Alcoholic Hepatitis (AH)Phase 2NCT02854631
Selonsertib in Combination With Prednisolone Versus Prednisolone Alone in Participants With Severe Alcoholic Hepatitis (AH)
A Phase 2 study testing Selonsertib and Prednisolone in people with Alcoholic Hepatitis (AH), run by Gilead Sciences at 44 sites in 7 countries.
Trial summary
The primary objective of this study is to evaluate the safety and tolerability of selonsertib (GS-4997) in combination with prednisolone versus prednisolone alone in participants with severe alcoholic hepatitis (AH). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alcoholic Hepatitis (AH)
- What is being tested?
- Selonsertib and Prednisolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 44 sitesin 7 countries
- Study dates
- 1 Sep 2016to 31 May 2018
- Phase
- Phase 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to give informed consent prior to any study specific procedures being performed. In individuals with hepatic encephalopathy (HE) which may impair decision-making, consent will be obtained per hospital procedures (eg, by Legally Authorized Representative)
- Clinical diagnosis of severe AH
- Maddrey's Discriminant Function (DF) ≥ 32 at screening
Who cannot join
- Pregnant or lactating females;
- Other causes of liver disease including chronic hepatitis B (hepatitis B surface antigen [HBsAg] positive), chronic hepatitis C (HCV RNA positive), acetaminophen hepatotoxicity, biliary obstruction, and autoimmune liver disease;
- Serum aspartate aminotransferase (AST) >400 U/L or alanine aminotransferase (ALT) >300 U/L;
- Model for End Stage Liver Disease (MELD) >30 at screening;
- Maddrey's DF >60 at screening;
- Grade 4 Hepatic Encephalopathy (HE) by West Haven criteria;
Show all 18Show fewer
- Concomitant or previous history of hepatocellular carcinoma;
- History of liver transplantation;
- HIV Ab positive;
- Clinical suspicion of pneumonia;
- Uncontrolled sepsis;
- Uncontrolled gastrointestinal (GI) bleeding or controlled GI bleeding within 7 days of screening that was associated with shock or required transfusion of more than 3 units of blood;
- Type 1 hepatorenal syndrome (HRS) or renal failure defined as a serum creatinine >221 μmol/L (>2.5 mg/dL) or the requirement for renal replacement therapy;
- Individuals dependent on inotropic (eg, epinephrine or norepinephrine) or ventilatory support (ie, endotracheal intubation or positive-pressure ventilation);
- Portal vein thrombosis;
- Acute pancreatitis;
- Cessation of alcohol consumption for more than 2 months before Baseline/ Day 1
- Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Trial locations and contacts
44 sites in 7 countries.
44 sites in 7 countries
United States11 sites
University of Michigan
Ann Arbor, Michigan
Beth Israel Deaconess Medical Center
Boston, Massachusetts
Southern California Research Centers
Coronado, California
Methodist Healthcare Dallas - The Liver Institute
Dallas, Texas
University of Arkansas for Medical Sciences
Little Rock, Arkansas
Cedars Sinai Medical Center
Los Angeles, California, 90048
Oschner Medical Center
New Orleans, Louisiana
Liver Institute of Virginia
Newport News, Virginia
University of Pennsylvania
Philadelphia, Pennsylvania
University of Washington
Seattle, Washington
Cleveland Clinic Florida
Weston, Florida
United Kingdom11 sites
Brighton & Sussex University Hospitals NHS Trust
Brighton
Hull and East Yorkshire Hospitals NHS Trust
Hull
Royal Liverpool & Broadgreen University Hospitals NHS Trust
Liverpool
Barts Health NHS Trust
London
Chelsea and Westminster Hospital
London
Imperial College
London
Kings College Hospital NHS Trust
London
Freeman Hospital
Newcastle
Nottingham University Hospitals NHS Trust
Nottingham
Derriford Hospital
Plymouth
Portsmouth Hospitals NHS Trust
Portsmouth
France10 sites
CHU Amiens Picardie
Amiens
CHU Angers
Angers
Hôpital Jean Minjoz
Besançon
C.H.U. de Caen
Caen
CHU henri Mondor
Créteil
CHU de Grenoble- Hopital Michallon
La Tronche
CHRU de Lille
Lille
Hôpital de la Croix Rousse
Lyon
Hopital La Pitie Salpetriere
Paris
Hopital Paul Brousse
Villejuif
Belgium5 sites
Cliniques Universitaires UCL Saint-Luc
Brussels
CUB Hopital Erasme
Brussels
Ghent University Hospital
Ghent
Universitair Ziekenhuis Leuven
Leuven
Centre Hospitalier Universitaire de Liege
Liège
Austria3 sites
Medizinische Universitat Graz
Graz
Universitätsklinik für Innere Medizin I
Innsbruck
Medical University Vienna
Vienna
Canada3 sites
University of Calgary
Calgary, Alberta
Toronto General Hospital
Toronto, Ontario
University of Manitoba
Winnipeg, Manitoba
About this study
Official title: A Phase 2, Double-Blind, Randomized Study Evaluating the Safety, Tolerability, and Efficacy of GS-4997 in Combination With Prednisolone Versus Prednisolone Alone in Subjects With Severe Alcoholic Hepatitis (AH)
The primary objective of this study is to evaluate the safety and tolerability of selonsertib (GS-4997) in combination with prednisolone versus prednisolone alone in participants with severe alcoholic hepatitis (AH).
