Thymosin alpha-1 dosage in clinical trials

Doses in published trials

Arms as registered

Verbatim arm text from ClinicalTrials.gov. Only arms naming Thymosin alpha-1 and a dose are shown.

1. NCT02366247 · Phase 3 · Unknown status · n=463

   Phase Ⅲ Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg-positive Chronic Hepatitis B

   • PEG-Tα1 — PEG-Tα1 (3.2 mg/ml, once a week, taken subcutaneously) and adefovir (10 mg, once daily, taken orally) for 48 weeks
   • Placebo to match PEG-Tα1 — PEG-Tα1 placebo (1ml, once a week, taken subcutaneously) and adefovir (10 mg, once daily, taken orally) for 48 weeks

2. NCT05658692 · Phase 4 · Unknown status · n=1,000

   Platform Adaptive Embedded Trial for Acute Respiratory Distress Syndrome

   • Immunomodulatory therapy — Thymosin Alpha（Thymalfasin for Injection） 1.6mg subcutaneously twice a week.

3. NCT02281266 · Phase 4 · Unknown status · n=360

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

   • treatment (T) — The patients of treatment arm will be administered subcutaneously Thymalfasin at dose of 1.6mg twice a week for 12 months after curative resection, followed by 12 months observation. Nucleoside analog plan to give to HBV DNA positive patients.

4. NCT06139419 · Phase 2 · Completed · n=114

   The Impact of Thymosin α-1 on the Efficacy of Concurrent Chemoradiotherapy Followed by Immunotherpay Consolidation for Locally Advanced NSCLC

   • Concurrent Tα-1 group — In this concurrent Tα-1 group, participants receive concurrent chemoradiotherapy followed by immunotherapy consolidation. During this treatment, thymosin alpha-1 was administered at 4.8mg each time.

5. NCT04428008 · Phase 2 · Completed · n=189

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

   • Active arm — 1.6 mg thymalfasin in 1 mL subcutaneous injection twice weekly after dialysis for 8 weeks

6. NCT04487444 · Phase 2 · Terminated · n=56

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

   • Ta1 treatment arm — Ta1 at a dose of 1.6 mg will be administered SC in 1 mL of diluent daily for a total of 1 week, in addition to standard of care.

7. NCT02976740 · Phase 2 · Unknown status · n=48

   SBRT Combination With rhGM-CSF and Tα1 for Stage IV NSCLC Patients Who Failed in Second-line Chemotherapy

   • SBRT+GM-CSF+Tα1 — Metastasis lesion will be treated with a SBRT of 50Gy/4-10F from day 1 to day 10 . Subcutaneous injection of Immunological Agent- human recombined granulocyte-macrophage colony stimulating factor (125ug/m² per day) will be executed from day 1 to day 14 in this cycle. Another metastasis lesion will be treated likewise concurrently with rhGM-CSF in a consecutive cycle. Subcutaneous injection of another Immunological Factors Thymosin Alpha 1(1.6mg Biw)will be executed from the fist WEEK to the 12th Weeks.

8. NCT02366208 · Phase 2 · Completed · n=116

   Phase II Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg Positive Chronic Hepatitis B

   • PEG-Tα1 — PEG-Tα1 (1.6 mg/ml, once a week, taken subcutaneously) for 24 weeks and adefovir (10 mg, once daily, taken orally) for 48 weeks
   • Placebo to match PEG-Tα1 — PEG-Tα1 placebo (1ml, once a week, taken subcutaneously) for 24 weeks and adefovir (10 mg, once daily, taken orally) for 48 weeks

9. NCT06821100 · Phase 1 · Recruiting · n=75

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

   • Treatment arm A — A 4.8 mg dose of Ta1 (dose of 1.6 mg in 1 mL of diluent X3) on Day 0, followed by vaccination
   • Treatment arm B — A 4.8 mg dose of Ta1 (dose of 1.6 mg in 1 mL of diluent X3) on Day 0 and Day 3, followed by vaccination

10. NCT04963712 · Early Ph 1 · Completed · n=20

    Zadaxin and HIV-positive Patients With Immune Reconstitution Disorder

    • Zadaxin-HIV(n=20) — Study participants will be given Zadaxin (1.6 mg subcutaneous injection, once a day) in the first 2 weeks, and changed frequency (1.6 mg subcutaneous injection, twice a week) in the successive 22 weeks.

11. NCT07866118 · N/A · Recruiting · n=60

    Thymalfasin for Immune Recovery in Adults With Sepsis

    • Thymalfasin Plus Standard Care — Participants will receive standard sepsis care plus thymalfasin 1.6 mg subcutaneously twice daily, approximately 12 hours apart, for 7 consecutive days (Days 1 to 7). Thirty participants are planned for this arm.

12. NCT06401447 · N/A · Active, not recruiting · n=50

    TPF Concurrent Chemo-radiotherapy Plus Immunotherapy for Local Advanced Esophageal Squamous Cell Carcinoma

    • Treatment Arm — 1. Take one cycle of induction chemo-immunotherapy, two cycle of concurrent chemoradiotherapy 3 weeks later, one cycle of consolidation chemo-immunotherapy 1 month after radiotherapy, and then 1 year of immunotherapy. 2. Radiotherapy: intensity modulated radiotherapy or volume modulated therapy. Modified involving field irradiation. PTV-C of 50.4Gy/28F, and PTV-G of 61.6Gy/28F with simultaneous integrated boost if no deep ulcers. 3. Chemotherapy: paclitaxel 60mg/m2, ivgtt; cisplatin 30mg/m2, ivgtt; 5-FU 500mg/m2, ivgtt and 500mg/m2, civ 24h; calcium folinate 200mg; q3w. 4. Immunotherapy: Sintilimab, 200mg, q3w. 5. Probiotics: Clostridium Butyricum (MIYAIRI 588), 20mg, tid, for 1 year. 6. Thymosin alpha-1: 1.6mg, qd, d1-5 during radiotherapy.