A Prospective, Open-Label, Single Arm, Non-Comparative Study to Evaluate the Effectiveness and Safety of Thyroxine Sodium in Indian Patients with Primary Hypothyroidism
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 4
- 主要终点
- 1 Number and percentage of patients with normalization in TSH & fT4 levels over a period of 180 days (6 months)
研究概览
简要总结
This is a prospective, single center, open-label, non-comparative study designed to evaluate effectiveness and safety of Thyroxine Sodium in treatment naïve patients newly diagnosed with primary hypothyroidism.
The study population will include treatment naïve patients with newly diagnosed primary hypothyroidism, with TSH level >10 mIU/L and fT4 level < 0.8 ng/dl; meeting inclusion and exclusion criteria, and ready to give informed consent for study participation. Selection of patients for the study will be totally at the discretion of investigators.
At baseline severity of disease will be assessed using Zulewski scale score. Patients will be prescribed Thyroxine Sodium at a dose of 1.7mcg/kg daily for 45 days. The dose will be escalated or titrated, based on progress patient is making after receiving Thyroxine Sodium at Follow-up Visit 1 (45 days) and/or at follow-up visit 2 (90 days) based on the TSH level. All patients will be followed up to a period of 180 days, after enrollment into the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Treatment naïve patients newly diagnosed with primary hypothyroidism
- •Patient with TSH level >10 mIU/L
- •Patients with fT4 level < 0.8 ng/dl
- •Patients willing to participate in the study, sign the Informed Consent Form (ICF) and ready to comply with protocol requirements.
排除标准
- •Patients with primary hypothyroidism who are already on treatment with thyroxine for more than a month
- •Pregnant and/or lactating women
- •Patients with any acute or chronic cardiac or any other systemic illness that in the opinion of the investigator does not justify the patient’s inclusion in the study.
结局指标
主要结局
1 Number and percentage of patients with normalization in TSH & fT4 levels over a period of 180 days (6 months)
时间窗: Baseline (Day 0) | 45 days | 90 days | 180 days
次要结局
- 1. To evaluate the effectiveness of thyroxine sodium in improving Zulewski score at 45, 90 and 180 days, compared to baseline(2. To evaluate the pattern of dose modification of thyroxine sodium at 45 and 90 days)