Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A Phase 3b Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects with Immune Thrombocytopenia for ≥6 Months
Subjects will be randomized in to blinded therapy of avatrombopag or placebo in a 3:1 ratio for a period of 12 weeks. Subjects who complete the 12 week treatment period and are eligible may continue to the open label extension phase which will last 2 years.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Avatrombopag Double Blind | Experimental | Study is 3:1 randomization ratio (avatrombopag to placebo). Investigational product administered orally once daily for 12 weeks |
|
| Placebo Comparator:Placebo Double Blind | Placebo Comparator | Study is 3:1 randomization ratio (avatrombopag to placebo). Investigational product administered orally once daily for 12 weeks |
|
| Avatrombopag Open Label Extension | Experimental | Investigational product administered orally for up to 2 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avatrombopag | Drug | Oral avatrombopag tablet or sprinkle capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Durable Platelet Response | The proportion of subjects achieving at least 6 out of 8 weekly platelet counts ≥50×10^9/L during the last 8 weeks of the 12 week Treatment Period in the Core Phase, in the absence of rescue medication | Last 8 weeks of 12 week treatment regimen |
| Alternative Primary: Platelet Response | The proportion of subjects for whom at least 2 consecutive platelet assessments are ≥50×10^9/L over the 12 weeks of treatment in the Core Phase in the absence of rescue medication. | 12 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Weeks Platelet Count ≥50×10^9/L | The percentage of weeks subjects have a platelet count ≥50×10^9/L during 12 weeks of treatment in the Core Phase, in the absence of rescue therapy. | 12 weeks of treatment |
| Platelet Response at Day 8 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 112 | Phoenix | Arizona | 85016 | United States | ||
| Site 103 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Leblebisatan, G. G., Aydinok, Y., Äcenal, Ş., Grainger, J., Grimes, A., Lambert, M., Zhang, J., Jamieson, B., Vredenburg, M., & Kolodny, S. (2025). PB0364: Evaluation of efficacy and safety of avatrombopag in children with ITP based on disease duration. RPTH, 9(Suppl 2). | ||
| Result | Leblebisatan, G. G., Aydinok, Y., Ünal Cangül, Ş., Grainger, J., Grimes, A., Lambert, M., Zhang, J., Jamieson, B., Vredenburg, M., & Kolodny, S. (2025). PB0348: Consistent response to avatrombopag for pediatric ITP across various baseline characteristics. RPTH, 9(Suppl 2). | ||
| Result | Grace, R. F., Leblebisatan, G., Aydinok, Y., Ünal Cangül, Ş., Grainger, J., Zhang, J., Alkhori Franzén, L., & Skuban, N. (2025). PS2234: Efficacy and safety of avatrombopag for the treatment of pediatric immune thrombocytopenia in the open-label extension of a Phase 3, randomized, double-blind, placebo-controlled trial. HemaSphere, 9(Suppl 1), 4067. | ||
| Result | Scott Kolodny, Rachael Grace, Göksel Leblebisatan, Yesim Aydinok, Şule Ünal, John Grainger, Amanda Grimes, Michelle Lambert, Jessica Zhang, Brian Jamieson, Michael Vredenburg. Baseline Correlates With Durability of Avatrombopag Response in Pediatric Immune Thrombocytopenia. Pediatr Blood Cancer. 2025;72(Suppl S94):e31765. Abstract [# 304]. | ||
| Result | Scott Kolodny, Rachael Grace, Göksel Leblebisatan, YesimAydinok, Şule Ünal, John Grainger, Amanda Grimes, Michele Lambert, Jessica Zhang, Brian Jamieson, Michael Vredenburg. Clinically Meaningful Response to Avatrombopag for Treatment of Pediatric Immune Thrombocytopenia. Pediatr Blood Cancer. 2025;72(Suppl S06):e31765. Abstract [# 2011]. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Open label extension optional and not all subjects entered this phase. 73 of 75 subjects entered this phase; 2 dropped out after the core phase.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: Avatrombopag Double Blind | Study is 3:1 randomization ratio (avatrombopag to placebo). Investigational product administered orally once daily for 12 weeks Avatrombopag: Oral avatrombopag tablet or sprinkle capsule |
| FG001 | Placebo Comparator:Placebo Double Blind |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Core Phase |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 2, 2021 | Nov 4, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo comparator tablet or sprinkle capsule |
|
The proportion of subjects with a platelet count ≥50×10^9/L at day 8, in the absence of rescue therapy.
