Personalized Long-term Human Albumin Treatment in Patients With Decompensated Cirrhosis and Ascites
Sponsor
Aleksander Krag (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05056220
Collaborator
EASL - CLIF Consortium (Other)
240
2
4
28
120
4.3
Study Details
Study Description
Brief Summary
ALB-TRIAL
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A 26-Week Randomized Multicentre, Double-Blinded and Placebo-Controlled, Clinical Trial of Human Albumin in the Treatment of Decompensated Cirrhosis Guided by the MICROB-PREDICT Biomarker
Anticipated Study Start Date
:
Jun 1, 2022
Anticipated Primary Completion Date
:
Sep 1, 2024
Anticipated Study Completion Date
:
Oct 1, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: High expected effect: Human Albumin 20% + Standard Medical Treatment
|
Drug: Human albumin
20%
|
| Placebo Comparator: High expected effect: NaCl 0.9% + Standard Medical Treatment
|
Drug: sodium chloride
0.9%
|
| Active Comparator: Low expected effect: Human Albumin 20% + Standard Medical Treatment
|
Drug: Human albumin
20%
|
| Placebo Comparator: Low expected effect: NaCl 0.9% + Standard Medical Treatment
|
Drug: sodium chloride
0.9%
|
Outcome Measures
Primary Outcome Measures
- Cumulative number of liver-related clinical outcomes [6 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- ...
Exclusion Criteria:
- ...
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Odense University Hospital | Odense | Denmark | 5000 | |
| 2 | Universitätsklinikum Frankfurt | Frankfurt | Germany | 60590 |
Sponsors and Collaborators
- Aleksander Krag
- EASL - CLIF Consortium
Investigators
- Principal Investigator: Aleksander Krag, Professor, Odense University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Aleksander Krag,
Professor,
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT05056220
Other Study ID Numbers:
- ALBTRIALv1.1
- 825694
First Posted:
Sep 24, 2021
Last Update Posted:
Sep 24, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: