Phase Ⅲ Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg-positive Chronic Hepatitis B
This trial is to assess the efficacy and safety of Polyethylene Glycol thymosin alpha1 (PEG-Tα1), a new long immunomodulator (Category 1.1 of Chemical Drugs) being developed from Hansoh Pharmaceutical of China, in combination with adefovir in HBeAg-positive patients with chronic hepatitis B.
Study InterventionsPEG-Tα1, Placebo to match PEG-Tα1, AdefovirPrimary EndpointsLoss of HBeAgStudy Period2013-08 → 2016-02 The Efficacy and Safety of Thymosin-α1 in Patients With HBV-related ACLF
A randomized controlled trial to evaluate efficacy and safety of Thymosin-α1 administration in patients with HBV-related Acute-on-chronic liver failure.
Study InterventionsThymosin-α1Primary EndpointsThe liver transplantation-free survival rate of 90 daysStudy Period2017-04-10 → 2019-07-30 Efficacy Study of Thymosin alpha1 & Pegylated Interferon-alpha2a to Treat Chronic Hepatitis B
The purpose of this study is to determine the optimal treatment duration of antiviral therapy for chronic hepatitis B.
Study InterventionsPegylated Interferon-alpha2a, Thymosin alpha1 & Pegylated Interferon-alpha2aPrimary EndpointsHBeAg seroconversion, HBV DNA titer<20,000 IU/mLStudy Period2005-12 → 2008-08 Radiotherapy Combined With Thymosin for Metastatic NSCLC Patients Who Showed Stable Disease After First Line TKI Therapy
The investigators postulated that the exploitation of the pro-immunogenic effects of radiotherapy with thymosin might result in abscopal responses among patients with metastatic cancer. The research is designed to evaluate the efficacy and toxicity of patients treated with hypofractionated radiotherapy combined with thymosin alpha 1. An exploratory biomarker analysis in blood and tumor samples is
Study InterventionsTKI, Thoracic Hypofractionated Radiotherapy, Thymosin Alpha 1Primary EndpointsThe proportion of patients with an abscopal response assessed at 1-6 months after the radiation therapyStudy Period2016-05 → 2020-05 Abscopal Effect for Metastatic Colorectal Cancer
Patients with colorectal cancer that had metastatic lesions after been treated with definitive surgery or chemoradiotherapy are being asked to participate in this study.
1. To observe immunity-mediated tumor response outside the radiation field (abscopal effect) after chemoradiotherapy of a metastatic site in metastatic colorectal cancer patients.
2. To induce the efficacy (effectiveness) of a ne
Study InterventionsRadiation therapy, ThymalfasinPrimary EndpointsThe proportion of patients with an abscopal response assessed at 7-8 weeks after the initiation of treatment.Study Period2015-09 → 2017-12 A Study Evaluating Concurrent Chemoradiotherapy Combined With Dual Immune Checkpoint Blockade for Limited-stage Small Cell Lung Cancer
This study will enroll patients with limited-stage small cell lung cancer (SCLC). Patients will receive chemotherapy (etoposide and platinum-based drugs) combined with dual immune checkpoint blockade (PD-1/CTLA-4) and thymosin alpha 1, with a total cycles of 4. Thoracic radiotherapy was performed no later than the three cycle of chemotherapy. Prophylactic cranial irradiation was recommended for pa
Study InterventionsImmuno-chemotherapy, Radiotherapy, Consolidative therapyPrimary EndpointsProgression-free survivalStudy Period2025-10-01 → 2029-09-30 Zadaxin and HIV-positive Patients With Immune Reconstitution Disorder
The purpose of this study is to evaluate the safety and efficacy of Zadaxin® in the treatment of HIV-positive patients with immune reconstitution disorders. Researchers previously used Zadaxin® (Thymosin α-1, Tα1) as an immune adjuvant for people infected with HIV-1 and found that Tα1 and Interferon-α (IFN-α) have a synergistic effect in immune enhancement. In addition, studies have found that the
Study InterventionsZadaxinPrimary EndpointsChange in CD4+T cell counts; Change in CD4/CD8 ratioStudy Period2021-09-01 → 2022-08-11 Immunotherapy for Elderly Patients With Chronic Osteoporotic Pain
Osteoporotic pain is the most common clinical symptom in elderly patients. The course of pain is prolonged and the effect of clinical treatment is limited. This study will observe the therapeutic effect of thymosin alpha 1 on elderly patient with osteoporotic pain and explore its immunotherapy mechanism.
Study InterventionsThymosin Alpha1Primary EndpointsChange of VAS scoresStudy Period2020-11-01 → 2021-12-31 Thymosin Alpha 1 Plus Maintenance Therapy With the Standard of Care (SoC) in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC), EGFR Wild Type
Thymosin alpha 1 plus maintenance therapy with the Standard of Care (SoC) chemotherapy plus cisplatin (or carboplatin) in patients with metastatic Non-Small Cell Lung Cancer (NSCLC), EGFR wild type
Study InterventionsThymalfasin (Thymosin alpha 1, Ta1), SoC (chemotherapy and platinum agent)Primary EndpointsTime to progression free survival (PFS)Study Period2016-09 → 2019-07 Optimized Treatment and Regression of HBV-induced Compensated Liver Cirrhosis
Six hundreds patients with chronic hepatitis B clinically diagnosed as compensated liver cirrhosis are randomly assigned in a 1:1 ratio. One arm is entecavir alone for 2 years; the other is entecavir alone for the first 0.5 year, entecavir plus thymosin-α for 1 year, entecavir for another additional 0.5 year.Patients will be assessed at baseline, at every six months for blood cell count, liver fun
Study InterventionsEntecavir, Thymosin-αPrimary EndpointsDecompensated rate of Liver Cirrhosis after 2 years treatmentStudy Period2013-06 → 2016-12 The Efficacy and Safety of Thymosin α1 for Sepsis (TESTS): A Multicentre, Double-blind, Randomised, Placebo-Controlled Phase 3 Trial
TESTS was a multicentre, double-blind, randomised, placebo-controlled Phase 3 trial evaluating thymosin α1 in adults aged 18–85 with sepsis. 1,106 participants were randomised (552 thymosin α1; 554 placebo). The primary endpoint was 28-day all-cause mortality. Results published in BMJ in January 2025 showed no significant difference in 28-day mortality between groups (thymosin α1: 17.4% vs placebo: 16.2%; OR 1.09, 95% CI 0.79–1.50; p=0.596). There was no significant benefit in secondary endpoints including 90-day mortality or organ failure scores. The trial did not support routine use of thymosin α1 for sepsis.
Study InterventionsThymosin α1 (1.6 mg subcutaneous twice daily for 5 days), PlaceboPrimary Endpoints28-day all-cause mortalityStudy Period2016-08 → 2022-12 Thymosin Alpha-1 for Immune-Related Adverse Events (irAE) Secondary to Immune Checkpoint Inhibitors
This Phase 2 trial evaluates the safety and efficacy of thymosin alpha-1 in managing immune-related adverse events (irAEs) in cancer patients receiving immune checkpoint inhibitors (ICIs). irAEs represent a major dose-limiting toxicity of PD-1/PD-L1/CTLA-4 blockade therapy. The trial tests whether thymosin alpha-1's immunomodulatory properties — promoting regulatory T cell function and modulating excessive inflammatory responses — can reduce the severity of irAEs while preserving anti-tumour immunity.
Study InterventionsThymosin Alpha-1, Standard of care for irAE managementPrimary EndpointsIncidence and severity of immune-related adverse events; Resolution rate of irAEsStudy Period2024-01 → 2026-12