Uljeongbu, Korea, Republic of

Immunotherapy for Advanced Liver Cancer

A multi-national, randomized, controlled trial (RCT) with multiple sites selected in Asia (Malaysia and Thailand). Subjects with no prior treatments for BCLC stage C disease and presenting with Child-Pugh class A or B liver reserve to be randomized 2:1 to AlloStim® vs. Physician's Choice (PC). PC to be declared prior to randomization. PC allowed to be either sorafenib, levantinib or FOLFOX4. The world incidence of hepatocellular carcinoma (HCC) is highest in East and South East Asia, with nearly half of the all HCC cases and deaths globally occurring in China. In Asian countries, the main treatment options for early or intermediate HCC (BCLC class A and B) include surgical resection, ablation (e.g., RFA, ETOH, cryoablation), transarterial chemoembolization (TACE), radiation or systemic chemotherapy depending on liver function status. However, in the Asian-Pacific region it is estimated that up to 80% of patients present with unresectable, advanced HCC (BCLC Stage C) that are not eligible for locoregional therapy, surgery or TACE due to tumor size and/or vascular involvement. For these patients, the standard of care for over a decade has been sorafenib (Bayer, A.G.), a oral kinase inhibitor based on the results of a RCT (SHARP study) of 602 patients randomized to sorafenib vs. placebo. Median overall survival (OS) was 10.7 months for sorafenib and 7.9 months for placebo (p<0.05). The SHARP study included a Western population. A separate study in Asian patients (226 patients from China, South Korea and Taiwan) comparing sorafenib to placebo (Sorafenib-AP study) demonstrated a OS of 6.5 months for sorafenib compared to 4.2 months for placebo (p<0.05). The placebo OS difference between Asian and Western patients (4.2mo vs 7.9 mo) suggests a difference in the disease characteristics in the Asian population. One significant difference is that the Asian population has an increased prevalence of HBV compared to Western population which may contribute to the increased incidence of HCC and worse OS outcomes observed in Asian patients compared to Western patients. In Thailand and Malaysia sorafenib is not available to a majority of the population presenting with advanced HCC, both due to cost and toxicity profile. This study is designed to evaluate whether AlloStim ® immunotherapy will provide a survival benefit to this population with an improved quality of life compared to approved first line therapy.

A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast

A Trial to Learn How Effective and Safe Odronextamab is Compared to Standard of Care for Adult Participants With Previously Treated Aggressive B-cell Non-Hodgkin Lymphoma

Multifunctional Nutrition Tube on Social Condition and Experience in Cerebralvascular Accident

The study will last 15 days for each participant. The goal of this clinical trial is to compare the differences on Psychological Condition and Experience in ischemic stroke patients using Intermittent Oro-esophageal Tube and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare Psychological Condition and Experience of two groups.

Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1

Long-term, Open-label, Safety Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD)

This study aims to enroll 30 participants who either participated in the open-label period (OLP) of the N-MOmentum study (CD-IA-MEDI-551-1155; NCT02200770), a global registrational study that determined the safety and efficacy of inebilizumab for treatment of NMOSD, or who are newly initiating inebilizumab treatment at the discretion of their physician at participating sites. Acquired from Horizon in 2024.

A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments

Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function

The purpose of this study is to investigate the effect of balcinrenone/dapagliflozin compared with dapagliflozin, on the risk of CV death, HF event with and without hospitalisation, in patients with chronic HF, impaired kidney function, and who have had a recent HF event. Eligible patients will randomly be assigned with a 1:1:1 ratio to receive once daily administration of one capsule and one tablet of one of the following treatments: 1. Balcinrenone/dapagliflozin 15 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet 2. Balcinrenone/dapagliflozin 40 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet 3. Dapagliflozin 10 mg tablet and matching placebo for balcinrenone/dapagliflozin capsule The study is event driven, and the average study duration for a participant is estimated to be 22 months including screening period, 20 months blinded treatment period and a one-month follow-up period on open-label dapagliflozin. The study will be conducted at approximately 700 sites in approximately 40 countries globally.

