DRUG
PEG-Tα1
1.6 mg/ml, once a week, taken subcutaneously
Phase II Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg Positive Chronic Hepatitis B
Status
Completed
Phase
Phase 2
Enrollment
116
Locations
12
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 116 HBeAg-positive patients were recruited from 12 hospitals in China, and randomized to two groups. The combination group (n= 57) received PEG-Tα1 (1.6 mg/ml, once a week, taken subcutaneously) and adefovir (10 mg, once daily, taken orally) for 24 weeks. The control group (n = 59) received placebo and adefovir. Both groups received adefovir continuously for additional 24 weeks. 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
May 2011
Primary completion
Jun 2013
Study completion
Aug 2013
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 * ALT \> 2 × Upper Limit Normal (ULN) * Serum bilirubin \< 2 × ULN. * Positive HBeAg and 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 ≤ 32g/L, or Serum albumin/globulin (A/G) ≤0.9, Neutrophile granulocyte \< 1.0 E＋09/L, Prothrombin time\>ULN＋3 seconds, Cholinesterase\<2500U/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. * Patients accepted immunomodulating or anti-viral treatment within 6 months before the trial. * Patients with autoimmune disease. * Thymosin allergy. * Pregnant or breast feeding.
Study locations
12 registered sites.
China. Showing up to 24 locations stored in the fast local snapshot.
302 Military Hoapital of China
Beijing, Beijing Municipality, China
Hainan General Hospital
Haikou, Hainan, China
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Second Xiangya Hospital of Central South University
Changsha, 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 First Hospital of Jilin University
Changchun, Jilin, China
The Sixth People's Hospital of Shenyang
Shenyang, Liaoning, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
West China Hospital Sichuan University
Chengdu, Sichuan, China
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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