Long-term Study in US Cystic Fibrosis Patients Receiving Digestive Enzyme Supplements to Assess Narrowing of the Large Intestine Causing Adverse Intestinal Symptoms (Fibrosing Colonopathy)

• Register: ClinicalTrials.gov
• Last refreshed on: 29 March 2021
• Main ID: NCT01652157
• Date of registration: 25/07/2012
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• Public title: Long-term Study in US Cystic Fibrosis Patients Receiving Digestive Enzyme Supplements to Assess Narrowing of the Large Intestine Causing Adverse Intestinal Symptoms (Fibrosing Colonopathy)
• Scientific title: A Long-Term Prospective Observational Safety Study of the Incidence of and Risk Factors for Fibrosing Colonopathy in US Patients With Cystic Fibrosis Treated With Pancreatic Enzyme Replacement Therapy: A Harmonized Protocol Across Sponsors(The CF-FC Study)
• Date of first enrolment: July 31, 2012
• Target sample size: 17
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01652157
• Study type: Observational

Countries of recruitment

United States

Contacts

• Name: Craig Peterson
• Affiliation: VIVUS, Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

The inclusion criteria for enrollment in the Base Study Population

- Diagnosed with cystic fibrosis,

- Enrolled in the Cystic Fibrosis Patient Registry

- Receiving medical care at a Cystic Fibrosis Foundation-accredited care center
providing data to the Cystic Fibrosis Patient Registry

Exclusion Criteria:

- None



Age minimum: N/A
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Fibrosing Colonopathy

Intervention(s)

Biological: CREON

Biological: ULTRESA

Biological: PANCREAZE

Biological: ZENPEP

Biological: other non-sponsor pancreatic enzyme replacement therapy

Biological: PERTZYE

Other: No pancreatic enzyme replacement therapy

Primary Outcome(s)

Incidence rate of fibrosing colonopathy confirmed by an independent adjudication panel in patients receiving PANCREAZE [Time Frame: up to 10 years]

Incidence rate of fibrosing colonopathy confirmed by an independent adjudication panel in patients not receiving pancreatic enzyme therapy. [Time Frame: up to 10 years]

Incidence rate of fibrosing colonopathy confirmed by an independent adjudication panel in patients receiving non-sponsor pancreatic enzyme replacement therapy [Time Frame: up to 10 years]

Incidence rate of fibrosing colonopathy confirmed by an independent adjudication panel in patients receiving PERTZYE. [Time Frame: up to 10 years]

Incidence rate of fibrosing colonopathy confirmed by an independent adjudication panel in patients receiving ULTRESA [Time Frame: up to 10 years]

Incidence rate of fibrosing colonopathy confirmed by an independent adjudication panel in patients receiving CREON [Time Frame: up to 10 years]

Incidence rate of fibrosing colonopathy confirmed by an independent adjudication panel in patients receiving ZENPEP [Time Frame: up to 10 years]

Secondary Outcome(s)

Odds ratio (95% confidence interval) to quantify the association between possible risk factors and confirmed fibrosing colonopathy [Time Frame: up to 10 years]

Secondary ID(s)

CFFC-OB-11

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Digestive Care, Inc.

Cystic Fibrosis Foundation

Nestle Health Science

VIVUS, Inc.