Exocrine Pancreatic InsufficiencyPhase 3SIMPLICITYNCT02734810
SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis
A Phase 3 study testing Liprotamase Powder for Oral Solution in people with Exocrine Pancreatic Insufficiency and Cystic Fibrosis, run by Anthera Pharmaceuticals at 21 sites in United States.
Trial summary
Liprotamase consists of 3 soluble, non-porcine digestive enzymes, lipase, protease, and amylase, combined in a fixed ratio. Liprotamase is stable in the stomach and can be formulated without enteric coating for administration either as a capsule or as a dosing solution dissolved in water or juice. Read more about this study
- Who is it for?
- Ages 28 days and older
- Conditions the study is for
- Exocrine Pancreatic Insufficiency, Cystic Fibrosis
- What is being tested?
- Liprotamase Powder for Oral Solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 21 sitesUnited States
- Study dates
- Jun 2016to Mar 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- For Part A: males or females ≥7 years of age
- For Part B: males or females 28 days to <7 years
- Diagnosis of cystic fibrosis based on presentation, genotype and/or sweat chloride
- Low fecal elastase
- Fair-to-good nutritional status
Who cannot join
- History or diagnosis of fibrosing colonopathy
- Distal intestinal obstruction syndrome in 6 months prior to screening
- Receiving enteral tube feedings
- Chronic diarrheal illness unrelated to pancreatic insufficiency
- Liver abnormalities, or liver or lung transplant, or significant bowel resection
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Investigator Site 117
Altamonte Springs, Florida, 32701
Investigator Site 124
Ann Arbor, Michigan, 48109-5212
Investigator Site 110
Atlanta, Georgia, 30342
Investigator Site 114
Aurora, Colorado, 80045
Investigator Site 111
Dallas, Texas, 75390-9063
Investigator Site 118
Durham, North Carolina, 27710
Investigator Site 109
Glenview, Illinois, 60025
Investigator Site 106
Hershey, Pennsylvania, 17033
Investigator Site 138
Hollywood, Florida, 33021
Investigator Site 116
Houston, Texas, 77030
Investigator Site 135
Las Vegas, Nevada, 89107
Investigator Site 139
Little Rock, Arkansas, 72202
Investigator Site 122
Louisville, Kentucky, 40202
Investigator Site 130
Miami, Florida, 33136
Investigator Site 129
Morgantown, West Virginia, 26506
Investigator Site 101
Oklahoma City, Oklahoma, 73104
Investigator Site 136
Oklahoma City, Oklahoma, 73112
Investigator Site
Orange, California, 92868
Investigator Site 132
Portland, Maine, 04102
Investigator Site 112
Richmond, Virginia, 23298
Investigator Site 105
Wichita, Kansas, 67214
About this study
Official title: A Phase 3, Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency
Liprotamase consists of 3 soluble, non-porcine digestive enzymes, lipase, protease, and amylase, combined in a fixed ratio. Liprotamase is stable in the stomach and can be formulated without enteric coating for administration either as a capsule or as a dosing solution dissolved in water or juice. The purpose of the present study is to provide efficacy and safety data for a new, soluble formulation of liprotamase, Liprotamase Powder for Oral Solution, in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI).
- Conditions
- Exocrine Pancreatic Insufficiency, Cystic Fibrosis
- Being tested
- Liprotamase Powder for Oral Solution
- Keywords
- Exocrine Pancreatic Insufficiency, Cystic Fibrosis, Liprotamase, Pancreatic Enzyme Replacement Therapy (PERT)
- Medical subject headings
- Exocrine Pancreatic Insufficiency, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liprotamase Powder for Oral SolutionDrug
Also called Liprotamase
Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Liprotamase Powder for Oral Solution in Subjects aged ≥7 years of age Receives: Drug: Liprotamase Powder for Oral Solution |
| Part B | Experimental | Liprotamase Powder for Oral Solution in Subjects aged 28 days to <7 years Receives: Drug: Liprotamase Powder for Oral Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Number of subjects reporting 1 or more adverse events
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Exocrine Pancreatic InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anthera Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02734810
- Sponsor's protocol ID
- AN-EPI3332
- Acronym
- SIMPLICITY
- Status last verified
- Apr 2018
- First submitted
- 6 Apr 2016
- Last updated
- 11 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency
- ClinicalTrials.gov ID
- NCT02734810
- Acronym / sponsor ID
- SIMPLICITY / AN-EPI3332
- Conditions
- Exocrine Pancreatic Insufficiency, Cystic Fibrosis
- Keywords
- Exocrine Pancreatic Insufficiency, Cystic Fibrosis, Liprotamase, Pancreatic Enzyme Replacement Therapy (PERT)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Anthera PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 12 Apr 2016 (estimated)
- Results
- Posted 11 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Liprotamase consists of 3 soluble, non-porcine digestive enzymes, lipase, protease, and amylase, combined in a fixed ratio. Liprotamase is stable in the stomach and can be formulated without enteric coating for administration either as a capsule or as a dosing solution dissolved in water or juice. The purpose of the present study is to provide efficacy and safety data for a new, soluble formulation of liprotamase, Liprotamase Powder for Oral Solution, in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: Liprotamase Powder for Oral SolutionLiprotamase Powder for Oral Solution in Subjects aged ≥7 years of age |
| Part B | Experimental | Drug: Liprotamase Powder for Oral SolutionLiprotamase Powder for Oral Solution in Subjects aged 28 days to <7 years |
Who may qualify
- Ages
- 28 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- For Part A: males or females ≥7 years of age
- For Part B: males or females 28 days to <7 years
- Diagnosis of cystic fibrosis based on presentation, genotype and/or sweat chloride
- Low fecal elastase
- Fair-to-good nutritional status
Key exclusion criteria (5 listed)
- History or diagnosis of fibrosing colonopathy
- Distal intestinal obstruction syndrome in 6 months prior to screening
- Receiving enteral tube feedings
- Chronic diarrheal illness unrelated to pancreatic insufficiency
- Liver abnormalities, or liver or lung transplant, or significant bowel resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liprotamase Powder for Oral SolutionAlso: LiprotamaseOral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy | Drug | Part A, Part B |
Primary outcome
Safety
Time frame: 1 week
Number of subjects reporting 1 or more adverse events
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Liprotamase Powder for Oral Solution in people with Exocrine Pancreatic Insufficiency and Cystic Fibrosis, run by Anthera Pharmaceuticals at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.