Phase Ⅲ Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg-positive Chronic Hepatitis B
PEG-Tα1
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
1 other identifier
interventional
463
1 country
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2013
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 12, 2015
CompletedFirst Posted
Study publicly available on registry
February 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedFebruary 19, 2015
January 1, 2015
2.3 years
February 12, 2015
February 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Loss of HBeAg
48 weeks
Secondary Outcomes (3)
Loss of HBV DNA
week 4, 12, 24, 36 and 48
HBeAg seroconversion
week 4, 12, 24, 36 and 48
Alanine aminotransferase normalization
week 4, 12, 24, 36 and 48
Study Arms (2)
PEG-Tα1
EXPERIMENTALPEG-Tα1 (3.2 mg/ml, once a week, taken subcutaneously) and adefovir (10 mg, once daily, taken orally) for 48 weeks
Placebo to match PEG-Tα1
PLACEBO COMPARATORPEG-Tα1 placebo (1ml, once a week, taken subcutaneously) and adefovir (10 mg, once daily, taken orally) for 48 weeks
Interventions
3.2mg/ml, once a week, taken subcutaneously
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
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
Tangdu Hospital
Xi’an, Shanxi, 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
Xijing Hospital
Xi’an, Shanxi, China
West China Hospital Sichuan University
Chengdu, Sichuan, China
Tianjin Second People's Hospital
Tianjin, Tianjin Municipality, China
XiXi Hospital of Hangzhou
Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2015
First Posted
February 19, 2015
Study Start
August 1, 2013
Primary Completion
December 1, 2015
Study Completion
February 1, 2016
Last Updated
February 19, 2015
Record last verified: 2015-01