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Safety, Tolerability and Preliminary Efficacy of FP-1201 in ALI and ARDS. Phase I/II

Primary Purpose

Acute Lung Injury, Acute Respiratory Distress Syndrome

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Interferon Beta
Sponsored by
Faron Pharmaceuticals Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lung Injury focused on measuring Open label

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult male or female patients with ALI/ARDS confirmed by the combination of the following diagnostic criteria:

    • An initiating clinical condition (e.g. sepsis, pneumonia, aspiration pneumonia, pancreatitis etc.)
    • Acute onset
    • Bilateral infiltrates documented by chest radiograph at end-aspiratory position
    • The absence of clinical evidence of left atrial hypertension
    • ALI: partial pressure of oxygen (PaO2) / fraction of inspired oxygen (FiO2) ratio ≤300 mmHg in a stable state after the patient has adapted to standardised ventilation. (Within the UK this equates to <40kPa)
    • ARDS: PaO2 /FiO2 ≤200 mmHg in a stable state after the patient has adapted to standardised ventilation. (Within the UK this equates to <26.7kPa)
  • Provision of signed written informed consent from the patient or patients legally authorized representative.
  • Age greater than or equal to 18.
  • Initiation of study drug within 48 hours of the diagnosis of ALI/ARDS.
  • All patients at entry are required to be receiving mechanical ventilatory support.
  • Only patients who are considered suitable for active life support should be enrolled in the study.
  • No clinical evidence of left atrial hypertension that would explain the pulmonary infiltrates; if measured the pulmonary arterial wedge pressure should be less than or equal to 18mmHg

Exclusion Criteria:

  • Patients with burns.
  • Women known to be pregnant, lactating or having a positive or indeterminate pregnancy test.
  • Patients with significant Chronic Obstructive Pulmonary Disease requiring ongoing treatment e.g. chronic use of oxygen or ventilatory support at home prior to admission.
  • Patients with primary lung cancer or the presence of secondary metastases in the lungs.
  • Patients requiring treatment for congestive heart failure.
  • Patients receiving renal dialysis therapy for chronic renal failure.
  • Patients taking immunomodulatory therapy or oral steroids on admission.
  • Prior use of interferon.
  • Inability to maintain blood pressure to ensure adequate end organ perfusion. It should be noted that the use of plasma colloids or vasopressor agents is allowed to achieve the maintenance of blood pressure.
  • Current participation in another experimental treatment protocol.

Sites / Locations

  • University Hospital of Wales
  • Edinburgh Royal Infirmary
  • Western Infirmary
  • Victoria Infirmary
  • Whittington Hospital
  • University College London Hospital
  • St Thomas' Hospital
  • St Mary's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interferon Beta

Arm Description

Interferon Beta

Outcomes

Primary Outcome Measures

Clinically Significant Treatment Emergent Events
Treatment-emergent adverse events (TEAEs) in safety population
All Cause Mortality at Day 28
The primary efficacy variable was all cause mortality at Day 28 following commencement of treatment

Secondary Outcome Measures

All Cause Mortality Rate at 6 Months
A long-term secondary efficacy variable was all cause mortality at 6 months following commencement of treatment

Full Information

First Posted
November 11, 2008
Last Updated
May 11, 2015
Sponsor
Faron Pharmaceuticals Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT00789685
Brief Title
Safety, Tolerability and Preliminary Efficacy of FP-1201 in ALI and ARDS. Phase I/II
Official Title
A Phase I/II Open-Label Study to Assess the Safety, Tolerability and Preliminary Efficacy of FP-1201 (Recombinant Human Interferon Beta) in the Treatment of Patients With Acute Lung Injury and Acute Respiratory Distress Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Faron Pharmaceuticals Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study was to assess the safety, tolerability and preliminary efficacy of FP-1201 (Interferon Beta) in patients with Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS).
Detailed Description
This was a phase I/II open-label study to assess the safety, tolerability and preliminary efficacy of FP-1201 (IFN β-1a) in the treatment of patients with ALI and ARDS. The primary objective in the study was to evaluate the safety and tolerability of FP-1201 in patients with ALI/ARDS and to assess the safety, tolerability and preliminary efficacy of the optimum tolerated dose (OTD) in patients likely to derive clinical benefit. The study consisted of a dose escalation phase to determine the maximum tolerated dose (MTD) and OTD followed by a separate cohort expansion phase in which the OTD was administered.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lung Injury, Acute Respiratory Distress Syndrome
Keywords
Open label

