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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatitis B, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PEG-Tα1

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

Group Type EXPERIMENTAL

PEG-Tα1

Intervention Type DRUG

1.6 mg/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) for 24 weeks 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

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PEG-Tα1

1.6 mg/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

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Polyethylene Glycol Thymosin alpha1

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No