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

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ClinicalTrials.gov Identifier: NCT00789685
Recruitment Status : Completed
First Posted : November 13, 2008
Results First Posted : May 27, 2015
Last Update Posted : May 27, 2015
Information provided by (Responsible Party):
Faron Pharmaceuticals Ltd

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).

Condition or disease Intervention/treatment Phase
Acute Lung Injury Acute Respiratory Distress Syndrome Drug: Interferon Beta Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Arm Intervention/treatment
Experimental: Interferon Beta
Interferon Beta
Drug: Interferon Beta
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.
Other Names:
  • FP-1201
  • IFN-beta

Primary Outcome Measures :
  1. Clinically Significant Treatment Emergent Events [ Time Frame: From first dose up until Day 28 ]
    Treatment-emergent adverse events (TEAEs) in safety population

  2. All Cause Mortality at Day 28 [ Time Frame: 28 days following commencement of therapy ]
    The primary efficacy variable was all cause mortality at Day 28 following commencement of treatment

Secondary Outcome Measures :
  1. All Cause Mortality Rate at 6 Months [ Time Frame: 6 months following commencement of therapy ]
    A long-term secondary efficacy variable was all cause mortality at 6 months following commencement of treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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): NCT00789685

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United Kingdom
University Hospital of Wales
Cardiff, United Kingdom, CG14 4XW
Edinburgh Royal Infirmary
Edinburgh, United Kingdom, EH16 4SA
Western Infirmary
Glasgow, United Kingdom, G11 6NT
Victoria Infirmary
Glasgow, United Kingdom, G42 9TY
Whittington Hospital
London, United Kingdom, N19 5NF
University College London Hospital
London, United Kingdom, NW1 2BU
St Thomas' Hospital
London, United Kingdom, SE1 7EH
St Mary's Hospital
London, United Kingdom, W2 1NY
Sponsors and Collaborators
Faron Pharmaceuticals Ltd
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Principal Investigator: Geoff Bellingan, MD University College London Hospital
Principal Investigator: Martin Kuper, MD Whittington Hospital
Principal Investigator: Martin Stotz, MD St Mary's Hospital, London
Principal Investigator: Richard Beale, MD St Thomas' Hospital
Principal Investigator: Mathew Wise, MD University Hospital of Wales
Principal Investigator: Alexander Binning, MD Western Infirmary
Principal Investigator: Alan Davidson, MD Victoria Infirmary
Principal Investigator: Timothy Walsh, MD Edinburgh Royal Infirmary
Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Faron Pharmaceuticals Ltd
ClinicalTrials.gov Identifier: NCT00789685    
Other Study ID Numbers: FPCLI001
First Posted: November 13, 2008    Key Record Dates
Results First Posted: May 27, 2015
Last Update Posted: May 27, 2015
Last Verified: May 2015
Keywords provided by Faron Pharmaceuticals Ltd:
Open label
Additional relevant MeSH terms:
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Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Lung Injury
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs