Last updated: 11/02/2026 03:50:21
Study To Assess Real-world disease proGression, Abstinence and drinking tRajectories in Alcohol-related liver disease (STARGAZER)
GSK study ID
307803
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Planned
Planned
Trial overview
Official title: Study To Assess Real world disease proGression, Abstinence and drinking tRajectories in Alcohol related liver disease (STARGAZER)
Trial description: Observational study in ALD to understand natural history and roles of biomarkers including liver stiffness.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Time to First Occurrence of Liver Decompensation and All-cause Mortality Composite Endpoint
Timeframe: Up to 48 months
Secondary outcomes:
Time to First Occurrence of Supportive Extended Liver-event Composite Endpoint And its Composite Component
Timeframe: Up to 48 months
Time to First Occurrence of Comprehensive Liver-Related Event Composite Endpoint and its Composite Component
Timeframe: Up to 48 months
Longitudinal Changes in Alcohol Consumption
Timeframe: Up to 48 months
Longitudinal changes in non-invasive tests and laboratory measures
Timeframe: Up to 48 months
Interventions:
Not applicable
Enrollment:
1200
Primary completion date:
2030-10-12
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Liver Diseases, Alcoholic
Product
Not applicable
Collaborators
Not applicable
Study date(s)
February 2027 to December 2030
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 75 Years
Accepts healthy volunteers
No
- History of chronic heavy alcohol consumption for greater than (>) 6 months prior to screening.
- Advanced Chronic Liver Disease (ACLD) defined by Vibration-Controlled Transient Elastography Liver Stiffness Measurement (VCTE-LSM) measurement greater than or equal to (>=)10 kilopascal (kPa).
- Diagnosis of liver disease is not primarily driven by heavy alcohol consumption.
- Significant medical comorbidity/ies associated with a life expectancy of less than 3 months, as determined by treating physicians at enrollment date.
Inclusion and exclusion criteria
Inclusion criteria:
- Advanced Chronic Liver Disease (ACLD) defined by Vibration-Controlled Transient Elastography Liver Stiffness Measurement (VCTE-LSM) measurement greater than or equal to (>=)10 kilopascal (kPa).
- Able and willing to comply with study procedures and provide informed consent.
History of chronic heavy alcohol consumption for greater than (>) 6 months prior to screening.
Exclusion criteria:
- Significant medical comorbidity/ies associated with a life expectancy of less than 3 months, as determined by treating physicians at enrollment date.
- Use of medications that may confound steatohepatitis assessment.
- Psychosocial or other conditions that may impair study participation or compliance.
Diagnosis of liver disease is not primarily driven by heavy alcohol consumption.
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Planned
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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