EASY: Extended Access to Sollpura Over Years

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ClinicalTrials.gov Identifier: NCT02823964

Recruitment Status : Completed

First Posted : July 6, 2016

Results First Posted : May 17, 2018

Last Update Posted : May 17, 2018

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Anthera Pharmaceuticals

Study Type	Interventional
Study Design	Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions	Exocrine Pancreatic Insufficiency Cystic Fibrosis
Intervention	Drug: Liprotamase
Enrollment	25

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Liprotamase
Arm/Group Description	Oral, soluble, non-enterically coat...
Arm/Group Description	Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement Liprotamase: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement
Period Title: Overall Study
Started	25
Completed	20
Not Completed	5
Reason Not Completed
Adverse Event	2
Physician Decision	1
Lack of Efficacy	1
Withdrawal by Subject	1

Baseline Characteristics

Arm/Group Title		Liprotamase
Arm/Group Description		Oral, soluble, non-enterically coat...
Arm/Group Description		Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement Liprotamase: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement
Overall Number of Baseline Participants		25
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	25 participants
		22.94 (6.84)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	25 participants
	Female	11 44.0%
	Male	14 56.0%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	25 participants
	American Indian or Alaska Native	0 0.0%
	Asian	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	0 0.0%
	White	25 100.0%
	More than one race	0 0.0%
	Unknown or Not Reported	0 0.0%

Outcome Measures

1.Primary Outcome


Title	Safety, as Measured by Number of Participants With Adverse Events Including Clinical or Laboratory Abnormalities
Description	Descriptive analysis
Description	Descriptive analysis
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Liprotamase
Arm/Group Description:	Oral, soluble, non-enterically coat...
Arm/Group Description:	Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement Liprotamase: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement
Overall Number of Participants Analyzed	25
Measure Type: Count of Participants Unit of Measure: Participants
Safety population	25 100.0%
total number of subjects with adverse events	9 36.0%

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Liprotamase
Arm/Group Description	Oral, soluble, non-enterically coat...
Arm/Group Description	Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement Liprotamase: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement
All-Cause Mortality
	Liprotamase
	Affected / at Risk (%)
Total	0/25 (0.00%)
Serious Adverse Events Serious Adverse Events
	Liprotamase
	Affected / at Risk (%)	# Events
Total	3/25 (12.00%)
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis ^†	2/25 (8.00%)	2
Injury, poisoning and procedural complications
Scalded Skin ^†	1/25 (4.00%)	1
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Liprotamase
	Affected / at Risk (%)	# Events
Total	9/25 (36.00%)
Gastrointestinal disorders
Gastrointestinal disorders ^†	2/25 (8.00%)	2
General disorders
Abdominal pain ^†	1/25 (4.00%)	1
Hepatobiliary disorders
Cholelithiasis ^†	1/25 (4.00%)	1
Immune system disorders
Minocycline allergy ^†	1/25 (4.00%)	1
Infections and infestations
Infective pulmonary exacerbation of CF ^†	4/25 (16.00%)	4
Viral infection ^†	2/25 (8.00%)	2
Injury, poisoning and procedural complications
Scalded skin ^†	1/25 (4.00%)	1
Investigations
Investigations ^†	3/25 (12.00%)	3
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders ^†	2/25 (8.00%)	2
Renal and urinary disorders
Kidney stone ^†	2/25 (8.00%)	2
Respiratory, thoracic and mediastinal disorders
Hemoptoe ^†	1/25 (4.00%)	1
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Nicole Ramza
Organization:	Anthera Pharmaceuticals
Phone:	510-856-5600
EMail:	info@anthera.com

Layout table for additonal information

Responsible Party:	Anthera Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT02823964
Other Study ID Numbers:	AN-EPI3334
First Submitted:	June 29, 2016
First Posted:	July 6, 2016
Results First Submitted:	April 19, 2018
Results First Posted:	May 17, 2018
Last Update Posted:	May 17, 2018

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