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OpenTrials
Completed

NCT Number: NCT04147208

Evaluate the Safety, Tolerability, and Antiviral Activity of GLS4 With Ritonavir in Patients With Chronic HBV Infection

The experiment is divided into two parts: Part 1 and Part 2.Part 1 was the initial treatment patient and Part 2 was the treated patient.

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Key information

Conditions

Chronic HBV Infection

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Ditan Hospital Affiliated to Capital Medical University, Beijing, Beijing Municipality, China

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About this study

About 125 subjects were planned to be included and assigned to the experimental group and the control group according to 4:1.At the same time, a liver biopsy group was set up in each part of the population to receive liver biopsy during the screening period and 48 weeks after completion of drug administration, which was used to detect HBV DNA, cccDNA, HBsAg, and evaluate the degree of liver inflammation and fibrosis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic HBV infection population
  • HBeAg positive
  • HBsAg≥250 IU/mL
  • No cirrhosis

Exclusion criteria

  • AST>5×ULN
  • Platelet count less than 90E+09/L
  • TBil>1.5×ULN
  • albumin<35 g/L
  • INR>1.5
  • AFP>50 ng/mL

Treatment and study plan

GLS4

Drug

Administered GLS4 120 mg orally three times daily in fed state

Other names: Morphothiadine Mesilate Capsules

RTV

Drug

Administered RTV 100 mg orally three times daily in fed state

Other names: Ritonavir tablet

ETV

Drug

Administered orally ETV 0.5 mg once daily in fasted state

Other names: Entecavir table

Primary outcomes

  1. The value of serum HBsAg decreased from baseline

    Time frame: 48 weeks after dosing

    The value of serum HBsAg at 48 weeks of treatment was lowered compared with baseline.

Secondary outcomes

  1. The value of serum HBeAg decreased from baseline

    Time frame: 48 weeks after dosing

    The value of serum HBeAg at 48 weeks of treatment was lowered compared with baseline.

  2. The value of HBV DNA decreased from baseline

    Time frame: 48 weeks after dosing

    The value of HBV DNA at 48 weeks of treatment was lowered compared with baseline.

  3. The value of serum HBsAg decreased from baseline

    Time frame: 24 weeks after dosing

    The value of serum HBsAg at 24 weeks of treatment was lowered compared with baseline.

  4. The value of serum HBeAg decreased from baseline

    Time frame: 24 weeks after dosing

    The value of serum HBeAg at 24 weeks of treatment was lowered compared with baseline.

  5. The value of HBV DNA decreased from baseline

    Time frame: 24 weeks after dosing

    The value of HBV DNA at 24 weeks of treatment was lowered compared with baseline.

Sponsors and collaborators

Lead sponsor

Sunshine Lake Pharma Co., Ltd.

Industry

Registry information

Official study title

Evaluate the Safety, Tolerability, and Antiviral Activity of GLS4 With Ritonavir in Combination With Entecavir in Comparison With Entecavir Alone in Patients With Chronic HBV Who Are HBeAg Positive

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Nov 1, 2019
Registry last updated
Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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