Phase 4
Completed N=15
PR-018: An Open-Label, Safety Extension of Study PR-011
Source: ClinicalTrials.gov NCT01131507 ↗Enrolled (actual)
15
Serious AEs
20.0%
Results posted
Mar 2014
Primary outcomePrimary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) — 15; 3; 10; 4 participants
Summary
A study to evaluate long term safety and effect on ability to thrive of EUR-1008 (APT-1008) 3,000 lipase units (Zenpep® [pancrelipase] delayed release capsules) in infants with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
15; 3; 10; 4; 1; 5 | — |
| SECONDARY Change From Baseline in Growth Percentiles at Month 3, 6, 9 and 12 |
22.0; 2.0; 6.0; 4.0; 5.5; 36.5 | — |
Eligibility Criteria
Inclusion Criteria
- Participant's parent or guardian signed informed consent form (ICF)
- Participants who have completed study PR-011 (NCT01100606)
Exclusion Criteria
- Participant having any condition that would, in the investigator's opinion, limit the participant's ability to complete the study or will result in excess risk to the participant that is above the standard of care
Data sourced from ClinicalTrials.gov (NCT01131507). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.