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CompletedNCT03638076Updated Jul 23, 2020

The Safety, Antiviral Activity, and Pharmacokinetics of Morphothiadine Mesilate Capsules

A Phase 2 interventional study of GLS4 and RTV in Chronic Hepatitis B, sponsored by Sunshine Lake Pharma Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-07-23.

Sponsored by Sunshine Lake Pharma Co., Ltd. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Jul 2017, registered Jul 2018).
Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The Safety, Antiviral Activity, and pharmacokinetics of Morphothiadine Mesilate Capsules/Ritonavir Tablets in Patients with Chronic Hepatitis B

Read the detailed description

Un-randomized, open Multiple-Dose Study to Evaluate the Safety, Antiviral Activity, and pharmacokinetics of Morphothiadine Mesilate Capsules/Ritonavir Tablets in Patients with Chronic Hepatitis B

20 subjects with Chronic Hepatitis B will be enrolled. 10 subjects will be assigned to group A and receive Morphothiadine Mesilate Capsule 120mg and Ritonavir Tablet 100mg twice daily for 48 weeks. 10 subjects will be assigned to group B and receive Morphothiadine Mesilate Capsule 120mg and Ritonavir Tablet 100mg three times daily for 48 weeks.

02

Conditions studied

  • Chronic Hepatitis B
03

In context

Hepatitis B

1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.

This study's enrollment of 20 is below the median of 120 across 1,187 interventional studies indexed under Hepatitis B.

Browse Hepatitis B studies →

Lead sponsor

Sunshine Lake Pharma Co., Ltd. is the lead sponsor of 82 studies on the registry; 13 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Have signed informed consent form.
  2. Positive HBsAg, positive or negative HBeAg, negative immunoglobulin M( if immunoglobulin M is positive, subject should have laboratory report showed that subject had HBsAg or HBV DNA positive more than 6 months) ; Positive HBsAg, positive or negative HBeAg, liver biopsy report showed evidence of chronic HBV infection, in the case of liver biopsy results, the liver biopsy results shall prevail.
  3. Subjects who have not received any antiviral treatment; or if Subjects received treatment with interferon/Peg-interferon, or anti-HBV nucleoside drugs, the drugs should be discontinued at least 3 months prior to the screening.
  4. For the subject HBeAg is positive, HBV DNA≥1.0×105 IU/mL（PCR）;For the subject HBeAg is negative , HBV DNA≥1.0×104 IU/mL（PCR）
  5. 1.3×ULN≤serum alanine aminotransferase(ALT) ≤5×ULN；
  6. 18\~65 years old,

Exclusion criteria

Exclusion Criteria:

  1. Investigator assessed subjects have other clinically significant abnormalities (other than HBV), such as uncontrollable heart disease, gastrointestinal, blood, nervous or other medical disorders, which may interfere with treatment, assessment, or compliance with the protocol;
  2. Laboratory results do not comply with the acceptance criteria at screening;
  3. People with positive urinalysis(Such as opioids, barbiturates, benzodiazepines, tricyclic antidepressants, phencyclidine, except for there is document proof that urinalysis positive result due to subject use short period or long period of prescription drug or over-the-counter(OTC) drug.
  4. Pregnant female or breast-feeding woman.
  5. The result of Fibroscan test was conducted within 6 months before screening is showed that fibroscan score 17.5, or Liver tissue test which was conducted within 24 months before screening showed cirrhosis
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    GLS4 120 mg+ RTV 100mg，bid

    Patients with chronic HBV infection will receive GLS4 120 mg+ Ritonavir Tablet 100 mg twice daily for 48 weeks.

    Drug: GLS4 · Drug: RTV

  • Experimental
    GLS4 120 mg+ RTV 100mg，tid

    Patients with chronic HBV infection will receive GLS4 120 mg+ Ritonavir Tablet 100 mg three times daily for 48 weeks .

    Drug: GLS4 · Drug: RTV

Interventions

  • DrugGLS4

    Subject in group A will receive Mesilate Capsule 120mg twice daily. Subject in group B will receive Mesilate Capsule 120mg three times daily.

    Also known as: Morphothiadine Mesilate Capsule

  • DrugRTV

    Subject in group A will receive Ritonavir tablet 100mg twice daily.Subject in group B will receive Ritonavir tablet 100mg three times daily.

    Also known as: Ritonavir tablet

06

What researchers measure

Primary outcomes

  1. The mean value of HBV DNA decreased from baseline

    The mean value of HBV DNA (unit IU/ml) at different time points in each group was lowered compared with baseline.

    Time frame: Prior to dosing and 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36, 40, 44 and 48 weeks after dosing and 7 days after drug withdrawal.

  2. Adverse events

    To assess the safety and tolerability after dosing.

    Time frame: From the baseline to 7 days after drug withdrawal.

Secondary outcomes

  1. The mean value of serum HBsAg decreased from baseline.

    The mean value of serum HBsAg at different time points in each group was lowered compared with baseline.

    Time frame: Prior to dosing and 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36, 40, 44 and 48 weeks after dosing and 7 days after drug withdrawal.

  2. The mean value of serum HBeAg(if any) decreased from baseline.

    The mean value of serum HBeAg (if any) at different time points in each group was lowered compared with baseline.

    Time frame: Prior to dosing and 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36, 40, 44 and 48 weeks after dosing and 7 days after drug withdrawal.

  3. Cmax

    Maximum observed plasma concentration of GLS4 and RTV.

    Time frame: Intensive blood collection after each administration at day1, day7 and 12 weeks, and before the first administration at 2, 4, 8, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36, 40, 44 and 48 week.

  4. AUC

    Area under the plasma concentration-time curve (AUC)

    Time frame: Intensive blood collection after each administration at day1, day7 and 12 weeks, and before the first administration at 2, 4, 8, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36, 40, 44 and 48 week.

  5. Css_min

    The Css_min of GLS4 and RTV.

    Time frame: Intensive blood collection after each administration at day1, day7 and 12 weeks, and before the first administration at 2, 4, 8, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36, 40, 44 and 48 week.

07

Study locations

1 site
  • The First Hospital of Jilin University
    Changchun, Jilin 130021, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03638076
Lead sponsor
Sunshine Lake Pharma Co., Ltd.
Responsible party
Sponsor
First posted
Aug 20, 2018
Start date
Jul 26, 2017
Primary completion
Nov 22, 2018
Completion
Nov 29, 2018
Last update
Jul 23, 2020

Study contacts

Junqi Niu, doctor
principal investigator · The First Hospital of Jilin University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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