DRUG
Thymosin Alpha1
Thymosin Alpha1 (1.6 mg subcutaneously injection twice a week) plus ETV (0.5 mg orally, daily) for 24 weeks, and followed by continuous ETV for at least 48 weeks
Efficacy and Safety of Combination Therapy of Thymalfasin and Entecavir in HBeAg-positive ETV-experienced Patients
Status
Unknown
Phase
Phase 4
Enrollment
240
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
This is a multicenter, randomized, open-label control trial of two arms conducted at 10 centres in China.The aim was to investigate whether sequential combination therapy with Thymosin alpha 1 and entecavir is superior to continuous ETV monotherapy in HBeAg-positive chronic hepatitis B patients with previous long-term entecavir therapy (≥ 2 years), and to select the optimal patients who may benefit from sequential combination therapy.
Full detailed description
To investigate whether sequential combination therapy with Thymosin alpha 1 and entecavir is superior to continuous ETV monotherapy in HBeAg-positive chronic hepatitis B patients with previous long-term entecavir therapy (≥ 1 years), and to select the optimal patients who may benefit from sequential combination therapy.
Interventions
Treatment arms and agents.
DRUG
Entecavir
ETV (0.5 mg orally, daily) for 72 weeks
Timeline
From registration to results.
First posted
Feb 28, 2018
Study start
Oct 25, 2017
Primary completion
Dec 30, 2018
Study completion
Dec 30, 2018
Results posted
Not reported
Registry updated
Feb 28, 2018
Outcomes
What the study measures.
Primary outcomes
HBeAg seroconversion rate at week 72
Time frame · week 72
HBeAg seroconversion rate at week 72
Secondary outcomes
HBeAg seroconversion rate at week 48
Time frame · week 48
HBeAg seroconversion rate at week 48
HBsAg loss at week 48
Time frame · week 48
HBsAg loss at week 48
HBsAg loss at week 72
Time frame · week 72
HBsAg loss at week 72
HBsAg seroconversion at week 72
Time frame · week 72
HBsAg seroconversion at week 72
HBsAg seroconversion at week 48
Time frame · week 48
HBsAg seroconversion at week 48
HBsAg decline during the clinical trial
Time frame · week 12, weeek 24, week 36, week 48 and week 72
HBsAg decline during the clinical trial
ALT normalization rate at week 72
Time frame · week 72
ALT normalization rate at week 72
ALT normalization rate at week 48
Time frame · week 48
ALT normalization rate at week 48
Rate of HBV DNA <20IU/mL at week 72
Time frame · week 72
Rate of HBV DNA \<20IU/mL at week 72
Rate of HBV DNA <20IU/mL at week 48
Time frame · week 48
Rate of HBV DNA \<20IU/mL at week 48
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 55 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * HBsAg positive and anti-HBs negative for more than 6 months * Being currently treated with ETV ≥1 years * HBeAg positivity and HBV DNA \<60IU/mL with HBsAg \<1500IU/mL and HBeAg \<200S/CO at screening * ALT ≤5\*ULN and total bilirubin ≤2\*ULN * Age ≥ 18 yrs but ≤ 55 yrs * Written informed consent Exclusion Criteria: * Patients who have contraindications for Thymosin alpha 1 in accordance with the approved summary of product characteristics * Patients with ALT \> 5 x ULN or total bilirubin \>2\*ULN * Patients with evidence of hepatocellular carcinoma at screening * Patients with Child-Pugh score ≥7 or had a history of hepatic encephalopathy or esophageal pile or ascites * Patients with serological evidence of co-infection with hepatitis A virus, hepatitis C, human immunodeficiency virus or hepatitis D virus * Patients with a history of excessive drinking: male \>40g/d,female \>40g/d * Pregnant or breast-feeding women * A history of liver transplantation or planned for liver transplantation * Patients of autoimmune disease * Patients with other diseases combined * Patients with creatinine \>1.5\*ULN * Investigator considered not proper for participating the trial * Patients with other maliginant tumor
Study locations
1 registered sites.
China. Showing up to 24 locations stored in the fast local snapshot.
Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Thymosin Alpha-1.
NCT IDStudyPhase / statusEnrollmentUpdated
Thymalfasin (Thymosin Alpha 1; Ta1) as an Enhancer of Vaccine Response Among Older Adults Receiving Booster Doses of COVID-19 Vaccine
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Thymosin-α1 for Recurrent Implantation Failure
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Recruiting
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2026-06
Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for Locally Advanced Mid-low Rectal Cancer
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Not applicable
Completed
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2026-06
Thymosin Alpha 1 Combined With Anti-PD-1 Monoclonal Antibody in Elderly Patients With Advanced Melanoma
Sun Yat-sen University · Melanoma · Immune-related Adverse Event
Phase 2
Recruiting
55
2026-06
TPF Concurrent Chemo-radiotherapy Plus Immunotherapy for Local Advanced Esophageal Squamous Cell Carcinoma
Fudan University · Esophageal Squamous Cell Carcinoma
Not applicable
Active, not recruiting
50
2026-04
Thymosin Alpha 1 to Prevent COVID-19 Infection in Renal Dialysis Patients
William B. Ershler, MD · COVID-19
Phase 2
Completed
189
2026-04
Phase II Trial of Neoadjuvant Thymalfasin, PD-1 Inhibitor, and Chemoradiotherapy for cStage III GEJ Adenocarcinoma
The First Affiliated Hospital with Nanjing Medical University · Gastric Cancer
Phase 2
Recruiting
48
2026-03
Efficacy and Safety of Anti-PD-1, Thymalfasin, and SOX in Neoadjuvant Treatment of cStage III Gastric/Gastroesophageal Junction Adenocarcinoma
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Phase 2
Recruiting
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