Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of AIR DNase™in Patients With Cystic Fibrosis Previously Treated With Pulmozyme®

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02722122
Recruitment Status : Unknown
Verified September 2016 by Protalix.
Recruitment status was:  Recruiting
First Posted : March 29, 2016
Last Update Posted : September 28, 2016
Sponsor:
Information provided by (Responsible Party):
Protalix

Brief Summary:
This study evaluates the Safety,Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of AIR DNase™in Patients with Cystic Fibrosis previously treated with Pulmozyme®.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: AIR DNase™ Phase 2

Detailed Description:

This is a proof-of-concept, open label study, to evaluate the safety, tolerability, pharmacokinetics and exploratory efficacy of 2.5 mg AIR DNase TM administered once daily for 28 days via inhalation to Cystic Fibrosis subjects who have previously been treated with Pulmozyme®.

This multicenter study will be conducted in approximately 10 sites and will enroll up to 15 subjects.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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®
Study Start Date : May 2016
Estimated Primary Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: AIR DNase™ 2.5 mg
2.5 mg of AIR DNase™ administered once daily via inhalation for 28 days
Drug: AIR DNase™



Primary Outcome Measures :
  1. Adverse events following daily administration of AIR DNase™ [ Time Frame: 56 days ]
    Adverse events from subject reporting or other assessments


Secondary Outcome Measures :
  1. Area under the curve [ Time Frame: Up to 4 hours ]
    AIR DNase concentrations measured at 0, 0.25, 0.5, 0.75, 1, 1.5, 2, and 4 hours

  2. Change from baseline to end of AIR DNase™ treatment in FEV1 [ Time Frame: Baseline and 28 days ]
  3. Change from baseline to end of AIR DNase™ treatment in FVC [ Time Frame: Baseline and 28 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02722122


Contacts
Layout table for location contacts
Contact: Einat Dekel, DVM Einat.Dekel@protalix.com
Contact: Yasmin Omer Azulay, MPH yomerazulay@cato.co.il

Locations
Layout table for location information
Israel
Carmel MC Recruiting
Haifa, Israel
Contact: Michal Shteinberg, M.D.    04-8250564      
Principal Investigator: Michal Shteinberg, M.D.         
Rambam MC Recruiting
Haifa, Israel
Contact: Lea Bentur, M.D.    04-7774360      
Principal Investigator: Lea Bentur, M.D.         
Hadassah MC Recruiting
Jerusalem, Israel
Contact: Eitan Kerem, M.D.    02-6777749      
Principal Investigator: Eitan Kerem, M.D.         
Schneider MC Recruiting
Petah Tikva, Israel
Contact: Hanna Blau, M.D.    03-9253803      
Principal Investigator: Hanna Blau, M.D.         
Sheba MC Recruiting
Ramat Gan, Israel
Contact: Ori Efrati, M.D.    03-5302884      
Principal Investigator: Ori Efrati, M.D.         
Sponsors and Collaborators
Protalix
Investigators
Layout table for investigator information
Study Director: Einat Dekel, DVM Sr. Director Clinical Development

Layout table for additonal information
Responsible Party: Protalix
ClinicalTrials.gov Identifier: NCT02722122     History of Changes
Other Study ID Numbers: PB-110-CF02
First Posted: March 29, 2016    Key Record Dates
Last Update Posted: September 28, 2016
Last Verified: September 2016

Keywords provided by Protalix:
Cystic Fibrosis
CF
AIR DNase™
Digestive System Diseases
Genetic Diseases, Inborn
Infant, New born, Diseases
Lung diseases
Pancreatic Diseases
Respiratory Tract Diseases

Additional relevant MeSH terms:
Layout table for MeSH terms
Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases