NCT00789685

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.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Faron Pharmaceuticals Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This was a phase I/II open-label study to assess the safety, tolerability and preliminary efficacy of FP-1201 (IFN β-1a) in the treatment of patients with ALI and ARDS. The primary objective in the study was to evaluate the safety and tolerability of FP-1201 in patients with ALI/ARDS and to assess the safety, tolerability and preliminary efficacy of the optimum tolerated dose (OTD) in patients likely to derive clinical benefit. The study consisted of a dose escalation phase to determine the maximum tolerated dose (MTD) and OTD followed by a separate cohort expansion phase in which the OTD was administered.

Conditions

• Acute Lung Injury
• Acute Respiratory Distress Syndrome

Interventions

Type	Name	Description
DRUG	Interferon Beta	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.

Timeline

• Start date: 2009-02-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2008-11-13
• Last updated: 2015-05-27
• Results posted: 2015-05-27

Locations

8 sites across 1 country: United Kingdom