Exocrine Pancreatic InsufficiencyPhase 4NCT02823964
EASY: Extended Access to Sollpura Over Years
A Phase 4 study testing Liprotamase in people with Exocrine Pancreatic Insufficiency and Cystic Fibrosis, run by Anthera Pharmaceuticals at 15 sites in 6 countries.
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 7 years and older
- Conditions the study is for
- Exocrine Pancreatic Insufficiency, Cystic Fibrosis
- What is being tested?
- Liprotamase
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 15 sitesin 6 countries
- Study dates
- Sep 2016to Mar 2018
- Phase
- Phase 4
- 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 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female subjects with cystic fibrosis-related exocrine pancreatic insufficiency who received liprotamase and completed Study AN-EPI3331 (SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis)
Who cannot join
- Any medical, psychological, or social condition that may put the subject at increased risk by participating in this study.
- Females who are nursing, pregnant, intending to become pregnant, or intending to nurse during the time of the study.
Trial locations and contacts
15 sites in 6 countries.
15 sites in 6 countries
Poland5 sites
Investigator Site 203
Karpacz, 58-540
Investigator Site 206
Lodz, 90-329
Investigator Site 205
Lublin, 20-362
Investigator Site 202
Rabka-Zdrój, 34-700
Investigator Site 209
Rzeszów, 35-612
Hungary4 sites
Investigator Site 301
Ajka, Veszprém megye, 8400
Investigator Site 303
Debrecen, Hajdú-Bihar, 4031
Investigator Site 304
Mosdós, Somogy County, 7257
Investigator Site 302
Törökbálint, Pest County, 2045
United States3 sites
Investigator Site 114
Aurora, Colorado, 80045
Investigator Site 121
Burlington, Vermont, 05401
Investigator Site 134
Jackson, Mississippi, 39216
About this study
Official title: An Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
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 the detailed description
The purpose of the present study is to evaluate the safety of long-term use of liprotamase in the management of cystic fibrosis-related exocrine pancreatic insufficiency
- Conditions
- Exocrine Pancreatic Insufficiency, Cystic Fibrosis
- Being tested
- Liprotamase
- Keywords
- exocrine pancreatic insufficiency, cystic fibrosis, pancreatic enzyme replacement therapy
- 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.
LiprotamaseDrug
Also called Sollpura
Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement
| Study group | Role | What they receive |
|---|---|---|
| Liprotamase | Experimental | Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement Receives: Drug: Liprotamase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, as Measured by Number of Participants With Adverse Events Including Clinical or Laboratory Abnormalities
Descriptive analysis
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startSep 2016
- Primary completionMar 2018
- Study completionMar 2018
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 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
- NCT02823964
- Sponsor's protocol ID
- AN-EPI3334
- Status last verified
- Apr 2018
- First submitted
- 29 Jun 2016
- Last updated
- 17 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 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT02823964
- Acronym / sponsor ID
- AN-EPI3334
- Conditions
- Exocrine Pancreatic Insufficiency, Cystic Fibrosis
- Keywords
- exocrine pancreatic insufficiency, cystic fibrosis, pancreatic enzyme replacement therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Anthera PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 6 Jul 2016 (estimated)
- Results
- Posted 17 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.
Detailed description
The purpose of the present study is to evaluate the safety of long-term use of liprotamase in the management of cystic fibrosis-related exocrine pancreatic insufficiency
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liprotamase | Experimental | Drug: LiprotamaseOral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female subjects with cystic fibrosis-related exocrine pancreatic insufficiency who received liprotamase and completed Study AN-EPI3331 (SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis)
Key exclusion criteria (2 listed)
- Any medical, psychological, or social condition that may put the subject at increased risk by participating in this study.
- Females who are nursing, pregnant, intending to become pregnant, or intending to nurse during the time of the study.
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 |
|---|---|---|
| LiprotamaseAlso: SollpuraOral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement | Drug | Liprotamase |
Primary outcome
Safety, as Measured by Number of Participants With Adverse Events Including Clinical or Laboratory Abnormalities
Time frame: 12 months
Descriptive analysis
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 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.
15 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liprotamase in people with Exocrine Pancreatic Insufficiency and Cystic Fibrosis, run by Anthera Pharmaceuticals at 15 sites in 6 countries.
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 1 inclusion and 2 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 17 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 15 sites in Poland, Hungary, United States, Czechia, Israel and 1 more country. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 17 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, as Measured by Number of Participants With Adverse Events Including Clinical or Laboratory Abnormalities (time frame: 12 months). 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 17 May 2018.