Oral TheraCLEC™ - Total in Cystic Fibrosis Subjects With Exocrine Pancreatic Insufficiency

Anthera Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Pancreatic Insufficiency; Cystic Fibrosis

Treatments: Drug: Liprotamase; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00095732

14269

I5L-MC-TCAA (Other Identifier)

TC-2A (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine the most effective dose of a new enzyme therapy on oral nutrient absorption in cystic fibrosis (CF) subjects with exocrine pancreatic insufficiency.

Enrollment: 129 patients

Sex: All

Ages: 7+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pancreatic insufficiency (PI) documented by fecal elastase <100 mcg/gram measured at screening

• Diagnosis of CF based upon the following criteria:

  • two clinical features consistent with CF AND
  • either genotype with two identifiable mutations consistent with CF OR
  • sweat chloride > 60 mEq/L by quantitative pilocarpine iontophoresis

• Forced Expiratory Volume Over One Second (FEV1) ≥30% predicted

• Clinically stable with no evidence of acute upper or lower respiratory tract infection

Exclusion criteria

• Pregnancy, breastfeeding or of childbearing potential and/or not willing to use accepted methods of birth control during enrollment in the study
• History of fibrosing colonopathy
• History of liver transplant or lung transplant
• Unable to discontinue enteral tube feedings during the study
• Subject weight <40 kg
• Known hypersensitivity to food additives
• Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to screening
• Unable to discontinue the use of pancreatic enzymes for a 72-hour period or any other condition that the investigator believes would interfere with the intent of this study or would make study participation not in the best interest of the subject

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

129 participants in 3 patient groups

Low Liprotamase Dose

Experimental group

Description:

Liprotamase in a fixed combination of lipase (5,000 units), protease (5,000 units) and amylase (750 units) administered orally (one Size 5 capsule of liprotamase and five Size 2 capsules of placebo) with each of three meals and two snacks daily for 28 days

Treatment:

Drug: Liprotamase

Drug: Placebo

Mid Liprotamase Dose

Experimental group

Description:

Liprotamase in a fixed combination of lipase (25,000 units), protease (25,000 units) and amylase (3,750 units) administered orally (one Size 5 capsule of liprotamase, one Size 2 capsule of liprotamase, and four Size 2 capsules of placebo) with each of three meals and two snacks daily for 28 days

Treatment:

Drug: Liprotamase

Drug: Placebo

High Liprotamase Dose

Experimental group

Description:

Liprotamase in a fixed combination of lipase (100,000 units), protease (100,000 units) and amylase (15,000 units) administered orally (one Size 5 capsule of placebo and five Size 2 capsules of liprotamase) with each of three meals and two snacks daily for 28 days

Treatment:

Drug: Liprotamase

Drug: Placebo