Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS)
Conditions
Interventions
Trade Name: Rebif
Product Name: Interferon Beta
Product Code: FP-1201
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Interferon Beta
Current Sponsor code: FP-1201
Concentration unit:
Sponsors
Faron Pharmaceuticals Limited
Eligibility
Sex/Gender
All
Inclusion 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: Pa02 /Fi02 ratio = 300 in a stable state after the patient has adapted to standardised ventilation.(Within the UK this equates to =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of FP-1201 in patients with ALI/ARDS To assess the safety, tolerability and preliminary efficacy of the Optimum tolerated dose in patients likely to derive clinical benefit ;Secondary Objective: To establish appropriate dose(s) of FP-1201 for use in future studies of patients with ALI/ARDS. To determine the pharmacokinetics (PK) of FP-1201 when administered intravenously daily as a single injection for a maximum of 6 days, to patients with ALI/ARDS. To demonstrate the pharmacodynamic activity of FP-1201 in patients with ALI/ARDS. To assess for evidence of neutralizing antibodies to interferon beta in patients with ALI/ARDS. ;Primary end point(s): 1. Safety Endpoints: Clinically significant treatment emergent adverse events, physical examination. Vital signs (i.e. Blood Pressure (BP) and heart rate (P/R) electrocardiogram (ECG) and laboratory finding including clinical chemistry, haematology and urinalysis. 2. Efficacy Endpoints: Primary Endpoint. Measurable objective response criteria All cause mortality at Day 28 following the commencement of FP-1201 therapy. Secondary Endpoints to be analysed at Day 28 following the commencement of FP-1201 therapy: Days alive and off ventilation Days on ITU (or up to the point when patient is ready for discharge from ITU) Days on vaso-active drugs Frequency of complications such as neck/thoracic, gastrointestinal, cardiac, haemodynamic, vascular or barotrauma. Short-term Secondary Endpoints: Changes in Pa02 /Fi02 ratio, and other relevant lung parameters during mechanical ventilation. Time to the development/resolution of clinically significant organ dysfunction e.g. renal, hepatic, haematological, and cardiovascular. Long-term Secondary Endpoints: All cause mortality rate at six months following the commencement of FP-1201 therapy. 3. Pharmacokinetic and Pharmacodynamic Endpoints: Serum levels of Interferon-Beta will be measured to characterise | — |
Countries
United Kingdom
Outcome results
None listed