AnemiaPhase 2NCT01146574
A Phase 2a Study To Evaluate The Pharmacokinetics, Safety, Efficacy, Tolerability, And Pharmacodynamics of Sotatercept (ACE-011) for the Correction of Anemia in Subjects With End-stage Renal Disease on Hemodialysis.
A Phase 2 study testing Sotatercept in people with Anemia, run by Celgene at 24 sites in United States.
Trial summary
This is the first study in hemodialysis subjects with anemia to evaluate the pharmacokinetics, safety, efficacy, tolerability, and pharmacodynamics of sotatercept (ACE-011) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- Sotatercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 24 sitesUnited States
- Study dates
- 30 Jun 2010to 7 Mar 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females ≥18 years of age.
- Subjects on hemodialysis for at least 12 weeks before screening
- Subjects on a stable dose of Erythrocyte Stimulating Agents product to maintain Hemoglobin (Hb) for at least 6 weeks prior to screening.
- 3 consecutive pre-dialysis Hb concentrations with a mean ≥10 to ≤ 12 g/dL (≥100 to ≤120 g/L) at screening and one pre-dialysis Hb concentration ≥8 to < 10 g/dL (≥ 80 to < 100 g/L) before randomization.
- Adequate iron status defined as serum transferrin saturation ≥ 20% before randomization.
Who cannot join
- Non renal causes of anemia.
- Subjects on peritoneal dialysis.
- Systemic hematological disease
- High sensitivity C-reactive protein >50mg/L at screening.
- Alanine transaminase (ALT) or aspartate transaminase (AST) laboratory values > 2 times the upper limit of normal (ULN) at screening.
- Uncontrolled diabetes mellitus (HbA1c > 9) at screening.
Show all 12Show fewer
- Uncontrolled hypertension.
- Red Blood Count (RBC) transfusions within 8 weeks prior to screening.
- Active serious infection or history of recurrent serious infection likely to recur during the study
- History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational product or to the iron products needed to normalize iron levels for subjects.
- Subjects that received treatment with another investigational drug or device within 28 days prior to Day 1
- Pregnant or lactating females.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
North American Research Institute
Azusa, California, 91702-3439
Northeast Clinical Research Center
Bethlehem, Pennsylvania, 18017
University of Virginia at University Ave.
Charlottesville, Virginia, 22908
MetroHealth Medical Systems
Cleveland, Ohio, 44109
West Glendale Dialysis
Glendale, California, 91205
Corva Kidney Center Webster
Houston, Texas, 77003
Beechnut Dialysis Center
Houston, Texas, 77036
Miracle Medical Clinic
Houston, Texas, 77055
Gessner Dialysis Center
Houston, Texas, 77074
Fresenius Medical Care North America MI
Kalamazoo, Michigan, 49007
California Institute of Renal Research
La Mesa, California, 91942
Kidney Specialists of Southen Nevada
Las Vegas, Nevada, 89106
University of Kentucky
Lexington, Kentucky, 40536
Academic Medical Center
Los Angeles, California, 90022
Academic Medical Research Institute
Los Angeles, California, 90022
DaVita Clinical Research
Minneapolis, Minnesota, 55404
Nephrology Associates, PC
Nashville, Tennessee, 37205
Nephrology Specialist Medical Group
Orange, California, 92868
Pines Clinical Research Inc.
Pembroke Pines, Florida, 33028
St. Louis University Medical Center
St Louis, Missouri, 63110
Washington University School of Medicine
St Louis, Missouri, 63110
Nephrology and Hypertension Associates, LTD
Tupelo, Mississippi, 38801
Tyler Nephrology Associates, PC
Tyler, Texas, 75702
Brookview Hill Research Associates, LLC
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase 2a, Multi-center, Randomized, Single Dose, Double-blind, Placebo-controlled Followed by a Multiple-dose, Single-blind, Placebo-controlled, Dose Escalation Study to Evaluate the Pharmacokinetics, Safety, Efficacy, Tolerability, and Pharmacodynamics of Sotatercept (ACE-011) for the Correction of Anemia in Subjects With End-stage Renal Disease (ESRD) on Hemodialysis (HD).
This is the first study in hemodialysis subjects with anemia to evaluate the pharmacokinetics, safety, efficacy, tolerability, and pharmacodynamics of sotatercept (ACE-011)
Read the detailed description
Part 1:
Approximately 8 subjects will be randomized to receive either a single 0.1 mg/kg subcutaneous dose of sotatercept or matching placebo in a 3:1 ratio
Part 2:
Approximately 8 subjects will be randomized to each of the 3 sequential dose groups (0.3mg/kg or 0.5mg/kg or 0.7 mg/kg) with a 3:1 ratio of sotatercept or placebo (6 subjects in the sotatercept arm and 2 in the placebo arm). A total of 24-36 subjects may be randomized in the 3 dose groups.
- Conditions
- Anemia
- Being tested
- Sotatercept, Placebo
- Keywords
- End-Stage Renal Disease, Anemia, Hemodialysis, Renal Anemia, ESRD
- Medical subject headings
- Anemia, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SotaterceptBiological
Also called ACE-011
Part 1: Sotatercept single dose 0.1mg/kg subcutaneous Part 2: Sotatercept starting dose groups of 0.3mg/kg, 0.5mg/kg or 0.7 mg/kg in a sequential design, dosed subcutaneously every 28 days for up to 8 doses
PlaceboBiological
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 0.1mg/kg Sotatercept | Experimental | Approximately 8 subjects will be randomized to receive either a single 0.1 mg/kg subcutaneous dose of sotatercept or matching placebo in a 3:1 ratio Receives: Biological: Sotatercept |
| 0.3mg/kg Sotatercept | Experimental | Dose Group 1: 0.3 mg/kg sotatercept subcutaneous every 28 days Receives: Biological: Sotatercept |
| 0.5mg/kg Sotatercept | Experimental | Dose Group 2: 0.5 mg/kg sotatercept subcutaneous every 28 days Receives: Biological: Sotatercept |
| 0.7mg/kg Sotatercept | Experimental | Dose Group 3: 0.7 mg/kg sotatercept subcutaneous every 28 days Receives: Biological: Sotatercept |
| Placebo | Placebo comparator | The Placebo to Sotatercept ratio is 1:3 meaning for every 1 patient that receives Placebo, 3 patients will receive Sotatercept. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed Maximum Concentration (Cmax)
Cmax is a pharmacokinetic parameter defined as the observed maximum concentration of the study drug in the serum and/or blood. Cmax will be estimated from the sotatercept concentration versus time data using noncompartmental method.
Measured: From first dose up to Day 28
Time to Maximum Concentration (Tmax)
Time to observed maximum concentration (Tmax) is defined as the amount of time in days for a drug to reach the maximum concentration after administration.
Measured: From first dose up to Day 28
Area Under Curve (AUC)-28 Days
AUC-28 days is defined as area under the concentration-time curve over the first 28-day dosing interval
Measured: From first dose up to Day 28
AUCinf: Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity
Area under the concentration-time curve from time zero extrapolated to infinity. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.
Measured: From first dose up to Day 28
Apparent Total Clearance (CL/F)
Apparent Total Clearance (CL/F) is defined as the volume of plasma from which the study drug is completely removed per unit of time. It is equal to the drug dose divided by the area-under-the-curve.
Measured: From first dose up to Day 28
Apparent Volume of Distribution Based on Terminal Phase (Vz/F)
Apparent volume of distribution based on terminal phase (Vz/F) is defined as the apparent volume in which the current amount of drug in the body must be dispersed in order to give the current plasma concentration. Apparent volume of distribution is important for determining the dose required to produce a desired plasma concentration of the drug.
Measured: From first dose up to Day 28
Terminal Half-Life (t1/2,z)
Terminal plasma half-life (t1/2,z) is the time taken for concentration of the study drug to decrease from its maximum concentration (Cmax) to half of Cmax in the blood plasma.
Measured: Days 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 15, 22, 29, 43, 57, 85 and 113
Secondary outcomes (10)
The Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Measured: From first dose up to 115 days post last dose
Number of Participants With Hemoglobin > 12g/dL
Number of participants with hemoglobin > 12g/dL including Hb values obtained after first study drug dose and before any rescue.
