Clinical trial NCT02366208: Phase II Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg Positive Chronic Hepatitis B
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis B, Chronic
Keywords: Polyethylene Glycol Thymosin alpha1
Adefovir
Hepatitis B e Antigens positive
Lead sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Nanjing Medical University
First posted: 2015-02-19
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: loss of HBeAg
timeFrame: 48 weeks
Secondary outcomes:
measure: loss of HBV DNA
timeFrame: week 4, 12, 24, 36 and 48
measure: HBeAg seroconversion
timeFrame: week 4, 12, 24, 36 and 48
measure: alanine aminotransferase normalization
timeFrame: week 4, 12, 24, 36 and 48
Other outcomes:
Locations:
city: Beijing
country: China
facility: 302 Military Hoapital of China
state: Beijing
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Shijiazhuang
country: China
facility: The Third Hospital of Hebei Medical University
state: Hebei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Nanjing
country: China
facility: 81 Military Hospital of China
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Nanjing
country: China
facility: The Second Hospital of Nanjing
state: Jiangsu
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: The Sixth People's Hospital of Shenyang
state: Liaoning
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital Sichuan University
state: Sichuan
Study officials:
References: