Open-Label Study to Evaluate the Safety and Efficacy of Avatrombopag and Remission Rates in Adults With ITP of ≤6 Months
Megadott ok: Corporate Decision
A legfontosabb adatok
- Fázis
- 3. fázis
A vizsgálat adatai
- Ki végzi
- Sobi, Inc.
- Azonosító
- NCT05046327
- A regiszteradat frissítve
- 2021. október 22.
- Eredeti leírás
This study will evaluate the safety and efficacy of avatrombopag in subjects with a confirmed diagnosis of primary ITP (≤6 months duration) over 26 weeks of treatment, and also evaluate the incidence of ITP remission.A teljes eredeti leírásKevesebb
A Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of Avatrombopag and Remission Rates in Adults With Immune Thrombocytopenia (ITP) of ≤6 Months Duration
This study will evaluate the safety and efficacy of avatrombopag in subjects with a confirmed diagnosis of primary ITP (≤6 months duration) over 26 weeks of treatment, and also evaluate the incidence of ITP remission.
Bevonási feltételek: Male or female subjects ≥18 years of age at Screening; Subject must be able to provide informed consent; Subject has a confirmed diagnosis of primary ITP according to the International Consensus Report on the Investigation and Management of Primary ITP within the previous 6 months prior to Visit 1 and has had a previous response to a first line treatment (corticosteroids, IVIg, or anti-D), in the opinion of the Investigator; Subject has at least one platelet count <30×10⁹/L at any time during the screening period or at the Baseline visit; Females of childbearing potential must have a negative pregnancy test at Screening and Baseline; Female subjects of childbearing potential who are sexually active and male subjects who are sexually active must agree to use effective methods of contraception; Subject is willing and able to comply with all aspects of the protocol.
Kizáró feltételek: Surgical resection of the spleen; Concurrent malignant disease, other than non-melanoma skin cancer or cervical cancer in-situ; Enrollment in another clinical study with any investigational drug or device within 30 days of Day 1/Visit 2 (or 5 half-lives, whichever is longer); however, participation in observational studies is permitted; Thrombocytopenia due to a known condition other than primary ITP (e.g., systemic lupus erythematosus, H. pylori infection, splenomegaly, chronic liver disease); Any history of arterial or venous thrombosis, including partial or complete thrombosis (history of superficial thrombophlebitis is not exclusionary); Subjects with known inherited thrombocytopenia (e.g., MYH-9 disorders); History of myelodysplastic syndrome (MDS) or other hematologic malignancies; Current history of significant cardiac arrhythmias or decompensated congestive heart failure; History of hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV); Known allergy to avatrombopag or any of its excipients; Subject is unable to take oral medication or has a malabsorption syndrome or any other uncontrolled gastrointestinal condition; Previous use of eltrombopag, romiplostim, recombinant human TPO or other platelet-producing agents; Previous use of mycophenolate mofetil (MMF), rituximab (or other B-cell lymphocyte depleting agents), mercaptopurine (6-MP) or alkylating agents; Any clinically relevant abnormality which makes the subject unsuitable for participation in the study, in the opinion of the Investigator; Considered unable or unwilling to comply with the study protocol requirements.