MedPath

Thymalfasin

Generic Name
Thymalfasin
Drug Type
Biotech
CAS Number
62304-98-7
Unique Ingredient Identifier
W0B22ISQ1C
Background

Thymalfasin is a chemically synthesized version of thymosin alpha 1 that is identical to human thymosin alpha 1. Thymosin alpha 1 is an acetylated polypeptide. Thymosin alpha 1 is now approved in 35 developing countries for the treatment of Hepatitis B and C. It is also used to boost the immune response in the treatment of other diseases.

Indication

⑴慢性乙型肝炎(简称乙肝)。本品是用来治疗那些18岁或以上的慢性乙型肝炎患者,患者的肝病有代偿性,和有乙型肝炎病毒复制(血清HBV-DNA阳性),在那些血清乙肝表面抗原(HBsAg)阳性最少6个月,且有ALT升高的患者所做的研究显示,本品治疗可以产生病毒性缓解(血清HBV-DNA失去)和ALT水平复常,在一些做出应答的患者,本品治疗可除去血清表面抗原。本品与α-干扰素联用时可能比单用本品或单用干扰素增加应答率。

⑵作为免疫损害患者的疫苗增强剂。免疫系统功能受到抑制者,包括接受慢性血液透析和老年病患者,本品增强患者对病毒性疫苗,例如流感疫苗或乙肝疫苗的免疫应答。血液透析患者在接种流感疫苗后,应用本品作为佐剂者有65%患者产生抗流感病毒抗体,滴度水平增加4倍以上,安慰剂组只有24%患者做出此反应。

Associated Conditions
Chronic Hepatitis B Infection, Chronic Hepatitis C Virus (HCV) Infection
Associated Therapies
Adjuvant Therapy

"Thymalfasin Immunotherapy Study with Triple Regimen in Advanced MSS/pMMR Colorectal Cancer"

First Posted Date
2025-02-17
Last Posted Date
2025-02-17
Lead Sponsor
Beijing Friendship Hospital
Target Recruit Count
52
Registration Number
NCT06829355
Locations
🇨🇳

Beijing Friendship Hospital, Capital Medical University, Beijing, China

Thymalfasin (Thymosin Alpha 1; Ta1) as an Enhancer of Vaccine Response Among Older Adults Receiving Booster Doses of COVID-19 Vaccine

Phase 1
Recruiting
Conditions
Vaccine Response
COVID-19 Vaccine
Immune Response to Covid 19 Vaccination
Interventions
First Posted Date
2025-02-11
Last Posted Date
2025-02-11
Lead Sponsor
The Methodist Hospital Research Institute
Target Recruit Count
75
Registration Number
NCT06821100
Locations
🇺🇸

Houston Methodist Hospital, Houston, Texas, United States

Thymalfasin and Recombinant Human IL-2 Injections in Treating Lymphocytopenia for Patients With Malignant Hematological Tumors

First Posted Date
2024-09-04
Last Posted Date
2024-09-04
Lead Sponsor
The First Affiliated Hospital of Xiamen University
Target Recruit Count
50
Registration Number
NCT06584006
Locations
🇨🇳

Zhijuan Lin, Xiamen, Fujian, China

Efficacy and Safety of Anti-PD-1, Thymalfasin, and SOX in Neoadjuvant Treatment of cStage III Gastric/Gastroesophageal Junction Adenocarcinoma

Phase 2
Recruiting
Conditions
Gastric Cancer
Esophagogastric Junction Adenocarcinoma
Interventions
First Posted Date
2024-06-17
Last Posted Date
2025-04-30
Lead Sponsor
Zekuan Xu
Target Recruit Count
30
Registration Number
NCT06461910
Locations
🇨🇳

The First Hospital of Nanjing Medical University, Nanjing, Jiangsu, China

Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for pMMR/MSS Locally Advanced Mid-low Rectal Cancer

Phase 2
Active, not recruiting
Conditions
Locally Advanced Rectal Cancer
Interventions
First Posted Date
2023-09-28
Last Posted Date
2025-04-02
Lead Sponsor
Beijing Friendship Hospital
Target Recruit Count
20
Registration Number
NCT06056804
Locations
🇨🇳

Peking Union Medical College Hospital, Beijing, China

🇨🇳

Beijing Friendship Hospital,Capital Medical University, Beijing, China

Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for Locally Advanced Mid-low Rectal Cancer

Not yet recruiting
Conditions
Colorectal Neoplasms
Interventions
First Posted Date
2023-09-06
Last Posted Date
2023-09-06
Lead Sponsor
Beijing Friendship Hospital
Target Recruit Count
26
Registration Number
NCT06024356
Locations
🇨🇳

Beijing Friendship Hospital, Capital medical University, Beijing, Xicheng Dis, China

Thymalfasin-based PRaG Mode for Advanced Refractory Solid Tumors

Phase 2
Recruiting
Conditions
Advanced Solid Tumor
Refractory Tumor
Interventions
Radiation: Radiotherapy
Drug: PD-1/PD-L1 inhibitor
First Posted Date
2023-03-30
Last Posted Date
2023-03-30
Lead Sponsor
Second Affiliated Hospital of Soochow University
Target Recruit Count
60
Registration Number
NCT05790447
Locations
🇨🇳

The Second Affiliated Hospital of SchoowUniversity, Suzhou, China

Zadaxin and HIV-positive Patients With Immune Reconstitution Disorder

Early Phase 1
Completed
Conditions
HIV-1-infection
Interventions
First Posted Date
2021-07-15
Last Posted Date
2023-07-18
Lead Sponsor
Shanghai Public Health Clinical Center
Target Recruit Count
20
Registration Number
NCT04963712
Locations
🇨🇳

Fudan University, Shanghai, Shanghai, China

Thymalfasin (Thymosin Alpha 1) to Treat COVID-19 Infection

Phase 2
Terminated
Conditions
Covid19
Interventions
First Posted Date
2020-07-27
Last Posted Date
2023-02-14
Lead Sponsor
Rhode Island Hospital
Target Recruit Count
56
Registration Number
NCT04487444
Locations
🇺🇸

The Miriam Hospital, Providence, Rhode Island, United States

Thymosin Alpha 1 to Prevent COVID-19 Infection in Renal Dialysis Patients

Phase 2
Active, not recruiting
Conditions
COVID-19
Interventions
First Posted Date
2020-06-11
Last Posted Date
2022-09-27
Lead Sponsor
William B. Ershler, MD
Target Recruit Count
262
Registration Number
NCT04428008
Locations
🇺🇸

Clinical Research Consultants, Kansas City, Kansas, United States

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