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Hepatitis BPhase 2NCT04568265

A Clinical Study of APG-1387 in Combination With Entecavir in Patients With Chronic Hepatitis B

A Phase 2 study testing APG-1387 and Entecavir 0.5 mg in people with Hepatitis B and Chronic Hep B, run by Ascentage Pharma Group Inc. at 4 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis B, Chronic Hep B, HBV
What is being tested?
APG-1387 and Entecavir 0.5 mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
122 participants
Where
4 sitesChina
Study dates
3 Jun 2020to 31 Oct 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • Co-infection with HIV, hepatitis C virus (HCV), or hepatitis delta virus (HDV); or other active and severe infections
  • Syphilis with positive antibody for treponema pallidum
  • Subjects with liver disease other than hepatitis B, including but not limited to chronic alcoholic hepatitis, drug-induced liver injury, autoimmune liver disease, hereditary liver disease (such as Wilson's disease), and active hepatitis due to other causes
  • History or manifestation of hepatic decompensation (e.g., Child-Pugh Class B or C, or history of ascites, gastrointestinal bleeding, hepatic encephalopathy, or spontaneous bacterial peritonitis)
  • Progressive fibrosis/cirrhosis, defined by liver fibrosis scan ≥ 12 kilopascal (kPa) at screening, or cirrhosis diagnosed by imaging examinations, or Metavir score F3, F4 fibrosis on liver biopsy at any time
  • Clinically diagnosed hepatocellular carcinoma, or diagnosis of hepatocellular carcinoma cannot be excluded, or serum alpha-fetoprotein greater than 50 μg/L
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  • History of malignancy (except cured and no evidence of recurrence of basal cell carcinoma of the skin or situ cervical cancer) or lymphoproliferative disease
  • History of neurological or mental disorders, such as epilepsy, dementia, and poor compliance
  • Uncontrolled primary diseases of other important organs, such as clear medical history of nervous system, cardiovascular system, urinary system (including chronic or intermittent urinary system diseases), digestive system, respiratory system, endocrine/metabolic and musculoskeletal system, such as poorly controlled diabetes, hypertension, etc., making the investigator consider the subject unsuitable
  • QTcB [QTcB = QT/(RR^ 0.5); RR is the normalized heart rate value, obtained by dividing 60 by heart rate in seconds; other parameters in milliseconds] > 450 milliseconds for men and > 470 milliseconds for women; any clinically important abnormality in the rhythm, conduction, or morphology of the resting electrocardiogram (ECG) (e.g., complete left bundle branch block, third degree heart block, second degree heart block); congenital long QT syndrome or family history of long QT syndrome
  • History of alcoholism (mean daily intake of ethanol ≥ 30 g (male) or ≥ 20 g (female) within 1 year), and drug abuse
  • Subjects planning to become pregnant within 1 year, who are pregnant or breastfeeding
  • Received or may receive continuous treatment with immunomodulators (e.g., steroids) or biological agents (e.g., monoclonal antibodies, interferons) within 3 months before screening
  • Participated in clinical trials within 3 months before screening
  • Trauma or major surgical operation within 4 weeks before screening
  • Previous treatment with inhibitors of apoptosis proteins
  • Any subject considered unsuitable for the trial by the investigator

Trial locations and contacts

4 sites in 1 country.

China4 sites, 4 recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan

    Enqiang Chen, Doctor, +86-028-8542 3052, chenenqiang1983@hotmail.com

    Enqiang Chen

    Not yet recruiting

  • Guangzhou Eighth People's Hospital

    Guangzhou, Guangdong

    Yujuan Guan, Master, +86-020-83710459, gz8hgyj@126.com

    Yujuan Guan

    Recruiting

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong

    Jinlin Hou, Master, +86-020-62787427, jlhousmu@163.com

    Jinlin Hou

    Recruiting

  • Huashan Hospital affiliated to Fudan University

    Shanghai, Shanghai Municipality

    Jimin Zhang, Doctor, +86-021-52888262, jmzhang@vip.126.com

    Jimin Zhang

    Not yet recruiting

Other trials in China

About this study

Official title: 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

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.

Read the detailed description

The study is divided into two parts:

Part 1 will evaluate the safety, tolerability, and pharmacokinetics of APG-1387 in combination with entecavir, including determination of the maximum tolerated dose (MTD)/ recommended dose in patients with CHB. APG-1387 will be administered once weekly via intravenous infusion for 30 minutes for consecutive 4 weeks. APG-1387 will be escalated at 3 dose cohorts of 12 mg, 20 mg, and 30 mg. Entecavir will be administered orally at 0.5 mg daily for 12 weeks: in combination with APG-1387 for the first 4 weeks, followed by entecavir maintenance monotherapy for additional 8 weeks. The total treatment duration will be 12 weeks.

Part 2 is a randomized, parallel, open-label study to investigate the preliminary anti-HBV efficacy of APG-1387 in combination with entecavir compared with entecavir monotherapy. CHB subjects will be randomly assigned to one of 4 cohorts at 1:1:1:1, including APG-1387 at 3 different doses (12 mg, 20 mg, and 30 mg) in combination with entecavir for 12 weeks, respectively, then continued entecavir monotherapy for additional 12 weeks; and one entecavir monotherapy cohort for 24 weeks. The course of treatment is 24 weeks in all cohorts.

Being tested
APG-1387, Entecavir 0.5 mg
Keywords
HBeAg-positive, HBeAg-negative
Medical subject headings
Hepatitis B, Hepatitis B, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • APG-1387Drug

    Weekly intravenous infusion for 30 minutes

  • Entecavir 0.5 mgDrug

    Also called Baraclude

    Taken daily by mouth

Study groups in NCT04568265
Study groupRoleWhat they receive
APG-1387 12 mg combined with entecavir 0.5 mgExperimentalNot described
Receives: Drug: APG-1387; Drug: Entecavir 0.5 mg
APG-1387 20 mg combined with entecavir 0.5 mgExperimentalNot described
Receives: Drug: APG-1387; Drug: Entecavir 0.5 mg
APG-1387 30 mg combined with entecavir 0.5 mgExperimentalNot described
Receives: Drug: APG-1387; Drug: Entecavir 0.5 mg
entecavir 0.5 mgExperimentalNot described
Receives: Drug: Entecavir 0.5 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting toxicity (DLT) rate at each dose level

    DLT will be assessed within the first 28-day cycle of study treatment via NCI CTCAE version 5.0

    Measured: 28 days

  2. Decline in Hepatitis B surface Antigen (HBsAg)

    The difference in HBsAg decline between APG-1387 combined with entecavir arms and entecavir monotherapy arm

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2020
  2. Study start3 Jun 2020
  3. Primary completion31 Oct 2022 (estimated)
  4. Study completion31 Oct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
122 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04568265
Sponsor's protocol ID
APG1387BC201
Status last verified
Aug 2021
First submitted
24 Sep 2020
Last updated
26 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing APG-1387 and Entecavir 0.5 mg in people with Hepatitis B and Chronic Hep B, run by Ascentage Pharma Group Inc. at 4 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (DLT) rate at each dose level (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04568265.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2021; AzTrials last refreshed its copy on 7 Nov 2026.

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