Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
NorthSea Therapeutics B.V.
This is a 62 week (including screening and follow-up), multicenter, randomized, double blind, placebo-controlled, parallel group study in male and female patients with a histological diagnosis of NASH. The study includes a screening period, double blind treatment period, and post-treatment follow up
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Provides signed written informed consent and agrees to comply with the study protocol.
Is a male or female aged 18 to 75 years, inclusive.
Has a histological diagnosis of NASH prior to study entry
Has (NAS) greater than or equal to 4, with a score of at least 1 in each component (steatosis, lobular inflammation, and ballooning),
Has a fibrosis score F1 to F3, inclusive (F1 capped at 30%),
Has a Proton Density Fat Fraction (PDFF) greater than or equal to 10% on MRI at screening
You may not be if
Has a known history of alcohol abuse or daily heavy alcohol consumption
Has had bariatric surgery within the past 5 years
Has significant systemic or major illnesses other than liver disease
Has a recent (within 6 months) history of cardiac dysrhythmias and/or cardiovascular disease
Has uncontrolled arterial hypertension
Positive for Hep B, Hepatitis C Virus (HCV) or HCV Polymerase Chain Reaction (PCR)
