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Pegasys in HBeAg-Positive Chronic Hepatitis B
NCT02604823Phase 4
Key facts
- Status
- Completed
- Start
- Nov 2003
- Primary completion
- Nov 2005
- Countries
- 1
- Sponsor
- Roche
- Modality
- Cytokines & Interferons
- Conditions
- Chronic Hepatitis B (CHB)
01
Overview
Phase 4, open-label trial of pegylated interferon alpha in Chronic Hepatitis B (CHB) (3 arms), sponsored by Roche. Primary endpoints: Percentage of participants with HBV DNA < 100,000 copies/mL at 72 weeks and Percentage of participants with HBeAg seroconversion at 72 weeks. Started Nov 2003; status: completed.
02
Design
3 arms- Study design
- Non-randomizedOpen-label
Group A
Naive Participants
Group B
Conventional Interferon Pretreated Participants
Group C
Lamivudine Pretreated Participants
03
Who it enrols
Adults 18-65 with HBeAg-positive chronic HBV. Must be treatment-naive or have failed/relapsed on conventional interferon or lamivudine. Excludes coinfection with HAV, HCV, HDV, HIV, and decompensated liver disease.
04
Endpoints
Primary
Percentage of participants with HBV DNA < 100,000 copies/mL
Percentage of participants with HBeAg seroconversion
Secondary
Number of participants who achieved HBV DNA levels below limit of detection
Number of participants with HBsAg loss
Number of participants with both HBsAg loss and presence of Anti-HBs
Number of participants with ALT normalization
Number of participants with combined response
Incidence of adverse events
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