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| ID | Type | Description | Link |
|---|---|---|---|
| ACE-011-ST-001 | Other Identifier | Celgene |
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Isotope needed to conduct RBC/PV analysis (primary endpoint) no longer available from manufacturer. No alternatives available for use.
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What hematopoietic precursor compartments as well as hemoglobin subtypes are affected by dosing with sotatercept (ACE-011)? Based upon a similar prior study with Procrit, Celgene has determined that all of these goals could be obtained by an intense 10-patient sotatercept (ACE-011) pharmacodynamic study, completed by two well-known experts in the red cell production field.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sotatercept | Experimental | Participants will receive a single 35 mg dose of sotatercept by subcutaneous (SC) injection on Day 1, Day 43, and Day 85. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sotatercept | Drug | single 35 mg SC dose of sotatercept on study Day 1, Day 43, and Day 85 |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Red Blood Cell Mass Following a Single Dose of Sotatercept | Blood samples were to be collected at baseline (Day 1, pre-dose) and at one timepoint between Day 14 and Day 28, and isotope dilution techniques used, to measure the change from baseline in red blood cell mass following a single dose of sotatercept. | Baseline (Day 1, pre-dose) and one timepoint between Day 14 and Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Plasma Volume Following a Single Dose of Sotatercept | Blood samples were collected at baseline (Day 1, pre-dose) and at one timepoint between Day 14 and Day 28, and isotope dilution techniques used, to measure the change from baseline in plasma volume following a single dose of sotatercept. | Baseline (Day 1, pre-dose) and one timepoint between Day 14 and Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
At the time of screening, participants who have any grade ≥3 toxicity (according to the currently active minor version of NCI CTCAE v4.0) except for the following disease-related toxicities:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Agnes Healthcare | Baltimore | Maryland | 21229 | United States | ||
| Weinberg Cancer Institution at Franklin Square |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30337358 | Background | Cappellini MD, Porter J, Origa R, Forni GL, Voskaridou E, Galacteros F, Taher AT, Arlet JB, Ribeil JA, Garbowski M, Graziadei G, Brouzes C, Semeraro M, Laadem A, Miteva D, Zou J, Sung V, Zinger T, Attie KM, Hermine O. Sotatercept, a novel transforming growth factor beta ligand trap, improves anemia in beta-thalassemia: a phase II, open-label, dose-finding study. Haematologica. 2019 Mar;104(3):477-484. doi: 10.3324/haematol.2018.198887. Epub 2018 Oct 18. |
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sotatercept | Participants received a single 35 mg dose of sotatercept by subcutaneous (SC) injection on Day 1, Day 43, and Day 85. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 5, 2012 |
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| Change From Baseline in Absolute Reticulocyte Count | Blood samples were to be collected at baseline (Day 1, pre-dose) and at Day 211 to measure the change from baseline in absolute reticulocyte count. | Baseline (Day 1, pre-dose) and Day 211 |
| Change From Baseline in Erythropoietin Levels | Blood samples were collected at baseline (Day 1, pre-dose) and at Day 211 to measure the change from baseline in erythropoietin levels. | Baseline (Day 1, pre-dose) and Day 211 |
| Change From Baseline in Hemoglobin Subtype A Following a Single Dose of Sotatercept | Blood samples were collected at baseline (Day 1, pre-dose) and on Day 29, and hemoglobin electrophoresis used, to measure the change from baseline in hemoglobin subtype A following a single dose of sotatercept. | Baseline (Day 1, pre-dose) and Day 29 |
| Change From Baseline in Hemoglobin Subtype A2 Following a Single Dose of Sotatercept | Blood samples were collected at baseline (Day 1, pre-dose) and on Day 29, and hemoglobin electrophoresis used, to measure the change from baseline in hemoglobin subtype A2 following a single dose of sotatercept. | Baseline (Day 1, pre-dose) and Day 29 |
| Change From Baseline in Hemoglobin Subtype C Following a Single Dose of Sotatercept | Blood samples were collected at baseline (Day 1, pre-dose) and on Day 29, and hemoglobin electrophoresis used, to measure the change from baseline in hemoglobin subtype C following a single dose of sotatercept. | Baseline (Day 1, pre-dose) and Day 29 |
| Number of Participants Who Experienced One or More Adverse Events (AEs) | An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. | Up to approximately 7 months |
| Baltimore |
| Maryland |
| 21237 |
| United States |
| Pennsylvania Oncology | Philadelphia | Pennsylvania | 19106 | United States |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sotatercept | Participants received a single 35 mg dose of sotatercept by subcutaneous (SC) injection on Day 1, Day 43, and Day 85. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Red Blood Cell Mass Following a Single Dose of Sotatercept | Blood samples were to be collected at baseline (Day 1, pre-dose) and at one timepoint between Day 14 and Day 28, and isotope dilution techniques used, to measure the change from baseline in red blood cell mass following a single dose of sotatercept. | No data were collected for Change from Baseline in Red Blood Cell Mass Following a Single Dose of Sotatercept. | Posted | Baseline (Day 1, pre-dose) and one timepoint between Day 14 and Day 28 |
|
| |||||||||||||||||||
| Secondary | Change From Baseline in Plasma Volume Following a Single Dose of Sotatercept | Blood samples were collected at baseline (Day 1, pre-dose) and at one timepoint between Day 14 and Day 28, and isotope dilution techniques used, to measure the change from baseline in plasma volume following a single dose of sotatercept. | All participants who received at least one dose of study treatment and had data for Change from Baseline in Plasma Volume Following a Single Dose of Sotatercept | Posted | Mean | Standard Deviation | mL | Baseline (Day 1, pre-dose) and one timepoint between Day 14 and Day 28 |
|
| ||||||||||||||||
| Secondary | Change From Baseline in Absolute Reticulocyte Count | Blood samples were to be collected at baseline (Day 1, pre-dose) and at Day 211 to measure the change from baseline in absolute reticulocyte count. | No data were collected for Change from Baseline in Absolute Reticulocyte Count. | Posted | Baseline (Day 1, pre-dose) and Day 211 |
|
| |||||||||||||||||||
| Secondary | Change From Baseline in Erythropoietin Levels | Blood samples were collected at baseline (Day 1, pre-dose) and at Day 211 to measure the change from baseline in erythropoietin levels. | All participants who received at least one dose of study treatment and had data for Change from Baseline in Erythropoietin Levels | Posted | Mean | Full Range | IU/L | Baseline (Day 1, pre-dose) and Day 211 |
|
| ||||||||||||||||
| Secondary | Change From Baseline in Hemoglobin Subtype A Following a Single Dose of Sotatercept | Blood samples were collected at baseline (Day 1, pre-dose) and on Day 29, and hemoglobin electrophoresis used, to measure the change from baseline in hemoglobin subtype A following a single dose of sotatercept. | All participants who received at least one dose of study treatment and had data for Change from Baseline in Hemoglobin Subtype A Following a Single Dose of Sotatercept | Posted | Mean | Full Range | Percentage of hemoglobin subtype A | Baseline (Day 1, pre-dose) and Day 29 |
|
| ||||||||||||||||
| Secondary | Change From Baseline in Hemoglobin Subtype A2 Following a Single Dose of Sotatercept | Blood samples were collected at baseline (Day 1, pre-dose) and on Day 29, and hemoglobin electrophoresis used, to measure the change from baseline in hemoglobin subtype A2 following a single dose of sotatercept. | All participants who received at least one dose of study treatment and had data for Change from Baseline in Hemoglobin Subtype A2 Following a Single Dose of Sotatercept | Posted | Mean | Full Range | Percentage of hemoglobin subtype A2 | Baseline (Day 1, pre-dose) and Day 29 |
|
| ||||||||||||||||
| Secondary | Change From Baseline in Hemoglobin Subtype C Following a Single Dose of Sotatercept | Blood samples were collected at baseline (Day 1, pre-dose) and on Day 29, and hemoglobin electrophoresis used, to measure the change from baseline in hemoglobin subtype C following a single dose of sotatercept. | All participants who received at least one dose of study treatment and had data for Change from Baseline in Hemoglobin Subtype C Following a Single Dose of Sotatercept | Posted | Mean | Full Range | Percentage of hemoglobin subtype C | Baseline (Day 1, pre-dose) and Day 29 |
|
| ||||||||||||||||
| Secondary | Number of Participants Who Experienced One or More Adverse Events (AEs) | An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. | All participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Up to approximately 7 months |
|
|
Up to approximately 7 months
The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all enrolled participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sotatercept 35 mg | Participants received a single 35 mg dose of sotatercept by SC injection on Day 1, Day 43, and Day 85. | 2 | 5 | 3 | 4 | 4 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CARDIO-RESPIRATORY ARREST | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
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| CARDIOGENIC SHOCK | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| PNEUMOPERITONEUM | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| DEVICE DISLOCATION | General disorders | MedDRA 15.1 | Systematic Assessment |
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| INFECTED SKIN ULCER | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
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| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
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| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
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| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
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| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
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| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| ASCITES | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| CONSTIPATION | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| OEDEMA PERIPHERAL | General disorders | MedDRA 15.1 | Systematic Assessment |
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| DEVICE RELATED INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| ESCHERICHIA INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| ORAL CANDIDIASIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| WOUND INFECTION STAPHYLOCOCCAL | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
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| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
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| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
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| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
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| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
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| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
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| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| ANXIETY | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
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| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
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| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| SKIN ULCER | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
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| HYPOTENSION | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
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The sponsor will comply with the requirements for publication of study results. In accordance with standard editorial and ethical practice, the sponsor will generally support publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Jul 12, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| C542017 | ACE-011 |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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