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Trial Code
Clinical trial summary
We are conducting a clinical trial for participants with genetically diagnosed alpha-1 antitrypsin deficiency (AATD). In this trial, we are recruiting participants with AATD (with a known or suspected PiZZ mutation) aged 18 to 70.
The clinical trial involves having single dose of the investigational drug via an intravenous (IV) infusion, safety assessments and repeated blood sampling to assess how safe the drug is, and to discover how your body processes the drug, how long the drug stays in your body and how the drug affects the body.
You will be reimbursed for your time and effort in this clinical trial.
If you are interested in participating in this trial:-
- You will need to attend a Screening appointment so we can check if you are suitable to take part in the trial. At this appointment, we will take blood, check your heart, and carry out a physical examination to check your overall health. The appointment will be scheduled within 6 weeks (or shorter) before you receive the investigational drug.
- If results from Screening appointment show you are suitable for the trial, you will be invited to take part.
- This will involve an in-house stay of 4 days/3 nights in our clinical research unit.
- After discharge, you will be required to attend the unit 4 times (about once per week) to monitor your safety during a 28-day period. You will not receive additional doses of the drug during this time.
- In addition to the above, there are 8 follow-up visits to check your health at months 2, 3, 4, 5, 6, 9, 12, 18 and 24 at the clinical research unit.
- This means the whole trial takes up to approximately 25.5 months from the Screening appointment through to the final visit.
- In total, if you are included in the clinical trial, you will be required to come into the unit approximately 15 times.
Who can take part?
We will check your suitability for the clinical trial using the following criteria:-
- You are aged between 18 to 70 years (inclusive).
- You have a Body Mass Index (BMI) < 30.
- You must have been diagnosed with alpha-1 antitrypsin deficiency (AATD) (with a known or suspected PiZZ mutation).
- You are willing to have genetic testing for mutations in the AAT gene (if it hasn’t previously been done).
- You must not have had any history or recent illnesses which may pose a risk and impact your safety.
- You must not have had a liver or lung transplant or are awaiting one.
- You must not be a regular smoker.
- You must not have had an active COVID infection within 7 day or have had a COVID vaccine within 1 month of enrolment.
- You must not test positive for HIV or Hepatitis B & C test.
- You must not have had prior treatment with another approved or experimental drug within 90 days of enrolment.
- You must not be pregnant or breastfeeding.
- You are able to understand and provide informed consent.
A full list of do’s and don’ts will be given to you by a member of our recruitment team if you are interested and want to find out more.
Clinical trial payment
In recognition of the time and effort involved in taking part in the trial, you will receive £2,550 (£1,700 clinical trial payment and £850 bonus) on completion of the clinical trial, provided you comply fully with all the clinical trial requirements. This amount is based on the anticipated clinical trial plan and will be adjusted pro-rata (i.e. same amount of money paid per unit of time), should we invite you to attend extra visits.
Clinical trial dates
Admission: 22nd October
Dismissal: 25th October
Follow-up visits: 29th October, 5th, 12th, 19th November, 21st December 2023, 20th January, 19th February, 21st March, 20th April, 19th July, October 17th 2025, 15th April and 12th October 2026.
Please call a member of the recruitment team on 0207 042 5800 to discuss alternative study dates.
Approval
The contents of this email have been approved by an ethics committee. Any response to this advertisement will be recorded. Your response will not place you under any obligation to participate in this trial.
You may be required to remain resident in the unit until resolution of any safety issues, after which you will be discharged from the unit.
Ref: C23018_June_2024 (email_website_advert text)
