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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
No Placebo-Only Group
Summary
This trial tests a new enzyme called adrulipase to help adults with cystic fibrosis digest food better. It aims to see if adrulipase is safe and works as well as or better than current pig-derived enzymes. The study will monitor how well patients can absorb fats and their overall digestive health.
Eligible Conditions
- Cystic Fibrosis
- Pancreatic Insufficiency
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ end of 3-week treatment period.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of 3-week treatment period.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Efficacy of Adrulipase: Coefficient of Fat Absorption (CFA)
Safety of Adrulipase
Secondary study objectives
Coefficient of Nitrogen Absorption (CNA)
Stool Weight
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
9 Previous Clinical Trials
397 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of a condition called fibrosing colonopathy.For adult males who are 18 years old or older, you need to have a body mass index (BMI) of 16.5 or higher.You have long-term diarrhea that is not caused by problems with your pancreas.You must be in good health and have a balanced diet.
Research Study Groups:
This trial has the following groups:- Group 1: Adrulipase
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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