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

Clinical Trials

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

Phase 2

Conditions: Non-Small Cell Lung Cancer

Interventions: Drug: Thymalfasin (Thymosin alpha 1, Ta1)
Drug: SoC (chemotherapy and platinum agent)

First Posted Date: 2016-09-19

Last Posted Date: 2016-09-19

Lead Sponsor: SciClone Pharmaceuticals

Target Recruit Count: 140

Registration Number: NCT02906150

Locations: 🇮🇹
Roma_Gemelli, Rome, Italy
🇮🇹
Roma_Tor Vergata, Rome, Italy
🇮🇹
Sant'Andrea Hospital, Rome, Italy

and more 5 locations

First Line Bio-immunotherapy With Thymosin Alpha 1 in Patients With Sensitizing EGFR Mutation Positive Non Small Cell Lung Cancer Who Are Taking Standard of Care Therapy

Phase 1

Conditions: EGFR Mutation Positive Non Small Cell Lung Cancer

Interventions: Drug: Thymalfasin (Thymosin alpha 1, Ta1)
Drug: SoC (tyrosine kinase inhibitor)

First Posted Date: 2016-09-19

Last Posted Date: 2016-09-19

Lead Sponsor: SciClone Pharmaceuticals

Target Recruit Count: 188

Registration Number: NCT02906163

Locations: 🇮🇹
Istituto Nazionale dei Tumori, Milan, Italy
🇮🇹
Presidio Sanitario San Camillo, Torino, Italy
🇮🇹
Azienda Sanitaria Locale Frosinone, Frosinone, Italy

and more 2 locations

Therapeutic Safety and Efficacy of REP 2139 (REP 9AC') in HBV Infected Patients

Phase 1

Completed

Conditions: Hepatitis B, Chronic

Interventions: Drug: REP 2139-Ca
Drug: Zadaxin
Drug: Pegasys

First Posted Date: 2016-01-05

Last Posted Date: 2016-01-05

Lead Sponsor: Replicor Inc.

Target Recruit Count: 12

Registration Number: NCT02646189

Locations: 🇧🇩
Farabi General Hospital, Dhaka, Bangladesh

SBRT Combined With Thymalfasin for Metastatic Esophageal Cancer

Phase 2

Conditions: Esophageal Cancer
Stereotactic Body Radiation Therapy
Metastatic Esophageal Cancer
Thymalfasin

Interventions: Radiation: Stereotactic Body Radiation Therapy
Drug: Thymalfasin

First Posted Date: 2015-09-10

Last Posted Date: 2017-11-28

Lead Sponsor: Hangzhou Cancer Hospital

Target Recruit Count: 29

Registration Number: NCT02545751

Locations: 🇨🇳
Hangzhou Cancer Hospital, Hangzhou, Zhejiang, China

Abscopal Effect for Metastatic Non-small Cell Lung Cancer.

Phase 2

Withdrawn

Conditions: Radiotherapy
Metastatic Non-small Cell Lung Cancer
Non-small Cell Lung Cancer
Thymalfasin

Interventions: Radiation: Radiotherapy
Drug: Thymalfasin

First Posted Date: 2015-09-07

Last Posted Date: 2019-03-26

Lead Sponsor: Zhejiang Provincial People's Hospital

Registration Number: NCT02542930

Abscopal Effect for Metastatic Small Cell Lung Cancer

Phase 2

Withdrawn

Conditions: Small Cell Lung Cancer
Radiotherapy
Thymalfasin

Interventions: Radiation: Radiotherapy
Drug: Thymalfasin

First Posted Date: 2015-09-04

Last Posted Date: 2019-03-21

Lead Sponsor: Zhejiang Provincial People's Hospital

Registration Number: NCT02542137

Abscopal Effect for Metastatic Colorectal Cancer

Phase 2

Withdrawn

Conditions: Colorectal Cancer
Metastatic Colorectal Cancer
Thymalfasin

Interventions: Radiation: Radiation therapy
Drug: Thymalfasin

First Posted Date: 2015-08-31

Last Posted Date: 2023-09-21

Lead Sponsor: Zhejiang Provincial People's Hospital

Registration Number: NCT02535988

Thymalfasin Adjuvant Therapy in Hepatitis B Virus (HBV)-Related Hepatocellular Carcinoma (HCC) After Curative Resection

Phase 4

Conditions: Curable Hepatitis B Virus-Related Hepatocellular Carcinoma

Interventions: Procedure: curative resection
Drug: nucleoside analog (suggest to use entecavir)
Drug: thymalfasin

First Posted Date: 2014-11-02

Last Posted Date: 2014-11-21

Lead Sponsor: Jia Fan

Target Recruit Count: 360

Registration Number: NCT02281266

Locations: 🇨🇳
Zhongshan Hospital, Shanghai, Shanghai, China

A Trial of Thymalfasin in Adult Patients With Hepatocellular Carcinoma

Phase 2

Completed

Conditions: Carcinoma, Hepatocellular

First Posted Date: 2004-04-30

Last Posted Date: 2008-01-15

Lead Sponsor: SciClone Pharmaceuticals

Registration Number: NCT00082082

Locations: 🇺🇸
Metropolitan Research, Fairfax, Virginia, United States
🇺🇸
Columbia University, New York, New York, United States
🇺🇸
William Beaumont Hospital, Royal Oak, Michigan, United States

and more 2 locations

Thymosin Plus PEG-Interferon in Non-Cirrhotic Hepatitis C Patients Who Did Not Respond to Interferon or Interferon Plus Ribavirin

Phase 3

Completed

Conditions: Hepatitis C
Hepatitis C, Chronic

First Posted Date: 2002-07-04

Last Posted Date: 2008-01-15

Lead Sponsor: SciClone Pharmaceuticals

Target Recruit Count: 500

Registration Number: NCT00040027

Locations: 🇺🇸
Center for Digestive and Liver Health, Savannah, Georgia, United States
🇺🇸
Baylor University Medical Center, Dallas, Texas, United States
🇺🇸
Atlanta Gastroenterology Associates, Atlanta, Georgia, United States

and more 44 locations

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