Clinical trial NCT03638076: The Safety, Antiviral Activity, and Pharmacokinetics of Morphothiadine Mesilate Capsules
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis B
Lead sponsor: Sunshine Lake Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-08-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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

Primary outcomes:
measure: The mean value of HBV DNA decreased from baseline
timeFrame: 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.
measure: Adverse events
timeFrame: From the baseline to 7 days after drug withdrawal.
Secondary outcomes:
measure: The mean value of serum HBsAg decreased from baseline.
timeFrame: 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.
measure: The mean value of serum HBeAg(if any) decreased from baseline.
timeFrame: 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.
measure: Cmax
timeFrame: 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.
measure: AUC
timeFrame: 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.
measure: Css_min
timeFrame: 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.
Other outcomes:
Locations:
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
Study officials:
affiliation: The First Hospital of Jilin University
name: Junqi Niu, doctor
role: PRINCIPAL_INVESTIGATOR
References: