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| ID | Type | Description | Link |
|---|---|---|---|
| update with ADF103814 |
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This is an open label, single-arm, multi-centre extension study for Korean patients with chronic hepatitis B and compensated liver disease who have completed one-year adefovir dipivoxil treatment in ADF103814. The objective is to assess clinical efficacy and safety of long term (up to 3 years) adefovir dipivoxil 10mg therapy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adefovir dipivoxil 10mg | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Hepatitis B Virus (HBV) DNA (log10 Copies/mL) Change From Baseline at Week 156 of Adefovir Therapy | HBV DNA was tested with Roche Cobas Amplicor HBV monitor test, Lower Limit of Detection 300 copies/mL) after 3 years (156 weeks: Weeks 1-52 in Study ADF103814; Weeks 53-156 in Study 108005) of adefovir therapy). Change from baseline was calculated as the Week 156 value minus the Baseline value. Baseline is defined as the first day of study ADF103814, of which Study 108005 is an extension. | Baseline, Week 156 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Achieving ALT Normalization at Week 104 & 156 | Alanine aminotransferase (ALT) normalization is defined as a value <= upper limit of normal (ULN) range based on the set of subjects with ALT>ULN at baseline. The normal range for ALT is 0-40 Units/Liter. | Week 104, Week 156 |
| Number of Participants Achieving Virological Response at Week 104 & 156 |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials, M.D., Ph.D | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Seoul | 137-701 | South Korea |
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Study ADF108005 (NCT00403585; 80 subjects enrolled) is an extension of Study ADF103814 (104 subjects enrolled). For several outcome measures, baseline is defined as the first day of Study 103814; thus, baseline data for 104 subjects are provided, even though 80 subjects were enrolled in Study 108005.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adefovir Dipivoxil | Adefovir Dipivoxil 10 mg tablets once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Initial Treatment Phase |
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| ||||||||||||||||||
| Open-Label Phase; Extension Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Adefovir Dipivoxil | Adefovir Dipivoxil 10 mg tablets once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hepatitis B Virus (HBV) DNA (log10 Copies/mL) Change From Baseline at Week 156 of Adefovir Therapy | HBV DNA was tested with Roche Cobas Amplicor HBV monitor test, Lower Limit of Detection 300 copies/mL) after 3 years (156 weeks: Weeks 1-52 in Study ADF103814; Weeks 53-156 in Study 108005) of adefovir therapy). Change from baseline was calculated as the Week 156 value minus the Baseline value. Baseline is defined as the first day of study ADF103814, of which Study 108005 is an extension. | Study ADF103814 Intent-to-Treat (ITT) Population: All subjects regardless of whether or not the subject completed the planned duration of the study will be analyzed with no data exclusion. As baseline is defined as the first day of study ADF103814, all 104 subjects enrolled in this study were analyzed. | Posted | Mean | Standard Deviation | log10 copies/mL | Baseline, Week 156 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adefovir Dipivoxil | Adefovir Dipivoxil 10 mg tablets once daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute pancreatitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinopathy diabetic | Endocrine disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C106812 | adefovir dipivoxil |
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Virological response is defined as HBV DNA level<300 copies/ml |
| Week 104, Week 156 |
| HBV DNA Levels at Each Collection Time Point From Baseline Through Week 156 | Serum HBV DNA. Baseline is defined as the first day of study ADF103814, of which Study 108005 is an extension. | Baseline, Weeks 68, 80, 92, 104, 120, 132, 144, 156 |
| Number of Participants With HBeAg Loss, HBeAg Seroconversion, HBsAg Loss and HBsAg Seroconversion at Week 104 & 156 | Hepatitis B e antigen (HBeAg) loss, HBeAg seroconversion (defined as HBeAg negative and hepatitis B e antibody [HBeAb] positive), hepatitis B surface antigen (HBsAg) loss and HBsAg seroconversion (defined as HBsAg negative and hepatitis B surface antibody [HBsAb] positive). HBeAg and HBsAg seroconversion are defined as the loss (becoming negative) of HBeAg and the concurrent appearance of antibodies against HBeAg and the loss of HBsAg and the concurrent appearance of antibodies against HBsAg, respectively. | Week 104 and 156 |
| Safety Assessment: Number of Participants With a Serious Adverse Event and an Adverse Event | The number of participants with a serious adverse event and an adverse event is reported. Refer to the adverse event section for details. | Treatment Phase (Weeks 53-156) |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
Adefovir Dipivoxil 10 mg tablets once daily
|
|
|
| Secondary | Number of Participants Achieving ALT Normalization at Week 104 & 156 | Alanine aminotransferase (ALT) normalization is defined as a value <= upper limit of normal (ULN) range based on the set of subjects with ALT>ULN at baseline. The normal range for ALT is 0-40 Units/Liter. | ITT Population: some participants were not tested at Weeks 104 or 156. | Posted | Number | Participants | Week 104, Week 156 |
|
|
|
| Secondary | Number of Participants Achieving Virological Response at Week 104 & 156 | Virological response is defined as HBV DNA level<300 copies/ml | ITT Population: some participants were not tested at Weeks 104 or 156. | Posted | Number | Participants | Week 104, Week 156 |