- Conditions
- Alcoholic Hepatitis (AH)
- Being tested
- Selonsertib, Prednisolone, Placebo
- Keywords
- Cirrhosis, Prednisone, Jaundice
- Medical subject headings
- Hepatitis, Alcoholic, Fibrosis, Jaundice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelonsertibDrug
Also called GS-4997
18 mg tablet administered orally once daily
PrednisoloneDrug
40 mg (4 x 10 mg tablets) administered orally once daily
PlaceboDrug
Selonsertib placebo tablet administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Selonsertib + Prednisolone | Experimental | Selonsertib + prednisolone for 28 days Receives: Drug: Selonsertib; Drug: Prednisolone |
| Prednisolone | Placebo comparator | Selonsertib placebo + prednisolone for 28 days Receives: Drug: Prednisolone; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Treatment-Emergent (TE) Adverse Events (AE), Serious AEs (SAE), AEs Leading to Premature Study Drug Discontinuation, and Grade 3 or 4 Laboratory Abnormalities
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Laboratory toxicity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03.
Measured: Up to Day 28 plus 30 days
Secondary outcomes (26)
Percentage of Participants Who Died by Day 28
The percentage of participants who died by Day 28 was calculated.
Measured: Day 28
Percentage of Participants Who Died by Week 8
The percentage of participants who died by Week 8 was calculated.
Measured: Week 8
Percentage of Participants Who Died by Week 12
The percentage of participants who died by Week 12 was calculated.
Measured: Week 12
Percentage of Participants Who Died by Week 24
The percentage of participants who died by Week 24 was calculated.
Measured: Week 24
Percentage of Participants With Survival at Day 28 Using Kaplan-Meier
The percentage of participants with survival at Day 28 using Kaplan-Meier was calculated.
Measured: Day 28
Percentage of Participants With Survival at Week 8 Using Kaplan-Meier
The percentage of participants with survival at Week 8 using Kaplan-Meier was calculated.
Measured: Week 8
Percentage of Participants With Survival at Week 12 Using Kaplan-Meier
The percentage of participants with survival at Week 12 using Kaplan-Meier was calculated.
Measured: Week 12
Percentage of Participants With Survival at Week 24 Using Kaplan-Meier
The percentage of participants with survival at Week 24 using Kaplan-Meier was calculated.
Measured: Week 24
Percentage of Participants Who Received a Liver Transplant
The percentage of participants who received a liver transplant by week 24 was calculated.
Measured: Day 28, Week 8, Week 12, and Week 24
Percentage of Participants With Hepatorenal Syndrome (HRS)
The occurrence of HRS was confirmed based on the following diagnostic criteria from the International Ascites Club (IAC): 1) Cirrhosis with ascites, 2) Diagnosis of acute kidney injury (AKI) according to the ICA-AKI criteria, 3) Absence of shock, 4) No current or recent treatment with nephrotoxic drugs, and 5) Absence of parenchymal renal disease as indicated by proteinuria >500 mg/day, microhematuria (> 50 red blood cells per high power field) and/or abnormal renal ultrasonography.
Measured: Up to 24 weeks
Percentage of Participants With Infection
The occurrence of bacterial, fungal, or viral infections was recorded. An infection was considered definite in participants with clinical evidence of infection and a positive culture from a normally sterile source (with the exception of spontaneous bacterial peritonitis).
Measured: Up to 24 weeks
Length of Hospital Stay
Length of initial hospital stay from first dose date of study drug was calculated for participants who were released from initial hospitalization separately from those who died during their initial hospitalization.
Measured: Up to 24 weeks
Change From Baseline in Liver Biochemistry Tests: Alanine Aminotransferase (ALT)
Change from Baseline was calculated as the value at endpoint minus the value at Baseline.
Measured: Baseline (Day 1) and up to 24 weeks
Change From Baseline in Liver Biochemistry Tests: Aspartate Aminotransferase (AST)
Change from Baseline was calculated as the value at endpoint minus the value at Baseline.
Measured: Baseline (Day 1) and up to 24 weeks
Change From Baseline in Liver Biochemistry Tests: Gamma Glutamyl Transferase (GGT)
Change from Baseline was calculated as the value at endpoint minus the value at Baseline.
Measured: Baseline (Day 1) and up to 24 weeks
Change From Baseline in Liver Biochemistry Tests: Alkaline Phosphatase
Change from Baseline was calculated as the value at endpoint minus the value at Baseline.
Measured: Baseline (Day 1) and up to 24 weeks
Change From Baseline in Liver Biochemistry Tests: Bilirubin
Change from Baseline was calculated as the value at endpoint minus the value at Baseline.
Measured: Baseline (Day 1) and up to 24 weeks
Change From Baseline in Liver Biochemistry Tests: Albumin
Change from Baseline was calculated as the value at endpoint minus the value at Baseline.
Measured: Baseline (Day 1) and up to 24 weeks
Change From Baseline in Liver Biochemistry Tests: International Normalized Ratio (INR)
Change from Baseline was calculated as the value at endpoint minus the value at Baseline.
Measured: Baseline (Day 1) and up to 24 weeks
Percentage of Participants With Lille Response (Score < 0.45) at Day 7
The Lille score is a tool used to predict which participants with severe alcoholic hepatitis (AH) were not responding to corticosteroid therapy. It ranges between 0 and 1, with low scores (< 0.16) indicating complete response or positive response to steroids (continue therapy) and high scores (≥ 0.56) indicating no response or poor response to steroids (stop therapy). The Lille score was calculated using baseline factors: age, albumin, total bilirubin, serum creatinine, prothrombin time; and the change in total bilirubin between baseline (Day 1) and Day 7. Lille response was defined as having a Lille score < 0.45.
Measured: Day 7
Percentage of Participants With a Lille Null Response (Score ≥ 0.56) at Day 7
The Lille score is a tool used to predict which participants with severe AH were not responding to corticosteroid therapy. It ranges between 0 and 1, with low scores (< 0.16) indicating complete response or positive response to steroids (continue therapy) and high scores (≥ 0.56) indicating no response or poor response to steroids (stop therapy). The Lille score was calculated using baseline factors: age, albumin, total bilirubin, serum creatinine, prothrombin time; and the change in total bilirubin between baseline (Day 1) and Day 7. Lille null response was defined as having a Lille score ≥ 0.56.
Measured: Day 7
Lille Score at Day 7 as a Continuous Variable
The Lille score is a tool used to predict which participants with severe AH were not responding to corticosteroid therapy. It ranges between 0 and 1, with low scores (< 0.16) indicating complete response or positive response to steroids (continue therapy) and high scores (≥ 0.56) indicating no response or poor response to steroids (stop therapy). The Lille score was calculated using baseline factors: age, albumin, total bilirubin, serum creatinine, prothrombin time; and the change in total bilirubin between baseline (Day 1) and Day 7.
Measured: Day 7
Percentage of Participants With Estimated Mortality at Month 2 and Month 6: Combined Scoring Including Lille Score at Day 7 and Baseline Model for End-Stage Liver Disease (MELD) Score
The Lille score is a tool used to predict which participants with severe AH were not responding to corticosteroid therapy. It ranges between 0 and 1, with low scores (< 0.16) indicating complete response or positive response to steroids (continue therapy) and high scores (≥ 0.56) indicating no response or poor response to steroids (stop therapy). MELD scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40, with higher scores indicating greater disease severity. A scoring system combining the Lille score at Day 7 and the baseline MELD score was used to calculate the percentage of participants expected to die by Month 2 and by Month 6.
Measured: Baseline and Day 7 Time Points used to calculate Overall Mortality Risk at Months 2 and 6
Change From Baseline in Prognostic Index: Model for End-Stage Liver Disease (MELD) Score
MELD scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40, with higher scores indicating greater disease severity. Change from Baseline was calculated as the value at endpoint minus the value at Baseline.
Measured: Baseline (Day 1) and up to 24 weeks
Change From Baseline in Prognostic Index: Child-Pugh-Turcotte (CPT) Score
CPT scores are used to assess the severity of cirrhosis. Scores can range from 5 to 15, with higher scores indicating a greater severity of disease
Measured: Baseline (Day 1) and up to 24 weeks
Change From Baseline in Prognostic Index: Maddrey Discriminant Function (DF) Score
Baseline Maddrey DF score is a prognostic tool used to determine the next step of treatment based on the severity of AH. Maddrey DF score of < 32 indicates mild to moderate AH and a lower chance of death in the next few months. Maddrey DF score of ≥ 32 indicates severe AH and a higher chance of death in the next few months. The score has no bounds.
Measured: Baseline (Day 1) and up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study start1 Sep 2016
- Primary completion16 Feb 2018
- Study completion31 May 2018
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.
- Other trials for Alcoholic Hepatitis (AH)Studies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854631
- Sponsor's protocol ID
- GS-US-416-2124
- Other IDs
- 2016-000821-37, 2016
- Status last verified
- Feb 2019
- First submitted
- 29 Jul 2016
- Last updated
- 6 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-Blind, Randomized Study Evaluating the Safety, Tolerability, and Efficacy of GS-4997 in Combination With Prednisolone Versus Prednisolone Alone in Subjects With Severe Alcoholic Hepatitis (AH)
- ClinicalTrials.gov ID
- NCT02854631
- Acronym / sponsor ID
- GS-US-416-2124
- Conditions
- Alcoholic Hepatitis (AH)
- Keywords
- Cirrhosis, Prednisone, Jaundice
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 16 Feb 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 3 Aug 2016 (estimated)
- Results
- Posted 6 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the safety and tolerability of selonsertib (GS-4997) in combination with prednisolone versus prednisolone alone in participants with severe alcoholic hepatitis (AH).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Selonsertib + Prednisolone | Experimental | Drug: Selonsertib, Drug: PrednisoloneSelonsertib + prednisolone for 28 days |
| Prednisolone | Placebo comparator | Drug: Prednisolone, Drug: PlaceboSelonsertib placebo + prednisolone for 28 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Willing and able to give informed consent prior to any study specific procedures being performed. In individuals with hepatic encephalopathy (HE) which may impair decision-making, consent will be obtained per hospital procedures (eg, by Legally Authorized Representative)
- Clinical diagnosis of severe AH
Key exclusion criteria (18 listed)
- Pregnant or lactating females;
- Other causes of liver disease including chronic hepatitis B (hepatitis B surface antigen [HBsAg] positive), chronic hepatitis C (HCV RNA positive), acetaminophen hepatotoxicity, biliary obstruction, and autoimmune liver disease;
- Serum aspartate aminotransferase (AST) >400 U/L or alanine aminotransferase (ALT) >300 U/L;
- Model for End Stage Liver Disease (MELD) >30 at screening;
- Maddrey's DF >60 at screening;
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 |
|---|---|---|
| SelonsertibAlso: GS-499718 mg tablet administered orally once daily | Drug | Selonsertib + Prednisolone |
| Prednisolone40 mg (4 x 10 mg tablets) administered orally once daily | Drug | Prednisolone, Selonsertib + Prednisolone |
| PlaceboSelonsertib placebo tablet administered orally once daily | Drug | Prednisolone |
Primary outcome
Percentage of Participants With Treatment-Emergent (TE) Adverse Events (AE), Serious AEs (SAE), AEs Leading to Premature Study Drug Discontinuation, and Grade 3 or 4 Laboratory Abnormalities
Time frame: Up to Day 28 plus 30 days
An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Laboratory toxicity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03.
26 secondary outcomes
Percentage of Participants Who Died by Day 28
Time frame: Day 28
Percentage of Participants Who Died by Week 8
Time frame: Week 8
Percentage of Participants Who Died by Week 12
Time frame: Week 12
Percentage of Participants Who Died by Week 24
Time frame: Week 24
Percentage of Participants With Survival at Day 28 Using Kaplan-Meier
Time frame: Day 28
Percentage of Participants With Survival at Week 8 Using Kaplan-Meier
Time frame: Week 8
Percentage of Participants With Survival at Week 12 Using Kaplan-Meier
Time frame: Week 12
Percentage of Participants With Survival at Week 24 Using Kaplan-Meier
Time frame: Week 24
Percentage of Participants Who Received a Liver Transplant
Time frame: Day 28, Week 8, Week 12, and Week 24
Percentage of Participants With Hepatorenal Syndrome (HRS)
Time frame: Up to 24 weeks
Percentage of Participants With Infection
Time frame: Up to 24 weeks
Length of Hospital Stay
Time frame: Up to 24 weeks
Change From Baseline in Liver Biochemistry Tests: Alanine Aminotransferase (ALT)
Time frame: Baseline (Day 1) and up to 24 weeks
Change From Baseline in Liver Biochemistry Tests: Aspartate Aminotransferase (AST)
Time frame: Baseline (Day 1) and up to 24 weeks
Change From Baseline in Liver Biochemistry Tests: Gamma Glutamyl Transferase (GGT)
Time frame: Baseline (Day 1) and up to 24 weeks
Change From Baseline in Liver Biochemistry Tests: Alkaline Phosphatase
Time frame: Baseline (Day 1) and up to 24 weeks
Change From Baseline in Liver Biochemistry Tests: Bilirubin
Time frame: Baseline (Day 1) and up to 24 weeks
Change From Baseline in Liver Biochemistry Tests: Albumin
Time frame: Baseline (Day 1) and up to 24 weeks
Change From Baseline in Liver Biochemistry Tests: International Normalized Ratio (INR)
Time frame: Baseline (Day 1) and up to 24 weeks
Percentage of Participants With Lille Response (Score < 0.45) at Day 7
Time frame: Day 7
Percentage of Participants With a Lille Null Response (Score ≥ 0.56) at Day 7
Time frame: Day 7
Lille Score at Day 7 as a Continuous Variable
Time frame: Day 7
Percentage of Participants With Estimated Mortality at Month 2 and Month 6: Combined Scoring Including Lille Score at Day 7 and Baseline Model for End-Stage Liver Disease (MELD) Score
Time frame: Baseline and Day 7 Time Points used to calculate Overall Mortality Risk at Months 2 and 6
Change From Baseline in Prognostic Index: Model for End-Stage Liver Disease (MELD) Score
Time frame: Baseline (Day 1) and up to 24 weeks
Change From Baseline in Prognostic Index: Child-Pugh-Turcotte (CPT) Score
Time frame: Baseline (Day 1) and up to 24 weeks
Change From Baseline in Prognostic Index: Maddrey Discriminant Function (DF) Score
Time frame: Baseline (Day 1) and up to 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Gilead Study Director study director
Gilead Sciences
44 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Selonsertib and Prednisolone in people with Alcoholic Hepatitis (AH), run by Gilead Sciences at 44 sites in 7 countries.
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 3 inclusion and 18 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 6 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States, United Kingdom, France, Belgium, Austria and 2 more countries. 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. 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?
Yes. Results are posted in the registry (first posted 6 Feb 2019). 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?
Percentage of Participants With Treatment-Emergent (TE) Adverse Events (AE), Serious AEs (SAE), AEs Leading to Premature Study Drug Discontinuation, and Grade 3 or 4 Laboratory Abnormalities (time frame: Up to Day 28 plus 30 days). 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 6 Feb 2019.