Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Trial record 15 of 349 for:    hepatitis b | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Guangzhou Yipinhong Pharmaceutical CO.,LTD
Sponsor:
Information provided by (Responsible Party):
Guangzhou Yipinhong Pharmaceutical CO.,LTD
ClinicalTrials.gov Identifier:
NCT02965859
First received: September 1, 2016
Last updated: November 21, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention Phase
Chronic Hepatitis B
Drug: Metacavir Enteric-coated Capsules 80mg
Drug: Metacavir Enteric-coated Capsules 160mg
Drug: Metacavir Enteric-coated Capsules 320mg
Drug: Metacavir Enteric-coated Capsules Placebo 240mg
Drug: Metacavir Enteric-coated Capsules Placebo 160mg
Drug: Metacavir Enteric-coated Capsules Placebo 320mg
Drug: Adefovir Dipivoxil Capsule10mg
Drug: Adefovir Dipivoxil Capsule Placebo 10mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Guangzhou Yipinhong Pharmaceutical CO.,LTD:

Primary Outcome Measures:
  • The change from baseline in the logarithms of measurement data of HBV-DNA at Week 12 of treatment. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The change from baseline in the logarithms of measurement data of HBV-DNA at Week 12 of treatment.(Unit:log10)


Secondary Outcome Measures:
  • Incidence of treatment-chronic hepatitis B [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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:%)

  • Incidence of Adverse Events(AEs) [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: December 2012
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Metacavir Enteric-coated Capsules 80mg
Drug: Metacavir Enteric-coated Capsules Placebo 240mg
Metacavir Enteric-coated Capsules Placebo 240mg
Drug: Adefovir Dipivoxil Capsule Placebo 10mg
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
Metacavir Enteric-coated Capsules 160mg
Drug: Metacavir Enteric-coated Capsules Placebo 160mg
Metacavir Enteric-coated Capsules Placebo 160mg
Drug: Adefovir Dipivoxil Capsule Placebo 10mg
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
Metacavir Enteric-coated Capsules 320mg
Drug: Adefovir Dipivoxil Capsule Placebo 10mg
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
Metacavir Enteric-coated Capsules Placebo 320mg
Drug: Adefovir Dipivoxil Capsule10mg
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
Metacavir Enteric-coated Capsules 320mg
Drug: Metacavir Enteric-coated Capsules Placebo 320mg
Metacavir Enteric-coated Capsules Placebo 320mg
Drug: Adefovir Dipivoxil Capsule Placebo 10mg
Adefovir Dipivoxil Capsule Placebo 10mg

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;
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02965859

Contacts
Contact: Maorong Wang 025-80864021

Locations
China, Jiangsu
81 Military Hospital of China Recruiting
Nanjing, Jiangsu, China
Contact: Maorong Wang    025-80864021      
Principal Investigator: Maorong Wang         
Sponsors and Collaborators
Guangzhou Yipinhong Pharmaceutical CO.,LTD
Investigators
Principal Investigator: Maorong Wang 81 Military Hospital of China
Principal Investigator: Yonggang Li Beijing 302 Hospital
Principal Investigator: Yongfeng Yang The Second Hospital of Nanjing
Principal Investigator: Yanlin Yu Wannan Medical College Yijishan Hospital
Principal Investigator: Jun Li The First Affiliated Hospital with Nanjing Medical University
  More Information

Responsible Party: Guangzhou Yipinhong Pharmaceutical CO.,LTD
ClinicalTrials.gov Identifier: NCT02965859     History of Changes
Other Study ID Numbers: PNA-20140110-v2 
Study First Received: September 1, 2016
Last Updated: November 21, 2016
Health Authority: China: Food and Drug Administration
United States: Food and Drug Administration

Keywords provided by Guangzhou Yipinhong Pharmaceutical CO.,LTD:
Chronic Hepatitis B

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Adefovir dipivoxil
Adefovir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on December 02, 2016