DRUG
PEG-Tα1
3.2mg/ml, once a week, taken subcutaneously
Phase Ⅲ Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg-positive Chronic Hepatitis B
Status
Unknown
Phase
Phase 3
Enrollment
463
Locations
32
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Full 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.
Interventions
Treatment arms and agents.
DRUG
Placebo to match PEG-Tα1
1ml, once a week, taken subcutaneously
DRUG
Adefovir
10 mg, once daily, taken orally for 48 weeks
Timeline
From registration to results.
First posted
Feb 19, 2015
Study start
Aug 2013
Primary completion
Dec 2015
Study completion
Feb 2016
Results posted
Not reported
Registry updated
Feb 19, 2015
Outcomes
What the study measures.
Primary outcomes
Loss of HBeAg
Time frame · 48 weeks
Secondary outcomes
Loss of HBV DNA
Time frame · week 4, 12, 24, 36 and 48
HBeAg seroconversion
Time frame · week 4, 12, 24, 36 and 48
Alanine aminotransferase normalization
Time frame · week 4, 12, 24, 36 and 48
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Sex
- ALL
- Healthy volunteers
- No
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.
Study locations
32 registered sites.
China. Showing up to 24 locations stored in the fast local snapshot.
302 Military Hoapital of China
Beijing, Beijing Municipality, China
Beijing YouAn Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Southwest Hospital
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
Hainan General Hospital
Haikou, Hainan, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
People's Hospital of Wuhan University
Wuhan, Hubei, China
Zhongshan Hospital of Hubei Province
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
The First Affiliated Hospital of South China University
Hengyang, Hunan, China
81 Military Hospital of China
Nanjing, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The Second Hospital of Nanjing
Nanjing, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, China
The First Hospital of Jilin University
Changchun, Jilin, China
Yanbian University Hospital
Yanbian, Jilin, China
The Sixth People's Hospital of Shenyang
Shenyang, Liaoning, China
Jinan Infectious Disease Hospital
Jinan, Shandong, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
The Six People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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