Study of Adefovir Dipivoxil for Korean Patients With Chronic Hepatitis B(CHB) Who Have Completed ADF 103814

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00403585
• Date of registration: 23/11/2006
• Prospective Registration: No
• Primary sponsor: GlaxoSmithKline
• Public title: Study of Adefovir Dipivoxil for Korean Patients With Chronic Hepatitis B(CHB) Who Have Completed ADF 103814
• Scientific title: A Phase IV, Open Label, Single Arm, Multicenter, Extension Study of Adefovir Dipivoxil for Korean Patients With Chronic Hepatitis B(CHB) Who Have Completed ADF 103814
• Date of first enrolment: July 2006
• Target sample size: 80
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00403585
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

Korea, Republic of

Contacts

• Name: GSK Clinical Trials, M.D., Ph.D
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion Criteria:

Subject has completed ADF103814 and continues with adefovir dipivoxil treatment via
prescription without interruption prior enrolment in this extension study.

Availability and willingness of subject to provide written informed consent.

Exclusion Criteria:

Use of immunosuppressive therapy requiring use of more than 5mg of prednisolone(or
equivalent) per day, immunomodulatory therapy (including interferon or thymosin) or
systemic cytotoxic agents during the study.

Previous or current lamivudine or antiviral therapy Clinical signs of decompensated liver
disease as indicated by the protocol Inadequate haematological function defined by the
protocol - Documented evidence of active liver disease due to other causes Hepatocellular
carcinoma as evidenced by the protocol Any serious or active medical or psychiatric
illnesses other than hepatitis B which, in the opinion of the investigator, would interfere
with patient treatment, assessment or compliance with the protocol. This would include any
uncontrolled clinically significant renal, cardiac, pulmonary, vascular, neurogenic,
digestive, metabolic (diabetes, thyroid disorders, adrenal disease), immunodeficiency
disorders or cancer.

Active alcohol or drug abuse or history of alcohol or drug abuse considered by the
investigator to be sufficient to hinder compliance with treatment, participation in the
study or interpretation of results.

Planned for liver transplantation Therapy with nephrotoxic drugs or competitors of renal
excretion can be expected during the course of the study.

History of hypersensitivity to nucleoside and/or nucleotide analogues. Inability to comply
with study requirements as determined by the study investigator.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Hepatitis B

Hepatitis B, Chronic

Intervention(s)

Drug: adefovir dipivoxil 10mg

Primary Outcome(s)

Hepatitis B Virus (HBV) DNA (log10 Copies/mL) Change From Baseline at Week 156 of Adefovir Therapy [Time Frame: Baseline, Week 156]

Secondary Outcome(s)

Number of Participants With HBeAg Loss, HBeAg Seroconversion, HBsAg Loss and HBsAg Seroconversion at Week 104 & 156 [Time Frame: Week 104 and 156]

Number of Participants Achieving ALT Normalization at Week 104 & 156 [Time Frame: Week 104, Week 156]

Number of Participants Achieving Virological Response at Week 104 & 156 [Time Frame: Week 104, Week 156]

Safety Assessment: Number of Participants With a Serious Adverse Event and an Adverse Event [Time Frame: Treatment Phase (Weeks 53-156)]

HBV DNA Levels at Each Collection Time Point From Baseline Through Week 156 [Time Frame: Baseline, Weeks 68, 80, 92, 104, 120, 132, 144, 156]

Secondary ID(s)

ADF108005

update with ADF103814

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 24/11/2010
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00403585