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.

• Conditions: Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS)

• Registration Number: EUCTR2008-000140-13-GB
• Lead Sponsor: Faron Pharmaceuticals Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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: Pa02 /Fi02 ratio = 300 in a stable state after the patient has adapted to standardised ventilation.(Within the UK this equates to <40 kPa)
•ARDS: Pa02 /Fi02 = 200 in a stable state after the patient has adapted to standardised ventilation.(Within the UK this equates to <26.7 kPa)

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 immumodulatory 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified