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

September 26, 2016 updated by: Protalix

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®

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Haifa, Israel
        • Recruiting
        • Rambam MC
        • Contact:
          • Lea Bentur, M.D.
          • Phone Number: 04-7774360
        • Principal Investigator:
          • Lea Bentur, M.D.
      • Haifa, Israel
        • Recruiting
        • Carmel MC
        • Contact:
          • Michal Shteinberg, M.D.
          • Phone Number: 04-8250564
        • Principal Investigator:
          • Michal Shteinberg, M.D.
      • Jerusalem, Israel
        • Recruiting
        • Hadassah MC
        • Contact:
          • Eitan Kerem, M.D.
          • Phone Number: 02-6777749
        • Principal Investigator:
          • Eitan Kerem, M.D.
      • Petah Tikva, Israel
        • Recruiting
        • Schneider MC
        • Contact:
          • Hanna Blau, M.D.
          • Phone Number: 03-9253803
        • Principal Investigator:
          • Hanna Blau, M.D.
      • Ramat Gan, Israel
        • Recruiting
        • Sheba MC
        • Contact:
          • Ori Efrati, M.D.
          • Phone Number: 03-5302884
        • Principal Investigator:
          • Ori Efrati, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events following daily administration of AIR DNase™
Time Frame: 56 days
Adverse events from subject reporting or other assessments
56 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 4 hours
Change from baseline to end of AIR DNase™ treatment in FEV1
Time Frame: Baseline and 28 days
Baseline and 28 days
Change from baseline to end of AIR DNase™ treatment in FVC
Time Frame: Baseline and 28 days
Baseline and 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Protalix

Investigators

  • Study Director: Einat Dekel, DVM, Sr. Director Clinical Development

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

February 1, 2017

Study Registration Dates

First Submitted

March 23, 2016

First Submitted That Met QC Criteria

March 28, 2016

First Posted (Estimate)

March 29, 2016

Study Record Updates

Last Update Posted (Estimate)

September 28, 2016

Last Update Submitted That Met QC Criteria

September 26, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PB-110-CF02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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