相关临床试验
200
34 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
1931
进行中（未招募）
13
6.5%
已完成
99
49.5%
Enrolling By Invitation
1
0.5%
尚未招募
20
10.0%
招募中
46
23.0%
Unknown
19
9.5%
撤回
2
1.0%
暂无批准数据
- Huonslab has completed patient enrollment in its pivotal Phase 1 clinical trial of HLB3-002 (Hydizyme™), a recombinant human hyaluronidase, with 243 healthy volunteers across four leading South Korean medical centers. - The randomized, double-blind, placebo-controlled study evaluates both allergenicity through intradermal administration and safety via subcutaneous delivery of the investigational biologic. - The company plans to submit a Biological License Application to South Korea's MFDS by the second half of 2025, representing a significant milestone for its HyDIFFUZE™ platform technology. - HLB3-002 is designed to enable subcutaneous delivery of therapeutics as an alternative to traditional intravenous administration, potentially improving patient convenience and reducing healthcare costs.
- A Korean study found that nine weeks of Leclaza treatment can lower the stage of inoperable lung cancer patients with EGFR mutations, making them eligible for surgery. - The NeoLazBAL phase 2 trial used lung lavage fluid biopsies to detect EGFR mutations and guide Leclaza treatment in suspected lung cancer patients. - Results showed a 55.8% partial remission rate with Leclaza, and surgical pathology confirmed lung adenocarcinoma in all patients who underwent resection. - Lung lavage fluid biopsy demonstrated 77.3% sensitivity for detecting EGFR mutations in stage I NSCLC, offering a less invasive diagnostic approach.
- A multi-center, double-blind, randomized trial is underway to compare ROTEM-guided tranexamic acid (TXA) administration with preemptive TXA in cardiovascular surgery patients. - The study aims to determine if ROTEM-guided TXA is non-inferior to preemptive TXA in reducing postoperative blood loss, with recruitment ongoing until December 2024. - The trial will also assess secondary outcomes such as blood transfusion rates, coagulation profiles, thromboembolic complications, and hospital costs. - Findings from this pragmatic trial will inform clinical practice by evaluating the effectiveness of ROTEM-guided TXA in real-world settings.
