Trial reportContemporary clinical trials2013
Incidence and clinical significance of elevated liver function tests in cystic fibrosis clinical trials.
Trial report in Contemporary clinical trials, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed.
- Decoding liver injury in cystic fibrosis: How to tell drug-induced liver injury from cystic fibrosis liver disease.World journal of gastroenterology · 2026Review
- Potential implicit bias in attribution of adverse events in randomized controlled trials in cystic fibrosis.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2023Article
- Rates of adverse and serious adverse events in children with cystic fibrosis.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2021Article
- Cystic fibrosis liver disease: A condition in need of structured transition and continuity of care.Canadian liver journal · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
rationaleEmergence of elevated liver function tests (LFTs) during a clinical trial may be due to underlying disease factors of the participants, thus cofounding safety assessments of therapies. Limited data exist addressing the frequency of elevated LFTs in the chronic disease setting of cystic fibrosis (CF). The objectives of this study were to characterize emergence rates of elevated LFTs in CF trials and their association with clinical outcomes.
methodsThe cohort was comprised of participants of three completed multicenter CF trials. LFTs were collected as safety endpoints, and hospitalization rates and changes in pulmonary function and weight were used to assess the association between elevated LFTs and clinical outcome.
results93/376 (25%) participants had ≥1 emergent elevated LFT exceeding the normal reference range over an average 8.3 month follow-up, and only 12/93 (13%) had a value determined by the physician as clinically significant. The emergence of an elevated LFT was not significantly associated with a greater rate of decline in pulmonary function or weight as compared to participants with normal LFTs. The emergence of an elevated LFT value was however associated with a higher hospitalization risk (relative risk:1.67, 95% confidence interval:1.11, 2.53).
conclusionsElevated LFTs are common among CF trials, although in most cases they are not deemed clinically significant. These elevated LFTs are associated with more frequent hospitalizations, but additional studies are needed to determine the causality of this association. Therapeutic trials in CF must define a priori criteria for clinical significance of elevated LFTs to enable unbiased safety assessments.
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