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Lipase

Adrulipase for Cystic Fibrosis (SPAN Trial)

Phase 2
Waitlist Available
Research Sponsored by First Wave Bio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of 3-week treatment period.
Awards & highlights

Summary

This trial will study the safety and efficacy of using a non-porcine lipase as a potential treatment for cystic fibrosis patients with EPI.

Eligible Conditions
  • Cystic Fibrosis
  • Pancreatic Insufficiency

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of 3-week treatment period.
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of 3-week treatment period. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy of adrulipase: Coefficient of fat absorption (CFA)
Safety of adrulipase
Secondary outcome measures
Coefficient of Nitrogen absorption (CNA)
Stool weight

Trial Design

1Treatment groups
Experimental Treatment
Group I: AdrulipaseExperimental Treatment1 Intervention
Upon study enrolment, the patient will be switched from their commercial PERT to receive adrulipase. Patients will initially receive a low dose of adrulipase. Upon the appearance of EPI symptoms, lasting at least three days, and upon discussion with the investigator, the patient will be switched to the medium dose of adrulipase. If signs and symptoms of EPI persist for three or more days, the patient will be switched to the high dose of adrulipase.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
adrulipase
2023
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

First Wave Bio, Inc.Lead Sponsor
6 Previous Clinical Trials
261 Total Patients Enrolled
2 Trials studying Cystic Fibrosis
68 Patients Enrolled for Cystic Fibrosis
Entero TherapeuticsLead Sponsor
6 Previous Clinical Trials
261 Total Patients Enrolled
2 Trials studying Cystic Fibrosis
68 Patients Enrolled for Cystic Fibrosis
First Wave BioPharma, Inc.Lead Sponsor
6 Previous Clinical Trials
261 Total Patients Enrolled
2 Trials studying Cystic Fibrosis
68 Patients Enrolled for Cystic Fibrosis

Media Library

Adrulipase (Lipase) Clinical Trial Eligibility Overview. Trial Name: NCT05719311 — Phase 2
Cystic Fibrosis Research Study Groups: Adrulipase
Cystic Fibrosis Clinical Trial 2023: Adrulipase Highlights & Side Effects. Trial Name: NCT05719311 — Phase 2
Adrulipase (Lipase) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05719311 — Phase 2
~5 spots leftby Jul 2025