Phase Ⅲ Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg-positive Chronic Hepatitis B

Hepatitis B, Chronic Clinical Trial

— PEG-Ta1  

Official 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 Ⅲ Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02366247
• Other study ID #: HS-20046-3
• Status: Active, not recruiting
• Phase: Phase 3
• First received: February 12, 2015
• Last updated: February 12, 2015
• Start date: August 2013
• Est. completion date: February 2016

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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 463
• Est. completion date: February 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• PEG-Ta1
3.2mg/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	Beijing YouAn Hospital, Capital Medical University	Beijing	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	West China Hospital Sichuan University	Chengdu	Sichuan
China	Southwest Hospital	Chongqing	Chongqing
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Hainan General Hospital	Haikou	Hainan
China	XiXi Hospital of Hangzhou	Hangzhou	Zhejiang
China	The First Affiliated Hospital of South China University	Hengyang	Hunan
China	Jinan Infectious Disease Hospital	Jinan	Shandong
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	The First Hospital of Lanzhou University	Lanzhou	Gansu
China	81 Military Hospital of China	Nanjing	Jiangsu
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	The Second Hospital of Nanjing	Nanjing	Jiangsu
China	The Six People's Hospital Affiliated to Shanghai Jiao Tong University	Shanghai	Shanghai
China	The Sixth People's Hospital of Shenyang	Shenyang	Liaoning
China	Shenzhen People's Hospital	Shenzhen	Guangdong
China	The First Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	The Third Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Taizhou Hospital of Zhejiang Province	Taizhou	Zhejiang
China	Tianjin Second People's Hospital	Tianjin	Tianjin
China	People's Hospital of Wuhan University	Wuhan	Hubei
China	Zhongshan Hospital of Hubei Province	Wuhan	Hubei
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	The Affiliated Hospital of Xuzhou Medical College	Xuzhou	Jiangsu
China	Yanbian University Hospital	Yanbian	Jilin

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