Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Mr Adam Khan
+44 (0)121 415 9131
a.r.khan@bham.ac.uk


Prof Mehul Dattani
+44 (0)20 7905 2657
m.dattani@ucl.ac.uk


Dr Study Team
-
GHDReversal@trials.bham.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

Study Location:

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Be Part of Research - Trial Details - The growth hormone deficiency reversal trial

The growth hormone deficiency reversal trial

Medical Conditions

Isolated growth hormone deficiency in pubertal children


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Growth hormone (GH) is a hormone essential for normal growth and development. If a child doesn’t have enough GH, the speed of growth is slower and final adult height reduced. Growth hormone deficiency (GHD) is a condition where the pituitary gland doesn’t make enough growth hormone in childhood. GH treatment allows children with GHD to grow normally. GH is given as daily injections continued until the child reaches adult height. GH is usually given for 5-10 years and can cost £10,000-23,000 per patient per year.
Children are tested for GHD by measuring the highest amount of GH in the blood following a test. When GH production is checked after children reach their final height, some children are found to have normal levels of GH; these children therefore no longer have GHD. Some doctors think that this change occurs during puberty. Many pubertal children on GH therapy are assumed to no longer have GHD but doctors usually continue daily GH injections until the child reaches final adult height. Therefore some children continue to have potentially unnecessary, costly daily injections.
The aim of this ‘GHD Reversal’ study is to find out whether certain children can stop their GH injections at puberty and still reach a similar final adult height to those children who continue to have daily GH injections.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Aug 2021 09 May 2024

What does the study involve?
The study will test whether the children who stop their GH injections reach a similar final adult height to those children that continue their injections. Children will have 6-monthly trial assessments at their hospitals endocrine clinic where they will have blood samples taken (to look at the level of GH and the lipids in it) and other biometric data (e.g. height, weight) collected. These activities are already done as part of standard care for these children and the trial visits should be matched up to the child's usual visit schedule. At the first and last trial assessments children will have an X-ray of their non-dominant hand, and at some they will be asked to complete a short questionnaire about their quality of life (the CHU-9D questionnaire). At the last trial assessment children will have another GH test.

What are the possible benfits and risks of participating?
If a child is in the group who are not taking growth hormone, this would mean that they no longer need to have daily injections.
If a child is randomised to the group who are continuing with their growth hormone injections they may not directly benefit from taking part in the study, however the information we get from the study may help us to improve the treatment of young people with growth hormone deficiency in the future.
Taking part in this study is very unlikely to cause any child any discomfort or side-effects.
If a child is put in the group who stop their injections of growth hormone then their growth will be monitored closely. At the first sign that a child might be developing another shortage of growth hormone they will be retested and growth hormone treatment restarted.

Where is the study run from?
The Chief Investigator is Professor Mehul Dattani at University College London (UCL). UCL are also the Sponsor. The study is being coordinated by the Birmingham Clinical Trials Unit at the University of Birmingham.

When is the study starting and how long is it expected to run for?
June 2020 to November 2027

Who is funding the study?
National Institute for Health Research - Health Technology Assessment Programme (UK

Who is the main contact?
Professor Mehul Dattani, m.dattani@ucl.ac.uk
Mr Adam Khan, a.r.khan@bham.ac.uk


Children with I-GHD whose stimulated GH levels are found to be normal when tested after they have entered puberty. After giving their consent, these children will be randomised (chosen by 50:50 chance by a computer) to either continue or stop their daily GH injections.

You can take part if:



You may not be able to take part if:


1. Multiple pituitary hormone deficiency (hypopituitarism) with or without additional pituitary hormone supplementation2. Known genetic cause of I-GHD3. Organic GHD (mid-brain tumours, congenital mid-brain malformations, septo-optic dysplasia; radiotherapy to the total body or brain)4. Ectopic posterior pituitary5. Other indications for GH therapy6. Receiving GH treatment during the (minimum 6 week) discontinuation period7. Receiving prednisolone or dexamethasone for a period of 4 weeks or longer in the time period immediately prior to randomisation8. Known history of persistent non-compliance with prescribed medication regimens9. Pregnant or lactating10. Any malignancy11. Currently participating in another Clinical Trial of an Investigational Medicinal Product (CTIMP)


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • The Royal London Hospital
    80 Newark Street
    London
    E1 2ES
  • Norfolk and Norwich University Hospital
    Colney Lane
    Norwich
    NR4 7UY
  • St James's University Hospital
    Beckett Street
    Leeds
    LS9 7TF
  • Southampton General Hospital
    Tremona Road
    Southampton
    SO16 6YD
  • King's College Hospital
    Denmark Hill
    London
    SE5 9RS
  • Great Ormond Street Hospital
    Great Ormond Street
    London
    WC1N 3JH
  • Royal Manchester Children's Hospital
    Oxford Road
    Manchester
    M13 9WL
  • Alder Hey Children's Hospital
    Eaton Road
    Liverpool
    L12 2AP
  • Nottingham Children's Hospital
    Queen's Medical Centre, Derby Road
    Nottingham
    NG7 2UH
  • Kepler Universitätsklinikum
    Krankenhausstrasse 9, Med Campus III
    Linz
    4020 Linz
  • Klinikum Wels-Grieskirchen
    Grieskirchner Straße 42
    Wels
    4600 Wels
  • LKH-Universitätsklinikum Graz
    Auenbrugger Platz 1
    Graz
    8036 Graz
  • Uniklinikum Salzburg
    Müllner Hauptstraße 48
    Salzburg
    5020 Salzburg
  • Universitätsklinik Innsbruck
    Anichstraße 35
    Innsbruck
    6020 Innsbruck
  • Newcastle Freeman Hospital
    Freeman Road
    Newcastle
    NE7 7DN
  • Birmingham Children's Hospital
    Steelhouse Lane
    Birmingham
    B4 6NH

This information has not yet been provided by the study team. You'll have an opportunity to discuss any risks and benefits that may be associated with this study prior to consenting to taking part.

Mr Adam Khan
+44 (0)121 415 9131
a.r.khan@bham.ac.uk


Dr Study Team
-
GHDReversal@trials.bham.ac.uk


Prof Mehul Dattani
+44 (0)20 7905 2657
m.dattani@ucl.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by University College London and funded by Health Technology Assessment Programme.




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Read full details for Trial ID: ISRCTN12552768

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Last updated 12 September 2024

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