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The Safety, Antiviral Activity, and Pharmacokinetics of Morphothiadine Mesilate Capsules | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

Un-randomized, Open, Multiple-Dose Study to Evaluate the Safety, Antiviral Activity, and Pharmacokinetics of Morphothiadine Mesilate Capsules (GLS4) /Ritonavir Tablets(RTV) in Patients With Chronic Hepatitis B

NCT03638076•Sunshine Lake Pharma Co., Ltd.

View on ClinicalTrials.gov

Summary

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

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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

•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

Locations (1)

The First Hospital of Jilin University

Changchun, Jilin, China

Key Dates

Start Date

July 26, 2017

Primary Completion Date

November 22, 2018

Completion Date

November 29, 2018

Last Updated

July 23, 2020

Enrollment

ACTUAL participants

Conditions

Chronic Hepatitis B

Interventions

GLS4

DRUG

RTV

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 23, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

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