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interferon Beta
Arm Type
Experimental
Arm Description
Interferon Beta
Intervention Type
Drug
Intervention Name(s)
Interferon Beta
Other Intervention Name(s)
FP-1201, IFN-beta
Intervention Description
Interferon Beta administered intravenously daily for 6 days. Doses of 0.12 MIU, 1.2 MIU, 2.7 MIU or 6.0 MIU (dose escalation phase) or 2.7 MIU (dose expansion phase) were administered.
Primary Outcome Measure Information:
Title
Clinically Significant Treatment Emergent Events
Description
Treatment-emergent adverse events (TEAEs) in safety population
Time Frame
From first dose up until Day 28
Title
All Cause Mortality at Day 28
Description
The primary efficacy variable was all cause mortality at Day 28 following commencement of treatment
Time Frame
28 days following commencement of therapy
Secondary Outcome Measure Information:
Title
All Cause Mortality Rate at 6 Months
Description
A long-term secondary efficacy variable was all cause mortality at 6 months following commencement of treatment
Time Frame
6 months following commencement of therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult male or female patients with ALI/ARDS confirmed by the combination of the following diagnostic criteria: An initiating clinical condition (e.g. sepsis, pneumonia, aspiration pneumonia, pancreatitis etc.) Acute onset Bilateral infiltrates documented by chest radiograph at end-aspiratory position The absence of clinical evidence of left atrial hypertension ALI: partial pressure of oxygen (PaO2) / fraction of inspired oxygen (FiO2) ratio ≤300 mmHg in a stable state after the patient has adapted to standardised ventilation. (Within the UK this equates to <40kPa) ARDS: PaO2 /FiO2 ≤200 mmHg in a stable state after the patient has adapted to standardised ventilation. (Within the UK this equates to <26.7kPa) Provision of signed written informed consent from the patient or patients legally authorized representative. Age greater than or equal to 18. Initiation of study drug within 48 hours of the diagnosis of ALI/ARDS. All patients at entry are required to be receiving mechanical ventilatory support. Only patients who are considered suitable for active life support should be enrolled in the study. No clinical evidence of left atrial hypertension that would explain the pulmonary infiltrates; if measured the pulmonary arterial wedge pressure should be less than or equal to 18mmHg Exclusion Criteria: Patients with burns. Women known to be pregnant, lactating or having a positive or indeterminate pregnancy test. Patients with significant Chronic Obstructive Pulmonary Disease requiring ongoing treatment e.g. chronic use of oxygen or ventilatory support at home prior to admission. Patients with primary lung cancer or the presence of secondary metastases in the lungs. Patients requiring treatment for congestive heart failure. Patients receiving renal dialysis therapy for chronic renal failure. Patients taking immunomodulatory therapy or oral steroids on admission. Prior use of interferon. Inability to maintain blood pressure to ensure adequate end organ perfusion. It should be noted that the use of plasma colloids or vasopressor agents is allowed to achieve the maintenance of blood pressure. Current participation in another experimental treatment protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geoff Bellingan, MD
Organizational Affiliation
University College London Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin Kuper, MD
Organizational Affiliation
Whittington Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin Stotz, MD
Organizational Affiliation
St Mary's Hospital, London
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Beale, MD
Organizational Affiliation
St Thomas' Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mathew Wise, MD
Organizational Affiliation
University Hospital of Wales
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexander Binning, MD
Organizational Affiliation
Western Infirmary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alan Davidson, MD
Organizational Affiliation
Victoria Infirmary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Timothy Walsh, MD
Organizational Affiliation
Edinburgh Royal Infirmary
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Wales
City
Cardiff
ZIP/Postal Code
CG14 4XW
Country
United Kingdom
Facility Name
Edinburgh Royal Infirmary
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
Western Infirmary
City
Glasgow
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
Victoria Infirmary
City
Glasgow
ZIP/Postal Code
G42 9TY
Country
United Kingdom
Facility Name
Whittington Hospital
City
London
ZIP/Postal Code
N19 5NF
Country
United Kingdom
Facility Name
University College London Hospital
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Facility Name
St Thomas' Hospital
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
St Mary's Hospital
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
18034430
Citation
Kiss J, Yegutkin GG, Koskinen K, Savunen T, Jalkanen S, Salmi M. IFN-beta protects from vascular leakage via up-regulation of CD73. Eur J Immunol. 2007 Dec;37(12):3334-8. doi: 10.1002/eji.200737793.
Results Reference
background
PubMed Identifier
24503265
Citation
Bellingan G, Maksimow M, Howell DC, Stotz M, Beale R, Beatty M, Walsh T, Binning A, Davidson A, Kuper M, Shah S, Cooper J, Waris M, Yegutkin GG, Jalkanen J, Salmi M, Piippo I, Jalkanen M, Montgomery H, Jalkanen S. The effect of intravenous interferon-beta-1a (FP-1201) on lung CD73 expression and on acute respiratory distress syndrome mortality: an open-label study. Lancet Respir Med. 2014 Feb;2(2):98-107. doi: 10.1016/S2213-2600(13)70259-5. Epub 2013 Dec 23.
Results Reference
result
Links:
URL
http://www.faronpharmaceuticals.com
Description
Sponsor's website

Learn more about this trial

Safety, Tolerability and Preliminary Efficacy of FP-1201 in ALI and ARDS. Phase I/II

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