NCT02965859

The Safety and Dose-range Study of Metacavir Enteric-coated Capsules in Patients With Chronic Hepatitis B

A Randomized,Double-blind,Double-dummy,Multiple-dose Parallel Control,Multiple Centers Study to Assess the Safety and Dose-range of Metacavir Enteric-coated Capsules for Patients With Chronic Hepatitis B

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Guangzhou Yipinhong Pharmaceutical CO.,LTD · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The study objective is to evaluate the safety and effectiveness of different doses of Metacavir Enteric-coated Capsules in treatment of chronic hepatitis B,as well as to find an appropriate clinical dosage by comparing the effect of different doses of treatment,in order to provide references of clinical trial of the next phase.

Detailed description

180 eligible subjects will be included.According to the set grouping method of dose escalation.Subjects will be randomized in a 1:1:1:1 proportion of Metacavir Enteric-coated Capsules(80mg/160mg/320mg) group,positive control group or placebo control group.Each group has 36 subjects. 1.Subjects will use the study medication(2 hours before or after meal,once a day) from Visit 3 to Visit 5. 1. Metacavir Enteric-coated Capsules 80mg Group:Metacavir Enteric-coated Capsules 80mg,Metacavir Enteric-coated Capsules Placebo 240mg,Adefovir Dipivoxil Capsule Placebo 10mg; 2. Metacavir Enteric-coated Capsules 160mg Group:Metacavir Enteric-coated Capsules 160mg,Metacavir Enteric-coated Capsules Placebo 160mg,Adefovir Dipivoxil Capsule Placebo 10mg; 3. Metacavir Enteric-coated Capsules 320mg Group:Metacavir Enteric-coated Capsules 320mg,Adefovir Dipivoxil Capsule Placebo 10mg; 4. Positive Control(Adefovir Dipivoxil Capsule) Group:Metacavir Enteric-coated Capsules Placebo 320mg,Adefovir Dipivoxil Capsule 10mg; 5. Placebo Control Group:Metacavir Enteric-coated Capsules Placebo 320mg,Adefovir Dipivoxil Capsule Placebo 10mg;

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	Metacavir Enteric-coated Capsules 80mg	Metacavir Enteric-coated Capsules 80mg
DRUG	Metacavir Enteric-coated Capsules 160mg	Metacavir Enteric-coated Capsules 160mg
DRUG	Metacavir Enteric-coated Capsules 320mg	Metacavir Enteric-coated Capsules 320mg
DRUG	Metacavir Enteric-coated Capsules Placebo 240mg	Metacavir Enteric-coated Capsules Placebo 240mg
DRUG	Metacavir Enteric-coated Capsules Placebo 160mg	Metacavir Enteric-coated Capsules Placebo 160mg
DRUG	Metacavir Enteric-coated Capsules Placebo 320mg	Metacavir Enteric-coated Capsules Placebo 320mg
DRUG	Adefovir Dipivoxil Capsule10mg	Adefovir Dipivoxil Capsule10mg
DRUG	Adefovir Dipivoxil Capsule Placebo 10mg	Adefovir Dipivoxil Capsule Placebo 10mg

Timeline

• Start date: 2012-12-01
• Primary completion: 2018-12-01
• First posted: 2016-11-17
• Last updated: 2016-11-22

Locations

1 site across 1 country: China