Clinical trial NCT02366247: Phase Ⅲ Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg-positive Chronic Hepatitis B
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hepatitis B, Chronic
Keywords: Polyethylene Glycol Thymosin alpha1
Adefovir
Hepatitis B e Antigens positive
Lead sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Nanjing Medical University
First posted: 2015-02-19
Enrollment: 463
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is to assess the efficacy and safety of Polyethylene Glycol thymosin alpha1 (PEG-Tα1), a new long immunomodulator (Category 1.1 of Chemical Drugs) being developed from Hansoh Pharmaceutical of China, in combination with adefovir in HBeAg-positive patients with chronic hepatitis B.

Detailed description: A total of 463 HBeAg-positive patients were recruited from 33 hospitals in China, and randomized to two groups. The combination group received PEG-Tα1 (3.2 mg/ml, once a week, taken subcutaneously) and adefovir (10 mg, once daily, taken orally) for 48 weeks. The control group received placebo and adefovir. The primary endpoint was the loss of HBeAg at 48 weeks. The secondary endpoints included 1) loss of hepatitis B virus (HBV) DNA, 2) HBeAg seroconversion and 3) alanine aminotransferase (ALT) normalization etc. at week 4, 12, 24, 36 and 48. The number of CD4＋and CD8＋T cells was also determined during 48 weeks.

Eligibility criteria: Inclusion Criteria:

* Chronic hepatitis B for more than 6 months, and didn't accept immunomodulating or anti-viral treatment within 6 months before the trial.
* ALT level \> 2 × Upper Limit Normal (ULN).
* Serum bilirubin \< 2 × ULN.
* Positive HBeAg and negative HBeAb.
* HBV-DNA between 1.00E＋05 IU/ml and 9.99E＋09 IU/ml.
* Informed Consent Form (ICF) signed.

Exclusion Criteria:

* Hepatitis A,C,D,E or HIV infection.
* Autoimmune hepatitis.
* Hepatic cirrhosis.
* Serum creatinine \>1.5 × ULN or Ccr \<50 ml/min, Haemoglobin \<110g/L (male) or \<100g/L (female), Platelet\<80 E＋09/L, Serum albumin ≤ 35g/L, or Serum albumin/globulin (A/G) ≤0.9, Neutrophile granulocyte \<1.0 E＋09/L, Prothrombin time\>ULN＋3 seconds, Cholinesterase\<4000U/L.
* Hepatitic carcinoma or Alpha Fetal Protein (AFP) \>100ng/ml .
* Patients with other severe diseases combined, which could affect the therapy.
* Patients accepted other clinical trial within 6 months before the first administrated.
* Thymosin allergy.
* Pregnant or breast feeding.

Primary outcomes:
measure: Loss of HBeAg
timeFrame: 48 weeks
Secondary outcomes:
measure: Loss of HBV DNA
timeFrame: week 4, 12, 24, 36 and 48
measure: HBeAg seroconversion
timeFrame: week 4, 12, 24, 36 and 48
measure: Alanine aminotransferase normalization
timeFrame: week 4, 12, 24, 36 and 48
Other outcomes:
Locations:
city: Beijing
country: China
facility: 302 Military Hoapital of China
state: Beijing
city: Beijing
country: China
facility: Beijing YouAn Hospital, Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: Southwest Hospital
state: Chongqing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
state: Hebei
city: Shijiazhuang
country: China
facility: The Third Hospital of Hebei Medical University
state: Hebei
city: Wuhan
country: China
facility: People's Hospital of Wuhan University
state: Hubei
city: Wuhan
country: China
facility: Zhongshan Hospital of Hubei Province
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Hengyang
country: China
facility: The First Affiliated Hospital of South China University
state: Hunan
city: Nanjing
country: China
facility: 81 Military Hospital of China
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Nanjing
country: China
facility: The Second Hospital of Nanjing
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical College
state: Jiangsu
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Yanbian
country: China
facility: Yanbian University Hospital
state: Jilin
city: Shenyang
country: China
facility: The Sixth People's Hospital of Shenyang
state: Liaoning
city: Jinan
country: China
facility: Jinan Infectious Disease Hospital
state: Shandong
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Shanghai
country: China
facility: The Six People's Hospital Affiliated to Shanghai Jiao Tong University
state: Shanghai
city: Xi'an
country: China
facility: Tangdu Hospital
state: Shanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Xi'an
country: China
facility: Xijing Hospital
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Second People's Hospital
state: Tianjin
city: Hangzhou
country: China
facility: XiXi Hospital of Hangzhou
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Hospital of Zhejiang Province
state: Zhejiang
Study officials:
References: