Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP) (CHIP)

Viatris

Status and phase: Terminated; Phase 3

Conditions: Adenomatous Polyposis Coli

Treatments: Drug: Placebo; Drug: Celecoxib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00585312

A3191193

Details and patient eligibility

About

To test whether celecoxib can be used to prevent colon polyp formation in children with familial adenomatous polyposis (FAP).

Full description

Per DMC recommendation, the study was terminated early (31Oct2013) due to low enrollment and low endpoint accumulation rate. No safety concerns were involved in the decision to terminate the study.

Enrollment: 106 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 10-17 years
• Confirmed deleterious FAP genotype based on central genetic testing or personal history ot >2 colorectal adenomas and a parent with the diagnosis of FAP and either A, B or C below A: Non-attenuated FAP genotype B: Attenuated FAP genotype and a personal history of colorectal adenomas and a first degree relative with FAP C: No genotype identified with a personal history of > 2 adenomas and have a parent with FAP
• Less than 30 polyps, which need to be removed to render the colon polyp-free before study drug can be given

Exclusion criteria

• Diagnosis of attenuated FAP based on central genetic testing in the absence of a personal history of >2 colorectal adenomas and a first degree relative (parent or sibling) with FAP.
• Sensitivity to COX-2 inhibitors

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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106 participants in 2 patient groups, including a placebo group

Celecoxib

Experimental group

Description:

celecoxib, 16 mg/kg/day, for 5 years

Treatment:

Drug: Celecoxib

Placebo

Placebo Comparator group

Description:

Masked, placebo comparator

Treatment:

Drug: Placebo