AEGIS-I, Phase II, dose ranging study of CSL112 in Acute MI
Research type
Research Study
Full title
A Phase 2b, Multi-center, Randomized, Placebo-controlled, Dose-ranging Study to Investigate the Safety and Tolerability of Multiple Dose Administration of CSL112 in Subjects with Acute Myocardial Infarction
IRAS ID
149697
Contact name
Anthony Gershlick
Contact email
Sponsor organisation
CSL Behring LLC (CSL)
Eudract number
2013-003458-26
ISRCTN Number
NA
Clinicaltrials.gov Identifier
NA
Research summary
CSL112 is being developed for use in patients who have experienced a Myocardial Infarction (MI or heart attack) for the reduction in risk of further heart-related problems (referred to as cardiovascular (CV) events), for example developing unstable angina or experiencing a further heart attack.
Even after recovery from a heart attack, patients continue to be at heightened risk. Effective and safe therapies that provide clinically important reductions in further CV events are needed for patients who have experienced a heart attack.
Before patients are enrolled in the main study, a safety lead-in period will be conducted, with a minimum of 8 participants. Data from the safety lead-in period will be provided to a Data Safety Monitoring Board (DSMB) for review. Based on this data, the DSMB will make a recommendation as to whether or not the main study may proceed.
The main study will investigate the safety and tolerability of multiple dose administration of two dose levels of CSL112 (low dose [2 g] or high dose [6 g]) compared with placebo in patients with acute myocardial infarction (AMI).
The minimum duration of the main study for an individual patient is expected to be approximately 112 days (16 weeks). The maximum duration for an individual patient is expected to be approximately 382 days (57 weeks). This estimation is based on:
- A 7-day screening period
- A 4-week treatment period: Treatment will be administered as a 2 hour IV infusion once weekly for 4 consecutive weeks (4 infusions in total).
- A minimum 12-week / maximum 52-week Major Adverse Cardiac events (MACE) follow-up period.REC name
East Midlands - Derby Research Ethics Committee
REC reference
14/EM/0160
Date of REC Opinion
9 May 2014
REC opinion
Favourable Opinion