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

NCT02965859 | Unknown Phase 2

• 1 other identifier: PNA-20140110-v2
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis B

Keywords

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

• The change from baseline in the logarithms of measurement data of HBV-DNA at Week 12 of treatment.

  The change from baseline in the logarithms of measurement data of HBV-DNA at Week 12 of treatment.（Unit：log10)

  12 weeks

Secondary Outcomes (2)

• Incidence of treatment-chronic hepatitis B

  12 weeks

• Incidence of Adverse Events(AEs)

  48 weeks

Study Arms (5)

Metacavir Enteric-coated Capsule 80mg

EXPERIMENTAL

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

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

Metacavir Enteric-coated Capsules 160mg

ACTIVE COMPARATOR

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

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

Metacavir Enteric-coated Capsules 320mg

PLACEBO COMPARATOR

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

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

Adefovir Dipivoxil Capsule

ACTIVE COMPARATOR

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

Drug: Metacavir Enteric-coated Capsules Placebo 320mg; Drug: Adefovir Dipivoxil Capsule10mg

Placebo

PLACEBO COMPARATOR

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

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

Interventions

Metacavir Enteric-coated Capsules 80mg DRUG

Metacavir Enteric-coated Capsules 80mg

Metacavir Enteric-coated Capsule 80mg

Metacavir Enteric-coated Capsules 160mg DRUG

Metacavir Enteric-coated Capsules 160mg

Metacavir Enteric-coated Capsules 160mg

Metacavir Enteric-coated Capsules 320mg DRUG

Metacavir Enteric-coated Capsules 320mg

Metacavir Enteric-coated Capsules 320mg; Placebo

Metacavir Enteric-coated Capsules Placebo 240mg DRUG

Metacavir Enteric-coated Capsules Placebo 240mg

Metacavir Enteric-coated Capsule 80mg

Metacavir Enteric-coated Capsules Placebo 160mg DRUG

Metacavir Enteric-coated Capsules Placebo 160mg

Metacavir Enteric-coated Capsules 160mg

Metacavir Enteric-coated Capsules Placebo 320mg DRUG

Metacavir Enteric-coated Capsules Placebo 320mg

Adefovir Dipivoxil Capsule; Placebo

Adefovir Dipivoxil Capsule10mg DRUG

Adefovir Dipivoxil Capsule10mg

Adefovir Dipivoxil Capsule

Adefovir Dipivoxil Capsule Placebo 10mg DRUG

Adefovir Dipivoxil Capsule Placebo 10mg

Metacavir Enteric-coated Capsule 80mg; Metacavir Enteric-coated Capsules 160mg; Metacavir Enteric-coated Capsules 320mg; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou Yipinhong Pharmaceutical CO.,LTD: lead

Study Sites (1)

81 Military Hospital of China

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

adefovir dipivoxil

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maorong Wang

  81 Military Hospital of China

  PRINCIPAL INVESTIGATOR

• Yonggang Li

  Beijing 302 Hospital

  PRINCIPAL INVESTIGATOR

• Yongfeng Yang

  The Second Hospital of Nanjing Medical University

  PRINCIPAL INVESTIGATOR

• Yanlin Yu

  Wannan Medical College Yijishan Hospital

  PRINCIPAL INVESTIGATOR

• Jun Li

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maorong Wang

CONTACT

025-80864021

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2016
• First Posted: November 17, 2016
• Study Start: December 1, 2012
• Primary Completion: December 1, 2018
• Last Updated: November 22, 2016

Record last verified: 2016-08

Locations

CN (1)