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

NCT ID: NCT02366247

Last Updated: 2015-02-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 463 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2016-02-29

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.

Detailed 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.

Conditions

Hepatitis B, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

PEG-Tα1

PEG-Tα1 (3.2 mg/ml, once a week, taken subcutaneously) and adefovir (10 mg, once daily, taken orally) for 48 weeks

Group Type: EXPERIMENTAL

PEG-Tα1

Intervention Type: DRUG

3.2mg/ml, once a week, taken subcutaneously

Adefovir

Intervention Type: DRUG

10 mg, once daily, taken orally for 48 weeks

Placebo to match PEG-Tα1

PEG-Tα1 placebo (1ml, once a week, taken subcutaneously) and adefovir (10 mg, once daily, taken orally) for 48 weeks

Group Type: PLACEBO_COMPARATOR

Placebo to match PEG-Tα1

Intervention Type: DRUG

1ml, once a week, taken subcutaneously

Adefovir

Intervention Type: DRUG

10 mg, once daily, taken orally for 48 weeks

Interventions

PEG-Tα1

3.2mg/ml, once a week, taken subcutaneously

Intervention Type: DRUG

Placebo to match PEG-Tα1

1ml, once a week, taken subcutaneously

Intervention Type: DRUG

Adefovir

10 mg, once daily, taken orally for 48 weeks

Intervention Type: DRUG

Other Intervention Names

Polyethylene Glycol thymosin alpha1

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Medical University

OTHER

Sponsor Role: collaborator

Jiangsu Hansoh Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

China

Other Identifiers

HS-20046-3

Identifier Type: -

Identifier Source: org_study_id