The Safety and Dose-range Study of Metacavir Enteric-coated Capsules in Patients With Chronic Hepatitis B
NCT02965859 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180
Last updated 2016-11-22
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.
Conditions
Interventions
- 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
Sponsors & Collaborators
-
Guangzhou Yipinhong Pharmaceutical CO.,LTD
lead INDUSTRY
Principal Investigators
-
Maorong Wang · 81 Military Hospital of China
-
Yonggang Li · Beijing 302 Hospital
-
Yongfeng Yang · The Second Hospital of Nanjing Medical University
-
Yanlin Yu · Wannan Medical College Yijishan Hospital
-
Jun Li · The First Affiliated Hospital with Nanjing Medical University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-12-31
- Primary Completion
- 2018-12-31
Countries
- China
Study Locations
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