An Exploratory Study to Evaluate the Tolerability and Safety of MWAV201 in Subjects With Wilson Disease

Launched by XINHUA HOSPITAL, SHANGHAI JIAO TONG UNIVERSITY SCHOOL OF MEDICINE · Oct 27, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring the safety and tolerability of a new treatment called MWAV201 for people with Wilson disease, a condition that affects how the body handles copper. The study aims to find out if MWAV201 is safe for patients who have been on a low copper diet and stable medication for at least a year. It is important for participants to understand the study procedures and be willing to follow them.

To be eligible for this trial, participants need to be between 18 and 65 years old and have a confirmed diagnosis of Wilson disease. They should not have severe liver issues or other significant health problems that could complicate their participation. The trial is not yet recruiting, so interested individuals will need to wait for the study to begin. Participants will be monitored closely to ensure their safety while taking the new treatment.

Gender

ALL

Eligibility criteria

• 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.