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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
SPAN Trial 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
SPAN Trial 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
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
SPAN 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
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned Adrulipase for medical use?
"Adrulipase has been assessed with a safety score of 2 on the Power scale, as it is currently undergoing Phase 2 trials. This indicates that although some evidence exists to support its safety, no data can yet confirm efficacy."
Answered by AI
Are there still opportunities for members of the public to join this experiment?
"As per the clinicaltrials.gov page, this medical research is still open for enrolment. The trial was initially posted on February 1st 2023 and recently updated in January 31st of the same year."
Answered by AI
How many individuals are participating in this experiment?
"The trial requires 12 patients who meet the prerequisites and are willing to attend one of two locations: The Cystic fibrosis Institute in Northfield, Illinois or Layish Childrens Lung Specialists in Las Vegas, Nevada."
Answered by AI
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