Clinical trial NCT03924947: A Study to Compare US Marketed Creon Manufactured With a Modernized Process at an Alternate Manufacturing Site and Manufactured With the Approved Manufacturing Process at an Alternate Active Pharmaceutical Ingredient Site, in Participants With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
Official title: A Phase 4 Study to Compare US Marketed Creon Drug Product With Drug Product Manufactured With a Modernized Process at an Alternate Manufacturing Site and With Drug Product Manufactured With the Approved Manufacturing Process at an Alternate Active Pharmaceutical Ingredient Site, in Subjects With EPI Due to Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis
Creon
Pancrelipase
ABT-SLV-245
Exocrine Pancreatic Insufficiency (EPI)
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-04-23
Enrollment: 36
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Part 1 is a study to demonstrate that Creon (pancrelipase) delayed release (DR) capsules manufactured with a modernized process (MP) is non-inferior to currently marketed pancrelipase DR capsules in participants with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF), as measured by coefficient of fat absorption (CFA). Part 2 is a study to demonstrate that Creon (pancrelipase) manufactured with an alternate active pharmaceutical ingredient site (AAPIS) is non-inferior to currently marketed active control (Creon®) in participants with EPI due to CF, as measured by CFA. Safety is evaluated in each part.


Eligibility criteria: Inclusion Criteria:

* Participant has a documented diagnosis of Cystic Fibrosis (CF) confirmed by:

  * a sweat chloride test \>= 60 mmol/L, and/or
  * documented CF-causing cystic fibrosis transmembrane conductance regulator (CFTR) mutations and clinical features of CF.
* Participant has diagnosis of moderate to severe Exocrine Pancreatic Insufficiency (EPI), as determined by Fecal Elastase 1 (FE-1) \< 15 μg/g at screening.
* Participant has EPI that is currently clinically controlled (no clinically overt steatorrhea or diarrhea) under treatment with a commercially available Pancreatic Enzyme Replacement Therapy (PERT), on an individually established dose regimen for more than 3 months prior to Screening, with a daily dose not exceeding 4,000 Lipase Units (LU)/g fat/day or 10,000 LU/kg/day.
* Participant is available for two (if participating in one of the parts) or four (if participating in both parts) hospitalization/confinement periods of 6 to 8 days each during the expected study window.
* Participant is able to consume a diet with 100 g fat/day, a minimum of 1 g/kg of protein/day and normal to low fiber content.

Exclusion Criteria:

* BMI percentile for age less than 10% in participants less than 18 years of age.
* Participant has a history of any of the following gastrointestinal disorders (acute pancreatitis within 6 months prior to Visit 2, chronic pancreatitis, fibrosing colonopathy, distal intestinal obstruction syndrome (DIOS) within 6 months prior to Visit 2, C. difficile infection within 6 months prior to Visit 2, celiac disease, gastric bypass or partial/total gastrectomy, Crohn's disease or other inflammatory bowel disease, small bowel surgery (other than minor resection due to meconium ileus without resultant malabsorption syndrome), or any type of malignancy involving the digestive tract in the last 5 years).
* Participant has a history of any clinically significant endocrine, respiratory (except mild asthma or CF related lung disease), neurological, cardiac, renal, hepatic (including Hepatitis B or C), hematologic or psychiatric disease or disorder, or any other uncontrolled medical illness which might limit participation in or completion of the study.
* Participant requires concomitant treatment with any medication not allowed by the protocol or a prohibited medication is expected to be needed during the study.
* Participant is currently receiving nutritional supplementation via tube feeding (nasogastric, gastrostomy, jejunostomy).
* Participant has clinically significant (as per Investigator's judgment) abnormalities in clinical chemistry, hematology, or urinalysis (excluding findings that are associated with CF) such as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels \>= 3 times the upper limit of normal values, or clinically significant (investigator opinion) elevation of uric acid.

Primary outcomes:
measure: Part 1 Coefficient of Fat Absorption (CFA)
timeFrame: Up to Day 8 of each DB treatment period
measure: Part 2 Coefficient of Fat Absorption (CFA)
timeFrame: Up to Day 8 of each DB treatment period
Secondary outcomes:
measure: Coefficient of Nitrogen Absorption (CNA)
timeFrame: Up to Day 8 of each DB treatment period
measure: Stool Fat
timeFrame: Up to Day 8 of each DB treatment period
measure: Stool Weight
timeFrame: Up to Day 8 of each DB treatment period
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California /ID# 164571
state: California
city: Ventura
country: United States
facility: Landon Pediatric Foundation /ID# 215411
state: California
city: Jacksonville
country: United States
facility: Nemours Children's Health System /ID# 164553
state: Florida
city: Orlando
country: United States
facility: Central FL Pulmonary Orlando /ID# 164558
state: Florida
city: Northfield
country: United States
facility: The Cystic Fibrosis Institute /ID# 210757
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics /ID# 164551
state: Iowa
city: Wichita
country: United States
facility: Via Christi Research /ID# 214266
state: Kansas
city: Cleveland
country: United States
facility: UH Cleveland Medical Center /ID# 206095
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Main Campus /ID# 212853
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital /ID# 225628
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia - Main /ID# 208114
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center /ID# 213434
state: Tennessee
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center Main Hospital /ID# 164574
state: Virginia
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: