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PEG-Tα1 + Adefovir in HBeAg-Positive Chronic Hepatitis B
NCT02366247Phase 3
Key facts
- Status
- Unknown
- Start
- Aug 2013
- Primary completion
- Dec 2015
- Countries
- 1
- Sponsor
- Hansoh Pharmaceutical Group
- Modality
- Peptides, Polymer-based Nanoparticles
- Conditions
- Chronic Hepatitis B (CHB)
01
Overview
Phase 3, randomised, double-blind trial in Chronic Hepatitis B (CHB) comparing PEG-Tα1 + Adefovir with Placebo + Adefovir (2 arms). Primary endpoint: Loss of Hepatitis B e Antigen at 48 weeks. Status: unknown.
02
Design
2 arms- Study design
- RandomizedDouble-blind
PEG-Tα1 + Adefovir
PEG-Tα1 (3.2 mg/ml, once a week, taken subcutaneously) and adefovir (10 mg, once daily, taken orally)
Placebo + Adefovir
PEG-Tα1 placebo (1ml, once a week, taken subcutaneously) and adefovir (10 mg, once daily, taken orally)
03
Who it enrols
HBeAg-positive chronic hepatitis B patients with elevated ALT and HBV DNA, excluding those with cirrhosis, other viral hepatitis, or recent antiviral/immunomodulator treatment.
04
Endpoints
Primary
Loss of Hepatitis B e Antigen
Secondary
Loss of Hepatitis B Virus DNA
HBeAg Seroconversion
Alanine Aminotransferase Normalization
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