Extension to study of safety and efficacy of CDZ173 in APDS patients

• Research type

  Research Study

• Full title

  An open-label, non-randomized extension study to evaluate the long term safety, tolerability, efficacy and pharmacokinetics of CDZ173 in patients with APDS/PASLI (Activated Phosphoinositide 3-kinase Delta Syndrome/p110δ-activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency)

• IRAS ID

  245872

• Contact name

  Siobhan Burns

• Contact email

  siobhan.burns2@nhs.net

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2016-000468-41

• Clinicaltrials.gov Identifier

  NCT02859727

• Duration of Study in the UK

  3 years, 3 months, 0 days

• Research summary

  The purpose of the study is to provide patients diagnosed with APDS/PASLI treatment with CDZ173 for up to 3 years and to collect long term information about how safe and effective the medication is. The study also examines the pharmacokinetics and bioavailability of CDZ173 when given as capsules and tablets respectively. Pharmacokinetics and bioavailability are the study of the way the human body absorbs, distributes and gets rid of a drug. All patients will have participated in the CCDZ173X2201 study.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  19/LO/0052

• Date of REC Opinion

  25 Feb 2019

• REC opinion

  Further Information Favourable Opinion