Acute Respiratory Distress SyndromePhase 2NCT02113735
Safety and Efficacy Study of Acthar in Subjects With ARDS
A Phase 2 study testing H.P. Acthar® Gel (repository corticotropin injection) in people with Acute Respiratory Distress Syndrome, run by Mallinckrodt.
Trial summary
This study is being performed to evaluate the potential efficacy and safety of Acthar as a treatment for moderate-severe Acute Respiratory Distress Syndrome (ARDS). Approximately 210 subjects will be randomized to 1 of 6 possible treatment groups in a 3:2:3:2:3:2 ratio. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- H.P. Acthar® Gel (repository corticotropin injection)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Aug 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Patients ≥ 18 years.
- ARDS as defined by:
- PaO2 /FiO2 ≤ 200 mmHg with PEEP ≥ 5cm H2O.
- Bilateral opacities on chest radiography not explained by atelectasis, effusions, nodules, or preexisting disease.
- Requirement for positive pressure ventilation via an endotracheal tube.
- Respiratory failure not fully explained by cardiac failure or fluid overload. If no identifiable risk factor for ARDS is identified, left atrial hypertension must be excluded by objective measures (e.g. transthoracic echocardiogram).
- Criteria 2a, 2b, and 2c must occur within the same 24 hr period.
- Enrollment between 24 hours and 10 days after ARDS criteria are met.
Who cannot join
- Subject unwilling to receive or intolerant of SC injections.
- Subject, surrogate, or physician not committed to full supportive care. A "Do Not Resuscitate" (DNR) order alone without other limitations of care does not require study exclusion.
- Moribund subject with death perceived to be imminent. For the purposes of this study, moribund is defined by a requirement for ≥ 2 high dose vasopressors AND acute organ failures in ≥ 3 organs for ≥ 24 hours prior to study entry.
- Home mechanical ventilation (noninvasive ventilation or via tracheotomy) except for continuous positive airway pressure or bi-level positive airway pressure (CPAP/BIPAP) used solely for sleep-disordered breathing prior to onset of ARDS.
- Known contraindication to Acthar per package insert Section 4 (Appendix C): scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, or adrenal cortical hyperfunction.
- Gastrointestinal/Hepatic: History of chronic active hepatitis, active Hepatitis B or acute or chronic Hepatitis C infection, OR moderate-severe chronic liver disease as defined by a Child-Pugh Score > 11(http://gihep.com/calculators/hepatology/child-pugh-score/), OR any evidence of hemodynamically significant active gastrointestinal (GI) bleeding.
Show all 12Show fewer
- Any subject with signs or symptoms concerning for an active infection that has not been treated for > 48 hours prior to randomization with either empiric broad-spectrum or pathogen-directed anti-microbial therapy.
- Immune System: Known immune-compromised status, including but not limited to individuals who have undergone organ transplantation or who are known to be positive for the human immunodeficiency virus (HIV).
- Burns >20% total body surface area, or any burn injury accompanied by smoke inhalational injury.
- Major surgery within 48 hours before randomization, OR evidence of currently active bleeding postoperatively, OR plan for any major surgery during the study period.
- Administration of any other investigational drug or participation in an interventional clinical research study for ARDS within 30 days of planned randomization or during the 60 day study duration.
