Page last updated: 2024-11-12

thymalfasin

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators

Description

Thymalfasin: A thymus hormone polypeptide found in thymosin fraction 5 (a crude thymus gland extract) but now produced by synthesis. It is used alone or with interferon as an immunomodulator for the treatment of CHRONIC HEPATITIS B and HEPATITIS C. Thymalfasin is also used for the treatment of chemotherapy-induced immunosuppression, and to enhance the efficacy of influenza and hepatitis B vaccines in immunocompromised patients. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

FloraRankFlora DefinitionFamilyFamily Definition
Thymusgenus[no description available]LamiaceaeThe mint plant family. They are characteristically aromatic, and many of them are cultivated for their oils. Most have square stems, opposite leaves, and two-lipped, open-mouthed, tubular corollas (united petals), with five-lobed, bell-like calyxes (united sepals).[MeSH]

Cross-References

ID SourceID
PubMed CID16130571
CHEMBL ID2103979
CHEBI ID135915
SCHEMBL ID15531955
MeSH IDM0086869

Synonyms (40)

Synonym
thymosin-alpha-1 & .alpha. ifn
69521-94-4
zadaxin
ac-sdaavdtsseittkdlkekkevveeaen-cooh
thymosin-alpha-1
emz702
thymosin .alpha.1
thymosin .alpha.1 (cattle)
thymlfasin
.alpha.1-thymosinthymalfasin
62304-98-7
thymosin alpha1 (human)
thymalfasin
thymosin alpha1 (ox)
thymosin alpha1 (cattle)
n-acetyl-l-seryl-l-alpha-aspartyl-l-alanyl-l-alanyl-l-valyl-l-alpha-aspartyl-l-threonyl-l-seryl-l-seryl-l-alpha-glutamyl-l-isoleucyl-l-threonyl-l-threonyl-l-lysyl-l-alpha-aspartyl-l-leucyl-l-lysyl-l-alpha-glutamyl-l-lysyl-l-lysyl-l-alpha-glutamyl-l-valyl-
l-asparagine, n-acetyl-l-seryl-l-alpha-aspartyl-l-alanyl-l-alanyl-l-valyl-l-alpha-asparatyl-l-threonyl-l-seryl-l-seryl-l-alpha-glutamyl-l-isoleucyl-l-threonyl-l-threonyl-l-lysyl-l-alpha-aspartyl-l-leucyl-l-lysyl-l-alpha-glutamyl-l-lysyl-l-lysyl-l-alpha-gl
thymalfasin [usan:inn]
alpha1-thymosinthymalfasin
ccris 7707
thymosin alpha(1)
alpha1-thymosin
thymosin alpha1
CHEBI:135915
w0b22isq1c ,
unii-w0b22isq1c
AKOS015994639
CHEMBL2103979
thymosins thymalfasin
thymosin alpha 1
HS-2030
SCHEMBL15531955
thymosin i+/-1 bovine
thymosin alpha1 bovine, >=90% (hplc)
ac-ser-asp-ala-ala-val-asp-thr-ser-ser-glu-ile-thr-thr-lys-asp-leu-lys-glu-lys-lys-glu-val-val-glu-glu-ala-glu-asn-oh
thymosin |a1
DTXSID80211374
thymosin a1 (cattle)
thymosin a1thymosin a1
AC-8935

Research Excerpts

Overview

Thymalfasin is an important peptide drug widely used for the single or combination treatment of hepatitis, sepsis, cancer, and immunodeficiency.

ExcerptReferenceRelevance
"Thymalfasin is an important peptide drug widely used for the single or combination treatment of hepatitis, sepsis, cancer, and immunodeficiency. "( Identification and determination of structurally related peptide impurities in thymalfasin by liquid chromatography-high-resolution mass spectrometry.
Cheng, Y; Kan, Y; Li, H; Li, M; Wu, P, 2022
)
2.39

Effects

ExcerptReferenceRelevance
"Thymalfasin has shown efficacy in the treatment of chronic HCV infection. "( Efficacy of triple therapy with thymalfasin, peginterferon alpha-2a, and ribavirin for the treatment of hispanic chronic HCV nonresponders.
Cano, C; García Samper, X; Góngora, J; Kershenobich, D; Parada, M; Poo, JL; Sánchez Avila, F; Torress-Ibarra, R; Uribe, M,
)
1.86

