Conditions: Chronic Hepatitis B
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 48
Healthy volunteers: no

Brief summary:
A randomized, open-label multicentre clinical trial of daily Myrcludex B versus entecavir in patients with HBeAg negative chronic hepatitis B.

Detailed description:
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.

Arms:
arm 1: Myrcludex B 0.5 mg daily for 12 weeks, followed by 12 weeks follow-up period arm 2: Myrcludex B 1 mg daily for 12 weeks, followed by 12 weeks follow-up period arm 3: Myrcludex B 2 mg daily for 12 weeks, followed by 12 weeks follow-up period arm 4: Entecavir 0.5 mg daily for 24 weeks arm 5: Myrcludex B 5 mg daily for 12 weeks, followed by 12 weeks follow-up period arm 6: Myrcludex B 10 mg daily for 24 weeks, followed by 12 weeks follow-up period

Interventions: intervention 1: Entecavir intervention 2: Myrcludex B
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: