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Study of CTX 4430 in Cystic Fibrosis Patients

Study details

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.

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Trials Tracker ID
TT001601
Age range
Between 18 and 30 years
Length of participation
55 weeks
Trial status
Closed with results
Therapeutic approach
Anti-Inflammatory
Search result from the Trials Tracker

A study looking at the long term treatment of a CFTR modulator (VX-661) when taken with Ivacaftor

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Study details

This is a Phase 3, OpenLabel, Rollover study to look at how safe and effective longterm treatment with VX-661 together with Ivacaftor is in paticipants aged 12 years and older with cystic fibrosis (CF) that have a F508de-lCFTR mutation. The study involves treating all participants who meet all the rules of the study from one of the parent studies (VX-661-106,108,109 or 111) with a combination of VX-661 and Ivacaftor for approximately 96 weeks with a follow-up 28 days after the last dose. Approximately 1375 participants are potentially eligible to be enrolled. There is also an observational cohort (group) that will...

Study results summary

This study assessed the long-term safety and effectiveness of a combined CFTR modulator treatment TEZ/IVA in people with CF ages 12 and older who had either one or two copies of the F508del CFTR gene variant. The results of this study support the long-term use of TEZ/IVA treatment for people aged 12 years and older with CF who have either one or two copies of the F508del CFTR gene variant.

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Trials Tracker ID
TT001591
Age range
12 years and older
Length of participation
96 weeks
Trial status
Closed with results
Therapeutic approach
Restore CFTR Function

Cystic fibrosis physiotherapy

Physiotherapy is a crucial part of the daily treatment regime required to keep people with cystic fibrosis (CF) fit and healthy. Find out more.

Strategic Research Centre: How CF exocrine pancreatic disease may lead to CF related diabetes

Recent research suggests that cystic fibrosis-related diabetes (CFRD) is caused by damage to the digestive-juice-producing part of the pancreas, triggering things to go wrong in the insulin-producing ‘beta’ cells in another part of the pancreas. Researchers will investigate how the damage to insulin-producing cells occurs and the best ways to measure it in people with cystic fibrosis.

MHRA issues Drug Safety Update for Kaftrio

News - Published Date:

The UK medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), have today published an update on Kaftrio highlighting a small increase in the risk of psychological side effects.

“I want Ezzah to achieve anything she wants to in life”

Blog - Published Date:

With your support this Wear Yellow Day (13 June), we can get closer to a life unlimited for children with CF like Ezzah. 

Ezzah’s mum Nilofer shares what the support of Cystic Fibrosis Trust has meant to their family.