Toxicity

ExcerptReferenceRelevance
" Thymosin alpha 1 was well tolerated and there were no serious adverse events."( A pilot study of the safety and efficacy of thymosin alpha 1 in augmenting immune reconstitution in HIV-infected patients with low CD4 counts taking highly active antiretroviral therapy.
Chadwick, D; Gotch, F; Imami, N; Paton, NI; Pido-Lopez, J; Pires, A; Ravindran, S; Villacian, JS, 2003
)
0.32
" All adverse drug reactions were mild and most involved the fluctuation of liver enzymes, which was most likely related to the positive immune effects caused by the response to Talpha1 treatment."( The efficacy and safety of thymosin alpha-1 in Japanese patients with chronic hepatitis B; results from a randomized clinical trial.
Iino, S; Kakumu, S; Kiyosawa, K; Kumada, H; Martins, EB; Sata, M; Suzuki, H; Toyota, J, 2005
)
0.33
" In addition, the number of adverse events was significantly reduced by ETV plus Tα1, compared to ETV alone (RR = 0."( The clinical efficacy and adverse effects of Entecavir plus Thymosin alpha-1 combination therapy versus Entecavir Monotherapy in HBV-related cirrhosis: a systematic review and meta-analysis.
Chen, JH; Hou, M; Li, B; Li, C; Peng, D; Wang, XF; Xing, HY, 2020
)
0.56
"ETV plus Tα1 might lead to a higher clinical response and a lower comprehensive adverse reaction rate in HBV-related patients with cirrhosis, compared to ETV alone."( The clinical efficacy and adverse effects of Entecavir plus Thymosin alpha-1 combination therapy versus Entecavir Monotherapy in HBV-related cirrhosis: a systematic review and meta-analysis.
Chen, JH; Hou, M; Li, B; Li, C; Peng, D; Wang, XF; Xing, HY, 2020
)
0.56
"Tα1 is safe for patients with HBV-related ACLF and significantly improves the 90-day liver transplantation-free survival rate."( Safety and efficacy of Thymosin α1 in the treatment of hepatitis B virus-related acute-on-chronic liver failure: a randomized controlled trial.
Cao, HJ; Chen, JF; Chen, SR; Gao, ZL; Lei, ZY; Lin, BL; Lin, DN; Weng, WZ; Xiong, J; Zhang, J; Zhang, SQ; Zheng, YB, 2022
)
0.72

Pharmacokinetics

ExcerptReferenceRelevance
" Results demonstrated that PEGylated sites and regions influenced the conformations and pharmacokinetic profiles of the peptide greatly with following order: alpha-helix, beta-turn, random coil and terminals, but little on the immunoactivity."( Studies of bioactivity, conformation and pharmacokinetic profiles of site-specific PEGylated thymosin alpha 1 derivatives.
Dong, S; Liu, K; Ma, J; Qi, C; Qie, J; Sun, H; Wang, L; Xie, J; Xu, X; Zhang, Y; Zhao, X; Zheng, J; Zhou, W, 2007
)
0.34
" The pharmacokinetic data of rHSA-L-Talpha1 and rHSA-Talpha1 administered in rats showed an improved pharmacokinetic profile with a conspicuous prolonged half life."( Bioactivity and pharmacokinetics of two human serum albumin-thymosin alpha1-fusion proteins, rHSA-Talpha1 and rHSA-L-Talpha1, expressed in recombinant Pichia pastoris.
Chen, J; Chen, JH; Cheng, DS; Jiang, YT; Tang, L; Wang, M; Yan, LY; Yin, YW; Zhang, XG, 2010
)
0.36

Compound-Compound Interactions

ExcerptReferenceRelevance
"To evaluate the therapeutic effect of ulinastatin combined with thymosin α1 in the treatment of severe sepsis in rats."( [Ulinastatin combined with thymosin α1 for treatment of severe sepsis: a histopathological observation in rats].
Deng, Q; Guo, J; Guo, X; He, Z; Lin, H; Liu, S; Zhang, Y, 2012
)
0.38
"To explore the role of human immunoglobulin (Ig) and thymosin α1 therapy for severe sepsis through comparison between bundles combined with human immunoglobulin (Ig) and thymosin α1 therapy group (A group) and bundles group (B group)."( The Therapeutic Effects of Thymosin α1 Combined with Human Immunoglobulin (Ig) and Bundles on Severe Sepsis: a Retrospective Study.
Li, CS; Li, Y, 2015
)
0.42
"A total of 526 subjects with severe sepsis in the ICU were divided into two groups: bundles combined with human immunoglobulin (Ig) and thymosin α1 therapy (A group) and bundles (B group)."( The Therapeutic Effects of Thymosin α1 Combined with Human Immunoglobulin (Ig) and Bundles on Severe Sepsis: a Retrospective Study.
Li, CS; Li, Y, 2015
)
0.42
"Bundles combined with human immunoglobulin (Ig) and thymosin α1 therapy may reduce APACHE II and SOFA scores, shorten the time of artificial ventilation and length of ICU stay, and improve the prognosis of subjects with severe sepsis."( The Therapeutic Effects of Thymosin α1 Combined with Human Immunoglobulin (Ig) and Bundles on Severe Sepsis: a Retrospective Study.
Li, CS; Li, Y, 2015
)
0.42
"To assess the effects of urinary trypsin inhibitor (UTI) ulinastatin combined with thymosin alpha1 (Tα1) on sepsis."( Effect of ulinastatin combined with thymosin alpha1 on sepsis: A systematic review and meta-analysis of Chinese and Indian patients.
Chen, Y; Fu, H; Liu, D; Wan, B; Xin, F; Yin, J; Yu, Z; Zhang, H, 2017
)
0.46
"Treatment of UTI combined with Tα1 (UTI+Tα1) decreased the short-term mortality rate in septic patients by 36%, 35%, and 31% for 28, 60, 90 days, respectively."( Effect of ulinastatin combined with thymosin alpha1 on sepsis: A systematic review and meta-analysis of Chinese and Indian patients.
Chen, Y; Fu, H; Liu, D; Wan, B; Xin, F; Yin, J; Yu, Z; Zhang, H, 2017
)
0.46
"This study aimed to research the clinical effect of Xuebijing combined with thymosin α1 on patients with severe pneumonia complicated with sepsis, and its effect on serum inflammatory factors."( Clinical effect of Xuebijing combined with thymosinα1 on patients with severe pneumonia complicated with sepsis and its effect on serum inflammatory factors.
Chen, Y; Gu, T; Li, S; Wang, J; Zhou, L, 2022
)
0.72

Dosage Studied

ExcerptRelevanceReference
" The dose-response relationship for these effects is not linear and may be bimodal."( Thymosin alpha-1 as adjunct for conventional therapy of malignant tumors: a review.
Bepler, G, 1994
)
0.29
" Our experiments did not show any great differences in the overall efficacy of the two drugs, although they showed quite a different dose-response effect."( Effect of synthetic thymic hormones on the cocaine-induced inhibition of the primary immune response in mice.
Di Francesco, P; Falchetti, R; Favalli, C; Garaci, E; Gaziano, R; Lanzilli, G; Ravagnan, G, 1993
)
0.29
" Dose-response studies demonstrated that 10 micrograms/ml of TF5 was the lowest concentration capable of enhancing IL-6 production."( Thymosin stimulates interleukin-6 production from rat spleen cells in vitro.
Attia, WY; Badamchian, M; Goldstein, AL; Spangelo, BL,
)
0.13
"The pharmacology, pharmacokinetics, clinical efficacy, adverse effects, and dosage and administration of thymosin alpha-1 (TA1) are reviewed."( Thymosin alpha-1.
Ancell, CD; Phipps, J; Young, L, 2001
)
0.31
" Daily dosing of 100 mg reduces serum HBV-DNA to below detectable levels within 6 weeks."( Treatment of chronic hepatitis B: case selection and duration of therapy.
Leung, N, 2002
)
0.31
"6 mg subcutaneously (sc), twice a week] and interferon alpha-2b (10 MIU sc, three times per week) for 26 weeks, subsequently followed by interferon alpha-2b monotherapy at the same dosage for an additional 26 weeks."( Long-term outcomes of thymosin-alpha 1 and interferon alpha-2b combination therapy in patients with hepatitis B e antigen (HBeAg) negative chronic hepatitis B.
Ayhan, S; Hock, LM; Ozden, N; Saruc, M; Turkel, N; Tuzcuoglu, I; Yuceyar, H, 2003
)
0.32
"6 mg per day for 7 days (as treatment group 1, adopted in the first trial), or double dosage of the above agents (as treatment group 2, adopted in the second trial)."( [Clinical trial with a new immunomodulatory strategy: treatment of severe sepsis with Ulinastatin and Maipuxin].
Lin, HY, 2007
)
0.34
" Dose-response studies suggested the possibility of improving the efficacy of this molecule reducing the overall toxic."( Thymosin alpha 1: from bench to bedside.
Bistoni, F; Favalli, C; Garaci, E; Mastino, A; Matteucci, C; Palamara, AT; Pica, F; Pierimarchi, P; Rasi, G; Romani, L; Serafino, A; Sinibaldi Vallebona, P, 2007
)
0.34
" As to in vivo studies, treatment of rh-T alpha 1 at either dosage did not significantly alter the liver weight."( Effect of recombinant human thymosin-alpha1, an immuno-modulating peptide with 28 amino acids, on the activity of cytochrome P450s.
He, F; Huang, M; Lin, Y; Wang, B; Zhou, SF, 2007
)
0.34
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Drug Classes (1)

ClassDescription
polypeptideA peptide containing ten or more amino acid residues.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Research

Studies (552)

TimeframeStudies, This Drug (%)All Drugs %
pre-1990137 (24.82)18.7374
1990's88 (15.94)18.2507
2000's141 (25.54)29.6817
2010's135 (24.46)24.3611
2020's51 (9.24)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 38.88

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index38.88 (24.57)
Research Supply Index6.51 (2.92)
Research Growth Index4.60 (4.65)
Search Engine Demand Index59.05 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (38.88)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials80 (13.54%)5.53%
Reviews83 (14.04%)6.00%
Case Studies8 (1.35%)4.05%
Observational1 (0.17%)0.25%
Other419 (70.90%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (42)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase II Study of Thymopeptide a1 During Split-course Chemoradiotherapy to Reduce Acute Pneumonia For Bulky None-small Cell Lung Cancer [NCT03659578]Phase 269 participants (Actual)Interventional2018-08-09Completed
A Phase III, Multicentre, Double Blinded Study In Patients With Chronic Hepatitis C Who Are Non-Responders To Prior Peginterferon Alpha + Ribavirin Therapy Comparing Treatment With Thymosin Alpha 1 + Peginterferon Alpha-2a Plus Ribavirin With Peginterfero [NCT01178996]Phase 3552 participants (Actual)Interventional2004-12-31Completed
Thymosin Alpha 1 in the Prevention of Pancreatic Infection Following Acute Necrotizing Pancreatitis [NCT02473406]Phase 4508 participants (Actual)Interventional2018-03-27Completed
A Pilot Trial of Thymalfasin (Ta1) to Treat COVID-19 Infection in Patients With Lymphocytopenia [NCT04487444]Phase 256 participants (Actual)Interventional2020-09-10Terminated(stopped due to The study was terminated due to slow enrollment and the transfer of the PI to another institution.)
Long-term Prognosis After Thymosin Alpha 1 Treatment in Patients With Sepsis: A Multicenter Cohort Study [NCT04901104]900 participants (Anticipated)Observational [Patient Registry]2021-07-01Not yet recruiting
Investigator Initiated Study of Thymosin in HBV-related HCC [NCT02281266]Phase 4360 participants (Anticipated)Interventional2015-01-31Not yet recruiting
A Multicenter, Randomized, Open-label Control Study to Evaluate Efficacy and Safety of Combination Therapy of Thymalfasin and Entecavir in HBeAg-positive ETV-experienced Patients [NCT03448744]Phase 4240 participants (Anticipated)Interventional2017-10-25Recruiting
Therapeutic Safety and Efficacy of REP 2139 (REP 9AC') in HBV Infected Patients [NCT02646189]Phase 1/Phase 212 participants (Actual)Interventional2011-08-31Completed
A Phase II, Multicentre, Open, Randomised, Dose Ranging Study to Investigate the Efficacy of Combination Therapy Containing Dacarbazine (DTIC) Plus Low Dose Interferon Alpha (aIFN) Plus Thymosin a1 Versus Both DTIC Plus Thymosin a1 and DTIC Plus aIFN in P [NCT00911443]Phase 2488 participants (Actual)Interventional2002-07-31Completed
A Pilot Trial of Thymalfasin (Ta1) to Prevent COVID-19 Infection in Renal Dialysis Patients [NCT04428008]Phase 2262 participants (Actual)Interventional2021-01-12Active, not recruiting
Efficacy and Safety of Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin in pMMR/MSS Locally Advanced Middle and Low Rectal Cancer: An Open, Multi-center, Prospective, Single-arm Phase II Clinical Study [NCT06056804]Phase 220 participants (Anticipated)Interventional2023-12-01Not yet recruiting
Treatment of Advanced Refractory Solid Tumors Based on Precise Thymalfasin-regulated PRaG Mode: an Open-label, Prospective, Multicenter Study (PRaG 5.0 Study) [NCT05790447]Phase 260 participants (Anticipated)Interventional2023-04-01Recruiting
Combination Treatment of Polyethylene Glycol Thymosin alpha1 (PEG-Tα1) and Adefovir for Hepatitis B e Antigen (HBeAg)-Positive Chronic Hepatitis B: A Multi-center Randomized, Double-blind, Parallel-controlled Phase Ⅲ Trial [NCT02366247]Phase 3463 participants (Actual)Interventional2013-08-31Active, not recruiting