| Day 8 |
| Percentage of Weeks Platelet Count Between ≥50×10^9/L and ≤150×10^9/L | The percentage of weeks subjects have a platelet count between ≥50×10^9/L and ≤150×10^9/L, during 12 weeks of treatment in the Core Phase, in the absence of rescue therapy. | 12 weeks of treatment |
| Rescue Medications | The proportion of subjects who require rescue medications during 12 weeks of treatment in the Core Phase of the study. | 12 weeks of treatment |
| Incidence of Any Bleeding Event (WHO Grade 1-4) | Overall incidence of bleeding events associated with ITP measured using the WHO Bleeding Scale (Grade 1-4). | 12 weeks of treatment |
| Long Beach |
| California |
| 90806 |
| United States |
| Site 119 | Orange | California | 92868 | United States |
| Site 109 | Sacramento | California | 95817 | United States |
| Site 101 | San Francisco | California | 94158 | United States |
| Site 111 | Aurora | Colorado | 80045 | United States |
| Site 120 | Wilmington | Delaware | 19803 | United States |
| Site 117 | Gainesville | Florida | 32610 | United States |
| Site 116 | Atlanta | Georgia | 30322 | United States |
| Site 107 | Peoria | Illinois | 61615 | United States |
| Site 104 | Boston | Massachusetts | 02115 | United States |
| Site 105 | Minneapolis | Minnesota | 55404 | United States |
| Site 114 | Jackson | Mississippi | 39216 | United States |
| Site 102 | Las Vegas | Nevada | 89135 | United States |
| Site 108 | Morristown | New Jersey | 07960 | United States |
| Site 118 | Charlotte | North Carolina | 28203 | United States |
| Site 113 | Durham | North Carolina | 27710 | United States |
| Site 106 | Columbus | Ohio | 43205 | United States |
| Site 121 | Philadelphia | Pennsylvania | 19104 | United States |
| Site 110 | Providence | Rhode Island | 02903 | United States |
| Site 115 | Houston | Texas | 77030 | United States |
| Site 201 | Toulouse | Occitanie | 31059 | France |
| Site 202 | Paris | Île-de-France Region | 75019 | France |
| Site 301 | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
| Site 302 | Hamburg | Free and Hanseatic City of Hamburg | 20246 | Germany |
| Site 303 | Kiel | Schleswig-Holstein | 24105 | Germany |
| Site 304 | Berlin | State of Berlin | 13353 | Germany |
| Site 801 | Budapest | 1094 | Hungary |
| Site 802 | Miskolc | 3526 | Hungary |
| Site 803 | Pécs | 7623 | Hungary |
| Site 502 | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-667 | Poland |
| Site 503 | Warsaw | Masovian Voivodeship | 02-091 | Poland |
| Site 505 | Zabrze | Silesian Voivodeship | 41-800 | Poland |
| Site 501 | Olsztyn | Warmian-Masurian Voivodeship | 10-561 | Poland |
| Site 504 | Lodz | Łódź Voivodeship | 91-738 | Poland |
| Site 907 | Chelyabinsk | 454076 | Russia |
| Site 904 | Moscow | 117198 | Russia |
| Site 906 | Moscow | 117997 | Russia |
| Site 901 | Moscow | 119049 | Russia |
| Site 902 | Nizhny Novgorod | 603136 | Russia |
| Site 905 | Saint Petersburg | 197022 | Russia |
| Site 903 | Volgograd | 400138 | Russia |
| Site 701 | Adana | 01330 | Turkey (Türkiye) |
| Site 704 | Ankara | 06230 | Turkey (Türkiye) |
| Site 706 | Antalya | 07059 | Turkey (Türkiye) |
| Site 702 | Antalya | 07160 | Turkey (Türkiye) |
| Site 705 | Denizli | 20160 | Turkey (Türkiye) |
| Site 709 | Istanbul | 34093 | Turkey (Türkiye) |
| Site 710 | Istanbul | 34093 | Turkey (Türkiye) |
| Site 703 | Istanbul | 34764 | Turkey (Türkiye) |
| Site 707 | Izmir | 35100 | Turkey (Türkiye) |
| Site 708 | Mersin | 33110 | Turkey (Türkiye) |
| Site 954 | Kharkiv | Kharkiv Oblast | 61000 | Ukraine |
| Site 952 | Vinnytsia | 21029 | Ukraine |
| Site 405 | Birmingham | England | B4 6NH | United Kingdom |
| Site 408 | Liverpool | England | L12 2AP | United Kingdom |
| Site 403 | London | England | SE5 9RS | United Kingdom |
| Site 410 | London | England | W12 0HS | United Kingdom |
| Site 407 | London | England | WC1N 3JH | United Kingdom |
| Site 402 | Manchester | England | M13 9WL | United Kingdom |
| Site 401 | Sheffield | England | S10 2TH | United Kingdom |
| Site 406 | Cardiff | Wales | CF14 4XW | United Kingdom |
| 40418942 | Result | Grace RF, Leblebisatan G, Aydinok Y, Unal S, Grainger JD, Zhang J, Smallwood L, de Leon E, Jamieson BD; AVA-PED-301 Study Group. Avatrombopag for the treatment of children and adolescents with immune thrombocytopenia (AVA-PED-301): a multicentre, randomised, double-blind, placebo-controlled, phase 3b study. Lancet Haematol. 2025 Jul;12(7):e494-e504. doi: 10.1016/S2352-3026(25)00107-3. Epub 2025 May 23. |
| 41411046 | Result | Grace RF, Leblebisatan G, Aydinok Y, Unal S, Grainger JD, Zhang J, Smallwood L, de Leon E, Jamieson BD, DiRaimo J. Avatrombopag for treating children and adolescents with immune thrombocytopenia: a plain language summary. Expert Rev Hematol. 2026 Feb;19(2):107-116. doi: 10.1080/17474086.2025.2604524. Epub 2025 Dec 18. |
Study is 3:1 randomization ratio (avatrombopag to placebo). Investigational product administered orally once daily for 12 weeks Placebo: Placebo comparator tablet or sprinkle capsule |
| FG002 | Avatrombopag Open Label Extension | Subjects received investigational drug up to 2 years. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Extension Phase |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: Avatrombopag | Study is 3:1 randomization ratio (avatrombopag to placebo). Investigational product administered orally once daily for 12 weeks Avatrombopag: Oral avatrombopag tablet or sprinkle capsule |
| BG001 | Placebo Comparator:Placebo | Study is 3:1 randomization ratio (avatrombopag to placebo). Investigational product administered orally once daily for 12 weeks Placebo: Placebo comparator tablet or sprinkle capsule |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Durable Platelet Response | The proportion of subjects achieving at least 6 out of 8 weekly platelet counts ≥50×10^9/L during the last 8 weeks of the 12 week Treatment Period in the Core Phase, in the absence of rescue medication | Full Analysis Set | Posted | Count of Participants | Participants | Last 8 weeks of 12 week treatment regimen |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Alternative Primary: Platelet Response | The proportion of subjects for whom at least 2 consecutive platelet assessments are ≥50×10^9/L over the 12 weeks of treatment in the Core Phase in the absence of rescue medication. | Full Analysis Set | Posted | Count of Participants | Participants | 12 weeks of treatment |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Weeks Platelet Count ≥50×10^9/L | The percentage of weeks subjects have a platelet count ≥50×10^9/L during 12 weeks of treatment in the Core Phase, in the absence of rescue therapy. | Full Analysis Set | Posted | Mean | Standard Deviation | percentage of weeks | 12 weeks of treatment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Platelet Response at Day 8 | The proportion of subjects with a platelet count ≥50×10^9/L at day 8, in the absence of rescue therapy. | Full Analysis Set | Posted | Count of Participants | Participants | Day 8 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Weeks Platelet Count Between ≥50×10^9/L and ≤150×10^9/L | The percentage of weeks subjects have a platelet count between ≥50×10^9/L and ≤150×10^9/L, during 12 weeks of treatment in the Core Phase, in the absence of rescue therapy. | Full Analysis Set | Posted | Mean | Standard Deviation | percentage of weeks | 12 weeks of treatment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rescue Medications | The proportion of subjects who require rescue medications during 12 weeks of treatment in the Core Phase of the study. | Full Analysis Set | Posted | Count of Participants | Participants | 12 weeks of treatment |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Any Bleeding Event (WHO Grade 1-4) | Overall incidence of bleeding events associated with ITP measured using the WHO Bleeding Scale (Grade 1-4). | Full Analysis Set | Posted | Count of Participants | Participants | 12 weeks of treatment |
|
|
Up to 12 weeks (Core Phase) and up to 2 years (Extension Phase)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental: Avatrombopag | Study is 3:1 randomization ratio (avatrombopag to placebo). Investigational product administered orally once daily for 12 weeks Avatrombopag: Oral avatrombopag tablet or sprinkle capsule | 0 | 54 | 5 | 54 | 50 | 54 |
| EG001 | Placebo Comparator:Placebo | Study is 3:1 randomization ratio (avatrombopag to placebo). Investigational product administered orally once daily for 12 weeks Placebo: Placebo comparator tablet or sprinkle capsule | 0 | 21 | 1 | 21 | 16 | 21 |
| EG002 | Open Label Extension Phase | All subjects received investigational drug for up to 2 years. | 0 | 73 | 22 | 73 | 71 | 73 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Immune Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Mouth Haemorrhage | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Oral Purpura | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Skin Haemorrhage | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Aplastic Anemia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Bone Marrow Disorder | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Bone Marrow Reticulin fibrosis | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dental Caries | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Mucosal Haemorrhage | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Abdominal Injury | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
| |
| Head Injury | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Vaginal Haemorrhage | Reproductive system and breast disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (26.1) | Non-systematic Assessment |
| |
| Heavy Menstrual Bleeding | Reproductive system and breast disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Tethered Cord Syndrome | Nervous system disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDRA (26.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Gingival Bleeding | Gastrointestinal disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| COVID 19 | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
| |
| Arthralagia | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (26.1) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Iron Deficiency | Metabolism and nutrition disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Viral Infection | Infections and infestations | MedDRA (26.1) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (26.1) | Non-systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Joint Injury | Injury, poisoning and procedural complications | MedDRA (26.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Head Injury | Injury, poisoning and procedural complications | MedDRA (26.1) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (26.1) | Non-systematic Assessment |
|
PIs are not allowed to publish clinical trial data on their own after trial completion.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medicine Development Leader | Sobi Inc. | 1-781-786-7370 | medinfo.us@sobi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 15, 2023 | Dec 20, 2024 | SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C533238 | avatrombopag |
Not provided
Not provided
Not provided
| Adverse Event |
|
| Sponsor Request |
|
| Lack of Efficacy |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Hungary |
|
| United States |
|
| Ukraine |
|
| Poland |
|
| United Kingdom |
|
| France |
|
| Germany |
|
| Russia |
|
|
|
|
|
|
|
|
|
|
|
|
|