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. 2023 Jun 6;2023(6):CD013532. doi: 10.1002/14651858.CD013532.pub2

Morgan 2022.

Study characteristics
Methods Phase II, multicentre, open‐label randomised trial
Participants Country: USA
Period of recruitment: not reported
Number randomised: 34
Postrandomisation dropouts: 0
Revised sample size: 34
Average age (years): not reported
Males: not reported
Decompensated cirrhosis:100%
Alcohol‐related cirrhosis: 100%
Acute‐on‐chronic liver failure: 100%
Alcohol‐related cirrhosis 100%
Viral‐related cirrhosis: 0%
Autoimmune disease‐related cirrhosis: 0%
Other causes of cirrhosis: 0%
Inclusion criteria
  • People with a clinical diagnosis of AH and a Maddrey discriminant function score ≥ 32


Exclusion criteria
  • Not reported

Interventions Experimental
  • Pegfilgrastim* (0.6 mg subcutaneously) on day 1 and day 8, and standard of care


Control
  • Standard medical therapy alone


All participants received standard medical therapy.
Standard medical therapy: prednisolone
*Pegfilgrastim: a long‐acting recombinant G‐CSF
Outcomes Primary outcome
  • Survival at day 90


Secondary outcomes
  • Incidence of acute kidney injury

  • Hepatorenal syndrome

  • Hepatic encephalopathy

  • Infections

Notes Conflicts of interest: no information provided
Funding: no information provided
ClinicalTrials.gov number: NCT02776059
Published only in abstract
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk This open‐label trial randomised participants. No further information was given.
Allocation concealment (selection bias) Unclear risk No information was given.
Blinding of participants and personnel (performance bias)
All outcomes High risk This was an open‐label study.
Blinding of outcome assessment (detection bias)
overall mortality Low risk No information was given, but for the mortality outcome, low risk of bias.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk No information was given.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk All included participants were analysed.
Selective reporting (reporting bias) Unclear risk The trial reported all‐cause mortality as a primary outcome.
Other bias Low risk We found no other bias.