This study will evaluate the efficacy, safety, and tolerability of PEGASYS in participants with HBeAg-negative chronic HBV. The anticipated time on study treatment is 48 weeks, and the target sample size is 60 individuals.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
180 uG in 0.5 mL solution administered once weekly for 48 weeks
Unnamed facility
Pleven, Bulgaria
Unnamed facility
Plovdiv, Bulgaria
Unnamed facility
Sofia, Bulgaria
Unnamed facility
Sofia, Bulgaria
Efficacy: Hepatitis B Virus - Deoxy ribonucleic acid (HBV-DNA) less than (<)20,000 Copies per milliliter (copies/mL) At End of Follow-Up
Time frame: 72 Weeks
Alanine Transaminase (ALT) Normalization at the End of Follow-Up
Time frame: 72 Weeks
Efficacy: Loss of Hepatitis B Virus Antigen ( HBsAg) and Seroconversion at End of Follow-Up
Time frame: 72 Weeks
Hepatitis B Virus (HBV) DNA Below the Limit of Quantification At the End of Follow-Up
Time frame: 72 Weeks
HBV DNA Suppression <20000 Copies/mL at the End of Treatment
Time frame: 48 Weeks
Alanine Transaminase (ALT) Normalization at the End of Treatment
Time frame: 48 Weeks
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Unnamed facility
Sofia, Bulgaria
Unnamed facility
Sofia, Bulgaria
Unnamed facility
Sofia, Bulgaria
Unnamed facility
Stara Zagora, Bulgaria