Safety and effect of QBW276 in patients with cystic fibrosis

Phase 1

• Conditions: Cystic Fibrosis; MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-004915-35-DE
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-14
• Study Completion: 2018-10-04
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 16

Inclusion Criteria

- Cohorts 1 and 2 = any genotype on any standard of care treatment
- Cohort 3 = F508del homozygotes on standard of care at that time
- FEV1 between 40 and 100%
- LCI2.5 = 8 if FEV1 is more than 80%

Other protocol-defined inclusion/exclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 56
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Adrenal or electrolyte abnormalities
- Lung transplant
- Autonomic dysfunction (e.g. recurrent episodes of fainting, palpitations, etc.)

Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified