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

Primary Purpose

Hepatitis B, Chronic

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
PEG-Tα1
Placebo to match PEG-Tα1
Adefovir
Sponsored by
Jiangsu Hansoh Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B, Chronic focused on measuring Polyethylene Glycol Thymosin alpha1, Adefovir, Hepatitis B e Antigens positive

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • 302 Military Hoapital of China
  • Hainan General Hospital
  • The Third Hospital of Hebei Medical University
  • The Second Xiangya Hospital of Central South University
  • 81 Military Hospital of China
  • Jiangsu Province Hospital
  • The Second Hospital of Nanjing
  • The First Hospital of Jilin University
  • The Sixth People's Hospital of Shenyang
  • The First Affiliated Hospital of Xi'an Jiaotong University
  • The Second Affiliated Hospital of Xi'an Jiaotong University
  • West China Hospital Sichuan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PEG-Tα1

Placebo to match PEG-Tα1

Arm Description

PEG-Tα1 (1.6 mg/ml, once a week, taken subcutaneously) for 24 weeks and adefovir (10 mg, once daily, taken orally) for 48 weeks

PEG-Tα1 placebo (1ml, once a week, taken subcutaneously) for 24 weeks and adefovir (10 mg, once daily, taken orally) for 48 weeks

Outcomes

Primary Outcome Measures

loss of HBeAg

Secondary Outcome Measures

loss of HBV DNA
HBeAg seroconversion
alanine aminotransferase normalization

Full Information

First Posted
February 12, 2015
Last Updated
February 12, 2015
Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Collaborators
Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02366208
Brief Title
Phase II Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg Positive Chronic Hepatitis B
Acronym
PEG-Tα1
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 II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Collaborators
Nanjing Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic
Keywords
Polyethylene Glycol Thymosin alpha1, Adefovir, Hepatitis B e Antigens positive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PEG-Tα1
Arm Type
Experimental
Arm Description
PEG-Tα1 (1.6 mg/ml, once a week, taken subcutaneously) for 24 weeks and adefovir (10 mg, once daily, taken orally) for 48 weeks
Arm Title
Placebo to match PEG-Tα1
Arm Type
Placebo Comparator
Arm Description
PEG-Tα1 placebo (1ml, once a week, taken subcutaneously) for 24 weeks and adefovir (10 mg, once daily, taken orally) for 48 weeks
Intervention Type
Drug
Intervention Name(s)
PEG-Tα1
Other Intervention Name(s)
Polyethylene Glycol Thymosin alpha1
Intervention Description
1.6 mg/ml, once a week, taken subcutaneously
Intervention Type
Drug
Intervention Name(s)
Placebo to match PEG-Tα1
Intervention Description
1ml, once a week, taken subcutaneously
Intervention Type
Drug
Intervention Name(s)
Adefovir
Intervention Description
10 mg, once daily, taken orally for 48 weeks
Primary Outcome Measure Information:
Title
loss of HBeAg
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
loss of HBV DNA
Time Frame
week 4, 12, 24, 36 and 48
Title
HBeAg seroconversion
Time Frame
week 4, 12, 24, 36 and 48
Title
alanine aminotransferase normalization
Time Frame
week 4, 12, 24, 36 and 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
302 Military Hoapital of China
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Hainan General Hospital
City
Haikou
State/Province
Hainan
Country
China
Facility Name
The Third Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Facility Name
81 Military Hospital of China
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
The Second Hospital of Nanjing
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Facility Name
The Sixth People's Hospital of Shenyang
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shanxi
Country
China
Facility Name
The Second Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shanxi
Country
China
Facility Name
West China Hospital Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China

12. IPD Sharing Statement

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Phase II Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg Positive Chronic Hepatitis B

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