Trial Profile
An Open-label, Non-controlled, Multicenter, Pilot Trial, Using Inhaled Molgramostim in Cystic Fibrosis Subjects With Nontuberculous Mycobacterial (NTM) Infection
Status:
Discontinued
Phase of Trial:
Phase II
Latest Information Update: 29 Oct 2021
Price :
$35
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At a glance
- Drugs Molgramostim (Primary)
- Indications Mycobacterial infections; Mycobacterium avium complex infections; Nontuberculous mycobacterium infections
- Focus Therapeutic Use
- Acronyms ENCORE
- Sponsors Savara Pharmaceuticals
- 13 Sep 2021 Number of treatment arms have been increased from 1 to 3 by the addition of two more groups, thus comprising 3 groups namely negative culture, positive culture and those not meeting recommendations for treatment with a multidrug NTM guideline-based antimycobacterial regimen. Intervention model is changed from single-group assignment to parallel assignment.
- 03 Sep 2020 Results presented in the Savara Pharmaceuticals Media Release.
- 03 Sep 2020 According to an Savara Pharmaceuticals media release, the decision to discontinue the study was not based on safety concerns.