Hepatitis B, Chronic Clinical Trial
— PEG-Ta1Official 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 II Trial
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.
Status | Completed |
Enrollment | 116 |
Est. completion date | August 2013 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | 302 Military Hoapital of China | Beijing | Beijing |
China | The First Hospital of Jilin University | Changchun | Jilin |
China | The Second Xiangya Hospital of Central South University | Changsha | Hunan |
China | West China Hospital Sichuan University | Chengdu | Sichuan |
China | Hainan General Hospital | Haikou | Hainan |
China | 81 Military Hospital of China | Nanjing | Jiangsu |
China | Jiangsu Province Hospital | Nanjing | Jiangsu |
China | The Second Hospital of Nanjing | Nanjing | Jiangsu |
China | The Sixth People's Hospital of Shenyang | Shenyang | Liaoning |
China | The Third Hospital of Hebei Medical University | Shijiazhuang | Hebei |
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 |
Lead Sponsor | Collaborator |
---|---|
Jiangsu Hansoh Pharmaceutical Co., Ltd. | Nanjing Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | loss of HBeAg | 48 weeks | Yes | |
Secondary | loss of HBV DNA | week 4, 12, 24, 36 and 48 | Yes | |
Secondary | HBeAg seroconversion | week 4, 12, 24, 36 and 48 | Yes | |
Secondary | alanine aminotransferase normalization | week 4, 12, 24, 36 and 48 | Yes |
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