A Multicenter, Open-label, Phase II Clinical Study to Evaluate the Safety and Efficacy of APG-1387 in Combination With Entecavir in Patients With Chronic Hepatitis B

Who is this study for? Patients with with chronic hepatitis B
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study is a multicenter, open-label, phase II clinical study in subjects with chronic hepatitis B (CHB), to characterize the safety, tolerability, pharmacokinetic profile and preliminary anti-hepatitis B virus (HBV) efficacy of APG-1387 in combination with entecavir, and to determine the optimal dose of APG-1387 in combination with entecavir.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Body mass index (BMI) within the range of 18 - 27.9

• Documented chronic HBV infection (e.g., HBsAg positive for at least 6 months).

• HBeAg-positive or HBeAg-negative

• Treatment-naïve and treatment-experienced subjects are required to:

∙ Treatment-naïve subjects:

⁃ No antiviral therapies including nucleos(t)ide analogues or immunomodulators such as interferon within 180 days prior to screening

• HBV DNA ≥ 2x10˄3 IU/mL for HBeAg negative subjects and ≥ 2x10˄4 IU/mL for HBeAg positive subjects (PCR)

• Alanine transaminase (ALT) ≥ upper limit of normal (ULN) and \< 10 × ULN (and excluding ALT elevation caused by non-HBV reasons such as drug or alcohol consumption)

‣ Treatment-experienced subjects:

⁃ Using entecavir \> 180 days prior to screening, and should continue the treatment regimen until enrolled into the study

• HBV DNA less than the lower limit of quantification (LLOQ) or \< 20 IU/mL (PCR)

• ALT \< 1.5 × ULN

• Adequate hematological function:

‣ White blood cell count (WBC) ≥ 3.5 × 10˄9/L

⁃ Hemoglobin ≥ 120 g/L for males and ≥ 110 g/L for females

⁃ Platelet count ≥ 100 × 10˄9/L

• Adequate renal and liver function:

‣ Serum creatinine ≤ 1×ULN

⁃ Serum albumin ≥ 35.0g/L

⁃ Urine protein is negative or 1 + (re-examination is required when 1 + or 24-hour urine protein quantification is added when necessary. If it turns negative or is within the normal range, it can be included)

⁃ Estimated creatinine clearance (CLCr) ≥ 50 mL/min based on serum creatinine measured at the screening assessment and actual body weight (calculated creatinine clearance by the Cockcroft-Gault formula)

⁃ Total bilirubin ≤1.5×ULN

⁃ International normalized ratio (INR) ≤ 1.5×ULN

⁃ Alkaline phosphatase ≤ 2.5×ULN

• Female subjects of childbearing potential should have a negative serum pregnancy test within 7 days prior to the first dose

• Subjects and theirs partners are willing to use effective contraception as defined in the protocol during the treatment and for at least 6 months after the last dose of study drug

• Ability to understand and willingness to sign a written informed consent form (the consent form must be signed by the subject prior to any study-specific procedures)

• Willingness and ability to comply with study procedures and follow-up examination

Locations
Other Locations
China
West China Hospital, Sichuan University
NOT_YET_RECRUITING
Chengdu
Guangzhou Eighth People's Hospital
RECRUITING
Guangzhou
Nanfang Hospital of Southern Medical University
RECRUITING
Guangzhou
Huashan Hospital affiliated to Fudan University
NOT_YET_RECRUITING
Shanghai
Time Frame
Start Date: 2020-06-03
Estimated Completion Date: 2025-10-31
Participants
Target number of participants: 122
Treatments
Experimental: APG-1387 12 mg combined with entecavir 0.5 mg
Experimental: APG-1387 20 mg combined with entecavir 0.5 mg
Experimental: APG-1387 30 mg combined with entecavir 0.5 mg
Experimental: entecavir 0.5 mg
Authors
Related Therapeutic Areas
Sponsors
Leads: Ascentage Pharma Group Inc.

This content was sourced from clinicaltrials.gov

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