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Active, not recruitingNo phase
An Exploratory Study to Evaluate the Tolerability and Safety of MWAV201 in Subjects With Wilson Disease
Key facts
- Who runs it
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Where
- China1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 9 people, planned
- Started
- 28 Oct 2024
- Expected to end
- May 2031
- Type of study
- Interventional
- Treatments tested
- MWAV201
- Record updated
- 12 August 2026
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- Other chronic liver disease (such as hepatitis B)
- 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
- Other conditions that, in the Investigator's opinion, may not be suitable for the subject to be enrolled
- Laboratory tests or clinical symptoms indicate decreased liver reserve function
- Significant hepatic inflammation as evidenced by liver function test
- Liver biopsy or liver stiffness measurement show progressive liver fibrosis
- Any signs of decompensated liver function (such as ascites)
- Body Mass Index ≥ 30 kg/m2
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
The primary objective of this study is to evaluate the tolerability and safety of MWAV201 in patients with Wilson disease.
The group in the trial
- MWAV201Treatment being tested
All subjects will receive a single intravenous (IV) infusion of MWAV201.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- An Open-Label, Dose Escalation Study to Evaluate the Tolerability, Safety, and Preliminary Efficacy of MWAV201 in Subjects With Wilson Disease
- Record updated
- 12 August 2026