Protocol - The New England Journal of Medicine
Protocol
This trial protocol has been provided by the authors to give readers additional information about their work. Protocol for: Khanna A, English SW, Wang XS, et al. Angiotensin II for the treatment of vasodilatory shock. N Engl J Med 2017;377:419-30. DOI: 10.1056/NEJMoa1704154
Angiotensin II for the Treatment of Vasodilatory Shock
Ashish Khanna, et al.
Protocol and Statistical Analysis Plan
Changes to Listing for the ATHOS-3 Protocol (NCT02338843) ........................... 2 Clinical Study Protocol: LJ501-CRH01 ............................................................................................ 5 Statistical Analysis Plan: LJ501-CRH01.......................................................................................... 62
La Jolla Pharmaceutical Company, Inc. Protocol: LJ501-CRH01
The following are the administrative changes to the trial registration as recorded in ; there were no changes to the ATHOS-3 protocol from inception to completion of the trial. There was a single amendment to the statistical analysis plan (SAP) which occurred prior to study completion and data unblinding. The amendment clarified and aligned the SAP with the protocol and did not involve any changes to the primary or secondary efficacy analyses.
Changes to Listing for the ATHOS-3 Protocol (NCT02338843)
Updated 2015_01_13 2015_01_14 2015_05_04
2015_06_22 2015_07_27 2015_07_30 2015_08_17 2015_08_24 2015_08_31 2015_09_08 2015_09_28 2015_10_13 2015_10_21
Type of Info Changed Nothing (earliest version on record) Protocol, Administrative
Recruitment status, Recruitment, Location/Contact, Misc. Recruitment, Location/Contact, Misc. Recruitment, Location/Contact, Misc. Location/Contact, Misc.
Recruitment, Location/Contact, Misc. Location/Contact, Misc.
Location/Contact, Misc.
Recruitment, Location/Contact, Misc. Recruitment, Location/Contact, Misc. Recruitment, Location/Contact, Misc. Location/Contact, Misc.
Before N/A
After N/A
Blank fields for NCT, blank field for description of placebo
NCT02338843 entered, placebo entered and named 0.9% Sodium Chloride Solution USP
Not yet recruiting, date field set to 2015-01, last release Recruiting, date field set to 2015-05, last release date 2015-
date 2015-01-13
05-01
Recruiting date field set to 2015-05, last release date 2015-05-01
Recruiting date field set to 2015-06, last release date 2015-06-21
Last release date 2015-07-25
Recruiting date field set to 2015-06, last release date 2015-0621
Recruiting date field set to 2015-07, last release date 2015-0725
Last release date 2015-07-29
Recruiting date field set to 2015-07, last release date 2015-07-29
Last release date 2015-08-16
Recruiting date field set to 2015-08, last release date 2015-0816
Last release date 2015-08-21
Last release date 2015-08-21
Last release date 2015-08-29
Recruiting date field set to 2015-08, last release date 2015-08-29
Maximum age field blank, last release date 2015-09-05
Recruiting date field set to 2015-09, last release date 2015-0905
Maximum age field deleted, last release date 2015-09-27
Recruiting date field set to 2015-09, last release date 2015-09-27
Last release date 2015-10-11
Recruiting date field set to 2015-10, last release date 2015-1011
Last release date 2015-10-21
2
La Jolla Pharmaceutical Company, Inc. Protocol: LJ501-CRH01
Updated Type of Info Changed
Before
2015_10_29 Location/Contact, Misc. Last release date 2015-10-21
After Last release date 2015-10-29
2016_01_11 2016_03_02 2016_05_02
Recruitment, Location/Contact, Misc.
Recruitment, Location/Contact, Misc.
Protocol, Recruitment, Location/Contact, Misc.
2016_09_04 Recruitment, Location/Contact, Misc.
2016_12_22
Protocol, Recruitment status, Recruitment, Location/Contact, Misc.
Recruiting date field set to 2015-10, last release date 2015-10-29
Recruiting date field set to 2016-01, last release date 2016-0109
Recruiting date field set to 2016-01, last release date 2016-01-09
Recruiting date field set to 2016-03, last release date 2016-0301
Brief Summary: Catecholamine-resistant hypotension Brief Summary: Catecholamine-resistant hypotension (CRH) is
(CRH) is an often fatal condition resulting from an
an often fatal condition resulting from an underlying cause
underlying cause such as septic shock, blood loss due such as septic shock, inflammation due to trauma, or
to trauma, or severe drug reactions.
severe drug reactions.
Condition: Catecholamine-resistant Hypotension (CRH)
Recruiting date field set to 2016-03, last release date 2016-03-01
Condition: Catecholamine-resistant Hypotension (CRH), distributive shock, high output shock, sepsis
Recruiting date field set to 2016-04, last release date 2016-0430
Recruiting date 2016-04 Last follow-up date (anticipated) 2016-09 Primary completion date (anticipated) 2016-06 Last release date 2016-04-30
Recruiting date 2016-09 Last follow-up date (anticipated) 2017-03 Primary completion date (anticipated) 2016-12 Last release date 2016-09-02
Brief Summary: This is a Phase 3, double-blind,
Brief Summary: This is a Phase 3, double-blind, randomized
randomized study of LJPC-501 (angiotensin II) in adult study of LJPC-501 (angiotensin II) in adult patients diagnosed
patients diagnosed with catecholamine-resistant
with catecholamine-resistant hypotension (CRH) conducted in
hypotension (CRH) conducted in multiple
multiple centers globally.
centers in the United States.
Detailed Description: Catecholamine-resistant hypotension
Detailed Description: Catecholamine-resistant
(CRH) is an often fatal condition resulting from an underlying
hypotension (CRH) is an often fatal condition resulting cause such as septic shock, inflammation due to trauma, or
from an underlying cause such as septic shock,
severe drug reactions. When these conditions occur, most
inflammation due to trauma, or severe drug reactions. patients will respond to either volume expansion or
When these conditions occur, most patients will respond vasopressor treatment. However, some patients will require
to either volume expansion or vasopressor treatment. excessive doses of vasopressors and will be deemed to be
However, 6-7% of patients will require excessive resistant.
doses of vasopressors and will be deemed to be Status: Active, not recruiting
resistant.
Date: 2016-12
Status: Recruiting
Primary outcome measure: An increased MAP, defined as achievement of a Day 1 MAP at 3 hours following the initiation
3
La Jolla Pharmaceutical Company, Inc. Protocol: LJ501-CRH01
Updated Type of Info Changed Date: 2016-09
Before
Primary outcome measure: Increased mean arterial pressure (MAP)
Safety Issue: Yes Secondary Outcome Measure: SOFA Score Safety Issue: Yes Enrollment (anticipated): 315 Last release date 2016-09-02
2017_04_06
Changes submitted and are Overall status: Active, not recruiting
pending
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: December 2016
Enrollment (actual): 345
Last release date 2016-12-22
After of study drug, of 75 mmHg OR a 10 mmHg increase in baseline MAP
Safety Issue: No
Secondary outcome measure: Change in cardiovascular (CV) and total SOFA score at hour 48 Safety Issue: No
Other outcome measure: Mortality at 7 days and 28 days; timeframe Day 7 and Day 28 Safety Issue: No
Other outcome measure: Achievement of MAP 75 mmHg obtained at Hour 1 and Hour 2; timeframe Hour 1 and Hour 2 Safety Issue: No
Other outcome measure: Change in average heart rate between the intervals of Hours 0 to 3, and Hours 3 to 48; timeframe Hours 0 to 3, and Hours 3 to 48 Safety Issue: No
Other outcome measure: Change in vasopressor dosing between Hours 3 and 48; timeframe Between Hours 3 and 48 Safety Issue: No
Enrollment (actual): 345
Last release date 2016-12-22
Overall status: Completed
Study Completion Date: February 18, 2017 [actual]
Primary Completion Date: December 1, 2016 [actual]
Enrollment (actual): 344
Last release date 2017-04-06;
Details are not provided for non-essential changes, ie contact info, locations, etc.
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