Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-24 @ 7:57 PM
NCT ID:
NCT00449904
Eligibility Criteria:
Inclusion Criteria
* Females of childbearing potential must be willing to use birth control
* Diagnosis of CF based upon the following criteria:
* Two clinical features consistent with CF; and either
* A genotype with two identifiable mutations consistent with CF, or
* Sweat chloride \> 60 milliequivalents per liter (mEq/L) by quantitative pilocarpine iontophoresis.
* Clinically stable with no evidence of acute upper or lower respiratory tract infection
* Exocrine pancreatic insufficiency (PI) determined by fecal elastase \< 100 micrograms per gram (µg/g) measured at Screening
* Able to take pancreatic enzyme supplementation in the form of capsules
* Able to perform the testing and procedures required for this study, as judged by the Investigator
Exclusion Criteria:
* Age \<7 years
* Pregnancy, breastfeeding or of childbearing potential and not willing to use birth control
* Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to Screening
* History of fibrosing colonopathy
* History of liver transplant, lung transplant or significant surgical resection of the bowel
* Any chronic diarrheal illness unrelated to PI
* Abnormal liver function (except for patients with Gilbert Syndrome)
* Signs and/or symptoms of liver cirrhosis or portal hypertension (e.g., splenomegaly, ascites, esophageal varices), or documented liver disease unrelated to CF
* Unable to discontinue enteral tube feedings during the study
* Any condition that the Investigator believes would interfere with the intent of this study or would make participation not in the best interest of the patient
* Baseline coefficient of fat absorption (CFA) ≥ 93% from the Phase III efficacy study
* Patient is unlikely to complete the study, as determined by the Investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Study:
NCT00449904
Study Brief:
Protocol Section:
NCT00449904