Genitourinary Syndrome of Menopause in Thai Gynecologic Cancer Survivors

Gynecological cancers, encompassing ovarian, endometrial, and cervical cancers, stand as significant health concerns for women. In 2017, a total of 12,354 new cases were diagnosed in Thailand, underlining the prevalence and impact of these conditions. Advances in cancer screening and treatment have notably improved outcomes, resulting in a growing number of survivors. By 2016, the United States alone recorded 15.5 million cancer survivors, with projections indicating a surge to 26.1 million by 2040. However, even with increased survival rates, challenges persist for survivors, encompassing chronic pain, complications from treatment, and disruptions to fertility, menopause, sexual function, and cognitive health. The treatment landscape for gynecological cancers is diverse, with the general principle for ovarian and endometrial cancers involving surgical staging. This comprehensive approach includes the removal of the uterus, fallopian tubes, both ovaries, peritoneum, pelvic lymph nodes, and any visible lesions. For cervical cancer, treatment varies based on disease stage. Early-stage cases often undergo surgery, potentially followed by pelvic irradiation. In advanced-stage cervical cancer, a combination of pelvic radiation and chemotherapy is commonly employed. In summary, many gynecological cancer treatments involve the removal of both ovaries or pelvic irradiation, inducing menopause in reproductive-age women. The female lower reproductive system, including the lower urinary tract, is intricately responsive to estrogenic stimulation. When estrogen is lacking, structural changes occur, giving rise to a cluster of symptoms collectively termed the genitourinary syndrome of menopause (GSM). Estrogen deficiency results in thinning of the vaginal epithelium lining, diminished collagen and elastin fibers, reduced blood supply, and moisture decline. These changes manifest as vaginal symptoms, including burning, itching, and pain during intercourse. Similarly, the urinary tract, deprived of estrogenic stimulation, undergoes alterations such as urethral shortening, thinning of the urethral epithelium, weakened urethral sphincter contractions, and reduced elasticity of the urinary bladder. This cascade of changes results in lower urinary tract symptoms, comprising dysuria, urinary urgency, incontinence, frequency, nocturia, and recurrent urinary tract infections. Postmenopausal women commonly experience these symptoms, and systematic literature reviews reveal a prevalence ranging from 13 to 87%. Furthermore, the chronic nature of these symptoms tends to intensify over time. Women who undergo early bilateral oophorectomy are more likely to enter menopause sooner, increasing the risk of developing various urogenital symptoms at a younger age. The impact of these symptoms on women's lives is profound, affecting daily activities, self-confidence, and intimate relationships. Vaginal symptoms, in particular, can lead to sexual dysfunction, exacerbating challenges in family relationships. Concurrently, urinary symptoms contribute to decreased quality of life, with frequency, nocturia, and urgency correlating with the risk of falls and bone fractures. Additionally, these symptoms are associated with depressed mood, anxiety, and embarrassment, further disrupting aspects of life such as sleep, daily commute, social interactions, and sexual relationships. Despite the significant impact on quality of life, the effective management of vaginal and genitourinary symptoms is impeded by various factors. These include a lack of knowledge and understanding of the diseases and available treatment options, feelings of embarrassment, and the notable observation that medical personnel often fail to inquire about these specific issues during patient consultations. The primary treatment for genitourinary symptoms is typically the use of vaginal estrogen. However, certain gynecological cancers, such as leiomyosarcoma, endometrial stromal sarcoma, and specific ovarian cancers, preclude the use of estrogen therapy. In such cases, non-hormonal alternatives like vaginal lubricants, moisturizers, and energy-based devices come into consideration. This study aim to explore the prevalence of GSM among gynecological cancer survivors. The investigation extends to understanding the magnitude of the problem, examining women's attitudes towards the condition, and assessing its broader impact on their quality of life. This comprehensive exploration seeks to contribute valuable insights to the understanding and management of the complex challenges faced by gynecological cancer survivors.

Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)

The I CAN study will enroll approximately 510 eligible participants with IgAN who are high risk of disease progression. Participants will be on stable concomitant IgAN treatment(s) consistent with standard of care for patients with IgAN for at least 3 months prior to Screening. Approximately 450 participants will be randomized in a 1:1 allocation ratio to receive a weight-based IV infusion of either ravulizumab or placebo. An interim analysis may be conducted at Week 34 to evaluate change in proteinuria and the final analysis will be conducted at Week 106 to evaluate eGFR. In addition, approximately 60 participants with eGFR 20-29 mL/min/1.73m2 will be enrolled in an Advanced Kidney Disease (AdKD) Cohort After Week 106, all participants have the option to enter an Open-label Ravulizumab Access Period.