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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02366208
Other study ID # HS-20046-2
Secondary ID
Status Completed
Phase Phase 2
First received February 12, 2015
Last updated February 12, 2015
Start date May 2011
Est. completion date August 2013

Study information

Verified date January 2015
Source Jiangsu Hansoh Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
PEG-Ta1
1.6 mg/ml, once a week, taken subcutaneously
Placebo to match PEG-Ta1
1ml, once a week, taken subcutaneously
Adefovir
10 mg, once daily, taken orally for 48 weeks

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Jiangsu Hansoh Pharmaceutical Co., Ltd. Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

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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