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Trials Tracker

Welcome to the Trials Tracker, bringing together all the cystic fibrosis (CF) trials currently recruiting in the UK so that you can find clinical trials you can take part in both in your region and further afield. The Trials Tracker is a new resource that we’ll be developing over time based on your feedback. If you’ve used the Trials Tracker and want to share your opinion, please complete our online poll or get in touch at clinicaltrials@cysticfibrosis.org.uk.

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Clinical trials

6-10 of 48 results for all trials

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Trial status

Inclusion age

FEV1

Trial type

Location

Mutation

Therapeutic category

HIT - CF Organoid Study

Cystic fibrosis is caused by gene changes (‘mutations’) in the CF gene ,over 2000 mutations in CFTR have been identified. New innovative and effective ‘mutation-specific’ drugs are available or in development for up to 90% of people with CF (ie. those with the most common 20-30 mutations). These are called ‘CFTR modulators.’ However, this leaves an important minority (~10%) of people with CF with no modulator in development as their mutations are very rare and only a small number of individuals have these specific mutations, making studying these patients in traditional trials very challenging. Therefore, the Human Individualized Treatment for CF (HIT-CF) project has been developed to address this unmet need, ie. to develop personalised treatments for this important group. HIT-CF is a Europe-wide, multi-centre project, which comprises two parts: This study is the the first part - the organoid study - in which patients with rare CFTR mutations will be recruited and intestinal organoids produced from rectal biopsies from each patient will be generated. Intestinal organoids, sometimes called ‘mini-intestines,’ are cell cultures made from stem cells so they contain the same mutations as the person from whom the biopsies are derived. Using this laboratory model, candidate modulator drugs can then be tested to assess for responsiveness (thus potentially predicting response in real life). In the second part of HIT-CF - the clinical trial - these modulators will then be tested in patients identified from the organoid study as likely responders, thus increasing the likelihood of showing efficacy. We plan to test drugs on organoids derived from 500 patients across Europe.

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  • Trial Reference Number

    119685

  • Trial status

    Project in Setup

  • Therapeutic category

    Restore CFTR Function

Intravenous iron in adults with cystic fibrosis

Cystic fibrosis (CF) is an inherited condition affecting over 10,000 patients in the UK, which leads to recurrent chest infections and poor absorption of nutrients from the gut. In the past, patients with CF died in childhood, but most now survive into adulthood. However, they require frequent contact with healthcare services, expensive and time-consuming treatments, and have poor health-related quality of life. Adults with cystic fibrosis often have low iron levels (iron deficiency). This is partly due to poor absorption of iron from the gut, and partly to the trapping of iron within cells of the immune system during periods of infection. Unfortunately, iron tablets are often ineffective in this setting, and may cause significant side effects in patients with cystic fibrosis. In other patient groups, intravenous iron is used routinely to correct iron deficiency. In these patients it has been shown to be safe, and to improve energy levels, exercise tolerance, cognitive function and quality of life, even in the absence of anaemia. Recent research suggests that iron may be particularly beneficial in patients with heart and lung disease. Despite these possible benefits, IV iron is rarely used in patients with CF, due in part to concerns about encouraging the growth of bacterial in the lungs. Iron deficiency therefore often goes untreated. However, since no clinical trials have examined the use of IV iron in CF patients to date, the risks and benefits remain uncertain. We plan to undertake a small pilot study examining the effects of IV iron in 20 adults with CF and low iron levels. We will primarily assess whether intravenous iron is safe and effective at treating iron deficiency in this group, but will also study various other clinical parameters, to guide the design of future larger studies.

Read more Phase IV
  • Trial Reference Number

    110427

  • Age

    18+

  • Trial status

    Open to recruitment

  • Therapeutic category

    Nutritional-GI

A Phase 1/2 Study of VX-121 in Subjects With Cystic Fibrosis and in Subjects without Cystic Fibrosis (VX17-121-001)

The purpose of this study is to evaluate safety and tolerability of VX-121 in healthy subjects and in subjects with cystic fibrosis.

Phase I/II
  • Trial Reference Number

    111537

  • Mutation

    One copy of F508del

  • Age

    18+

  • Trial status

    Closed to recruitment - in follow up

  • Therapeutic category

    Restore CFTR Function

Gastro-oesphageal reflux in patients with cystic fibrosis and its effect on lung function

Gastro - oesophageal reflux disease(GORD) is a condition where acid from the stomach leaks out of the stomach and up into the oesophagus (gullet) It is common in patient with Cystic Fibrosis. Although symptoms such as heartburn and acid taste in the mouth can occur, often there are no symptoms. Studies have suggested a link between a worsening lung function and the amount of GORD. A potential mechanism is by the stomach content travelling into the lungs causing inflammation and altering the usual organisms that are present. If that is the case, there may be opportunities for new drugs and /or surgical procedures. The aim of this observational study is to investigate if GORD affects the lung function. The study will assess mircobiology and presence of markers of reflux aspiration. These are substances that are found in the gastrointrestinal tract and that , if detected in sputum, support the presence of stomach contents in the lungs. In addition factors that may influence GORD such as antacids tablets and enteral feeding ( via a tube into the stomach) will be evaluated. GORD will be measured by using special probes that assess the function of the oesophagus, PH (acidity) and presence of gastic contents within the gullet. The participants will provide measures of lung function, clinical details, blood, and sputum samples as well as complete symptoms questionnaires

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  • Trial Reference Number

    105287

  • Age

    18+

  • Length of participation

    24 hours

  • Trial status

    Closed

  • Therapeutic category

    Other

Gut - CF

Cystic fibrosis affects the digestive system and leads to a number of unpleasant symptoms. Those relating to the bowels are often overlooked and can be hard to treat. We are hoping to evaluate a new questionnaire –the CF bowel score (CF-BS)–specifically designed to look at CF bowel disease. We hope it will improve identification and allow us to measure response to treatment. The patient will complete the CF-BS at their routine clinic appointment along with providing relevant clinical information. One group of patients will be sent home with the CF-BS to complete at home and return to us within a week. A final group of patients will be asked to complete the form before and after certain treatments so we can assess how bowel symptoms change over a course of treatment. Once we are happy that the CF-BS questionnaire captures symptoms that affect CF patients it will be distributed to the rest of the patients at the Manchester Adult CF Centre. This will allow us to identify the number of patients with bowel symptoms and allow us to better treat them

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  • Trial Reference Number

    106002

  • Age

    18+

  • Length of participation

    1 week

  • Trial status

    Closed

  • Therapeutic category

    Other

6-10 of 48 results for all trials