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

Chronic Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02965859
• Other study ID #: PNA-20140110-v2
• Status: Recruiting
• Phase: Phase 2
• First received: September 1, 2016
• Last updated: November 21, 2016
• Start date: December 2012

Study information

• Verified date: August 2016
• Source: Guangzhou Yipinhong Pharmaceutical CO.,LTD
• Contact: Maorong Wang
• Phone: 025-80864021
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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;

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 a-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-a,thymosin a-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.

Study Design

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

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Metacavir Enteric-coated Capsules 80mg
Metacavir Enteric-coated Capsules 80mg
• Metacavir Enteric-coated Capsules 160mg
Metacavir Enteric-coated Capsules 160mg
• Metacavir Enteric-coated Capsules 320mg
Metacavir Enteric-coated Capsules 320mg
• Metacavir Enteric-coated Capsules Placebo 240mg
Metacavir Enteric-coated Capsules Placebo 240mg
• Metacavir Enteric-coated Capsules Placebo 160mg
Metacavir Enteric-coated Capsules Placebo 160mg
• Metacavir Enteric-coated Capsules Placebo 320mg
Metacavir Enteric-coated Capsules Placebo 320mg
• Adefovir Dipivoxil Capsule10mg
Adefovir Dipivoxil Capsule10mg
• Adefovir Dipivoxil Capsule Placebo 10mg
Adefovir Dipivoxil Capsule Placebo 10mg

Locations

Country	Name	City	State
China	81 Military Hospital of China	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Yipinhong Pharmaceutical CO.,LTD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Incidence of treatment-chronic hepatitis B	The proportion of subjects whose HBV-DNA are down to double logarithms at Week 12 of treatment.(Unit:%); The proportion of subjects whose HBV-DNA are not detected or less than upper limit of normal at Week 12 of treatment.(Unit:%); The proportion of subjects (HBeAg positive at baseline) whose is changed at Week 12 of treatment.(Unit:%); The proportion of subjects whose HBsAg is changed to negative at Week 12 of treatment.(Unit:%)	12 weeks	No
Secondary	Incidence of Adverse Events(AEs)		48 weeks	Yes