Status:
COMPLETED
OPTION 2: A Trial to Assess the Safety and Efficacy of MS1819 in Enteric Capsules in Patients With Cystic Fibrosis
Lead Sponsor:
Entero Therapeutics
Conditions:
Exocrine Pancreatic Insufficiency (EPI)
Cystic Fibrosis (CF)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary objectives of this study are to assess the safety and efficacy of MS1819 in enteric capsules vs porcine pancreatic enzyme replacement therapy (PERT) in patients with exocrine pancreatic in...
Detailed Description
This is a Phase 2, open-label, multicenter, 2, 2x2 crossover study assessing the safety and efficacy of MS1819, 2240 mg/day vs porcine PERT, and 4480 mg/day vs porcine PERT given at the same dose and ...
Eligibility Criteria
Inclusion
- Cystic fibrosis, based on 2 clinical features consistent with CF, plus either a new/historic sweat chloride ≥60 mmol/L (measured while not on a CFTR modulator) or genotype.
- Under stable dose of porcine PERT
- A fair or better nutritional status
- Fecal elastase \<100 µg/g
- Standard-of-care medications including CFTR modulators are allowed
Exclusion
- History or diagnosis of fibrosing colonopathy
- Any chronic diarrheal illness unrelated to pancreatic insufficiency
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥5 ×upper limit of normal (ULN), or total bilirubin level ≥1.5 ×ULN at the Screening visit
- Feeding via an enteral tube during 6 months before screening
- Forced expiratory volume ≤30% at the Screening visit
Key Trial Info
Start Date :
July 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 8 2021
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04375878
Start Date
July 20 2020
End Date
April 8 2021
Last Update
September 13 2022
Active Locations (15)
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1
Investigator Site 105
Long Beach, California, United States, 90806
2
Investigator Site 102
Altamonte Springs, Florida, United States, 32701
3
Investigator Site 107
Miami, Florida, United States, 33136
4
Investigator Site 101
Glenview, Illinois, United States, 60025