An upcoming study will evaluate the response to prolonged treatment with herombopag in patients with immune thrombocytopenia (ITP).
Researchers will soon initiate the recruiting process for this phase 3 clinical trial. The study’s design is an interventional subtype with single group assignment and an open-label model. It expects to include an estimated 117 participants previously diagnosed with ITP.
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All individuals will be part of the intervention group that consists of receiving a treatment scheme with herombopag along with the standard of care. The authors aim to allow patients currently undergoing treatment with this drug as part of the HR-TPO-ITP-III-PED clinical trial to continue receiving this intervention upon the possibility of benefiting from it.
The treatment duration will be determined by the physician, who must identify whenever a patient has failed treatment or no longer benefits from it, in which cases, the administration of this drug will be suspended. If none of these events occur, the maximum duration will be 6 months.
Moreover, the primary outcomes will measure the proportion of participants with myelofibrosis, and new or progression of existing cataracts, while recording all adverse and severe adverse events, associated or not with herombopag, especially those that caused discontinuation or permanent withdrawal from the medication.
The researchers will monitor such adverse events for a 28 day follow-up after the last dose. Moreover, the study will register the blood levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), total and direct bilirubin, and creatinine in a timeframe of 6 months.
Secondary outcomes include assessing the platelet count at each visit, the incidence and severity of bleeding episodes, the proportion of individuals that required emergency treatment for aggravated ITP, and those with recurrent ITP.
The inclusion criteria consist of children 6 to 17 years of age, of both sexes, who have already completed the part B of the HR-TPO-ITP-III-PED clinical trial with platelet response.
This study, titled “Extension study of herombopag for pediatric patients with chronic immune thrombocytopenia,” is expected to initiate on January 2023 and end by June 2024.
Reference
Extension study of herombopag for pediatric patients with chronic immune thrombocytopenia. ClinicalsTrials.gov. Accessed January 26, 2023.
