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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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10 October 2016 |
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Main ID: |
NCT02722122 |
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Date of registration:
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23/03/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of AIR DNase™in Patients With Cystic Fibrosis Previously Treated With Pulmozyme®
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Scientific title:
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A Proof-of-Concept, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of AIR DNase™in Patients With Cystic Fibrosis Previously Treated With Pulmozyme® |
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Date of first enrolment:
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May 2016 |
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Target sample size:
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15 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02722122 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Israel
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Contacts
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Name:
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Einat Dekel, DVM |
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Address:
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Telephone:
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Email:
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Einat.Dekel@protalix.com |
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Affiliation:
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Name:
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Einat Dekel, DVM |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sr. Director Clinical Development |
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Key inclusion & exclusion criteria
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Main Inclusion Criteria:
1. Age = 12 years of age (inclusive) at the time of screening
2. Weight = 36 kg
3. Prior confirmed diagnosis of CF
4. At least 4 months treatment with Pulmozyme® prior to screening.
5. The subject is medically stable for at least one month prior to the screening visit.
6. Stable inhaled regimen of either: antibiotics, steroids, hypertonic saline at least
four months prior to screening visit.
7. FEV1 of >40% and <90% and FVC = 40% of predicted normal for age, gender, and height
at screening .
8. Female and male subjects whose co-partners are of child bearing potential must agree
to use two medically acceptable methods of contraception, not including the rhythm
method.
9. Be willing and able to adhere to the study visit schedule and other protocol
requirements
10. Be willing and able to provide voluntary written informed consent
Main Exclusion Criteria:
1. Has a history of lung transplantation.
2. Female subjects who are pregnant or lactating.
3. History of severe or unexplained adverse reactions during aerosol delivery of any
medicinal product.
4. History or presence of hypersensitivity or reaction to inhaled proteins.
5. Participation in another clinical trial within 60 days prior to screening.
6. Presence of any medical, emotional, behavioral or psychological condition that in the
judgment of the Investigator would interfere with the subject's safety or compliance
with the requirements of the study.
7. Have positive serology for human immunodeficiency virus (HIV) or Hepatitis B or
Hepatitis C infection.
Age minimum:
12 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Drug: AIR DNase™
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Primary Outcome(s)
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Adverse events following daily administration of AIR DNase™
[Time Frame: 56 days]
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Secondary Outcome(s)
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Change from baseline to end of AIR DNase™ treatment in FEV1
[Time Frame: Baseline and 28 days]
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Change from baseline to end of AIR DNase™ treatment in FVC
[Time Frame: Baseline and 28 days]
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Area under the curve
[Time Frame: Up to 4 hours]
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Secondary ID(s)
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PB-110-CF02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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