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Study of CTX 4430 in Cystic Fibrosis Patients

Details

Therapeutic category
The type of treatment or therapy being studied. A therapy could range from a medication addressing a particular characteristic of CF to a device or activity e.g. exercise

Anti-Inflammatory

Trial status

Closed to recruitment - in follow up

Phase
The different stages involved in the development of a new medication. Phase I focuses on initial safety in people. Phase 2 evaluates safety, correct dose and early signs of whether the medication works. Phase 3 is the stage before medication licensing and looks at safety and medication effectiveness. Phase 4 evaluates longer term use of a medication after it has been licensed for use

Phase II/III

Full title

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 Administered Orally Once-Daily for 48 Weeks in Adult Patients with Cystic Fibrosis

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.

Trial type

Medication

Length of participation
The length of time a participant will take part in a trial, from the first to the last appointment

55 weeks

Intervention
The name of the treatment or therapy being researched

CTX-4430 or Placebo

Recruitment target
The number of participants who need to be recruited for the trial in the UK

195

Last edited date

09 November 2017

Sponsor

Celtaxsys, Inc

Sponsor type

Commercial

Who can take part?

Age

18+

Top inclusion criteria
  • Confirmed diagnosis of pulmonary CF
  • 18 to 30 years of age inclusive at the time of Screening
  • FEV1 ≥50 percent predicted at Screening
  • At least 1 pulmonary exacerbation in the 12 months before Screening
Top exclusion criteria
  • Any significant clinical/laboratory/radiological/spirometric sign of unstable or unexpectedly deteriorating respiratory disease within 14 days before screening
  • History of organ transplantation
  • History of alcoholism or drug abuse within 2 years before Screening

CF centres running this trial

Closed

Frimley Park Hospital

Address

Portsmouth Road Frimley Camberley Surrey GU16 7UJ

Recruitment starts

June 2016

Recruitment ends

October 2016

Contact

Orchard, Chris

Get in touch

Closed

King's College Hospital NHS Foundation Trust

Address

Denmark Hill London Greater London SE5 9RS

Recruitment ends

March 2017

Contact

Perrin, Felicity

Get in touch

Closed

Leeds Teaching Hospitals NHS Trust

Address

St. James's University Hospital Beckett Street Leeds West Yorkshire LS9 7TF

Recruitment starts

May 2016

Recruitment ends

April 2017

Contact

Peckham, Daniel

Get in touch

Closed

Liverpool Heart and Chest Hospitals NHS Foundation Trust

Address

Thomas Drive Liverpool Merseyside L14 3PE

Contact

,

Get in touch
Show all participating centres