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

Information source: CSL Behring
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cystic Fibrosis

Intervention: CR002 Liquid API (Biological); Placebo (Biological)

Phase: Phase 1

Status: Completed

Sponsored by: CSL Behring

Official(s) and/or principal investigator(s):
Program director Clinical R&D, Study Director, Affiliation: CSL Behring

Summary

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

Clinical Details

Official title: A Double Blind, Randomized, Placebo Controlled, Single Dose, Phase I Study of the Safety and Tolerability of Alpha1 Proteinase Inhibitor (Human) Inhalation Solution (CR002) in Subjects With Cystic Fibrosis

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Frequency of Adverse events

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Site 11, Sofia, Bulgaria

Site 12, Varna, Bulgaria

Site 30, Debrecen, Hungary

Site 24, Bialystok, Poland

Site 22, Gdansk, Poland

Site 21, Poznan, Poland

Site 20, Rabka Zdroj, Poland

Site 23, Warszawa, Poland

Site 42, Papworth Hospital, United Kingdom

Site 40, Penarth, United Kingdom

Site 41, Southampton, United Kingdom

Additional Information

Starting date: April 2011
Last updated: April 3, 2012

Page last updated: August 23, 2015

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