|
|
|
| Secondary | HBV DNA Levels at Each Collection Time Point From Baseline Through Week 156 | Serum HBV DNA. Baseline is defined as the first day of study ADF103814, of which Study 108005 is an extension. | Study ADF103814 ITT Population. As baseline is defined as the first day of study ADF103814, all 104 subjects enrolled in this study were analyzed. Some participants were not tested at various weeks. | Posted | Mean | Standard Deviation | log 10 copies/mL | Baseline, Weeks 68, 80, 92, 104, 120, 132, 144, 156 |
|
|
|
| Secondary | Number of Participants With HBeAg Loss, HBeAg Seroconversion, HBsAg Loss and HBsAg Seroconversion at Week 104 & 156 | Hepatitis B e antigen (HBeAg) loss, HBeAg seroconversion (defined as HBeAg negative and hepatitis B e antibody [HBeAb] positive), hepatitis B surface antigen (HBsAg) loss and HBsAg seroconversion (defined as HBsAg negative and hepatitis B surface antibody [HBsAb] positive). HBeAg and HBsAg seroconversion are defined as the loss (becoming negative) of HBeAg and the concurrent appearance of antibodies against HBeAg and the loss of HBsAg and the concurrent appearance of antibodies against HBsAg, respectively. | All participants achieving viological response, defined as an HBV DNA level ≤ 300. Some participants were not tested at various weeks. | Posted | Number | Participants | Week 104 and 156 |
|
|
|
| Secondary | Safety Assessment: Number of Participants With a Serious Adverse Event and an Adverse Event | The number of participants with a serious adverse event and an adverse event is reported. Refer to the adverse event section for details. | ITT Population | Posted | Number | participants | Treatment Phase (Weeks 53-156) |
|
|
|
| 2 |
| 80 |
| 43 |
| 80 |
| Nasal bone fracture | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders |
|
| Cholecystitis | Hepatobiliary disorders |
|
| Pancreatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Xerophthalmia | Eye disorders |
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| Abdominal pain | Gastrointestinal disorders |
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| Diarrhoea | Gastrointestinal disorders |
|
| Epigastric discomfort | Gastrointestinal disorders |
|
| Epigastric hunger pain | Gastrointestinal disorders |
|
| Epigastric pain | Gastrointestinal disorders |
|
| Gastritis | Gastrointestinal disorders |
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| Heartburn | Gastrointestinal disorders |
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| Indigestion | Gastrointestinal disorders |
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| Mouth dry | Gastrointestinal disorders |
|
| Oral submucous fibrosis | Gastrointestinal disorders |
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| Reflux oesophagitis | Gastrointestinal disorders |
|
| Umbrical cord area pain | Gastrointestinal disorders |
|
| Chest pain | General disorders |
|
| Fatigue | General disorders |
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| Fever | General disorders |
|
| Weakness generalized | General disorders |
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| Liver fatty | Hepatobiliary disorders |
|
| Ascites | Infections and infestations |
|
| Bronchitis | Infections and infestations |
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| Broncitis aggravated | Infections and infestations |
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| Bronchitis chronic | Infections and infestations |
|
| Folliculitis | Infections and infestations |
|
| Herpes zoster | Infections and infestations |
|
| Pharyngitis | Infections and infestations |
|
| Alpha-fetoprotein increased | Investigations |
|
| Alanine aminotransferase increased | Investigations |
|
| Aspartate aminotransferase increased | Investigations |
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| Creatine phosphokinase increased | Investigations |
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| Arthralgia | Musculoskeletal and connective tissue disorders |
|
| Finger sprain | Musculoskeletal and connective tissue disorders |
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| Lipoma | Musculoskeletal and connective tissue disorders |
|
| Left wrist pain | Musculoskeletal and connective tissue disorders |
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| Left knee pain | Musculoskeletal and connective tissue disorders |
|
| Myalgia | Musculoskeletal and connective tissue disorders |
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| Pain neck/shoulder | Musculoskeletal and connective tissue disorders |
|
| Right middle finger pain | Musculoskeletal and connective tissue disorders |
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| Epidermal cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Dizziness | Nervous system disorders |
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| Headache | Nervous system disorders |
|
| Numbness | Nervous system disorders |
|
| Tingling skin | Nervous system disorders |
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| Vertigo | Nervous system disorders |
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| Common cold | Respiratory, thoracic and mediastinal disorders |
|
| Coughing | Respiratory, thoracic and mediastinal disorders |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| Week 92, n=77 |
|
| Week 104, n=76 |
|
| Week 120, n=76 |
|
| Week 132, n=78 |
|
| Week 144, n=74 |
|
| Week 156, n=73 |
|
| Title | Measurements |
|---|---|
|
| Week 104 HBsAg seroconversion, n=77 |
|
| Week 156 HBeAg loss, n=73 |
|
| Week 156 HBeAg seroconversion, n=73 |
|
| Week 156 HBsAg loss, n=73 |
|
| Week 156 HBsAg seroconversion, n=73 |
|