Trial · NCT02279498
SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis
NCT02279498, Phase 3, Completed, Anthera Pharmaceuticals; results first posted 2018-08-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis. Trials, record NCT02279498. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02279498
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis
- NCT number
- NCT02279498
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 128 participants, actual
- Lead sponsor
- Anthera Pharmaceuticals
- Conditions
- Exocrine Pancreatic Insufficiency, Cystic Fibrosis
- Interventions
- Liprotamase, porcine (pig) PERT
- First posted
- 2014-10-31
- Last updated
- 2018-08-14
- Results first posted
- 2018-08-14
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment Difference in Coefficient of Fat Absorption (CFA) Change From Baseline | Baseline, 7 weeks | The primary endpoint evaluates the difference between treatment arms in change from baseline in coefficient of fat absorption (CFA). As such, descriptive statistics for individual treatment arms are not provided in this measure, but are reported in the secondary endpoints |
| Secondary | Coefficient of Fat Absorption (CFA) | Baseline, 7 weeks | Change from baseline in coefficient of fat absorption |
| Secondary | Coefficient of Nitrogen Absorption (CNA) | Baseline, 7 weeks | Change from baseline in coefficient of nitrogen absorption |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Treatment Difference in Coefficient of Fat Absorption (CFA) Change From Baseline | Baseline, 7 weeks | Analysis population evaluates all subjects who received at least one dose of study drug. Missing Visit 7 CFA values were multiply imputed using baseline CFA, baseline BMI, sex, age, acid suppression usage, and region. | percent change from baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Coefficient of Fat Absorption (CFA) | Baseline, 7 weeks | Analysis population evaluates observed case data without multiple imputation for missing values | fat absorbed as % of fat ingested | MEAN |
| SECONDARY | Coefficient of Nitrogen Absorption (CNA) | Baseline, 7 weeks | Analysis population evaluates observed case data without multiple imputation for missing values | percent of nitrogen ingested | MEAN |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Treatment Difference in Coefficient of Fat Absorption (CFA) Change From Baseline | Treatment Difference | -11.852 | 95% Confidence Interval -16.0 to -7.7 | percent change from baseline | |
| Coefficient of Fat Absorption (CFA) | Liprotamase | 76.5 | Standard Deviation 16.13 | fat absorbed as % of fat ingested | |
| Coefficient of Fat Absorption (CFA) | Porcine (Pig) PERT | 89.5 | Standard Deviation 5.84 | fat absorbed as % of fat ingested | |
| Coefficient of Nitrogen Absorption (CNA) | Liprotamase | 95.8 | Standard Deviation 2.46 | percent of nitrogen ingested | |
| Coefficient of Nitrogen Absorption (CNA) | Porcine (Pig) PERT | 97.5 | Standard Deviation 1.21 | percent of nitrogen ingested |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Liprotamase | 65 | |
| Overall Study | STARTED | Porcine (Pig) PERT | 63 | |
| Overall Study | COMPLETED | Liprotamase | 47 | |
| Overall Study | COMPLETED | Porcine (Pig) PERT | 59 | |
| Overall Study | NOT COMPLETED | Liprotamase | 18 | |
| Overall Study | NOT COMPLETED | Porcine (Pig) PERT | 4 |
Source ClinicalTrials.gov
Adverse events52
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Infective pulmonary exacerbation | Infections and infestations | Liprotamase | 13 | 65 | 13 |
| other | Infective pulmonary exacerbation | Infections and infestations | Porcine (Pig) PERT | 17 | 63 | 17 |
| other | Alanine aminotransferase increased | Investigations | Liprotamase | 2 | 65 | 2 |
| other | Alanine aminotransferase increased | Investigations | Porcine (Pig) PERT | 0 | 63 | 0 |
| other | Pyrexia | General disorders | Liprotamase | 1 | 65 | 1 |
| other | Pyrexia | General disorders | Porcine (Pig) PERT | 3 | 63 | 3 |
| other | Systemic inflammatory response syndrome | General disorders | Liprotamase | 1 | 65 | 1 |
| other | Systemic inflammatory response syndrome | General disorders | Porcine (Pig) PERT | 0 | 63 | 0 |
| other | Chest discomfort | General disorders | Liprotamase | 0 | 65 | 0 |
| other | Chest discomfort | General disorders | Porcine (Pig) PERT | 1 | 63 | 1 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Liprotamase | 0 | 65 |
| Total, all-cause mortality | Porcine (Pig) PERT | 0 | 63 |
| Total, other adverse events | Liprotamase | 41 | 65 |
| Total, other adverse events | Porcine (Pig) PERT | 38 | 63 |
| Total, serious adverse events | Liprotamase | 7 | 65 |
| Total, serious adverse events | Porcine (Pig) PERT | 6 | 63 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32761612 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Liprotamase vs Porcine (Pig) PERT: deaths from any cause | Trial comparisons |
| Liprotamase vs Porcine (Pig) PERT: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02279498
GET https://conductscience.org/api/trials/v1/NCT02279498/events?page=2