Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of AIR DNase™in Patients With Cystic Fibrosis Previously Treated With Pulmozyme®
NCT ID: NCT02722122
Last Updated: 2016-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
15 participants
INTERVENTIONAL
2016-05-31
Brief Summary
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Detailed Description
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This multicenter study will be conducted in approximately 10 sites and will enroll up to 15 subjects.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AIR DNase™ 2.5 mg
2.5 mg of AIR DNase™ administered once daily via inhalation for 28 days
AIR DNase™
Interventions
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AIR DNase™
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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.
12 Years
ALL
No
Sponsors
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Protalix
INDUSTRY
Responsible Party
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Principal Investigators
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Einat Dekel, DVM
Role: STUDY_DIRECTOR
Sr. Director Clinical Development
Locations
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Carmel MC
Haifa, , Israel
Rambam MC
Haifa, , Israel
Hadassah MC
Jerusalem, , Israel
Schneider MC
Petah Tikva, , Israel
Sheba MC
Ramat Gan, , Israel
Countries
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Central Contacts
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Facility Contacts
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Michal Shteinberg, M.D.
Role: primary
Lea Bentur, M.D.
Role: primary
Eitan Kerem, M.D.
Role: primary
Hanna Blau, M.D.
Role: primary
Ori Efrati, M.D.
Role: primary
Other Identifiers
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PB-110-CF02
Identifier Type: -
Identifier Source: org_study_id
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