A phase 2a clinical Study of Hepalatide for Injection in Subjects with Chronic Hepatitis D
This is a four-arm parallel-group, randomized, placebo-controlled, double-blind, multicenter Phase IIa clinical trial. The CHD subjects who meet the eligibility criteria will be randomly assigned 1:1:1:1 to receive either the placebo or investigational drug (2.1 mg, 4.2 mg, or 6.3 mg), with 6 subjects per group . The placebo or the corresponding dose of the investigational drug will be given for 4 consecutive weeks, followed by a 4-week follow-up period. Subjects will be given entecavir for the treatment of hepatitis B infection during and after the end of the trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
23
Either the placebo or hepalatide (2.1 mg, 4.2 mg, or 6.3 mg) will be given for 4 consecutive weeks. s.c., once daily.
Either the placebo or hepalatide (2.1 mg, 4.2 mg, or 6.3 mg) will be given for 4 consecutive weeks. s.c., once daily.
The first affiliated hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
The first hospital of Jilin University
Changchun, China
the National cancer center of Mongolia
Ulaanbaatar, Mongolia
Hepatitis D Virus(HDV) RNA level
HDV RNA level at week4
Time frame: Week 4
Change in Alanine transaminase(ALT) from baseline
Changes in ALT values at Week 4 compared to baseline
Time frame: Week 4
Change in HDV RNA from baseline
Changes in HDV RNA levels at Week 4 compared to baseline
Time frame: Week 4
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