A Phase II Study of Stereotactic Body Radiation Therapy and ZADAXIN's® (Thymalfasin) Induced Tumor Effects in Patients With Heavily Pretreated, Metastatic Esophageal Cancer [NCT02545751]Phase 229 participants (Anticipated)Interventional2016-01-31Recruiting
Multicenter, Randomized, Controlled Study to Evaluate the Efficacy of Thymosin alpha1 in Patients With Severe Sepsis [NCT00711620]366 participants (Actual)Interventional2008-05-31Completed
A Phase II Study of Radiotherapy and ZADAXIN's® (Thymalfasin) Induced Abscopal Effect in Patients With Heavily Pretreated, Metastatic Non-small Cell Lung Cancer. [NCT02542930]Phase 20 participants (Actual)Interventional2016-01-31Withdrawn(stopped due to No recruitment.)
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 [NCT02906150]Phase 2140 participants (Anticipated)Interventional2016-09-30Not yet recruiting
A Phase II Study of Radiotherapy and ZADAXIN's® (Thymalfasin) Induced Abscopal Effect in Patients With Heavily Pretreated, Metastatic Small Cell Lung Cancer [NCT02542137]Phase 20 participants (Actual)Interventional2015-09-30Withdrawn(stopped due to No recruitment.)
A Phase II Trial of Hypofractionated Radiotherapy Combined With Thymosin for Metastatic NSCLC Patients Who Showed Stable Disease After First Line TKI Therapy [NCT02787447]Phase 246 participants (Anticipated)Interventional2016-05-31Recruiting
Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine and Thymosin Alpha 1 in HIV-Positive, Asymptomatic and Symptomatic Individuals [NCT00001036]Phase 112 participants InterventionalCompleted
The Efficacy and Safety of Thymosin Alpha 1 for Sepsis: a Multicenter , Double-Blinded, Randomized and Controlled Clinical Trial [NCT02867267]Phase 31,106 participants (Actual)Interventional2016-09-06Completed
A Pilot, Randomized, Open-label Study in Patients on Chronic Dialysis With End Stage Renal Disease (Esrd), to Evaluate the Enhancing Effect of Two Doses of Thymosin Alpha 1 on the Immunogenicity of h1n1sw Monovalent Vaccine [NCT01031966]Phase 2120 participants (Actual)Interventional2009-11-30Completed
A Prospective, Open, Randomized Controlled Stage II Trial Investigating the Efficacy and Safety of Thymosin Alpha-1 in Treating Moderate to Severe Immune-related Adverse Events [NCT06178146]Phase 440 participants (Anticipated)Interventional2023-09-01Recruiting
Efficacy of Thymosin Alpha 1 on Improving Monocyte Function for Sepsis [NCT02883595]Phase 420 participants (Actual)Interventional2016-03-31Completed
A Phase II Study of Radiotherapy and ZADAXIN's® (Thymalfasin) Induced Abscopal Effect in Patients With Heavily Pretreated, Metastatic Colorectal Cancer [NCT02535988]Phase 20 participants (Actual)Interventional2015-09-30Withdrawn(stopped due to No recruitment.)
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 [NCT02906163]Phase 1/Phase 2188 participants (Anticipated)Interventional2016-10-31Not yet recruiting
A Randomized Controlled Trial to Evaluate Efficacy and Safety of Thymosin-α1 Administration in Patients With HBV-related Acute-on-chronic Liver Failure [NCT03082885]120 participants (Actual)Interventional2017-04-10Completed
Efficacy and Safety of Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for Locally Advanced Mid-low Rectal Cancer: a Single-center, Retrospective, Controlled Study [NCT06024356]26 participants (Anticipated)Observational2023-09-20Not yet recruiting
An Clinic Trial of Recombinant Human Interferon Alpha Nasal Drops to Prevent Coronavirus Disease 2019 in Medical Staff in Epidemic Area [NCT04320238]Phase 32,944 participants (Anticipated)Interventional2020-01-21Recruiting
A Multicenter, Randomized, Controlled Trial of Combination Therapy for HBeAg Positive Chronic Hepatitis B: Comparing Thymosin Alpha 1 and Pegylated Interferon-alpha2a With Pegylated Interferon-alpha2a Alone. [NCT00291616]Phase 452 participants (Actual)Interventional2005-12-31Completed
A Trial of Thymalfasin With Trans Arterial Chemo-Embolization (TACE) in the Treatment of Adult Patients With Unresectable Hepatocellular Carcinoma: A Phase II Trial [NCT00082082]Phase 20 participants InterventionalCompleted
Effects of Thymosin α1 on Inflammatory Response for Acute Aortic Syndrome Patients [NCT05339529]100 participants (Anticipated)Interventional2022-07-01Recruiting
Phase I/II Clinical Trial on Thymosin Alfa 1 of Allogeneic Hematopoietic Transplantation [NCT00580450]Phase 1/Phase 29 participants (Anticipated)Interventional2007-12-31Not yet recruiting
Thymosin α1 Use in Rheumatic Heart Disease Patients Undergoing Cardiac Surgery on Cardiopulmonary Bypass [NCT05487469]200 participants (Anticipated)Interventional2022-07-01Recruiting
[NCT00040027]Phase 3500 participants Interventional2002-04-30Completed
[NCT00039962]Phase 3500 participants Interventional2002-05-31Completed
A Prospective Phase II Controlled Study to Evaluate the Impact of Thymosin Alpha 1 on the Completion Rate of Consolidation Immunotherapy After Radical Radiochemotherapy for Locally Advanced Non-Small Cell Lung Cancer [NCT06139419]Phase 2114 participants (Anticipated)Interventional2023-07-25Recruiting
A Prospective Single-arm Cohort Study Evaluating the Safety and Efficacy of Thymalfasin (Zadaxin®) in the Treatment of HIV-positive Patients With Immune Reconstitution Disorders [NCT04963712]Early Phase 120 participants (Actual)Interventional2021-09-01Completed
Combination Treatment of Polyethylene Glycol Thymosin alpha1 (PEG-Tα1) and Adefovir for Hepatitis B e Antigen (HBeAg) -Positive Chronic Hepatitis B: A Multi-center Randomized, Double-blind, Parallel-controlled Phase II Trial [NCT02366208]Phase 2116 participants (Actual)Interventional2011-05-31Completed
Effect of Refnot on Immunity in Cancer Patients [NCT05898451]Phase 255 participants (Actual)Interventional2009-06-04Completed
The Efficacy and Safety of Thymosin-alpha 1 Used for Adjuvant Treatment After Radical Resection of High-risk Stage II and Stage III Colorectal Cancer [NCT05086614]Phase 32,500 participants (Anticipated)Interventional2021-04-01Recruiting
Immunotherapy for Elderly Patients With Chronic Osteoporotic Pain [NCT04524169]Phase 4100 participants (Anticipated)Interventional2020-11-01Not yet recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00911443 (3) [back to overview]Overall Survival
NCT00911443 (3) [back to overview]Overall Tumor Response
NCT00911443 (3) [back to overview]Progression Free Survival

Overall Survival

The survival time for each patient is defined as the time between randomization and death. Patients lost to follow-up or still alive at the date of last evaluation have been censored. (NCT00911443)
Timeframe: 2 years

Interventionmonths (Median)
Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg9.3
Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg8.6
Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg10.3
Dacarbazin + Thymosin-alpha-1 3.2 mg9.3
Dacarbazin + Interferon Alpha6.6

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Overall Tumor Response

Tumor response is measured according to Response Evaluation Criteria In Solid Tumors (RECIST) computing number of Complete Response plus Partial Response (NCT00911443)
Timeframe: 1 year

Interventionparticipants (Number)
Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg7
Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg10
Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg6
Dacarbazin + Thymosin-alpha-1 3.2 mg12
Dacarbazin + Interferon Alpha4

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Progression Free Survival

Progression Free Survival is defined as the time from the randomization to progression or death (NCT00911443)
Timeframe: 2 years

Interventionmonths (Median)
Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg1.9
Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg1.8
Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg1.8
Dacarbazin + Thymosin-alpha-1 3.2 mg2.0
Dacarbazin + Interferon Alpha1.8

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