NCT00789685

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2009

Typical duration for phase_1

Geographic Reach
1 country

8 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 13, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

May 27, 2015

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

2.6 years

First QC Date

November 11, 2008

Results QC Date

May 11, 2015

Last Update Submit

May 11, 2015

Conditions

Acute Lung InjuryAcute Respiratory Distress Syndrome

Keywords

Open label

Outcome Measures

Primary Outcomes (2)

  • Clinically Significant Treatment Emergent Events

    Treatment-emergent adverse events (TEAEs) in safety population

    From first dose up until Day 28

  • All Cause Mortality at Day 28

    The primary efficacy variable was all cause mortality at Day 28 following commencement of treatment

    28 days following commencement of therapy

Secondary Outcomes (1)

  • All Cause Mortality Rate at 6 Months

    6 months following commencement of therapy

Study Arms (1)

Interferon Beta

EXPERIMENTAL

Interferon Beta

Drug: Interferon Beta

Interventions

Interferon BetaDRUG

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.

Also known as: FP-1201, IFN-beta
Interferon Beta

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University Hospital of Wales

Cardiff, CG14 4XW, United Kingdom

Location

Edinburgh Royal Infirmary

Edinburgh, EH16 4SA, United Kingdom

Location

Western Infirmary

Glasgow, G11 6NT, United Kingdom

Location

Victoria Infirmary

Glasgow, G42 9TY, United Kingdom

Location

Whittington Hospital

London, N19 5NF, United Kingdom

Location

University College London Hospital

London, NW1 2BU, United Kingdom

Location

St Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

St Mary's Hospital

London, W2 1NY, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 18034430BACKGROUND

  • 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.

    PMID: 24503265RESULT

Related Links

MeSH Terms

Conditions

Acute Lung InjuryRespiratory Distress Syndrome

Interventions

Interferon-beta

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

Interferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Results Point of Contact

Title
Dr Ilse Piippo, MD
Organization
Faron Pharmaceuticals Limited
ilse.piippo@faronpharmaceuticals.com
+358 2469 5151

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2008

First Posted

November 13, 2008

Study Start

February 1, 2009

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

May 27, 2015

Results First Posted

May 27, 2015

Record last verified: 2015-05

Locations

GB(8)