Evaluation of North Star Desiccated Porcine Thyroid Extract Tablets for Treating Primary Hypothyroidism in Adults

What this Trial Is About

This research aims to evaluate the effectiveness and safety of North Star desiccated porcine thyroid extract tablets in adults with primary hypothyroidism, including Hashimotos Thyroiditis. The trial is a Phase 3, open-label, single-arm study conducted across multiple centers, focusing on treatment outcomes for this condition. Participants will receive North Star desiccated porcine thyroid extract tablets as the study treatment. The study monitors thyroid-stimulating hormone TSH levels to assess whether they remain within the normal range at 24 weeks and at prior post-baseline visits without abnormal readings. Safety evaluations include tracking adverse events, serious adverse events, laboratory tests, ECGs, and physical exams through 30 weeks. During the study, participants will be closely monitored with regular assessments of thyroid function and safety measures. Researchers will collect clinical data, lab results, and examine physical health to understand treatment impact. The total follow-up period extends to at least 30 weeks, allowing detailed observation of treatment effects and potential side effects in adults aged 18 to 75 years with stable hypothyroidism management.

An Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of North Star Desiccated Porcine Thyroid Extract Tablets.