Open Label Safety Study of DCI-1020 in Pediatric Cystic Fibrosis (CF) Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00663975
• Date of registration: 17/04/2008
• Prospective Registration: Yes
• Primary sponsor: Digestive Care, Inc.
• Public title: Open Label Safety Study of DCI-1020 in Pediatric Cystic Fibrosis (CF) Patients
• Scientific title: An Open-Label, Multi-Center Safety and Efficacy Study of DCI-1020 in Pediatric Cystic Fibrosis Patients With Exocrine Pancreatic Insufficiency
• Date of first enrolment: February 2009
• Target sample size: 24
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT00663975
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Tibor Sipos, PhD
• Affiliation: DCI

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female age = 2 years of age

- Confirmed diagnosis of CF based on the following criteria:

- One or more clinical features consistent with the CF phenotype, AND

- Positive sweat chloride = 60 mEq/liter (by pilocarpine iontophoresis), OR

- Genotype with two identifiable mutations consistent with CF

- Adequate nutritional status

- Pancreatic insufficiency documented by spot fecal elastase-1 (FE 1) greater or equal
to 100 micrograms/g stool

- Clinically stable with no evidence of an acute medical condition

- Parent/Guardian able to understand and sign a written informed consent and comply
with the requirements of the study

Exclusion Criteria:

- History of fibrosing colonopathy

- History of being refractory to pancreatic enzyme replacement therapy

- Solid organ transplant

- History of intra-abdominal surgery

- A current diagnosis or a history of distal intestinal obstruction syndrome (DIOS) in
the past six (6) months, or 2 or more episodes of DIOS in the past twelve (12) months

- Conditions known to increase fecal fat loss including: inflammatory bowel disease ,
celiac disease, Crohn's disease, tropical Sprue, Whipple's disease

- A known contraindication, sensitivity or hypersensitivity to porcine pancreatic
enzymes

- Active liver disease with liver enzymes (alanine aminotransferase (ALT/SGPT),
aspartate aminotransferase (AST/SGOT) or bilirubin = 3 times the upper limit of
normal

- Acute pancreatitis or acute exacerbation of chronic pancreatitis

- Antibiotic use as follows:

- Acute treatment with any systemic (oral or IV) antibiotics two (2) weeks prior to
screening

- Treatment with erythromycin and unwilling to discontinue the treatment two (2) weeks
prior to the screening. (azithromycin is allowed)

- Change in chronic treatment with systemic (oral and IV) antibiotics during the trial

NOTE:

Study patient may remain on a chronic regimen of systemic (oral or IV) antibiotics (with
exception of erythromycin), if he/she started the antibiotics at least 2 weeks prior to
study screening, was at his/her usual bowel pattern at the time of screening, and does not
stop or change these antibiotics during the study.

- Receiving enteral tube feeding during the study

- Breast feeding during the study (expressed breast milk may be used, but not feeding
at the breast)

- Expected inability to cooperate with or be non-adherent to required study procedures

- Use of narcotics

- Poorly controlled diabetes

- Participation in an investigational study of a drug, biologic, or device not
currently approved for marketing, within 30 days of screening visit

- A medical condition which the investigator deems significant enough to interfere with
the ability of the study patient to participate in the trial or interfering with
assessment of effects of enzyme therapy on fat absorption



Age minimum: N/A
Age maximum: 2 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Digestive System Diseases

Exocrine Pancreatic Insufficiency

Pancreatic Disease

Cystic Fibrosis

Intervention(s)

Drug: DCI 1020

Primary Outcome(s)

Quantitative fecal fat content (%of fat/g of dry stool) in the spot stool samples collected over the 3 day In-home Treatment Period [Time Frame: 3 consecutive days]

Secondary ID(s)

DCI 07-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors