The primary objective of this exploratory study at Xinhua Hospital, Shanghai Jiao Tong University School of Medicine is to evaluate the tolerability and safety of MWAV201 in patients with Wilson disease. It enrolls men and women aged 18 to 65 with a confirmed diagnosis of Wilson disease who have followed a low-copper diet and standardized medication for at least 1 year and whose disease has been stable for at least 1 year. The trial has no assigned phase category (NA) and is active but no longer recruiting.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Male or female aged 18 and 65 years inclusive; * Confirmed diagnosis of Wilson disease; * Low copper diet and standardized medication for ≥ 1 year; * Stable Wilson disease for ≥ 1 year; * Able to understand and willing to follow study procedures. Exclusion Criteria: * Significant hepatic inflammation as evidenced by liver function test. * Liver biopsy or liver stiffness measurement show progressive liver fibrosis. * Laboratory tests or clinical symptoms indicate decreased liver reserve function. * Other chronic liver disease (such as hepatitis B). * Any signs of decompensated liver function (such as ascites). * History of liver transplant or plan to receive liver transplant. * Other diseases with clinical significance, such as cardiovascular and cerebrovascular diseases, kidney diseases, respiratory system diseases, neurological diseases, mental illnesses, active infections, etc. * Body Mass Index ≥ 30 kg/m2. * Other conditions that, in the Investigator's opinion, may not be suitable for the subject to be enrolled.