Safety and Tolerability Study of Liquid Alpha1 Proteinase Inhibitor (API) in Subjects With Cystic Fibrosis

Phase 1

Completed

• Conditions: Cystic Fibrosis
• Interventions: Biological: CR002 Liquid API; Biological: Placebo

• Registration Number: NCT01347190
• Lead Sponsor: CSL Behring

Brief Summary

Study to assess safety and tolerability of a single dose of study-drug administered to Cystic Fibrosis (CF) patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-05-03
• Study First Submitted QC: 2011-05-03
• Study First Posted: 2011-05-04
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-03
• Last Update Posted: 2012-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Have a confirmed diagnosis of CF: one or more clinical findings consistent with CF and at least one of the following:

  1. Sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test OR
  2. A genotype with two identifiable mutations consistent with CF (∆F508 homozygous or two alleles known to cause a class I, II, or III mutation)

• Have an FEV1 ≥30% of predicted normal as defined by age, gender, and height

Exclusion Criteria

• Oxygen saturation <90%
• Changed in treatment regimen within 2 weeks prior to screening
• Antibiotics regimen change < 4 weeks before screening
• Persistent colonization with Burkholderia cepacia
• Serum IgA < 50% of lower level of normal

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liquid API	CR002 Liquid API	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Frequency of Adverse events	44 Days (Day -21 to Day 22)

Trial Locations

Locations (11)

Site 20; 🇵🇱 Rabka Zdroj, Poland

Site 24; 🇵🇱 Bialystok, Poland

Site 11; 🇧🇬 Sofia, Bulgaria

Site 12; 🇧🇬 Varna, Bulgaria

Site 30; 🇭🇺 Debrecen, Hungary

Site 41; 🇬🇧 Southampton, United Kingdom

Site 21; 🇵🇱 Poznan, Poland

Site 22; 🇵🇱 Gdansk, Poland

Site 42; 🇬🇧 Papworth Hospital, United Kingdom

Site 40; 🇬🇧 Penarth, United Kingdom

Site 23; 🇵🇱 Warszawa, Poland