Overview

Evaluation of (R)-Roscovitine Safety and Effects in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation

Status:
Terminated

Trial end date:
2018-07-26

Target enrollment:

Participant gender:

Summary

This is a phase II, dose ranging, multicenter, randomized, double-blind, placebo-controlled study. The aim of this study is to assess the safety of increasing doses of roscovitine administered orally for 4 cycles of 4 consecutive days (treatment "on") separated by a 3 days treatment free period (treatment "off") in adult CF subjects with Cystic Fibrosis carrying 2 Cystic Fibrosis causing mutations with at least one F508del-CFTR mutation and chronically infected with Pseudomonas aeruginosa. This study involved 36 Cystic Fibrosis patients: 24 treated and 12 controls.

Phase:

Phase 2

Details

Lead Sponsor:

University Hospital, Brest

Collaborators:

Cyclacel Pharmaceuticals, Inc.
ManRos Therapeutics

Treatments:

Roscovitine