020 7042 5800 - 9:00am to 5:00pm - Mon to Fri
Duration of stay
A stay of 2 days / 1 night in our clinical research unit and 8 follow-up visits.
Ages
18-65
Location
London Bridge
Gender
Males & Females
Ethnicity
Any
Payment
£1,830
Smoking Restrictions
Smokers and non-smokers included
Trial Code
C22003 (Part B)
Paid on completion of the study.
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We are conducting a clinical trial for a new medicine that could be used to treat people with Glanzmann thrombasthenia.

  • In this clinical trial we are recruiting male and female participants aged 18 to 65 years with Glanzmann thrombasthenia. We will observe how your body processes the new medicine and how long the new medicine stays in your body.
  • You will be paid for your time and commitment if you participate in this clinical trial.

Clinical trial summary

This clinical trial will be divided into 3 parts:

  • Part A: During this part of the study, different dose levels of the study drug will be tested. This study part will consist of 5 cohorts which will involve about 1-6 participants per group. Each participant will receive a single dose. This part will involve an in-house stay.
  • Part B: This part of the study will involve 3 cohorts with a minimum of 3 participants per group, with the possibility of expanding to 12. Each cohort will test a different dose level, with each participant receiving multiple doses for 3 months.
  • Part C: This part of the study will involve 3 cohorts, with each participant receiving multiple doses for 9 months. This part will not involve an in-house stay.
  • During your in-house stays, you will receive standard meals each day including breakfast, lunch, evening meals and snacks, served at specific times. You will have to consume all your meals and snacks.

If you are interested in participating in the trial:

Part B:

  • 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 perform several tests, including but not limited to taking blood samples, checking your heart and carrying out a physical examination.
  • Following the screening appointment, you will complete a Run-in Observation Period or Historical Bleeding Data collection period – this will involve an observation for up to 90 days to record bleeding events or you will be asked for estimated bleeding frequency over the past 90 days. This is to determine how often you usually experience bleeds.
  • If results from your screening appointment show you are suitable for the trial, you will be invited to take part.
  • This will involve receiving multiple doses of the study drug for 3 months in our clinical research unit. Your first dose will be on Day 1 and will be at intervals based on data from Part A.
  • A stay of 2 days / 1 night in our clinical research unit. You will arrive one day before you are dosed (Day -1). You will then be dosed on Day 1 and discharged on the same day
  • You will be required to attend the clinic on Day 8, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 for treatment visits and 28 days after your last dose for an end of study visit.
  • This means the whole process takes approximately 33 weeks from your screening visit through to your final visit.
  • In total, if you are included in the clinical trial you will come to the research unit 12 times.
  • During your treatment visits, you will receive multiple doses of the study drug via an injection under the skin (subcutaneous) into your abdomen or thigh. We will conduct several assessments (like those we did at screening) to check how well you tolerate the new study drug, and to help us understand how long it takes for your body to get rid of the study drug.
Register for this trial

Who can take part?

We will check your suitability for the clinical trial (only for Part B) using the following criteria:-

  • You must be male or female between 18 and 65 years of age.
  • You must be diagnosed with Glanzmann thrombasthenia.
  • You must not have received a COVID-19 vaccine within the last 28 days, any live vaccines within 4 weeks and must agree to not receive a live vaccine during the study period.
  • You must also agree to not receive a COVID-19 vaccination throughout the dosing period and for 4 weeks after the final dose.
  • Female participants of childbearing potential must agree to use highly effective contraception methods (excluding oestrogen containing combined oral contraceptive) and avoid egg donation for 14 days prior to Day 1, during the study treatment, and for 6 months after the last dose.
  • Male participants of child-producing potential must agree to use highly effective contraceptive methods and avoid sperm donation for 14 days prior to Day 1, during the study treatment, and for 6 months after the last dose.
  • You must not have a BMI above 30 kg/m2

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 involved in taking part in the trial, you will receive £1830 (£1120 clinical trial payment and £710 bonus) if you are dosed on a weekly basis, 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

Please contact us via the registration button to receive a call from a member of the recruitment team or call us direct on 020 7042 5800.

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:  C22003_JUL_2023 (email_website_advert text)

Register for this trial
If you would like to speak to a member of our Volunteer Recruitment Team, call us on 020 7042 5800
Register for this clinical trial

Contact our Volunteer Recruitment Team

Ref: C22003 (Part B) - (email_website_advert text)

Comments from volunteers

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

The initial process to get accepted on the trials was easy, and the payment was prompt and precise. The staff here at the clinic are lovely, very professional, helpful, and understanding.

Elisabeth

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