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

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

Sponsors

Lead sponsor: Guangzhou Yipinhong Pharmaceutical CO.,LTD

Source Guangzhou Yipinhong Pharmaceutical CO.,LTD
Brief 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;

Overall Status Unknown status
Start Date December 2012
Primary Completion Date December 2018
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
The change from baseline in the logarithms of measurement data of HBV-DNA at Week 12 of treatment. 12 weeks
Secondary Outcome
Measure Time Frame
Incidence of treatment-chronic hepatitis B 12 weeks
Incidence of Adverse Events(AEs) 48 weeks
Enrollment 180
Condition
Intervention

Intervention type: Drug

Intervention name: Metacavir Enteric-coated Capsules 80mg

Description: Metacavir Enteric-coated Capsules 80mg

Arm group label: Metacavir Enteric-coated Capsule 80mg

Intervention type: Drug

Intervention name: Metacavir Enteric-coated Capsules 160mg

Description: Metacavir Enteric-coated Capsules 160mg

Arm group label: Metacavir Enteric-coated Capsules 160mg

Intervention type: Drug

Intervention name: Metacavir Enteric-coated Capsules 320mg

Description: Metacavir Enteric-coated Capsules 320mg

Intervention type: Drug

Intervention name: Metacavir Enteric-coated Capsules Placebo 240mg

Description: Metacavir Enteric-coated Capsules Placebo 240mg

Arm group label: Metacavir Enteric-coated Capsule 80mg

Intervention type: Drug

Intervention name: Metacavir Enteric-coated Capsules Placebo 160mg

Description: Metacavir Enteric-coated Capsules Placebo 160mg

Arm group label: Metacavir Enteric-coated Capsules 160mg

Intervention type: Drug

Intervention name: Metacavir Enteric-coated Capsules Placebo 320mg

Description: Metacavir Enteric-coated Capsules Placebo 320mg

Intervention type: Drug

Intervention name: Adefovir Dipivoxil Capsule10mg

Description: Adefovir Dipivoxil Capsule10mg

Arm group label: Adefovir Dipivoxil Capsule

Intervention type: Drug

Intervention name: Adefovir Dipivoxil Capsule Placebo 10mg

Description: Adefovir Dipivoxil Capsule Placebo 10mg

Eligibility

Criteria:

Inclusion Criteria:

- Are at least 18 years of age and no older than 65;

- Subjects,with an established clinical history of HBV at Screening,has a positive HBsAg test(>6months) regardless of a positive/negative HBeAg test;

- At Screening,HBV-DNA>10^5 copies/ml in HBeAg positive or HBV-DNA>10^4 copies/ml in HBeAg negative(HBV-DNA was evaluated by polymerase chain reaction fluorescent labeling.);

- Subjects with abnormal liver function test defined as alanine aminotransferase(ALT) was 2~10 times upper limit of normal in HBeAg positive or 1.5~10 times upper limit of normal in HBeAg negative;

- Subjects who are willing to require any other treatment for anti-hepatitis B during the study period;

- Subjects who are willing to take measures for effective non-pharmaceutical contraception;

- Given their signed written informed consent to participate;

Exclusion Criteria:

- Subjects with hepatitis C(HCV),hepatitis D(HDV),autoimmune hepatitis,hereditary liver disease or any other active hepatitis;

- A positive human immunodeficiency virus(HIV) test result;

- Subjects,who in the opinion of the investigator,have a current diagnosis of hepatocellular carcinoma or serum α-fetoprotein(AFP)>100ug/L;

- Subjects with severe hepatitis or decompensated liver disease defined as hepatic encephalopathy,ascites,low protein blood syndrome(albumin ≤30g/l) or variceal bleeding;

- Serum Creatinine(SCr) exceeds upper limit of normal;

- At Screening,ALT>10 times upper limit of normal,Total Bilirubin(TBIL)>double upper limit of normal or transient hepatic decompensation caused by condition aggravation;

- Subjects who required treatment with nucleoside antiviral drugs such as lamivudine,Adefovir dipivoxil,Telbivudine,Tenofovir disoproxil or Entecavir before Screening;

- Subjects who require treatment with interferon-α,thymosin α-1 or other antiviral therapy,immunosuppressive agents,immune modulators within 6 months before Screening;

- Subjects with cardiac disease,hematological system disease,cancer,impaired immunity or psychiatric disease;

- Hemoglobin<10g/dl,white blood cell count<3.5 10^9/L,platelets<80 10^9/L;

- Subjects,who in the opinion of the investigator,have a current diagnosis of pancreatitis pre-dose within 24 weeks;

- History of hypersensitivity or allergy to any of the study drugs;

- Subjects who participate in other clinical trials within 3 months prior to Screening;

- Women who are pregnant or lactating or planning a pregnancy recently;

- Subjects in the opinion of the investigator,could not participate in the study.

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Overall Official
Overall Contact

Last name: Maorong Wang

Phone: 025-80864021

Location
facility status contact investigator 81 Military Hospital of China Maorong Wang 025-80864021 Maorong Wang Principal Investigator
Location Countries

China

Verification Date

August 2016

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 5
Arm Group

Arm group label: Metacavir Enteric-coated Capsule 80mg

Arm group type: Experimental

Description: Metacavir Enteric-coated Capsules 80mg Metacavir Enteric-coated Capsules Placebo 240mg Adefovir Dipivoxil Capsule Placebo 10mg;

Arm group label: Metacavir Enteric-coated Capsules 160mg

Arm group type: Active Comparator

Description: Metacavir Enteric-coated Capsules 160mg Metacavir Enteric-coated Capsules Placebo 160mg Adefovir Dipivoxil Capsule Placebo 10mg;

Arm group label: Metacavir Enteric-coated Capsules 320mg

Arm group type: Placebo Comparator

Description: Metacavir Enteric-coated Capsules 320mg Adefovir Dipivoxil Capsule Placebo 10mg

Arm group label: Adefovir Dipivoxil Capsule

Arm group type: Active Comparator

Description: Metacavir Enteric-coated Capsules Placebo 320mg Adefovir Dipivoxil Capsule 10mg;

Arm group label: Placebo

Arm group type: Placebo Comparator

Description: Metacavir Enteric-coated Capsules Placebo 320mg Adefovir Dipivoxil Capsule Placebo 10mg;

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov