Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Faron Pharmaceuticals Ltd
ClinicalTrials.gov Identifier:
NCT00789685
First received: November 11, 2008
Last updated: September 30, 2011
Last verified: September 2011
History of Changes

November 11, 2008
September 30, 2011
August 2008
September 2011   (final data collection date for primary outcome measure)
  • Clinically significant treatment emergent events [ Time Frame: 21 days following aministration ] [ Designated as safety issue: Yes ]
  • All cause mortality [ Time Frame: 28 days following commencement of therapy ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00789685 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety, Tolerability and Preliminary Efficacy of FP-1201 in ALI and ARDS. Phase I/II
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.

The purpose of this study is 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).
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acute Lung Injury
  • Acute Respiratory Distress Syndrome
Drug: Interferon Beta
Doses escalation of Interferon Beta to be administered intravenously daily for 6 days. Doses of 0.12 MIU, 1.2 MIU, 2.7 MIU and 6.0 MIU to be administered.
Other Names:
  • FP-1201
  • IFN-beta
Experimental: Interferon Beta
Intervention: Drug: Interferon Beta
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
September 2011
September 2011   (final data collection date for primary outcome measure)

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: PaO2 /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 COPD 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00789685
FPCLI001
Yes
Faron Pharmaceuticals Ltd
Faron Pharmaceuticals Ltd
Not Provided
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
Principal Investigator: Richard Beale, MD St Thomas' Hospital
Principal Investigator: Mathew Wise, MD The University of New South Wales
Principal Investigator: Sandy Binning, MD Western Infirmary
Principal Investigator: Alan Davidson, MD Victoria Infirmary
Principal Investigator: Timothy Walsh, MD Edinburgh Royal Infirmary
Faron Pharmaceuticals Ltd
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP