protocolSection identificationModule nctId: NCT06302491, orgStudyIdInfo id: AND017-BTH-205, briefTitle: A Study of Safety and Efficiency of AND017 in Patients With Transfusion Dependent and Non-transfusion Dependent β-thalassemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Kind Pharmaceuticals LLC, class: INDUSTRY, descriptionModule briefSummary: This is a phase II, randomized, double-blinded, placebo-controlled study to treat patients with transfusion-dependent and non-transfusion dependent β -thalassemia with AND017 and optimal supportive care, including blood transfusion and iron removal, based on the clinician's judgment and practice., conditionsModule conditions: β -Thalassemia, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: AND017 capsules, interventions name: AND017 Placebo, outcomesModule primaryOutcomes measure: Evaluate the safety and tolerability of different oral doses of AND017 in the treatment of β-thalassemia subjects, secondaryOutcomes measure: Change in mean Hb levels relative to baseline at weeks 8-12 and week 20-24 post-treatment compared to baseline (mean Hb values during the 4 weeks prior to the first dose)., secondaryOutcomes measure: The level of Hb and the change from baseline at each visit throughout the treatment period., secondaryOutcomes measure: Proportion of patients with mean Hb elevation ≥1.0 g/dL from baseline to weeks 8-12 after dosing., secondaryOutcomes measure: Levels of and changes from baseline in red blood cell count throughout the treatment period, secondaryOutcomes measure: Levels of and changes from baseline in reticulocyte count throughout the treatment period, secondaryOutcomes measure: Levels of and changes from baseline in mean corpuscular volume (MCV) throughout the treatment period, secondaryOutcomes measure: Levels of and changes from baseline in mean corpuscular hemoglobin (MCH) throughout the treatment period, secondaryOutcomes measure: Levels of and changes from baseline in mean corpuscular hemoglobin concentration (MCHC) throughout the treatment period, secondaryOutcomes measure: Throughout the treatment period, changes in the levels and relative baseline of transferrin will be assessed., secondaryOutcomes measure: Throughout the treatment period, changes in the levels and relative baseline of transferrin saturation (TSAT) will be assessed., secondaryOutcomes measure: Throughout the treatment period, changes in the levels and relative baseline of ferritin will be assessed., secondaryOutcomes measure: Throughout the treatment period, changes in the levels and relative baseline of serum iron level will be assessed., secondaryOutcomes measure: Throughout the treatment period, changes in the levels and relative baseline of total iron binding capacity (TIBC) will be assessed., secondaryOutcomes measure: Change in transfusion load (units transfused) at 12-24 weeks post-dose compared to baseline (12 weeks to W0 before first dose)., secondaryOutcomes measure: Change in number of transfusions at 12-24 weeks post-dose compared to baseline (12 weeks to W0 before first dose)., secondaryOutcomes measure: Proportion of subjects with ≥33% reduction in transfusion load (transfusion units) relative to baseline (12 weeks prior to first dose to W0) from baseline to any consecutive 12-week period after dosing., secondaryOutcomes measure: Duration (days) of maintenance below this transfusion dose after a 33% reduction in transfusion load from baseline has been achieved., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False