky, 40536, United States

Location

Study Site

Madisonville, Kentucky, 42431, United States

Location

Study Site

Auburn, Maine, 04210, United States

Location

Study Site

Baltimore, Maryland, 21215, United States

Location

Study Site

Petoskey, Michigan, 49770, United States

Location

Study Site

Durham, North Carolina, 27710, United States

Location

Study Site

Philadelphia, Pennsylvania, 19104, United States

Location

Study Site

Rapid City, South Dakota, 57701, United States

Location

Related Publications (2)

  • 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.

    PMID: 33217027DERIVED

  • Tricoci 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.

    PMID: 26307570DERIVED

MeSH Terms

Interventions

CSL112

Study Officials

  • Dr. Denise D'Andrea

    CSL Limited

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2011

First Posted

December 26, 2011

Study Start

February 1, 2012

Primary Completion

December 1, 2012

Study Completion

March 1, 2013

Last Updated

February 6, 2014

Record last verified: 2014-01

Locations

US(11)