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Last Updated: September 19, 2020

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CLINICAL TRIALS PROFILE FOR THYMALFASIN

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Clinical Trials for Thymalfasin

Trial ID Title Status Sponsor Phase Summary
NCT00001036 The Safety and Effectiveness of a Type of Interleukin-2 Plus Zidovudine Plus Thymosin in HIV-Positive Patients With and Without Symptoms of Infection Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 To determine the safety of thymosin alpha 1 given twice weekly in a regimen of daily oral zidovudine (AZT) and biweekly polyethylene glycolated interleukin-2 (PEG IL-2). To determine the effect of thymosin alpha 1 and PEG IL-2 in combination with AZT on immunologic and pharmacokinetic markers. AIDS is characterized by diminished T helper cell number and function. Thymosin alpha 1 appears to both increase IL-2 receptors on lymphocytes in vitro and enhance lymphocyte maturation in vivo; thus, the drug may further enhance the CD4 T cell levels in patients receiving AZT and PEG IL-2.
NCT00039962 Thymosin Plus PEG-Interferon in Hepatitis C Patients With Cirrhosis Who Did Not Respond to Interferon or Interferon Plus Ribavirin Completed SciClone Pharmaceuticals Phase 3 Chronic hepatitis C infection is one of the leading causes of chronic liver disease in the United States. Approximately one-third of patients with hepatitis C infection develop cirrhosis of the liver, which can lead to liver failure or liver cancer. The current treatment for hepatitis C infection in previously untreated patients is successful in only about half of patients. There is no established therapy for non-responders. This is a randomized, double-blinded, multicenter trial to determine the effectiveness of thymosin alpha 1 (thymalfasin) 1.6 mg twice weekly plus PEGinterferon alfa-2a 180 ug/wk compared to placebo plus PEGinterferon alfa-2a in adults with chronic hepatitis C with early cirrhosis or progression to cirrhosis who are non-responders to previous treatment with interferon or interferon plus ribavirin. The definition of non-response requires a positive HCV RNA test at the end of a course of at least 12 weeks of therapy. Patients will receive treatment for 12 months, and will be followed-up for a further 6 months after the end of therapy
NCT00040027 Thymosin Plus PEG-Interferon in Non-Cirrhotic Hepatitis C Patients Who Did Not Respond to Interferon or Interferon Plus Ribavirin Completed SciClone Pharmaceuticals Phase 3 Chronic hepatitis C infection is one of the leading causes of chronic liver disease in the United States. Approximately one-third of patients with hepatitis C infection develop cirrhosis of the liver, which can lead to liver failure or liver cancer. The current treatment for hepatitis C infection in previously untreated patients is successful in only about half of patients. There is no established therapy for non-responders. This is a randomized, double-blinded, multicenter trial to determine the effectiveness of thymosin alpha 1 (thymalfasin) 1.6 mg twice weekly plus PEGinterferon alfa-2a 180 ug/wk compared to placebo plus PEGinterferon alfa-2a in adults with chronic hepatitis C without cirrhosis who are non-responders to previous treatment with interferon or interferon plus ribavirin. The definition of non-response requires a positive HCV RNA test at the end of a course of at least 12 weeks of therapy. Patients will receive treatment for 12 months, and will be followed-up for a further 6 months after the end of therapy.
NCT00082082 A Trial of Thymalfasin in Adult Patients With Hepatocellular Carcinoma Completed SciClone Pharmaceuticals Phase 2 The objective of this Phase II trial is to compare the efficacy and safety of 6 months of treatment with thymalfasin plus trans arterial chemoembolization (TACE) with TACE alone in adult patients with non-surgical hepatocellular carcinoma (HCC).
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Thymalfasin

Condition Name

Condition Name for
Intervention Trials
Thymalfasin 4
Sepsis 2
Radiotherapy 2
Non-small Cell Lung Cancer 2
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Condition MeSH

Condition MeSH for
Intervention Trials
Lung Neoplasms 4
Carcinoma, Non-Small-Cell Lung 3
Hepatitis 3
Infection 3
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Clinical Trial Locations for Thymalfasin

Trials by Country

Trials by Country for
Location Trials
United States 58
China 11
Italy 8
Spain 3
Puerto Rico 2
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Trials by US State

Trials by US State for
Location Trials
California 4
New York 3
Michigan 3
Florida 3
Virginia 3
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Clinical Trial Progress for Thymalfasin

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 4 3
Phase 3 3
Phase 2 10
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Not yet recruiting 9
Completed 6
Recruiting 4
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Clinical Trial Sponsors for Thymalfasin

Sponsor Name

Sponsor Name for
Sponsor Trials
SciClone Pharmaceuticals 7
Zhejiang Provincial People’s Hospital 3
sigma-tau i.f.r. S.p.A. 2
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Sponsor Type

Sponsor Type for
Sponsor Trials
Other 12
Industry 10
NIH 1
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