Chronic Hepatitis b
Conditions
Keywords
thymosin alpha, entecavir
Brief summary
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.
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
DRUGThymosin 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
DRUGEntecavir
ETV (0.5 mg orally, daily) for 72 weeks
Sponsors
Wen-hong Zhang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HBeAg seroconversion rate at week 72 | week 72 | HBeAg seroconversion rate at week 72 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HBsAg loss at week 72 | week 72 | HBsAg loss at week 72 |
| HBsAg seroconversion at week 72 | week 72 | HBsAg seroconversion at week 72 |
| HBsAg seroconversion at week 48 | week 48 | HBsAg seroconversion at week 48 |
| HBeAg seroconversion rate at week 48 | week 48 | HBeAg seroconversion rate at week 48 |
| HBsAg loss at week 48 | week 48 | HBsAg loss at week 48 |
| ALT normalization rate at week 72 | week 72 | ALT normalization rate at week 72 |
| ALT normalization rate at week 48 | week 48 | ALT normalization rate at week 48 |
| Rate of HBV DNA <20IU/mL at week 72 | week 72 | Rate of HBV DNA \<20IU/mL at week 72 |
| Rate of HBV DNA <20IU/mL at week 48 | week 48 | Rate of HBV DNA \<20IU/mL at week 48 |
| HBsAg decline during the clinical trial | week 12, weeek 24, week 36, week 48 and week 72 | HBsAg decline during the clinical trial |
Countries
China
Contacts
Primary ContactYiqi Yu, MD
Backup ContactYing Yue, MD
Outcome results
None listed