Adefovir Dipivoxil In Compensated Chronic Hepatitis B Patients

Chronic Hepatitis B Clinical Trial

Official title:

Phase III Study of Adefovir Dipivoxil Tablets in Patients With Compensated Chronic Hepatitis B -Comparative Study Against Lamivudine-

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00316719
• Other study ID #: ADF105220
• Status: Completed
• Phase: Phase 3
• First received: April 19, 2006
• Last updated: October 1, 2009
• Start date: January 2006
• Est. completion date: January 2008

Study information

• Verified date: October 2009
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

This study is designed to compare the efficacy and safety of adefovir dipivoxil 10 mg with lamivudine 100 mg in Japanese patients with compensated chronic hepatitis B over 52-week periods.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 64 Years

Eligibility

Inclusion criteria:

• Have compensated chronic hepatitis B.

• Have not been treated with anti HBV agents with antiproliferative activity against. However, previous Interferon (IFN) therapy is permitted.

• Ability to read, understand, and sign the informed consent.

• Have a positive serum HBV-DNA >= 1,000,000 copies/mL and ALT level 50-500 U/L

Exclusion criteria:

• Having or suspected of having liver cancer.

• Co-infected with Hepatitis C virus (HCV) or Human Immunodeficiency virus (HIV).

• Autoimmune hepatitis.

• Received any previous transplantation or having a plan for any transplantation.

• Existence of any serious complication, except hepatitis B.

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• LAM group
Subjects took one LAM 100mg tablet orally once daily and one ADV placebo tablet orally once daily.
• ADV group
Subjects took one ADV 10mg tablet orally once daily and one LAM placebo tablet orally once daily.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in Hepatitis B Virus (HBV) DNA at Week 52		Baseline and Week 52	No
Secondary	Percentage of Participants With HBV DNA Loss (<400 Copies/mL) at Week 52		Week 52	No
Secondary	Time to Onset of HBV DNA Loss (< 400 Copies/mL)		From Baseline to Week 52	No
Secondary	Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 52		Week 52	No
Secondary	Percentage of Participants With Hepatitis B e Antigen/Antibody (HBeAg/Ab) Seroconversion at Week 52		Week 52	No
Secondary	Time to Onset of HBeAg Loss		From Baseline to Week 52	No
Secondary	Time to Onset of HBeAg/Ab Seroconversion		From Baseline to Week 52	No
Secondary	Percentage of Participants With Hepatitis B s Antigen (HBsAg) Loss at Week 52		Week 52	No
Secondary	Percentage of Participants With Hepatitis B s Antigen/ Antibody (HBsAg/Ab) Seroconversion at Week 52		Week 52	No
Secondary	Mean Alanine Aminotransferase (ALT) Level at Week 52		Week 52	No
Secondary	Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 52		Week 52	No
Secondary	Time to Onset of ALT Normalization		From Baseline to Week 52	No
Secondary	Rate of Emergence of Resistant Virus at Week 52		Week 52	No