Acute Lung InjuryPhase 1/2NCT00789685

Safety, Tolerability and Preliminary Efficacy of FP-1201 in ALI and ARDS. Phase I/II

A Phase 1/2 study testing Interferon Beta in people with Acute Lung Injury and Acute Respiratory Distress Syndrome, run by Faron Pharmaceuticals Ltd at 8 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Lung Injury, Acute Respiratory Distress Syndrome
What is being tested?: Interferon Beta
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 8 sitesUnited Kingdom
Study dates: Feb 2009to Sep 2011
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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: partial pressure of oxygen (PaO2) / fraction of inspired oxygen (FiO2) ratio ≤300 mmHg in a stable state after the patient has adapted to standardised ventilation. (Within the UK this equates to <40kPa)

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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

Who cannot join

Patients with burns.
Women known to be pregnant, lactating or having a positive or indeterminate pregnancy test.
Patients with significant Chronic Obstructive Pulmonary Disease 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.

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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.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United Kingdom8 sites

University Hospital of Wales
Cardiff, CG14 4XW
Edinburgh Royal Infirmary
Edinburgh, EH16 4SA
Western Infirmary
Glasgow, G11 6NT
Victoria Infirmary
Glasgow, G42 9TY
Whittington Hospital
London, N19 5NF
University College London Hospital
London, NW1 2BU
St Thomas' Hospital
London, SE1 7EH
St Mary's Hospital
London, W2 1NY

Other trials in United Kingdom

About this study

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.

Read the 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
Being tested: Interferon Beta
Keywords: Open label
Medical subject headings: Acute Lung Injury, Respiratory Distress Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Interferon BetaDrug
Also called FP-1201, IFN-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.

Study groups in NCT00789685
Study group	Role	What they receive
Interferon Beta	Experimental	Interferon Beta Receives: Drug: Interferon Beta

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinically Significant Treatment Emergent Events
Treatment-emergent adverse events (TEAEs) in safety population
Measured: From first dose up until Day 28
All Cause Mortality at Day 28
The primary efficacy variable was all cause mortality at Day 28 following commencement of treatment
Measured: 28 days following commencement of therapy

Secondary outcomes (1)

All Cause Mortality Rate at 6 Months
A long-term secondary efficacy variable was all cause mortality at 6 months following commencement of treatment
Measured: 6 months following commencement of therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2009Sep 2011

First posted13 Nov 2008 (estimated)
Study startFeb 2009
Primary completionSep 2011
Study completionSep 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Acute Lung InjuryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00789685
Sponsor's protocol ID: FPCLI001
Status last verified: May 2015
First submitted: 11 Nov 2008
Last updated: 27 May 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Kiss J, Yegutkin GG, Koskinen K, Savunen T, Jalkanen S, Salmi M. IFN-beta protects from vascular leakage via up-regulation of CD73. Eur J Immunol. 2007 Dec;37(12):3334-8. doi: 10.1002/eji.200737793.
PubMed 18034430
Bellingan G, Maksimow M, Howell DC, Stotz M, Beale R, Beatty M, Walsh T, Binning A, Davidson A, Kuper M, Shah S, Cooper J, Waris M, Yegutkin GG, Jalkanen J, Salmi M, Piippo I, Jalkanen M, Montgomery H, Jalkanen S. The effect of intravenous interferon-beta-1a (FP-1201) on lung CD73 expression and on acute respiratory distress syndrome mortality: an open-label study. Lancet Respir Med. 2014 Feb;2(2):98-107. doi: 10.1016/S2213-2600(13)70259-5. Epub 2013 Dec 23.
PubMed 24503265

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Lung Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00789685
Acronym / sponsor ID: FPCLI001
Conditions: Acute Lung Injury, Acute Respiratory Distress Syndrome
Keywords: Open label
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Faron Pharmaceuticals LtdIndustry (pharma, biotech, devices)
Study start: Feb 2009
Primary completion: Sep 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 13 Nov 2008 (estimated)
Results: Posted 27 May 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Interferon Beta	Experimental	Drug: Interferon BetaInterferon Beta

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Adult male or female patients with ALI/ARDS confirmed by the combination of the following diagnostic criteria:
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.

Key exclusion criteria (10 listed)

Patients with burns.
Women known to be pregnant, lactating or having a positive or indeterminate pregnancy test.
Patients with significant Chronic Obstructive Pulmonary Disease 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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Interferon BetaAlso: FP-1201, IFN-betaInterferon 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.	Drug	Interferon Beta

Primary outcome

Clinically Significant Treatment Emergent Events
Time frame: From first dose up until Day 28
Treatment-emergent adverse events (TEAEs) in safety population
All Cause Mortality at Day 28
Time frame: 28 days following commencement of therapy
The primary efficacy variable was all cause mortality at Day 28 following commencement of treatment

1 secondary outcome

All Cause Mortality Rate at 6 Months
Time frame: 6 months following commencement of therapy

Results and safety

Results posted to the registry on 27 May 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Interferon Beta	37	25

Primary outcome: Clinically Significant Treatment Emergent Events

Time frame: From first dose up until Day 28. Number. Unit: Number of patients

Measure	Safety Population n = 37
TEAEs	37
Severe TEAEs	30
Serious TEAEs	22
Drug-Related TEAEs	20
Serious Drug-Related TEAEs	8
TEAEs leading to withdrawal	6

Population analysed: Patients included in Safety population

Primary outcome: All Cause Mortality at Day 28

Time frame: 28 days following commencement of therapy. Number. Unit: percentage of patients who died

Measure	Safety Population n = 37
Value	8.1

Population analysed: Patients included in Safety population

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Over the course of the study (Days 1 - 28) and at withdrawal. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Safety Population	22 of 37 (59.5%)	37 of 37 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 18034430Kiss J, Yegutkin GG, Koskinen K, Savunen T, Jalkanen S, Salmi M. IFN-beta protects from vascular leakage via up-regulation of CD73. Eur J Immunol. 2007 Dec;37(12):3334-8. doi: 10.1002/eji.200737793.
Results publication: PubMed 24503265Bellingan G, Maksimow M, Howell DC, Stotz M, Beale R, Beatty M, Walsh T, Binning A, Davidson A, Kuper M, Shah S, Cooper J, Waris M, Yegutkin GG, Jalkanen J, Salmi M, Piippo I, Jalkanen M, Montgomery H, Jalkanen S. The effect of intravenous interferon-beta-1a (FP-1201) on lung CD73 expression and on acute respiratory distress syndrome mortality: an open-label study. Lancet Respir Med. 2014 Feb;2(2):98-107. doi: 10.1016/S2213-2600(13)70259-5. Epub 2013 Dec 23.
Sponsor's websiteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Geoff Bellingan, MD principal investigator

University College London Hospitals

Martin Kuper, MD principal investigator

Whittington Hospital

Martin Stotz, MD principal investigator

St Mary's Hospital, London

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Interferon Beta in people with Acute Lung Injury and Acute Respiratory Distress Syndrome, run by Faron Pharmaceuticals Ltd at 8 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinically Significant Treatment Emergent Events (time frame: From first dose up until Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00789685, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015.