NCT03746483 - OPTION: A Trial to Assess the Safety & Efficacy of MS1819 in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 10, 2019

Primary Completion Date

July 13, 2019

Study Completion Date

July 27, 2019

Conditions

Exocrine Pancreatic Insufficiency (EPI)Cystic Fibrosis (CF)

Interventions

DRUG

MS1819

MS1819, an oral, non-systemic, that is non-enterically-coated. It is a yeast-derived (non-porcine) lipase pancreatic enzyme replacement.

DRUG

Porcine PERT

Porcine PERT is being used as a comparator to MS1819 as a second drug/intervention

Trial Locations (14)

Investigator Site 106, Hershey

Investigator Site 102, Altamonte Springs

Investigator Site 107, Miami

Investigator Site 104, Toledo

Investigator Site 110, Cleveland

Investigator Site 101, Glenview

Investigator Site 111, Wichita

Investigator Site 109, Dallas

Investigator Site 103, Las Vegas

Investigator Site 105, Long Beach

Investigator Site 108, Portland

Investigator Site 203, Karpacz

Investigator Site 202, Rabka-Zdrój

Investigator Site 204, Sopot