A Efficacy and Safety Study of Adefovir Dipivoxil to Treat Chinese Patients With HBeAg+ve Chronic Hepatitis B

Chronic Hepatitis B Clinical Trial

Official title:

A Multi-Centre, Double-Blind , Randomized, Placebo-Controlled Phase II/III Study of Adefovir Dipivoxil for the Treatment of Chinese Patients With HBeAg Positive Chronic Hepatitis B Followed by Long-Term (5 Years Total) Adefovir Dipivoxil Treatment. (Report on Year 1 and Year 2 Data)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00857675
• Other study ID #: ADF30001
• Status: Completed
• Phase: Phase 3
• First received: March 5, 2009
• Last updated: April 2, 2009
• Start date: December 2002
• Est. completion date: March 2008

Study information

• Verified date: April 2009
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether Adefovir Dipivoxil is effective and safe in treatment of Chinese Patients with HBeAg positive Chronic Hepatitis B for 5 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Aged 18-65 years

• Presence of HBsAg and HBeAg at the time of screening and for at least 6 months prior to screening.

• Positive HBV DNA plasma assay with screening value equal or more than 10 (6) copies/mL (Roche COBAS AMPLICORTM HBV MONITOR Test, LLOD less than 300 copies/mL) at the time of screening (within 4 weeks of randomisation).

• Evidence of elevated serum ALT levels defined as serum ALT level greater than or equal to 2.0 times (inclusive) the upper limit of the normal range (ULN) in the previous 6 months, and serum ALT levels greater than 1.0 times the ULN at the time of screening.

Exclusion Criteria:

• Evidence of hepatocellular carcinoma;

• Clinical signs of liver decompensation;

• Serum creatinine more than 1.5 mg/dL;

• ALT more than 10 x ULN; seropositivity for hepatitis C or D virus or HIV;

• Lamivudine therapy within 3 months prior to screening;

• ADV therapy or any other anti-HBV therapy within the previous 6 months;

• Use of systemic antiviral agents, immunomodulators, immunosuppressive therapy, Chinese Traditional Medicines or agents known to lower ALT levels during the study.

Related Conditions & MeSH terms

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

Intervention

Drug:
• AAAA
Adefovir Dipivoxil (12 weeks) + open lable Adefovir Dipivoxil (28 weeks) + Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (52-260weeks)
• AAPA
Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (28 weeks) + placebo (12 weeks) + open label-Adefovir Dipivoxil (52-260 weeks)
• PAAA
Placebo (12 weeks) + Open label Adefovir Dipivoxil (28 weeks) + Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (52-260 weeks)

Locations

Country	Name	City	State
China	GSK Investigational Site	Beijing
China	GSK Investigational Site	Beijing
China	GSK Investigational Site	Changchun	Jilin
China	GSK Investigational Site	Chongqing
China	GSK Investigational Site	Chongquin
China	GSK Investigational Site	Guangzhou	Guangdong
China	GSK Investigational Site	Guangzhou	Guangdong
China	GSK Investigational Site	Hangzhou	Zhejiang
China	GSK Investigational Site	Jinan	Shandong
China	GSK Investigational Site	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The log10 reduction in HBV DNA from baseline at week 12 between ADV 10mg and matching placebo		Week 12
Secondary	The proportion of subjects with ALT normalisation		Week 52, 104, 156, 208, 260
Secondary	log10 reduction in serum HBV DNA		Week 52, 104, 156, 208, 260
Secondary	The proportion of subjects with HBV DNA 10(5) copies/mL or a 2 log10 reduction from Baseline HBV DNA level		Week 52, 104, 156, 208, 260
Secondary	The proportion of subjects with HBeAg loss		Week 52, 104, 156, 208, 260
Secondary	The proportion of subjects with HBeAg seroconversion		Week 52, 104, 156, 208, 260
Secondary	The proportion of subjects developing N236T and A181V HBV DNA genotypic mutations associated with ADV resistance		Week 52, 104, 156, 208, 260
Secondary	The proportion of subjects with HBV DNA undetectable (<300 copies/mL)		Week 52, 104, 156, 208, 260