Trial intelligence / Profile preview

PF-06835919 in Hereditary Fructose Intolerance

NCT06089265Phase 2

Key facts

Status
Completed
Start
Jun 2023
Primary completion
Nov 2023
Countries
1
Sponsor
Maastricht University Medical Center+
Modality
Small Molecules
Conditions
hereditary fructose intolerance (HFI)
01

Overview

Phase 2, open-label trial of PF-06835919 in hereditary fructose intolerance (HFI) (2 arms), sponsored by Maastricht University Medical Center+. Primary endpoints: Intestinal Fructose Tolerance at 9 days, Renal Fructose Tolerance at 9 days and 1 more. Started Jun 2023; status: completed.

02

Design

2 arms
Study design
Non-randomizedOpen-label
  • HFI patients

    HFI participants receive PF-06835919 for 9 days followed by challenge.

  • Healthy controls

    Healthy controls receive no intervention, only fructose tolerance test.

03

Endpoints

Primary

  • Intestinal Fructose Tolerance

  • Renal Fructose Tolerance

  • Hepatic Fructose Tolerance

Secondary

  • Intrahepatic Lipid Content

  • Blood Pressure

  • Glycosylated Transferrin

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