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

• Status: Completed
• Trial end date: 2018-11-29
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunshine Lake Pharma Co., Ltd.
• Treatments: Antiviral Agents; Ritonavir

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