- Presence of any other clinically significant disease or disorder (including those listed in Appendix C package insert Section 5 [Warnings and Precautions]) which, in the opinion of the Investigator (by its nature or by being inadequately controlled), might put the subject at risk due to participation in the study, or may influence the results of the study or the subject's ability to complete the study.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Safety and Efficacy Study of H.P. Acthar® Gel (Acthar) in Subjects With Acute Respiratory Distress Syndrome (ARDS)
This study is being performed to evaluate the potential efficacy and safety of Acthar as a treatment for moderate-severe Acute Respiratory Distress Syndrome (ARDS). Approximately 210 subjects will be randomized to 1 of 6 possible treatment groups in a 3:2:3:2:3:2 ratio. Study medication (SM) will be administered via subcutaneous (SC) injection for 4 weeks using a blinded gradually tapering regimen, and subjects will be followed for 60 days post-randomization.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- H.P. Acthar® Gel (repository corticotropin injection), Placebo
- Keywords
- ARDS, Acute Respiratory Distress Syndrome, Acthar, ACTH, H.P. Acthar Gel
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H.P. Acthar® Gel (repository corticotropin injection)Drug
Also called Acthar
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | H.P. Acthar® Gel , 64 U, 0.8 mL daily Receives: Drug: H.P. Acthar® Gel (repository corticotropin injection) |
| Group 2 | Placebo comparator | Placebo, 0.8 mL, daily Receives: Drug: Placebo |
| Group 3 | Experimental | H.P. Acthar® Gel , 32 U, 0.4 mL, 2x daily Receives: Drug: H.P. Acthar® Gel (repository corticotropin injection) |
| Group 4 | Placebo comparator | Placebo, 0.4 mL, 2x daily Receives: Drug: Placebo |
| Group 5 | Experimental | H.P. Acthar® Gel , 16 U, 0.2 mL, 2x daily Receives: Drug: H.P. Acthar® Gel (repository corticotropin injection) |
| Group 6 | Placebo comparator | Placebo, 0.2 mL, 2x daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of ventilator-free days (subjects alive and breathing without assistance for ≥ 48 hr) by Day 28 after randomization
Measured: 60 days (28 days of treatment with a 32 day follow-up period)
Secondary outcomes (8)
Mortality at Day 28 and Day 60
Measured: 60 days (28 days of treatment with a 32 day follow-up period)
Number of ICU-free and hospital free days for all subjects who survive to ICU and hospital discharge, respectively
Measured: 60 days (28 days of treatment with a 32 day follow-up period)
Number of extra-pulmonary organ failure-free days
Measured: 60 days (28 days of treatment with a 32 day follow-up period)
Change in PaO2/FiO2 ratio and oxygenation index (OI) from baseline for subjects on mechanical ventilation
Measured: 60 days (28 days of treatment with a 32 day follow-up period)
Change in Systemic Organ Failure Assessment Score (SOFA) score from baseline.
Measured: 60 days (28 days of treatment with a 32 day follow-up period)
Number of treatment-emergent serious adverse events
Measured: 60 days (28 days of treatment with a 32 day follow-up period)
Number, severity and site of new infections developing at least 48 hr after initiation of Study Medication
Measured: 60 days (28 days of treatment with a 32 day follow-up period)
Proportion of subjects who discontinue treatment because of serious safety concerns
Measured: 60 days (28 days of treatment with a 32 day follow-up period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startAug 2014 (estimated)
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Why it stopped: A company decision was made not to proceed with the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mallinckrodt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113735
- Sponsor's protocol ID
- QSC01-ARDS-01
- Status last verified
- Sep 2017
- First submitted
- 8 Apr 2014
- Last updated
- 27 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel Group Safety and Efficacy Study of H.P. Acthar® Gel (Acthar) in Subjects With Acute Respiratory Distress Syndrome (ARDS)
- ClinicalTrials.gov ID
- NCT02113735
- Acronym / sponsor ID
- QSC01-ARDS-01
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- ARDS, Acute Respiratory Distress Syndrome, Acthar, ACTH, H.P. Acthar Gel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: A company decision was made not to proceed with the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MallinckrodtIndustry (pharma, biotech, devices)
- Study start
- Aug 2014 (estimated)
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 15 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being performed to evaluate the potential efficacy and safety of Acthar as a treatment for moderate-severe Acute Respiratory Distress Syndrome (ARDS). Approximately 210 subjects will be randomized to 1 of 6 possible treatment groups in a 3:2:3:2:3:2 ratio. Study medication (SM) will be administered via subcutaneous (SC) injection for 4 weeks using a blinded gradually tapering regimen, and subjects will be followed for 60 days post-randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: H.P. Acthar® Gel (repository corticotropin injection)H.P. Acthar® Gel , 64 U, 0.8 mL daily |
| Group 2 | Placebo comparator | Drug: PlaceboPlacebo, 0.8 mL, daily |
| Group 3 | Experimental | Drug: H.P. Acthar® Gel (repository corticotropin injection)H.P. Acthar® Gel , 32 U, 0.4 mL, 2x daily |
| Group 4 | Placebo comparator | Drug: PlaceboPlacebo, 0.4 mL, 2x daily |
| Group 5 | Experimental | Drug: H.P. Acthar® Gel (repository corticotropin injection)H.P. Acthar® Gel , 16 U, 0.2 mL, 2x daily |
| Group 6 | Placebo comparator | Drug: PlaceboPlacebo, 0.2 mL, 2x daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients ≥ 18 years.
