Trial reportJournal of translational medicine2011
Safety and pharmacokinetics of recombinant human hepatocyte growth factor (rh-HGF) in patients with fulminant hepatitis: a phase I/II clinical trial, following preclinical studies to ensure safety.
Trial report in Journal of translational medicine, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers.
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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.
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Who cites it
32 citing papers in PubMed, 63 citations in OpenAlex.
- Clinical immunogenicity and pharmacokinetic assessments of E3112, a recombinant human hepatocyte growth factor.Future science OA · 2026Article
- Serum Hepatocyte Growth Factor Predicts Outcomes in Non-Acetaminophen Drug-Induced Acute Liver Failure.Liver international : official journal of the International Association for the Study of the Liver · 2026Article
- Modulating Renal Fibrosis: The Emerging Role of Hepatocyte Growth Factor.International journal of nephrology · 2026Review
- Article
- Role of mitogens in normal and pathological liver regeneration.Hepatology communications · 2025Review
- Platelet Membrane-Coated HGF-PLGA Nanoparticles Promote Therapeutic Angiogenesis and Tissue Perfusion Recovery in Ischemic Hindlimbs.ACS applied bio materials · 2025Article
- The Functions and Application Prospects of Hepatocyte Growth Factor in Reproduction.Current gene therapy · 2024Review
- Designing receptor agonists with enhanced pharmacokinetics by grafting macrocyclic peptides into fragment crystallizable regions.Nature biomedical engineering · 2023Article
- The effect of hepatocyte growth factor on intestinal adaption in an experimental model of short bowel syndrome.Pediatric surgery international · 2023Article
- Dialysis based-culture medium conditioning improved the generation of human induced pluripotent stem cell derived-liver organoid in a high cell density.Scientific reports · 2022Article
- Construction of HGF-Displaying Yeast by Cell Surface Engineering.Microorganisms · 2022Article
- Article
- Zinc Administration and Improved Serum Markers of Hepatic Fibrosis in Patients with Autoimmune Hepatitis.Journal of clinical medicine · 2021Article
- Cyclic Peptide-Based Biologics Regulating HGF-MET.International journal of molecular sciences · 2020Review
- A chemically unmodified agonistic DNA with growth factor functionality for in vivo therapeutic application.Science advances · 2020Article
- HGF-MET Signaling Shifts M1 Macrophages Toward an M2-Like Phenotype Through PI3K-Mediated Induction of Arginase-1 Expression.Frontiers in immunology · 2020Article
- Radiation-primed hepatocyte transplantation in murine monogeneic dyslipidemia normalizes cholesterol and prevents atherosclerosis.Journal of hepatology · 2019Article
- Ron Receptor Signaling Ameliorates Hepatic Fibrosis in a Diet-Induced Nonalcoholic Steatohepatitis Mouse Model.Journal of proteome research · 2018Article
- Prolonged co-treatment with HGF sustains epithelial integrity and improves pharmacological rescue of Phe508del-CFTR.Scientific reports · 2018Article
- The recovery of the PT-INR to less than 1.3 predicts survival in patients with severe acute liver injury.Journal of gastroenterology · 2018Article
Corrections and comments
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Authors and funding
15 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundHepatocyte growth factor (HGF) stimulates hepatocyte proliferation, and also acts as an anti-apoptotic factor. Therefore, HGF is a potential therapeutic agent for treatment of fatal liver diseases. We performed a translational medicine protocol with recombinant human HGF (rh-HGF), including a phase I/II study of patients with fulminant hepatitis (FH) or late-onset hepatic failure (LOHF), in order to examine the safety, pharmacokinetics, and clinical efficacy of this molecule.
methodsPotential adverse effects identified through preclinical safety tests with rh-HGF include a decrease in blood pressure (BP) and an increase in urinary excretion of albumin. Therefore, we further investigated the effect of rh-HGF on circulatory status and renal toxicity in preclinical animal studies. In a clinical trial, 20 patients with FH or LOHF were evaluated for participation in this clinical trial, and four patients were enrolled. Subjects received rh-HGF (0.6 mg/m2/day) intravenously for 12 to 14 days.
resultsWe established an infusion method to avoid rapid BP reduction in miniature swine, and confirmed reversibility of renal toxicity in rats. Although administration of rh-HGF moderately decreased BP in the participating subjects, this BP reduction did not require cessation of rh-HGF or any vasopressor therapy; BP returned to resting levels after the completion of rh-HGF infusion. Repeated doses of rh-HGF did not induce renal toxicity, and severe adverse events were not observed. Two patients survived, however, there was no evidence that rh-HGF was effective for the treatment of FH or LOHF.
conclusionsIntravenous rh-HGF at a dose of 0.6 mg/m2 was well tolerated in patients with FH or LOHF; therefore, it is desirable to conduct further investigations to determine the efficacy of rh-HGF at an increased dose.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.