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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

41-45 of 49 results for all trials

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A Study to Evaluate Safety and Pharmacokinetics of VX-659 in Healthy Subjects and in Adults With Cystic Fibrosis

Cystic fibrosis (CF) is an autosomal recessive chronic disease with serious morbidities and frequent premature mortality. At present, there is no cure. CF affects approximately 70,000 individuals worldwide The aims of the study is to evaluate the safety and tolerability of VX-659 in triple combination with TEZ/IVA for 14 days in subjects with CF This is a randomized, double-blind, placebo-controlled, single- and multiple-dose, first-in-human dose escalation study of VX-659 that includes evaluations of relative and absolute bioavailability. Part D (Subjects with CF) Part D has a randomized, double-blind, placebo-controlled, parallel-group design. Approximately 12 subjects will be enrolled and randomized 3:1 to TC:placebo. Subjects will receive 14 days of treatment. Part D may be initiated while Parts A, B, and C are ongoing after review of safety, tolerability, and available PK data. The dose of VX-659 will be at least 1 dose level below the highest Part C dose for which safety and tolerability results are available and supportive. The dosage of TEZ/IVA will be TEZ 100 mg qd/IVA 150 mg q12h, which will be administered as TEZ 100-mg/IVA 150-mg FDC in the morning and IVA 150 mg in the evening. The decision to initiate successive cohorts and dose selection will be based on safety and tolerability data from preceding dose group(s) and available PK data from a minimum of 6 subjects (to ensure 4 subjects receiving active drug) in the preceding cohort.

Read more Phase I
  • Trial Reference Number

    88595

  • Mutation

    One copy of F508del

  • Age

    18+

  • Length of participation

    6 months

  • Trial status

    Archived

  • Therapeutic category

    Restore CFTR Function

AZTEC-CF - Gilead IN-UK-205-4065

This study’s primary objective is to investigate whether there is immediate clinical benefit in the use of Cayston® in acute exacerbations of CF. Repeated courses of antibiotics via a drip (also known as intravenous or IV antibiotics) can cause long-term side effects including deafness and chronic kidney disease. It is therefore important to explore newer approaches for treating chest infections in CF. Nebulised antibiotics provide an opportunity to deliver antibiotics straight to the lungs with significantly less of the drug being absorbed into the blood stream. This means that potential side effects and long-term damage to other organs are minimised. Furthermore nebulised antibiotics are generally well tolerated, less invasive and require less time to administer. AZTEC-CF aims to evaluate whether inhaled antibiotic treatment is beneficial in the treatment of acute chest infections

Read more Phase IV
  • Trial Reference Number

    91099

  • Age

    18+

  • Length of participation

    2 exacerbations

  • Trial status

    Closed to recruitment - in follow up

  • Therapeutic category

    Anti-Infective

Study of CTX 4430 in Cystic Fibrosis Patients

The purpose of this study is to assess the safety and tolerability of multiple oral doses of CTX-4430 when administered to cystic fibrosis (CF) patients once-daily (QD) for 15 days. This study will include two dose levels. For each dose level, blood samples will be collected for exploratory PK and PD assay validation. In addition, sputum will be collected for exploratory biomarker analysis. Following multiple dose administration, pulmonary function and exploratory lung clearance index (LCI) measurements will be taken.

Read more Phase II/III
  • Trial Reference Number

    51654

  • Age

    18+

  • Length of participation

    55 weeks

  • Trial status

    Closed to recruitment - in follow up

  • Therapeutic category

    Anti-Inflammatory

A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic Fibrosis

Cystic Fibrosis (CF) is a genetic disease caused by mutations in the gene encoding a cell transport protein (ion channel). This ion channel transports chloride ions in and out of cells in multiple organ systems. When ions are not transported correctly the salt and water balance in cells and tissues is not controlled, leading to the production of sticky mucus in the lungs, airways and intestines. Vertex is developing treatments to help increasing production of the ion channel and increase transport of chloride ions. IVA and Orkambi are two drugs that have been approved for treatment. Vertex is also developing TEZ and now VX-440. VX-440 increases the production of the ion channel, but in a different way to the current treatments. So, it is hoped that by using VX-440 as well as current treatments the production of the ion channel will be increased even further. Primary Objectives 1) To evaluate the safety and tolerability of VX-440 in dual and triple combination with tezacaftor (TEZ) and/or ivacaftor (IVA). 2) To evaluate to effectiveness of VX-440 in dual and triple combination with TEZ and/or IVA

Read more Phase II
  • Trial Reference Number

    82171

  • Age

    13 - 17

  • Length of participation

    20 weeks

  • Trial status

    Closed to recruitment - in follow up

  • Therapeutic category

    Restore CFTR Function

A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age and Have a CFTR Gating Mutation (VX15-770-124 Arrival)

This is a Phase 3, 2-part, open-label study designed to evaluate the safety, PK, PD, and efficacy of ivacaftor in subjects with CF who are <24 months of age at treatment initiation and have a CFTR gating mutation on at least 1 allele. Part A is designed to evaluate the safety and PK of multiple-dose administration of ivacaftor in subjects <24 months of age and to confirm (or adjust if necessary) the doses for Part B. Part B is designed to evaluate the safety, PK, PD, and efficacy of ivacaftor in subjects <24 months of age over 24 weeks.

Read more Phase III
  • Trial Reference Number

    71722

  • Age

    0 - 12

  • Trial status

    Open to recruitment

  • Therapeutic category

    Restore CFTR Function

41-45 of 49 results for all trials