- ARDS as defined by:
- Enrollment between 24 hours and 10 days after ARDS criteria are met.
Key exclusion criteria (12 listed)
- Subject unwilling to receive or intolerant of SC injections.
- Subject, surrogate, or physician not committed to full supportive care. A "Do Not Resuscitate" (DNR) order alone without other limitations of care does not require study exclusion.
- Moribund subject with death perceived to be imminent. For the purposes of this study, moribund is defined by a requirement for ≥ 2 high dose vasopressors AND acute organ failures in ≥ 3 organs for ≥ 24 hours prior to study entry.
- Home mechanical ventilation (noninvasive ventilation or via tracheotomy) except for continuous positive airway pressure or bi-level positive airway pressure (CPAP/BIPAP) used solely for sleep-disordered breathing prior to onset of ARDS.
- Known contraindication to Acthar per package insert Section 4 (Appendix C): scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, or adrenal cortical hyperfunction.
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 |
|---|---|---|
| H.P. Acthar® Gel (repository corticotropin injection)Also: Acthar | Drug | Group 1, Group 3, Group 5 |
| Placebo | Drug | Group 2, Group 4, Group 6 |
Primary outcome
Number of ventilator-free days (subjects alive and breathing without assistance for ≥ 48 hr) by Day 28 after randomization
Time frame: 60 days (28 days of treatment with a 32 day follow-up period)
8 secondary outcomes
Mortality at Day 28 and Day 60
Time frame: 60 days (28 days of treatment with a 32 day follow-up period)
Number of ICU-free and hospital free days for all subjects who survive to ICU and hospital discharge, respectively
Time frame: 60 days (28 days of treatment with a 32 day follow-up period)
Number of extra-pulmonary organ failure-free days
Time frame: 60 days (28 days of treatment with a 32 day follow-up period)
Change in PaO2/FiO2 ratio and oxygenation index (OI) from baseline for subjects on mechanical ventilation
Time frame: 60 days (28 days of treatment with a 32 day follow-up period)
Change in Systemic Organ Failure Assessment Score (SOFA) score from baseline.
Time frame: 60 days (28 days of treatment with a 32 day follow-up period)
Number of treatment-emergent serious adverse events
Time frame: 60 days (28 days of treatment with a 32 day follow-up period)
Number, severity and site of new infections developing at least 48 hr after initiation of Study Medication
Time frame: 60 days (28 days of treatment with a 32 day follow-up period)
Proportion of subjects who discontinue treatment because of serious safety concerns
Time frame: 60 days (28 days of treatment with a 32 day follow-up period)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2017.
Related trials for Acute Respiratory Distress Syndrome
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing H.P. Acthar® Gel (repository corticotropin injection) in people with Acute Respiratory Distress Syndrome, run by Mallinckrodt.
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 8 inclusion and 12 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: withdrawn, as of the sponsor's last update on 27 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of ventilator-free days (subjects alive and breathing without assistance for ≥ 48 hr) by Day 28 after randomization (time frame: 60 days (28 days of treatment with a 32 day follow-up period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2017.