Measured: Pre-dose; Dose 1-Days 1, 8, 15, 22, 29; Doses 2, 3, 4, 5, 6, 7-Days 1, 15, 29; Follow-up Phase Days 225, 253, 281, and 309
Proportion of Participants With Rise in Hemoglobin > 2 g/dL During 4 Week Period
Proportion of participants with rise in hemoglobin (Hb) > 2 g/dL during a 4-week period including Hb values obtained after first study drug dose and before any rescue.
Measured: Pre-dose; Dose 1-Days 1, 8, 15, 22, 29; Doses 2, 3, 4, 5, 6, 7-Days 1, 15, 29; Follow-up Phase Days 225, 253, 281, and 309
Blood Pressure Changes From Baseline
Blood pressure was generally recorded on the day of dialysis and represent pre-dialysis values. Baseline is defined as blood pressure measurements recorded on Day 1 of the first dose administered.
Measured: From pre-dose up to the final visit 112 days after last dose (up to 225 days)
Changes in Follicle Stimulating Hormone (FSH)
The change in follicle stimulating measured at pre-specified timepoints throughout the treatment period.
Measured: Day 1 (baseline), Day 15, Day 29, and Day 113
Number of Participants With Hemoglobin > 10g/dL
Number of participants with hemoglobin > 10g/dL including Hb values obtained after first study drug dose and before any rescue. Baseline is defined as hemoglobin measurements recorded on Day 1 of the first dose administered.
Measured: Pre-dose; Dose 1-Days 1, 8, 15, 22, 29; Doses 2, 3, 4, 5, 6, 7-Days 1, 15, 29; Follow-up Phase Days 225, 253, 281, and 309
Number of Participants With Change From Baseline Hemoglobin ≥ 1g/dL
Number of participants with a change from in hemoglobin values ≥ 1g/dL including Hb values obtained after first study drug dose and before any rescue. Baseline is defined as hemoglobin measurements recorded on Day 1 of the first dose administered.
Measured: Pre-dose; Dose 1-Days 1, 8, 15, 22, 29; Doses 2, 3, 4, 5, 6, 7-Days 1, 15, 29; Follow-up Phase Days 225, 253, 281, and 309
Number of Participants With Hemoglobin > 10g/dL and Change From Baseline Hemoglobin ≥ 1g/dL
Number of participants with Hemoglobin > 10g/dL and a change from in hemoglobin values ≥ 1g/dL including Hb values obtained after first study drug dose and before any rescue. Baseline is defined as hemoglobin measurements recorded on Day 1 of the first dose administered.
Measured: Pre-dose; Dose 1-Days 1, 8, 15, 22, 29; Doses 2, 3, 4, 5, 6, 7-Days 1, 15, 29; Follow-up Phase Days 225, 253, 281, and 309
Length of Time to Rescue Therapy
The length of time in days that participants who were rescued received treatment. When applicable, participants were rescued for anemia. During the rescue, participants discontinued sotatercept and were unblinded to the study treatment. Participants who were rescued continued in the treatment phase of 200 days and a follow-up phase of 112 days after the treatment phase. Rescue is defined as the need for a blood transfusion or Erythropoiesis-stimulating agent (ESA) therapy.
Measured: From first dose up to blood transfusion or ESA therapy, up to approximately 209 days
Change From Baseline in Hemoglobin Values
Dose Cycle 1 is defined as the first 28 days of treatment for Dose Groups 0.3 mg/kg, 0.5 mg/kg, and 0.7 mg/kg and the first 14 days of treatment for Dose Group 0.7/0.4 mg/kg. End of the Treatment Period is defined as the day before the follow-up phase started. Baseline is defined as hemoglobin measurements recorded on Day 1 of the first dose administered.
Measured: From first dose up to Day 225
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2010 (estimated)
- Study start30 Jun 2010
- Primary completion7 Mar 2016
- Study completion7 Mar 2016
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 AnemiaStudies of the same condition, open and under way.
- More trials run by CelgeneThe 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
- Responsible party
- Sponsor
- Investigators
- William T Smith, MD, Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01146574
- Sponsor's protocol ID
- ACE-011-REN-001
- Status last verified
- Feb 2024
- First submitted
- 16 Jun 2010
- Last updated
- 1 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Multi-center, Randomized, Single Dose, Double-blind, Placebo-controlled Followed by a Multiple-dose, Single-blind, Placebo-controlled, Dose Escalation Study to Evaluate the Pharmacokinetics, Safety, Efficacy, Tolerability, and Pharmacodynamics of Sotatercept (ACE-011) for the Correction of Anemia in Subjects With End-stage Renal Disease (ESRD) on Hemodialysis (HD).
- ClinicalTrials.gov ID
- NCT01146574
- Acronym / sponsor ID
- ACE-011-REN-001
- Conditions
- Anemia
- Keywords
- End-Stage Renal Disease, Anemia, Hemodialysis, Renal Anemia, ESRD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Collaborators
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
- Study start
- 30 Jun 2010 (actual)
- Primary completion
- 7 Mar 2016 (actual)
- Study completion
- 7 Mar 2016 (actual)
- First posted
- 17 Jun 2010 (estimated)
- Results
- Posted 1 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is the first study in hemodialysis subjects with anemia to evaluate the pharmacokinetics, safety, efficacy, tolerability, and pharmacodynamics of sotatercept (ACE-011)
Detailed description
Part 1:
Approximately 8 subjects will be randomized to receive either a single 0.1 mg/kg subcutaneous dose of sotatercept or matching placebo in a 3:1 ratio
Part 2:
Approximately 8 subjects will be randomized to each of the 3 sequential dose groups (0.3mg/kg or 0.5mg/kg or 0.7 mg/kg) with a 3:1 ratio of sotatercept or placebo (6 subjects in the sotatercept arm and 2 in the placebo arm). A total of 24-36 subjects may be randomized in the 3 dose groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 0.1mg/kg Sotatercept | Experimental | Biological: SotaterceptApproximately 8 subjects will be randomized to receive either a single 0.1 mg/kg subcutaneous dose of sotatercept or matching placebo in a 3:1 ratio |
| 0.3mg/kg Sotatercept | Experimental | Biological: SotaterceptDose Group 1: 0.3 mg/kg sotatercept subcutaneous every 28 days |
| 0.5mg/kg Sotatercept | Experimental | Biological: SotaterceptDose Group 2: 0.5 mg/kg sotatercept subcutaneous every 28 days |
| 0.7mg/kg Sotatercept | Experimental | Biological: SotaterceptDose Group 3: 0.7 mg/kg sotatercept subcutaneous every 28 days |
| Placebo | Placebo comparator | Biological: PlaceboThe Placebo to Sotatercept ratio is 1:3 meaning for every 1 patient that receives Placebo, 3 patients will receive Sotatercept. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females ≥18 years of age.
- Subjects on hemodialysis for at least 12 weeks before screening
- Subjects on a stable dose of Erythrocyte Stimulating Agents product to maintain Hemoglobin (Hb) for at least 6 weeks prior to screening.
- 3 consecutive pre-dialysis Hb concentrations with a mean ≥10 to ≤ 12 g/dL (≥100 to ≤120 g/L) at screening and one pre-dialysis Hb concentration ≥8 to < 10 g/dL (≥ 80 to < 100 g/L) before randomization.
- Adequate iron status defined as serum transferrin saturation ≥ 20% before randomization.
Key exclusion criteria (12 listed)
- Non renal causes of anemia.
- Subjects on peritoneal dialysis.
- Systemic hematological disease
- High sensitivity C-reactive protein >50mg/L at screening.
- Alanine transaminase (ALT) or aspartate transaminase (AST) laboratory values > 2 times the upper limit of normal (ULN) 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 |
|---|---|---|
| SotaterceptAlso: ACE-011Part 1: Sotatercept single dose 0.1mg/kg subcutaneous Part 2: Sotatercept starting dose groups of 0.3mg/kg, 0.5mg/kg or 0.7 mg/kg in a sequential design, dosed subcutaneously every 28 days for up to 8 doses | Biological | 0.1mg/kg Sotatercept, 0.3mg/kg Sotatercept, 0.5mg/kg Sotatercept, 0.7mg/kg Sotatercept |
| PlaceboPlacebo | Biological | Placebo |
Primary outcome
Observed Maximum Concentration (Cmax)
Time frame: From first dose up to Day 28
Cmax is a pharmacokinetic parameter defined as the observed maximum concentration of the study drug in the serum and/or blood. Cmax will be estimated from the sotatercept concentration versus time data using noncompartmental method.
Time to Maximum Concentration (Tmax)
Time frame: From first dose up to Day 28
Time to observed maximum concentration (Tmax) is defined as the amount of time in days for a drug to reach the maximum concentration after administration.
Area Under Curve (AUC)-28 Days
Time frame: From first dose up to Day 28
AUC-28 days is defined as area under the concentration-time curve over the first 28-day dosing interval
AUCinf: Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity
Time frame: From first dose up to Day 28
Area under the concentration-time curve from time zero extrapolated to infinity. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.
Apparent Total Clearance (CL/F)
Time frame: From first dose up to Day 28
Apparent Total Clearance (CL/F) is defined as the volume of plasma from which the study drug is completely removed per unit of time. It is equal to the drug dose divided by the area-under-the-curve.
Apparent Volume of Distribution Based on Terminal Phase (Vz/F)
Time frame: From first dose up to Day 28
Apparent volume of distribution based on terminal phase (Vz/F) is defined as the apparent volume in which the current amount of drug in the body must be dispersed in order to give the current plasma concentration. Apparent volume of distribution is important for determining the dose required to produce a desired plasma concentration of the drug.
Terminal Half-Life (t1/2,z)
Time frame: Days 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 15, 22, 29, 43, 57, 85 and 113
Terminal plasma half-life (t1/2,z) is the time taken for concentration of the study drug to decrease from its maximum concentration (Cmax) to half of Cmax in the blood plasma.
10 secondary outcomes
The Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)
Time frame: From first dose up to 115 days post last dose
Number of Participants With Hemoglobin > 12g/dL
Time frame: Pre-dose; Dose 1-Days 1, 8, 15, 22, 29; Doses 2, 3, 4, 5, 6, 7-Days 1, 15, 29; Follow-up Phase Days 225, 253, 281, and 309
Proportion of Participants With Rise in Hemoglobin > 2 g/dL During 4 Week Period
Time frame: Pre-dose; Dose 1-Days 1, 8, 15, 22, 29; Doses 2, 3, 4, 5, 6, 7-Days 1, 15, 29; Follow-up Phase Days 225, 253, 281, and 309
Blood Pressure Changes From Baseline
Time frame: From pre-dose up to the final visit 112 days after last dose (up to 225 days)
Changes in Follicle Stimulating Hormone (FSH)
Time frame: Day 1 (baseline), Day 15, Day 29, and Day 113
Number of Participants With Hemoglobin > 10g/dL
Time frame: Pre-dose; Dose 1-Days 1, 8, 15, 22, 29; Doses 2, 3, 4, 5, 6, 7-Days 1, 15, 29; Follow-up Phase Days 225, 253, 281, and 309
Number of Participants With Change From Baseline Hemoglobin ≥ 1g/dL
Time frame: Pre-dose; Dose 1-Days 1, 8, 15, 22, 29; Doses 2, 3, 4, 5, 6, 7-Days 1, 15, 29; Follow-up Phase Days 225, 253, 281, and 309
Number of Participants With Hemoglobin > 10g/dL and Change From Baseline Hemoglobin ≥ 1g/dL
Time frame: Pre-dose; Dose 1-Days 1, 8, 15, 22, 29; Doses 2, 3, 4, 5, 6, 7-Days 1, 15, 29; Follow-up Phase Days 225, 253, 281, and 309
Length of Time to Rescue Therapy
Time frame: From first dose up to blood transfusion or ESA therapy, up to approximately 209 days
Change From Baseline in Hemoglobin Values
Time frame: From first dose up to Day 225
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- 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.
William T Smith, MD study director
Celgene Corporation
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sotatercept in people with Anemia, run by Celgene at 24 sites in United States.
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 5 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: finished, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States. 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 1 Mar 2024). 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?
Observed Maximum Concentration (Cmax) (time frame: From first dose up to Day 28). The study lists 7 primary outcomes in all. 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 1 Mar 2024.