Safety and Tolerability Study of Liquid Alpha1 Proteinase Inhibitor (API) in Subjects With Cystic Fibrosis
This study has been completed.
Sponsor:
CSL Behring
Information provided by (Responsible Party):
CSL Behring
ClinicalTrials.gov Identifier:
NCT01347190
First received: May 3, 2011
Last updated: April 3, 2012
Last verified: April 2012
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Purpose
Study to assess safety and tolerability of a single dose of study-drug administered to Cystic Fibrosis (CF) patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Cystic Fibrosis |
Biological: CR002 Liquid API Biological: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by CSL Behring:
Primary Outcome Measures:
- Frequency of Adverse events [ Time Frame: 44 Days (Day -21 to Day 22) ] [ Designated as safety issue: Yes ]
| Enrollment: | 25 |
| Study Start Date: | April 2011 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Liquid API |
Biological: CR002 Liquid API
A single nominal dose of CR002 (three different dose groups) will be inhaled as an aerosol mist produced by an I-neb Adaptive Aerosol Delivery (AAD) System.
|
| Placebo Comparator: Placebo |
Biological: Placebo
A single nominal dose of Placebo will be inhaled as an aerosol mist produced by an I-neb Adaptive Aerosol Delivery (AAD) System.
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Have a confirmed diagnosis of CF: one or more clinical findings consistent with CF and at least one of the following:
- Sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test OR
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01347190
Locations
| Bulgaria | |
| Site 11 | |
| Sofia, Bulgaria | |
| Site 12 | |
| Varna, Bulgaria | |
| Hungary | |
| Site 30 | |
| Debrecen, Hungary | |
| Poland | |
| Site 24 | |
| Bialystok, Poland | |
| Site 22 | |
| Gdansk, Poland | |
| Site 21 | |
| Poznan, Poland | |
| Site 20 | |
| Rabka Zdroj, Poland | |
| Site 23 | |
| Warszawa, Poland | |
| United Kingdom | |
| Site 42 | |
| Papworth Hospital, United Kingdom | |
| Site 40 | |
| Penarth, United Kingdom | |
| Site 41 | |
| Southampton, United Kingdom | |
Sponsors and Collaborators
CSL Behring
Investigators
| Study Director: | Program director Clinical R&D | CSL Behring |
More Information
No publications provided
| Responsible Party: | CSL Behring |
| ClinicalTrials.gov Identifier: | NCT01347190 History of Changes |
| Other Study ID Numbers: | CR002_1004, 2010-022671-60 |
| Study First Received: | May 3, 2011 |
| Last Updated: | April 3, 2012 |
| Health Authority: | Bulgaria: Ministry of Health Hungary: National Institute of Pharmacy Poland: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by CSL Behring:
|
Cystic Fibrosis |
Additional relevant MeSH terms:
|
Alpha 1-Antitrypsin Deficiency Cystic Fibrosis Fibrosis Liver Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Subcutaneous Emphysema Emphysema |
Pathologic Processes Pancreatic Diseases Infant, Newborn, Diseases Alpha 1-Antitrypsin Protease Inhibitors Trypsin Inhibitors Serine Proteinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013