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

February 12, 2015 updated by: Jiangsu Hansoh Pharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

463

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • 302 Military Hoapital of China
      • Beijing, Beijing, China
        • Beijing Youan Hospital, Capital Medical University
    • Chongqing
      • Chongqing, Chongqing, China
        • The First Affiliated Hospital of Chongqing Medical University
      • Chongqing, Chongqing, China
        • Southwest Hospital
    • Gansu
      • Lanzhou, Gansu, China
        • The First Hospital of Lanzhou University
    • Guangdong
      • Shenzhen, Guangdong, China
        • Shenzhen People's Hospital
    • Hainan
      • Haikou, Hainan, China
        • Hainan General Hospital
    • Hebei
      • Shijiazhuang, Hebei, China
        • The Third Hospital of Hebei Medical University
      • Shijiazhuang, Hebei, China
        • The First Hospital of Hebei Medical University
    • Hubei
      • Wuhan, Hubei, China
        • People's Hospital of Wuhan University
      • Wuhan, Hubei, China
        • Zhongshan Hospital of Hubei Province
    • Hunan
      • Changsha, Hunan, China
        • The Second Xiangya Hospital of Central South University
      • Changsha, Hunan, China
        • The Third Xiangya Hospital of Central South University
      • Hengyang, Hunan, China
        • The First Affiliated Hospital of South China University
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Jiangsu Province Hospital
      • Nanjing, Jiangsu, China
        • 81 Military Hospital of China
      • Nanjing, Jiangsu, China
        • The Second Hospital of Nanjing
      • Xuzhou, Jiangsu, China
        • The Affiliated Hospital of Xuzhou Medical College
    • Jilin
      • Changchun, Jilin, China
        • The First Hospital of Jilin University
      • Yanbian, Jilin, China
        • Yanbian University Hospital
    • Liaoning
      • Shenyang, Liaoning, China
        • The Sixth People's Hospital of Shenyang
    • Shandong
      • Jinan, Shandong, China
        • Qilu Hospital of Shandong University
      • Jinan, Shandong, China
        • Jinan Infectious Disease Hospital
    • Shanghai
      • Shanghai, Shanghai, China
        • The Six People's Hospital Affiliated to Shanghai Jiao Tong University
    • Shanxi
      • Xi'an, Shanxi, 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
    • Sichuan
      • Chengdu, Sichuan, China
        • West China Hospital Sichuan University
    • Tianjin
      • Tianjin, Tianjin, China
        • Tianjin Second People's Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Xixi hospital of Hangzhou
      • Taizhou, Zhejiang, China
        • Taizhou Hospital of Zhejiang Province

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PEG-Tα1
PEG-Tα1 (3.2 mg/ml, once a week, taken subcutaneously) and adefovir (10 mg, once daily, taken orally) for 48 weeks
Drug: Adefovir
10 mg, once daily, taken orally for 48 weeks
Drug: PEG-Tα1
3.2mg/ml, once a week, taken subcutaneously
Other Names:
  • Polyethylene Glycol thymosin alpha1
PLACEBO_COMPARATOR: 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
Drug: Adefovir
10 mg, once daily, taken orally for 48 weeks
Drug: Placebo to match PEG-Tα1
1ml, once a week, taken subcutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Loss of HBeAg
Time Frame: 48 weeks
48 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
HBeAg seroconversion
Time Frame: week 4, 12, 24, 36 and 48
week 4, 12, 24, 36 and 48
Loss of HBV DNA
Time Frame: week 4, 12, 24, 36 and 48
week 4, 12, 24, 36 and 48
Alanine aminotransferase normalization
Time Frame: week 4, 12, 24, 36 and 48
week 4, 12, 24, 36 and 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Collaborators

Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2015

Study Completion (ANTICIPATED)

February 1, 2016

Study Registration Dates

First Submitted

February 12, 2015

First Submitted That Met QC Criteria

February 12, 2015

First Posted (ESTIMATE)

February 19, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

February 19, 2015

Last Update Submitted That Met QC Criteria

February 12, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-20046-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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