Trial Outcomes & Findings for EASY: Extended Access to Sollpura Over Years (NCT NCT02823964)

Last Updated: 2018-05-17

Results Overview

Descriptive analysis

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

25 participants

Primary outcome timeframe

12 months

Results posted on

2018-05-17

Participant milestones
Measure	Liprotamase Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement Liprotamase: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement
Overall Study STARTED	25
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	5

Reasons for withdrawal
Measure	Liprotamase Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement Liprotamase: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement
Overall Study Adverse Event	2
Overall Study Physician Decision	1
Overall Study Lack of Efficacy	1
Overall Study Withdrawal by Subject	1

EASY: Extended Access to Sollpura Over Years

Baseline characteristics by cohort
Measure	Liprotamase n=25 Participants Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement Liprotamase: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement
Age, Continuous	22.94 years STANDARD_DEVIATION 6.84 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

Timeframe: 12 months

Descriptive analysis

Outcome measures
Measure	Liprotamase n=25 Participants Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement Liprotamase: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement
Safety, as Measured by Number of Participants With Adverse Events Including Clinical or Laboratory Abnormalities Safety population	25 Participants
Safety, as Measured by Number of Participants With Adverse Events Including Clinical or Laboratory Abnormalities total number of subjects with adverse events	9 Participants

Serious events: 3 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events
Measure	Liprotamase n=25 participants at risk Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement Liprotamase: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement
Infections and infestations Infective pulmonary exacerbation of cystic fibrosis	8.0% 2/25 • Number of events 2 • 1 year
Injury, poisoning and procedural complications Scalded Skin	4.0% 1/25 • Number of events 1 • 1 year

Other adverse events
Measure	Liprotamase n=25 participants at risk Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement Liprotamase: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement
Gastrointestinal disorders Gastrointestinal disorders	8.0% 2/25 • Number of events 2 • 1 year
Hepatobiliary disorders Cholelithiasis	4.0% 1/25 • Number of events 1 • 1 year
Respiratory, thoracic and mediastinal disorders Hemoptoe	4.0% 1/25 • Number of events 1 • 1 year
Infections and infestations Infective pulmonary exacerbation of CF	16.0% 4/25 • Number of events 4 • 1 year
Infections and infestations Viral infection	8.0% 2/25 • Number of events 2 • 1 year
Injury, poisoning and procedural complications Scalded skin	4.0% 1/25 • Number of events 1 • 1 year
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	8.0% 2/25 • Number of events 2 • 1 year
Renal and urinary disorders Kidney stone	8.0% 2/25 • Number of events 2 • 1 year
Investigations Investigations	12.0% 3/25 • Number of events 3 • 1 year
Immune system disorders Minocycline allergy	4.0% 1/25 • Number of events 1 • 1 year
General disorders Abdominal pain	4.0% 1/25 • Number of events 1 • 1 year

Anthera Pharmaceuticals

Phone: 510-856-5600

Restriction type: OTHER