020 7042 5802 - 9:00am to 5:00pm - Mon to Fri
Recruiting Adults With Heterozygous Familial Hypercholesterolemia (HeFH) Or Premature Coronary Artery Disease (CAD)
Receive £2,450 in recognition of your time.
Duration of stay
4 nights and 9 follow-ups.
Ages
18-65
Location
London Bridge
Gender
Males & Females
Ethnicity
Any
Payment
£2,450
Nicotine Users
Eligible
Clinical trial summary
We are conducting a clinical trial, called the Heart-2 study. The Heart-2 study is evaluating the safety and tolerability of a study drug in addition to seeing if it may lower cholesterol in people with heterozygous familial hypercholesterolemia (HeFH) or premature coronary artery disease (CAD). People with premature CAD experience cholesterol driven blockage of coronary arteries early in life and are at high risk of further complications. Study participants will be reimbursed for their time commitment to this study.
- The study drug is designed to turn off a gene in the liver to potentially lower the amount of 'bad' cholesterol in the body.
- The study drug is given one time through an intravenous infusion (this means that the drug will be administered into a vein.
- The Heart-2 study is assessing if the study drug can safely and permanently reduce ‘bad’ cholesterol after a single dose.
- This clinical trial will involve you staying at our clinical facility based in London Bridge for up to 4 nights (see below).
If you are interested in participating in this trial:
- To be considered for the trial, you will first need to attend a screening appointment so we can check if you are eligible to take part in the trial. At this appointment, we will perform a number of tests including taking blood samples, checking your heart and carrying out a physical examination.
- If results from your screening appointment show you are eligible for the trial, you will be invited to take part.
- If you do decide to take part, the trial will involve:
- A stay of up to 5 days/4 nights in our clinical facility based in London Bridge.
- Receiving a single dose of the study drug through an intravenous infusion. We will conduct a number of assessments (like those we did at screening) to check how well you tolerate the study drug, and how effective the study drug is at lowering ‘bad’ cholesterol.
- After your stay with us, you will be required to return for 9 follow-up visits over the year.
- After the End of Study visit, you will continue to take part in a long-term follow-up study, which will monitor your safety and effectiveness of the study drug for a total of 15 years after the date of the first administration of the study drug.
Who can take part?
We will check your suitability for the clinical trial using the following criteria:
- You must be male or female between 18 and 65 years.
- You must have a body mass index (BMI) between 18kg/m2 and 40kg/m2 inclusive.
- You must be diagnosed with heterozygous familial hypercholesterolemia (HeFH) or premature coronary artery disease (CAD).
- You must be taking a statin, which is a cholesterol-lowering medication, or have a history of not tolerating these medicines. Statins include, Lipitor (torvastatin), Lescol (fluvastatin), Lipostat (pravastatin), Crestor (rosuvastatin), and Zocor (simvastatin).
- You must not be currently taking a PCSK9 inhibitor, such as Praluent (alirocumab), Repatha (evolocumab), or Leqvio (inclisiran) to lower cholesterol.
- Male participants must be either surgically sterile or must agree to use condoms and refrain from donating sperm for 90 days after the study drug administration.
- Female participants cannot be pregnant or capable of getting pregnant (post-menopausal or surgically sterile).
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.
Duration of Stay
The trial will involve a stay of up to 4 nights and 9 follow-up visits.
Clinical trial reimbursement
In recognition of the time involved in taking part in the trial, you will receive up to £2,450 on completion of the clinical trial, provided you comply fully with all the clinical trial requirements. This amount is based on the number of visits you have to attend and the time you commit to the study.
Location
We are based in London Bridge near both the Underground and overhead train Stations.
Our unit address is: Richmond Pharmacology 1A Newcomen Street (Corner of Newcomen and Borough High Street) London SE1 1YR Please note the postcode will take you 5 minutes down the road from the clinic, I would use the map below as a reference (the clinic is on Borough High St, just up from Tesco and opposite the road from Foxtons)
Clinical trial dates
Please call a member of the recruitment team on 020 7042 5800 to discuss study dates, or register to receive a call.
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.
In the event of any safety issues following study drug administration, you may be required to remain resident in the unit until resolution of [such][any] safety issues, after which you will be discharged from the unit.
Ref: C23021_Jun_2024 (email_website_advert text)
Trial code:
C23021
Speak to a member of our Volunteer Recruitment Team
Comments from volunteers
Thanks very much to the Volunteer Recruitment Team. I am so excited to be part of this trial. I can’t thank you and your colleagues enough for all your help, professionalism, and kindness.
Steve K
Unbelievable service! They looked after me so well, and I would recommend them to anyone interested in participating in a clinical trial. I want to thank all the staff at trials4us for their continued efforts and for looking after me so well.
Chas
Very impressive. Thank you for taking care of me and for the valuable service you offer.
Joann
Very professional environment in the heart of London to conduct studies that help discover the medicines of the future.
James
Recruiting people with type 2 diabetes
Get paid $150 for your time in this study
Register now
Duration of stay
You will need to attend an in-person visit, In total, you will come to the research unit at least once.
View trial dates
Ages
18-70
Location
London Bridge
Gender
Males & Females
Ethnicity
Any
Payment
£1,000
Ages
C23017
Smoking Restrictions
Smokers and non-smokers included
Register now
Email us
Call: 020 7042 5800
Study Summary
We are conducting a study for participants with genetically diagnosed alpha-1 antitrypsin deficiency (Alpha 1) who are interested in participating in future gene editing clinical trials.
In this study, we are recruiting participants with Alpha 1 (with a known or suspected PiZZ mutation) aged 18 to 70. We will give you a tour of the clinical trials unit and conduct a number of clinical assessments to establish your current health status.
This study is to help participants with Alpha 1 decide if they want to participate in future gene editing clinical trials.
In this study, we are recruiting participants with Alpha 1 (with a known or suspected PiZZ mutation) aged 18 to 70. We will give you a tour of the clinical trials unit and conduct a number of clinical assessments to establish your current health status.
This study is to help participants with Alpha 1 decide if they want to participate in future gene editing clinical trials.
If you are interested in participating in this patient engagement study
- You will need to attend an in-person visit, we will give you a tour of the clinical trial unit and perform tests to check your general health to obtain a clinical baseline.
- The tests can be spread over multiple days (if required).
- You will have a follow-up call with a doctor a week after the in-person visit.
- This means the whole process takes approximately 1 week.
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 must have been diagnosed with alpha-1 antitrypsin deficiency (Alpha 1) (with a known or suspected PiZZ mutation).
- You must be able and willing to provide informed consent.
- You must be willing and able to comply with study assessments.
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.
Study payment
In recognition of the time and effort involved in taking part in the study, you will receive £150 on completion of the study, provided you comply fully with all the study requirements.
Study dates
Following the completion of your registration form, a member of our recruitment team will contact you via phone and email to inform of the available 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: C23017_MAR_2024 (email_website_advert text)
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: C23017_MAR_2024 (email_website_advert text)
Register now
Speak to a member of our Volunteer Recruitment Team
Call: 020 7042 5800