RESULT: Reliable, Emergent Solution Using Liprotamase Treatment
Public ClinicalTrials.gov record NCT03051490. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Liprotamase powder is a non-porcine, soluble and stable mixture of biotechnology-derived lipase, protease, and amylase digestive enzymes. The purpose of the present study is to to evaluate the non-inferiority of liprotamase compared with porcine-derived, enterically-coated pancreatic enzyme replacement therapy (PERT). The primary efficacy endpoint of the study will be comparative efficacy measured as the change from baseline in the coefficient of fat absorption (CFA) in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI).
Study identification
- NCT ID
- NCT03051490
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 140 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 7 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 28, 2017 (Actual)
- Primary completion
- Feb 28, 2018 (Actual)
- Completion
- Jun 2018 (Estimated)
- Last update posted
- Mar 8, 2018
2017 – 2018
United States locations
- U.S. sites
- 28
- U.S. states
- 19
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigator Site 139 | Little Rock | Arkansas | 72202 | — |
| Investigator Site #123 | Long Beach | California | 90806 | — |
| Investigator Site 107 | Los Angeles | California | 90033 | — |
| Investigator Site 143 | Orange | California | 92868 | — |
| Investigator Site 150 | Denver | Colorado | 80206 | — |
| Investigator Site 147 | Wilmington | Delaware | 19803 | — |
| Investigator Site 117 | Altamonte Springs | Florida | 32701 | — |
| Investigator Site 102 | Jacksonville | Florida | 32207 | — |
| Investigator Site 130 | Miami | Florida | 33136 | — |
| Investigator Site 151 | West Palm Beach | Florida | 33407 | — |
| Investigator Site 110 | Atlanta | Georgia | 30342 | — |
| Investigator Site 109 | Glenview | Illinois | 60025 | — |
| Investigator Site 148 | Iowa City | Iowa | 52242 | — |
| Investigator Site #122 | Louisville | Kentucky | 40202 | — |
| Investigator Site 132 | Portland | Maine | 04102 | — |
| Investigator Site 124 | Ann Arbor | Michigan | 48109 | — |
| Investigator Site 140 | Kalamazoo | Michigan | 49008 | — |
| Investigator Site 134 | Jackson | Mississippi | 39216 | — |
| Investigator Site 135 | Las Vegas | Nevada | 89107 | — |
| Investigator Site 118 | Durham | North Carolina | 27710 | — |
| Investigator Site #103 | Cleveland | Ohio | 44106 | — |
| Site Investigator #113 | Toledo | Ohio | 43606 | — |
| Investigator Site 101 | Oklahoma City | Oklahoma | 73104 | — |
| Investigator Site 136 | Oklahoma City | Oklahoma | 73112 | — |
| Investigator Site 106 | Hershey | Pennsylvania | 17033 | — |
| Investigator Site 111 | Dallas | Texas | 75235 | — |
| Investigator Site 116 | Houston | Texas | 77030 | — |
| Investigator Site 112 | Richmond | Virginia | 23298 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 22 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03051490, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 8, 2018 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03051490 live on ClinicalTrials.gov.