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
  Purpose

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).


Condition Intervention Phase
Acute Lung Injury
Acute Respiratory Distress Syndrome
Drug: Interferon Beta
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Faron Pharmaceuticals Ltd:

Primary Outcome Measures:
  • 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 ]

Enrollment: 37
Study Start Date: August 2008
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interferon Beta 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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: 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00789685

Locations
United Kingdom
University Hospital of Wales
Cardiff, United Kingdom, CG14 4XW
Edinburgh Royal Infirmary
Edinburgh, United Kingdom, EH16 4SA
Victoria Infirmary
Glasgow, United Kingdom, G42 9TY
Western Infirmary
Glasgow, United Kingdom, G11 6NT
St Mary's Hospital
London, United Kingdom, W2 1NY
University College London Hospital
London, United Kingdom, NW1 2BU
Whittington Hospital
London, United Kingdom, N19 5NF
St Thomas' Hospital
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
Faron Pharmaceuticals Ltd
Investigators
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
  More Information

Additional Information:
Publications:
Responsible Party: Faron Pharmaceuticals Ltd
ClinicalTrials.gov Identifier: NCT00789685     History of Changes
Other Study ID Numbers: FPCLI001
Study First Received: November 11, 2008
Last Updated: September 30, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Faron Pharmaceuticals Ltd:
Open label

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Injury
Wounds and Injuries
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Interferon-beta
Interferons
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 16, 2014