Safety, Efficacy and PK/PD of POL7080 in Patients With Ex... | NCT02096315

Studies
Safety, Efficacy and PK/PD of POL7080 in Patients With Exacerbation of Non-cystic Fibrosis Bronchiectasis.

NCT02096315

Sponsor

Polyphor Ltd.

Status

Terminated

Last Update Posted

Feb 1, 2017Estimated

Enrollment

20Estimated

Phase

Phase 2

Conditions

Bronchiectasis
Lower Respiratory Infection

Interventions

POL7080

Countries

Spain
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Nov 2015Actual

Completion Date

Nov 2015Actual

First Submitted Date

Mar 18, 2014

First Submission Date that Met QC Criteria

Mar 21, 2014

First Posted Date

Mar 26, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 31, 2017

Last Update Posted Date

Feb 1, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To test whether POL7080 is effective in patients with exacerbation of non-cystic fibrosis bronchiectasis caused by Pseudomonas aeruginosa infection.

Detailed Description

Patients will be recruited after written informed consent.
Adverse events will be coded using Medical Dictionary for regulatory activities (MedDRA).
Descriptive statistics will be used for all the safety and efficacy variables.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
POL7080	Experimental	POL7080 administered daily	Drug: POL7080

Interventions

Name	Type	Description	Arm Group Labels	Other Names
POL7080	Drug	Intravenous infusion	POL7080

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sputum bacterial clearance	Reduction in CFU/mL (colony forming units/mL) of Pseudomonas aeruginosa	Day 4, Day 5, Day 10, Day 15 and Day 20

Secondary Outcomes

Measure	Description	Time Frame
Adverse events	Number of adverse events reported by the patients or observed by the investigator will be recorded. Onset, end date, severity, causal relationship, outcome and measures taken will be summarized. Death, discontinuations and serious adverse events will be listed and narrative summaries will be provided.	Daily assessment up to 20 days from informed consent.

Other Outcomes

Measure	Description	Time Frame
To measure the plasma concentrations of POL7080	Blood samples to measure POL7080 concentrations before, during and after administration of POL7080	Day 3

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and female aged ≥18 to <80 years and suffering from exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection
Sputum sample collected for culture before starting treatment

Exclusion Criteria:

Female patients who are pregnant or breast feeding or unwilling to follow reliable method of contraception
Subjects suffering from cystic fibrosis, active pulmonary mycobacterial infection, end stage chronic obstructive pulmonary disease on long term oxygen therapy, severe uncontrolled asthma, active sarcoidosis and active allergic broncho-pulmonary aspergillosis
Current exacerbation of bronchiectasis is associated with lung abscess or empyema
Current exacerbation episode is suspected or documented to be due to pathogens other than Pseudomonas aeruginosa
Patients with known HIV infection with CD4+ (cluster of differentiation 4) cell count < 200/mm3
Patients who are currently enrolled in, or have not yet completed at least 30 days since ending another investigational device or drug trial or are receiving other investigational agent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eva Polverino, MD	Hospital Clinic, Barcelona, SPAIN	Principal Investigator
Adam Hill, MD PhD	Royal Infirmary, Edinburgh, U.K.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Bellvitge		Barcelona			Spain
Hospital Clinic

Condition Browse Module

MeSH Terms

ID	Term
D001987	Bronchiectasis
D011552	Pseudomonas Infections

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections

Browse Leaves

Not provided

Browse Branches

Not provided