At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 37 enrolled
Drug / intervention
Interferon Betadrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 2 clinical trial evaluating Interferon Beta for Acute Lung Injury and Acute Respiratory Distress Syndrome. Completed, enrolled 37 participants across 8 sites.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2008
Enrollment StartFeb 2009
Primary CompletionSep 2011
TodayJul 2026
First PostedNov 13, 2008
Enrollment StartFeb 1, 2009
Primary CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 17.6 years ago
Interventions
Interferon Betadrug
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.