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Status unknownNCT02965859Updated Nov 22, 2016

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

A Phase 2 interventional study of Metacavir Enteric-coated Capsules 80mg and Metacavir Enteric-coated Capsules 160mg in Chronic Hepatitis B, sponsored by Guangzhou Yipinhong Pharmaceutical CO.,LTD. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-11-22.

Sponsored by Guangzhou Yipinhong Pharmaceutical CO.,LTD · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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;
02

Conditions studied

  • Chronic Hepatitis B

Keywords

  • Chronic Hepatitis B
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's planned enrollment of 180 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Guangzhou Yipinhong Pharmaceutical CO.,LTD is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    Metacavir Enteric-coated Capsule 80mg

    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

  • Active comparator
    Metacavir Enteric-coated Capsules 160mg

    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

  • Placebo comparator
    Metacavir Enteric-coated Capsules 320mg

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

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

  • Active comparator
    Adefovir Dipivoxil Capsule

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

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

  • Placebo comparator
    Placebo

    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

  • DrugMetacavir Enteric-coated Capsules 80mg

    Metacavir Enteric-coated Capsules 80mg

  • DrugMetacavir Enteric-coated Capsules 160mg

    Metacavir Enteric-coated Capsules 160mg

  • DrugMetacavir Enteric-coated Capsules 320mg

    Metacavir Enteric-coated Capsules 320mg

  • DrugMetacavir Enteric-coated Capsules Placebo 240mg

    Metacavir Enteric-coated Capsules Placebo 240mg

  • DrugMetacavir Enteric-coated Capsules Placebo 160mg

    Metacavir Enteric-coated Capsules Placebo 160mg

  • DrugMetacavir Enteric-coated Capsules Placebo 320mg

    Metacavir Enteric-coated Capsules Placebo 320mg

  • DrugAdefovir Dipivoxil Capsule10mg

    Adefovir Dipivoxil Capsule10mg

  • DrugAdefovir Dipivoxil Capsule Placebo 10mg

    Adefovir Dipivoxil Capsule Placebo 10mg

06

What researchers measure

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)

    Time frame: 12 weeks

Secondary outcomes

  1. Incidence of treatment-chronic hepatitis B

    1. The proportion of subjects whose HBV-DNA are down to double logarithms at Week 12 of treatment.(Unit：%) 2. The proportion of subjects whose HBV-DNA are not detected or less than upper limit of normal at Week 12 of treatment.(Unit：%) 3. The proportion of subjects (HBeAg positive at baseline) whose is changed at Week 12 of treatment.(Unit：%) 4. The proportion of subjects whose HBsAg is changed to negative at Week 12 of treatment.(Unit：%)

    Time frame: 12 weeks

  2. Incidence of Adverse Events(AEs)

    Time frame: 48 weeks

07

Study locations

1 of 1 sites recruiting
  • 81 Military Hospital of China
    Nanjing, Jiangsu, China
    • Maorong Wang · Contact · 025-80864021
    • Maorong Wang · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02965859
Lead sponsor
Guangzhou Yipinhong Pharmaceutical CO.,LTD
Responsible party
Sponsor
First posted
Nov 17, 2016
Start date
Dec 2012
Primary completion
Dec 2018 (estimated)
Last update
Nov 22, 2016

Study contacts

Maorong Wang
Contact
025-80864021
Maorong Wang
principal investigator · 81 Military Hospital of China
Yonggang Li
principal investigator · Beijing 302 Hospital
Yongfeng Yang
principal investigator · The Second Hospital of Nanjing Medical University
Yanlin Yu
principal investigator · Wannan Medical College Yijishan Hospital
Jun Li
principal investigator · The First Affiliated Hospital with Nanjing Medical University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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