Chronic Hepatitis B Clinical Trial
Official title:
A Phase 1b/2a Randomized, Open-label Clinical Trial of Daily Myrcludex B Versus Entecavir in Patients With HBeAg Negative Chronic Hepatitis B
A randomized, open-label multicentre clinical trial of daily Myrcludex B versus entecavir in patients with HBeAg negative chronic hepatitis B.
This is a randomized, open-label multicentre clinical trial of daily Myrcludex B versus
entecavir in patients with HBeAg negative chronic hepatitis B. Accounting for screen-outs
about 76 patients will be screened and 48 of them will be randomized into 6 treatment groups:
Arm A (8 patients): Myrcludex B 0.5 mg / day / sc / 12 weeks Arm B (8 patients): Myrcludex B
1 mg / day / sc / 12 weeks Arm C (8 patients): Myrcludex B 2 mg / day / sc / 12 weeks Arm D
(8 patients): Entecavir 0.5 mg / day / orally / 24 weeks Arm E (8 patients): Myrcludex B 5 mg
/ day / sc / 12 weeks Arm F (8 patients): Myrcludex B 10 mg / day / sc / 24 weeks
The study consists of screening period up to 28 days (Day -28 -1); baseline visit (Day 0),
treatment period up to 12 weeks for groups A-C, E and 24 weeks for groups D, F; follow-up
period up to 12 weeks for groups A-C, E, F.
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