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

NCT02366247 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 463

Last updated 2015-02-19

No results posted yet for this study

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.

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

PEG-Tα1

3.2mg/ml, once a week, taken subcutaneously

DRUG

Placebo to match PEG-Tα1

1ml, once a week, taken subcutaneously

DRUG

Adefovir

10 mg, once daily, taken orally for 48 weeks

Sponsors & Collaborators

  • Nanjing Medical University

    collaborator OTHER

  • Jiangsu Hansoh Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2015-12-31
Completion
2016-02-29

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02366247 on ClinicalTrials.gov