NA

• Register: EUCTR
• Last refreshed on: 30 April 2018
• Main ID: EUCTR2016-002851-92-ES
• Date of registration: 08/08/2016
• Prospective Registration: Yes
• Primary sponsor: ANTHERA Pharmaceuticals, Inc.
• Public title: NA
• Scientific title: An Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis - EASY: Extended Access to Sollpura over Years
• Date of first enrolment: 19/09/2016
• Target sample size: 70
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-002851-92
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Canada, Czech Republic, Hungary, Israel, Poland, Spain, United States

Contacts

• Name: Nicole Ramza
• Affiliation: Anthera Pharmaceuticals, Inc.

• Name: Nicole Ramza
• Affiliation: Anthera Pharmaceuticals, Inc.

Key inclusion & exclusion criteria

Inclusion criteria:
Subjects are eligible for enrollment if they meet the following inclusion criteria:
1. Male or female subjects who received liprotamase and completed Study AN-EPI3331.
2. Signed informed consent by subject and/or subject’s legally authorized representative.
Are the trial subjects under 18? yes
Number of subjects for this age range: 35
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Any medical, psychological, or social condition that, at the discretion of the investigator, may put the subject at increased risk by participating in this study or confound interpretation of study results.
2. Treatment with any PERT other than study drug, investigational drugs, or devices
3. Females who are nursing, pregnant, intending to become pregnant, or intending to nurse during the time of the study, or who have a positive pregnancy test at Visit Day 1. All sexually-active subjects of reproductive potential are required to remain on a reliable method of birth control. Females and males are required to continue using a reliable method of birth control throughout the study, and for at least 3 months following completion of study therapy. A reliable method of birth control is defined as one of the following: oral or injectable contraceptives, intrauterine device, contraceptive implants, tubal ligation, hysterectomy, or a double-barrier method (diaphragm with spermicidal foam or jelly, or a condom), abstinence or vasectomy.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

Product Name: Liprotamasa
Pharmaceutical Form: Capsule
INN or Proposed INN: SIN ASIGNAR
CAS Number: 9001-62-1
Other descriptive name: LIPASA
Concentration unit: IU international unit(s)
Concentration type: range
Concentration number: 10000-40000
INN or Proposed INN: SIN ASIGNAR
CAS Number: 9000-99-1
Other descriptive name: PROTEASA
Concentration unit: IU international unit(s)
Concentration type: range
Concentration number: 10000-40000
INN or Proposed INN: SIN ASIGNAR
CAS Number: 9000-90-2
Other descriptive name: AMILASA
Concentration unit: IU international unit(s)
Concentration type: range
Concentration number: 1500-6000

Primary Outcome(s)

Primary end point(s): The primary objective of this study is to evaluate the safety of long-term use of liprotamase in the management of EPI due to CF amongst subjects who received liprotamase and completed the prior study with liprotamase (AN-EPI3331). Safety will be evaluated based on adverse events (AEs) and serious AEs (SAEs); including but not limited to abnormal laboratory results, abnormal findings in physical examinations, and abnormal vital signs deemed clinically significant by the investigator.
By-subject listings of all AEs, including abnormal and clinically significant vital sign parameters and physical examination results will be presented.

Secondary Objective: The secondary endpoints will include:
• Change in weight, height, and BMI from baseline.
• Changes in measures of growth including weight, height, and BMI relative to population anthropomorphic measures.
• Signs and symptoms of malabsorption including stool frequency, stool consistency, bloating, steatorrhea, abdominal pain, and flatulence compared with baseline.

Timepoint(s) of evaluation of this end point: At each study Visit during the treatment period.

Main Objective: The primary objective of this study is to evaluate the safety of long-term use of liprotamase in the management of Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency (EPI). Safety will be evaluated based on the occurrence of adverse events (AEs) and serious AEs (SAEs); including but not limited to abnormal laboratory results, abnormal findings in physical examinations and abnormal vital signs deemed clinically significant by the investigator.

Secondary Outcome(s)

Secondary end point(s): In this study efficacy will be evaluated from measures of body weight and BMI (for adults) and growth (for pediatric subjects) relative to baseline and/or relative to published population growth charts. In addition, efficacy (i.e. control of EPI) will be evaluated from the signs and symptoms of malabsorption. The secondary endpoints will include:
• Change in weight, height, and BMI from baseline.
• Changes in measures of growth including weight, height, and BMI relative to population anthropomorphic measures.
• Signs and symptoms of malabsorption including stool frequency, stool consistency, bloating, steatorrhea, abdominal pain, and flatulence compared with baseline.
For efficacy analyses of change from baseline, baseline will be defined as the last observation prior to initiation of liprotamase dosing.

Timepoint(s) of evaluation of this end point: At each study Visit during the treatment period.

Secondary ID(s)

062,037

2016-002851-92-HU

AN-EPI3334

NCT02823964

Source(s) of Monetary Support

Anthera Pharmaceuticals, Inc.