Condition: Cystic Fibrosis · Sponsor: Eloxx Pharmaceuticals, Inc.
This is a Phase 2 open-label, dose-escalation study to evaluate the safety, tolerability, PK, and PD of multiple dose levels of SC administered ELX-02 with and without ivacaftor in patients with CF with at least one G542X allele. In total, up to 16 patients will be enrolled in the trial; up to 4 patients will be homozygotes for G542X, and the remaining patients will be compound heterozygotes with one G542X or phenotypically similar nonsense allele and any Class 1 or Class 2 mutation. Each patient will receive up to 5 escalating doses as follows: * ELX-02 0.3 mg/kg per day SC * ELX-02 0.75 mg/kg per day SC * ELX-02 1.5 mg/kg per day SC * An individualized dose of ELX-02, as high as 3.0 mg/kg per day SC, based on the patients observed safety and tolerability, PK at previous doses and the results of laboratory tests. * ELX-02 1.5 mg/kg per day SC plus 150 mg ivacaftor every 12 bid
This description comes directly from the study's public registry record.
Contact details are listed per location below or on the registry record.
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| Long Beach Memorial | Long Beach, California, United States | — |
| Stanford School of Medicine | Palo Alto, California, United States | — |
| National Jewish Health | Denver, Colorado, United States | — |
| Johns Hopkins | Baltimore, Maryland, United States | — |
| Boston Children's Hospital | Boston, Massachusetts, United States | — |
| Nationwide Children's Hospital | Columbus, Ohio, United States | — |
| Baylor College of Medicine | Houston, Texas, United States | — |
| Foothills Hospital Calgary (University of Calgary) | Calgary, Alberta, Canada | — |
| St. Michael's Hospital | Toronto, Ontario, Canada | — |
| The University of Montreal Health Centre | Montreal, Quebec, Canada | — |
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Source record: clinicaltrials.gov/study/NCT04135495