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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
SBEI of Higher Professional Education "South Ural State Medical university" of the MoH of the RF
Chelyabinsk, Russia
1-st MMU n.a. I.M. Sechenov based in Moscow State-Owned Health Care Institution "Infectious Clinical Hospital № 2 of Moscow Healthcare Department"
Moscow, Russia
FSBI of Higher Education "People's Friendship University"
Moscow, Russia
Proportion of Patients With HBsAg Response at 12 Week of Therapy
HBsAg response is defined as serum HBsAg decline of at least 0.5 logs IU/ml (or HBsAg negativation) at week 12 compared to baseline.
Time frame: 12 week
Proportion of Patients With HBsAg Response at 24 Week of Therapy
HBsAg response is defined as serum HBsAg decline of at least 0.5 logs IU/ml (or HBsAg negativation) at week 24 compared to baseline.
Time frame: 24 weeks
Proportion of Patients With HBV DNA Response at Week 12 of Therapy
HBV DNA response is defined as persistent reduction of HBV DNA by \>1 log IU/ml or negativation at week 12 compared to baseline.
Time frame: 12 weeks
Proportion of Patients With Biochemical Response at 12 Weeks of Therapy
Biochemical response is defined as normalization of ALT level at week 12 compared to baseline.
Time frame: 12 weeks
Proportion of Patients With cccDNA Response at 24 Week of Therapy
Virological cccDNA response is defined as reduction of intrahepatic cccDNA by 0.5 logs in comparison to baseline at week 24.
Time frame: 24 weeks
Proportion of Patients With HBV DNA Response at Week 24 of Therapy
HBV DNA response is defined as persistent reduction of HBV DNA by \>1 log IU/ml or negativation at week 24 compared to baseline.
Time frame: 24 weeks
Proportion of Patients With Biochemical Response at 24 Weeks of Therapy
Biochemical response is defined as normalization of ALT level at week 24 compared to baseline.
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FSBHI "Central Clinical Hospital RAS"
Moscow, Russia
LLC "Clinical Hospital of Tsentrosoyuz"
Moscow, Russia
SPb SBHI "The Center for Prevention and Control of AIDS and Infectious Diseases"
Saint Petersburg, Russia
SPb SIH "Clinical Centre of Infectious Diseases Named After S.P. Botkin"
Saint Petersburg, Russia
Medical Company "Hepatolog" LLC
Samara, Russia
SBIH "Stavropol Regional Clinical Hospital"
Stavropol, Russia
Time frame: 24 weeks