Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001081101p
Ethics application status
Not yet submitted
Date submitted
16/07/2019
Date registered
6/08/2019
Date last updated
6/08/2019
Date data sharing statement initially provided
6/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Concentrated Albumin Prior to Rescue Infliximab (CAPRI) in Acute Severe Ulcerative Colitis (ASUC)
Scientific title
Pharmacokinetic impact of concentrated Albumin Prior to Rescue Infliximab (CAPRI) in Acute Severe Ulcerative Colitis (ASUC)
Secondary ID [1] 298740 0
nil known
Universal Trial Number (UTN)
Trial acronym
CAPRI in ASUC
Linked study record
not applicable

Health condition
Health condition(s) or problem(s) studied:
Ulcerative colitis 313669 0
Inflammatory Bowel Disease 313670 0
Condition category
Condition code
Oral and Gastrointestinal 312084 312084 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intravenous infusion of 2 x100mls concentrated albumin (20%)as single administration immediately prior to rescue infliximab (either 5mg/kg or 10mg/kg [if endoscopic mayo score 3 and CRP:Albumin ratio >1 at time of rescue]) versus placebo (saline)
Intervention code [1] 315006 0
Treatment: Drugs
Comparator / control treatment
Control group: infusion of saline prior to infliximab
Control group
Placebo

Outcomes
Primary outcome [1] 320730 0
Pharmacokinetics of Infliximab (Area under curve) following administration, with serial serum measurements of drug level post infusion
Timepoint [1] 320730 0
Every 12 hours following administration for initial 72 hours and then daily until discharge
Secondary outcome [1] 372626 0
Proportion of patients requiring a Colectomy as assessed by medical records
Timepoint [1] 372626 0
30 days post intervention and 90 days post intervention
Secondary outcome [2] 372629 0
Infliximab stool loss measured by collection of daily stool
Timepoint [2] 372629 0
7 days post intervention
Secondary outcome [3] 372630 0
Brambell (neonatal) receptor saturation measured by serum assay
Timepoint [3] 372630 0
7 days post intervention
Secondary outcome [4] 372631 0
Time to next infliximab infusion assessed by medical records
Timepoint [4] 372631 0
Time in days from administration of Albumin/placebo to next infliximab infusion
Secondary outcome [5] 372634 0
Time to CRP normalization measured by serial serum measurements
Timepoint [5] 372634 0
Time in days from 1st infusion of infliximab
Secondary outcome [6] 372635 0
Serum albumin change
Timepoint [6] 372635 0
Daily assessment following first infusion

Eligibility
Key inclusion criteria
A) Inpatients with Acute Severe Ulcerative Colitis (ASUC)

B) Refractory to IV steroids, requiring rescue Infliximab (IFX), as defined by the Oxford index

C) Hypoalbuminaemia (serum albumin < 30 at time of IFX rescue)

D) Naïve to infliximab
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Not fulfilling Truelove Witts Criteria for ASUC
2. Normal albumin level at time of IFX rescue
3. IV steroid responders
4. IBD-U which, during follow-up, is diagnosed as Crohn’s colitis
5. Prior IFX exposure
6. Positive stool for C.Difficile
7. Toxic megacolon

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis
Difference in area under curve

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2019
Actual
Date of last participant enrolment
Anticipated
1/10/2021
Actual
Date of last data collection
Anticipated
1/04/2022
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 14224 0
The Alfred - Prahran
Recruitment hospital [2] 14225 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 27217 0
3004 - Prahran
Recruitment postcode(s) [2] 27218 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 303297 0
Hospital
Name [1] 303297 0
Alfred Hospital
Country [1] 303297 0
Australia
Primary sponsor type
Hospital
Name
Alfred Hospital
Address
55 Commercial Road,
Melbourne
VIC 3004
Country
Australia
Secondary sponsor category [1] 303419 0
None
Name [1] 303419 0
Address [1] 303419 0
Country [1] 303419 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 303828 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 303828 0
Alfred Hospital
55 Commercial Road,
Melbourne
VIC 3004
Ethics committee country [1] 303828 0
Australia
Date submitted for ethics approval [1] 303828 0
28/08/2019
Approval date [1] 303828 0
Ethics approval number [1] 303828 0

Summary
Brief summary
Double blinded randomized controlled trial (RCT) comparing administration of IV albumin versus placebo prior to rescue infliximab in Acute Severe Ulcerative Colitis (ASUC). We hypothesise that administration of intravenous albumin prior to rescue infliximab will increase serum albumin levels and the amount of IFX that is protein-bound, therefore reducing IFX clearance and increasing drug exposure and efficacy.
Trial website
not applicable
Trial related presentations / publications
not applicable
Public notes
not applicable

Contacts
Principal investigator
Name 94954 0
Dr David Gibson
Address 94954 0
Alfred Hospital,
55 Commercial Road,
Melbourne,
VIC 3004
Country 94954 0
Australia
Phone 94954 0
+61 0390767258
Fax 94954 0
Email 94954 0
[email protected]
Contact person for public queries
Name 94955 0
David Gibson
Address 94955 0
Alfred Hospital,
55 Commercial Road,
Melbourne,
VIC 3004
Country 94955 0
Australia
Phone 94955 0
+61 0390767258
Fax 94955 0
Email 94955 0
[email protected]
Contact person for scientific queries
Name 94956 0
David Gibson
Address 94956 0
Alfred Hospital,
55 Commercial Road,
Melbourne,
VIC 3004
Country 94956 0
Australia
Phone 94956 0
+61 0390767258
Fax 94956 0
Email 94956 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.