NCT02722122

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®.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 29, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Last Updated

September 28, 2016

Status Verified

September 1, 2016

Enrollment Period

9 months

First QC Date

March 23, 2016

Last Update Submit

September 26, 2016

Conditions

Cystic Fibrosis

Keywords

Cystic FibrosisCFAIR DNase™Digestive System DiseasesGenetic Diseases, InbornInfant, New born, DiseasesLung diseasesPancreatic DiseasesRespiratory Tract Diseases

Outcome Measures

Primary Outcomes (1)

  • Adverse events following daily administration of AIR DNase™

    Adverse events from subject reporting or other assessments

    56 days

Secondary Outcomes (3)

  • Area under the curve

    Up to 4 hours

  • Change from baseline to end of AIR DNase™ treatment in FEV1

    Baseline and 28 days

  • Change from baseline to end of AIR DNase™ treatment in FVC

    Baseline and 28 days

Study Arms (1)

AIR DNase™ 2.5 mg

EXPERIMENTAL

2.5 mg of AIR DNase™ administered once daily via inhalation for 28 days

Drug: AIR DNase™

Interventions

AIR DNase™DRUG
AIR DNase™ 2.5 mg

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 12 years of age (inclusive) at the time of screening
  • Weight ≥ 36 kg
  • Prior confirmed diagnosis of CF
  • At least 4 months treatment with Pulmozyme® prior to screening.
  • The subject is medically stable for at least one month prior to the screening visit.
  • Stable inhaled regimen of either: antibiotics, steroids, hypertonic saline at least four months prior to screening visit.
  • FEV1 of \>40% and \<90% and FVC ≥ 40% of predicted normal for age, gender, and height at screening .
  • 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.
  • Be willing and able to adhere to the study visit schedule and other protocol requirements
  • Be willing and able to provide voluntary written informed consent

You may not qualify if:

  • Has a history of lung transplantation.
  • Female subjects who are pregnant or lactating.
  • History of severe or unexplained adverse reactions during aerosol delivery of any medicinal product.
  • History or presence of hypersensitivity or reaction to inhaled proteins.
  • Participation in another clinical trial within 60 days prior to screening.
  • 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.
  • Have positive serology for human immunodeficiency virus (HIV) or Hepatitis B or Hepatitis C infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Carmel MC

Haifa, Israel

RECRUITING

Rambam MC

Haifa, Israel

RECRUITING

Hadassah MC

Jerusalem, Israel

RECRUITING

Schneider MC

Petah Tikva, Israel

RECRUITING

Sheba MC

Ramat Gan, Israel

RECRUITING

MeSH Terms

Conditions

Cystic FibrosisDigestive System DiseasesGenetic Diseases, InbornDiseaseLung DiseasesPancreatic DiseasesRespiratory Tract Diseases

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Einat Dekel, DVM

    Sr. Director Clinical Development

    STUDY DIRECTOR

Central Study Contacts

Einat Dekel, DVM

CONTACT

Einat.Dekel@protalix.com

Yasmin Omer Azulay, MPH

CONTACT

yomerazulay@cato.co.il

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2016

First Posted

March 29, 2016

Study Start

May 1, 2016

Primary Completion

February 1, 2017

Last Updated

September 28, 2016

Record last verified: 2016-09

Locations

IL(5)