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

NCT ID: NCT02965859

Last Updated: 2016-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Brief Summary

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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

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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

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Chronic Hepatitis B

Keywords

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Chronic Hepatitis B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Metacavir Enteric-coated Capsule 80mg

1. Metacavir Enteric-coated Capsules 80mg
2. Metacavir Enteric-coated Capsules Placebo 240mg
3. Adefovir Dipivoxil Capsule Placebo 10mg;

Group Type EXPERIMENTAL

Metacavir Enteric-coated Capsules 80mg

Intervention Type DRUG

Metacavir Enteric-coated Capsules 80mg

Metacavir Enteric-coated Capsules Placebo 240mg

Intervention Type DRUG

Metacavir Enteric-coated Capsules Placebo 240mg

Adefovir Dipivoxil Capsule Placebo 10mg

Intervention Type DRUG

Adefovir Dipivoxil Capsule Placebo 10mg

Metacavir Enteric-coated Capsules 160mg

1. Metacavir Enteric-coated Capsules 160mg
2. Metacavir Enteric-coated Capsules Placebo 160mg
3. Adefovir Dipivoxil Capsule Placebo 10mg;

Group Type ACTIVE_COMPARATOR

Metacavir Enteric-coated Capsules 160mg

Intervention Type DRUG

Metacavir Enteric-coated Capsules 160mg

Metacavir Enteric-coated Capsules Placebo 160mg

Intervention Type DRUG

Metacavir Enteric-coated Capsules Placebo 160mg

Adefovir Dipivoxil Capsule Placebo 10mg

Intervention Type DRUG

Adefovir Dipivoxil Capsule Placebo 10mg

Metacavir Enteric-coated Capsules 320mg

1. Metacavir Enteric-coated Capsules 320mg
2. Adefovir Dipivoxil Capsule Placebo 10mg

Group Type PLACEBO_COMPARATOR

Metacavir Enteric-coated Capsules 320mg

Intervention Type DRUG

Metacavir Enteric-coated Capsules 320mg

Adefovir Dipivoxil Capsule Placebo 10mg

Intervention Type DRUG

Adefovir Dipivoxil Capsule Placebo 10mg

Adefovir Dipivoxil Capsule

1. Metacavir Enteric-coated Capsules Placebo 320mg
2. Adefovir Dipivoxil Capsule 10mg;

Group Type ACTIVE_COMPARATOR

Metacavir Enteric-coated Capsules Placebo 320mg

Intervention Type DRUG

Metacavir Enteric-coated Capsules Placebo 320mg

Adefovir Dipivoxil Capsule10mg

Intervention Type DRUG

Adefovir Dipivoxil Capsule10mg

Placebo

1. Metacavir Enteric-coated Capsules Placebo 320mg
2. Adefovir Dipivoxil Capsule Placebo 10mg;

Group Type PLACEBO_COMPARATOR

Metacavir Enteric-coated Capsules 320mg

Intervention Type DRUG

Metacavir Enteric-coated Capsules 320mg

Metacavir Enteric-coated Capsules Placebo 320mg

Intervention Type DRUG

Metacavir Enteric-coated Capsules Placebo 320mg

Adefovir Dipivoxil Capsule Placebo 10mg

Intervention Type DRUG

Adefovir Dipivoxil Capsule Placebo 10mg

Interventions

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Metacavir Enteric-coated Capsules 80mg

Metacavir Enteric-coated Capsules 80mg

Intervention Type DRUG

Metacavir Enteric-coated Capsules 160mg

Metacavir Enteric-coated Capsules 160mg

Intervention Type DRUG

Metacavir Enteric-coated Capsules 320mg

Metacavir Enteric-coated Capsules 320mg

Intervention Type DRUG

Metacavir Enteric-coated Capsules Placebo 240mg

Metacavir Enteric-coated Capsules Placebo 240mg

Intervention Type DRUG

Metacavir Enteric-coated Capsules Placebo 160mg

Metacavir Enteric-coated Capsules Placebo 160mg

Intervention Type DRUG

Metacavir Enteric-coated Capsules Placebo 320mg

Metacavir Enteric-coated Capsules Placebo 320mg

Intervention Type DRUG

Adefovir Dipivoxil Capsule10mg

Adefovir Dipivoxil Capsule10mg

Intervention Type DRUG

Adefovir Dipivoxil Capsule Placebo 10mg

Adefovir Dipivoxil Capsule Placebo 10mg

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou Yipinhong Pharmaceutical CO.,LTD

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maorong Wang

Role: PRINCIPAL_INVESTIGATOR

81 Military Hospital of China

Yonggang Li

Role: PRINCIPAL_INVESTIGATOR

Beijing 302 Hospital

Yongfeng Yang

Role: PRINCIPAL_INVESTIGATOR

The Second Hospital of Nanjing Medical University

Yanlin Yu

Role: PRINCIPAL_INVESTIGATOR

Wannan Medical College Yijishan Hospital

Jun Li

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Locations

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81 Military Hospital of China

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Maorong Wang

Role: CONTACT

Phone: 025-80864021

Facility Contacts

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Maorong Wang

Role: primary

Other Identifiers

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PNA-20140110-v2

Identifier Type: -

Identifier Source: org_study_id