A Phase 1/2, Open-Label, Single and Multiple Ascending Dose Study of CRMA-1001 in Adults With Chronic Hepatitis B
This research study is looking into a new treatment called CRMA-1001 for adults who have long-term (chronic) Hepatitis B. The main goal is to find out if CRMA-1001 is safe and how well people can tolerate it when given in different doses. Researchers will also be checking how the medicine moves through the body and what effects it has. CRMA-1001 is a special type of gene therapy delivered directly into a vein through a drip. Patients will continue to take their usual antiviral medication throughout the study. This is an early-stage study, meaning it's the first time this treatment is being tested in a larger group of people.
At a glance
What is this study about?
This study is testing a brand-new medicine called CRMA-1001 for people living with chronic Hepatitis B. Chronic Hepatitis B is a long-term liver infection that can sometimes lead to serious health problems. The aim of this research is to see if CRMA-1001 is safe for people to take and to understand any side effects it might cause. They also want to learn how the medicine behaves in the body and if it has any positive effects on the condition.
CRMA-1001 is a type of 'gene therapy', which means it works by targeting the genes involved in Hepatitis B. It's given through a drip directly into a vein. Researchers will start with a small number of people getting a low dose, then gradually increase the dose for other groups of people. This helps them find the safest and most effective amount.
By carefully studying CRMA-1001, scientists hope to gather important information that could potentially lead to new and better treatments for chronic Hepatitis B in the future. It's important to remember that this is an early stage of research, and the main focus is on safety.
Key takeaways
- This study tests a new gene therapy (CRMA-1001) for chronic Hepatitis B.
- It aims to check the safety and tolerability of the new treatment.
- Participants will receive the medicine through a drip.
- You must already be taking oral antiviral treatment for Hepatitis B.
- Researchers will study how the medicine works in the body.
- This is an early-stage study, focusing on finding a safe dose.
Who may be eligible?
To join this study, you need to be an adult between 18 and 64 years old and weigh between 45 and 150 kilograms. You must have been diagnosed with chronic (long-term) Hepatitis B and already be taking medicine for it by mouth.
There are also some health checks you need to pass. For example, your liver test results (called ALT and AST) and another blood test (total bilirubin) need to be within a certain healthy range, or only slightly above it.
You won't be able to join if you have serious scarring or damage in your liver (called significant fibrosis or cirrhosis), or if you have any other liver problems apart from Hepatitis B. There might be some other reasons you can't join that the study team will explain.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 18 and 64 years old?
- Have you been diagnosed with long-term Hepatitis B?
- Are you currently taking oral medicine for Hepatitis B?
- Do you have good overall liver health (not severe scarring/damage)?
- Are you within the weight range of 45kg to 150kg?
What does participation involve?
If you choose to take part, you will receive the study medicine, CRMA-1001, through a drip into your vein. This will happen in a medical setting. Some participants will receive a single dose, while others will receive multiple doses over a period. It's important that you continue taking your usual antiviral medicine for Hepatitis B throughout your time in the study.
The study team will monitor your health closely through regular visits, blood tests, and other assessments. These checks are to ensure your safety and to see how your body is reacting to the new medicine. Although the exact number of visits and the full duration of the study will be explained in detail by the research team, you should expect to attend medical appointments regularly for some time after receiving the treatment for thorough follow-up.
Potential risks and benefits
Locations (4)
- Hospices Civils De LeonVerified postcodeLyon, France· Recruiting
- Queen Mary Hospital, The University of Hong KongVerified postcodeHong Kong, Hong Kong· Recruiting
- New Zealand Clinical ResearchVerified postcodeAuckland, New Zealand· Recruiting
- King's College HospitalVerified postcodeLondon, United Kingdom· Recruiting
Common questions
What is CRMA-1001?
CRMA-1001 is a new gene therapy treatment being tested for chronic Hepatitis B, given through a drip.
Who can join this study?
Adults with chronic Hepatitis B, aged 18-64, who are already on antiviral medication and meet other health requirements.
Do I stop my current Hepatitis B medicine?
No, you will continue taking your usual oral antiviral medicine throughout the study.
What is the main goal of the study?
The main goal is to check if CRMA-1001 is safe and well-tolerated in people with chronic Hepatitis B.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time, for any reason, without it affecting your medical care.
How to find out more
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Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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