Trial Outcomes & Findings for Study of Adefovir Dipivoxil for Korean Patients With Chronic Hepatitis B(CHB) Who Have Completed ADF 103814 (NCT NCT00403585)
NCT ID: NCT00403585
Last Updated: 2010-12-15
Results Overview
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.
COMPLETED
PHASE4
80 participants
Baseline, Week 156
2010-12-15
Participant Flow
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.
Participant milestones
| Measure |
Adefovir Dipivoxil
Adefovir Dipivoxil 10 mg tablets once daily
|
|---|---|
|
Initial Treatment Phase
STARTED
|
104
|
|
Initial Treatment Phase
COMPLETED
|
102
|
|
Initial Treatment Phase
NOT COMPLETED
|
2
|
|
Open-Label Phase; Extension Study
STARTED
|
80
|
|
Open-Label Phase; Extension Study
COMPLETED
|
74
|
|
Open-Label Phase; Extension Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Adefovir Dipivoxil
Adefovir Dipivoxil 10 mg tablets once daily
|
|---|---|
|
Initial Treatment Phase
Lost to Follow-up
|
2
|
|
Open-Label Phase; Extension Study
Withdrawal by Subject
|
2
|
|
Open-Label Phase; Extension Study
HBV DNA Mutation Positive
|
4
|
Baseline Characteristics
Study of Adefovir Dipivoxil for Korean Patients With Chronic Hepatitis B(CHB) Who Have Completed ADF 103814
Baseline characteristics by cohort
| Measure |
Adefovir Dipivoxil
n=104 Participants
Adefovir Dipivoxil 10 mg tablets once daily
|
|---|---|
|
Age Continuous
|
35.3 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
|
104 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 156Population: 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.
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.
Outcome measures
| Measure |
Adefovir Dipivoxil
n=104 Participants
Adefovir Dipivoxil 10 mg tablets once daily
|
|---|---|
|
Hepatitis B Virus (HBV) DNA (log10 Copies/mL) Change From Baseline at Week 156 of Adefovir Therapy
Baseline, n=104
|
7.94 log10 copies/mL
Standard Deviation 1.66
|
|
Hepatitis B Virus (HBV) DNA (log10 Copies/mL) Change From Baseline at Week 156 of Adefovir Therapy
Week 156, n=74
|
3.89 log10 copies/mL
Standard Deviation 1.59
|
|
Hepatitis B Virus (HBV) DNA (log10 Copies/mL) Change From Baseline at Week 156 of Adefovir Therapy
Change from Baseline
|
-4.16 log10 copies/mL
Standard Deviation 1.79
|
SECONDARY outcome
Timeframe: Week 104, Week 156Population: ITT Population: some participants were not tested at Weeks 104 or 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.
Outcome measures
| Measure |
Adefovir Dipivoxil
n=77 Participants
Adefovir Dipivoxil 10 mg tablets once daily
|
|---|---|
|
Number of Participants Achieving ALT Normalization at Week 104 & 156
Week 104, n=77
|
63 Participants
|
|
Number of Participants Achieving ALT Normalization at Week 104 & 156
Week 156, n=73
|
65 Participants
|
SECONDARY outcome
Timeframe: Week 104, Week 156Population: ITT Population: some participants were not tested at Weeks 104 or 156.
Virological response is defined as HBV DNA level\<300 copies/ml
Outcome measures
| Measure |
Adefovir Dipivoxil
n=77 Participants
Adefovir Dipivoxil 10 mg tablets once daily
|
|---|---|
|
Number of Participants Achieving Virological Response at Week 104 & 156
Week 104, n=77
|
20 Participants
|
|
Number of Participants Achieving Virological Response at Week 104 & 156
Week 156, n=73
|
24 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 68, 80, 92, 104, 120, 132, 144, 156Population: 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.
Serum HBV DNA. Baseline is defined as the first day of study ADF103814, of which Study 108005 is an extension.
Outcome measures
| Measure |
Adefovir Dipivoxil
n=104 Participants
Adefovir Dipivoxil 10 mg tablets once daily
|
|---|---|
|
HBV DNA Levels at Each Collection Time Point From Baseline Through Week 156
Week 120, n=76
|
3.88 log 10 copies/mL
Standard Deviation 1.44
|
|
HBV DNA Levels at Each Collection Time Point From Baseline Through Week 156
Baseline, n=104
|
7.94 log 10 copies/mL
Standard Deviation 1.66
|
|
HBV DNA Levels at Each Collection Time Point From Baseline Through Week 156
Week 68, n=74
|
3.90 log 10 copies/mL
Standard Deviation 1.37
|
|
HBV DNA Levels at Each Collection Time Point From Baseline Through Week 156
Week 80, n=73
|
3.79 log 10 copies/mL
Standard Deviation 1.36
|
|
HBV DNA Levels at Each Collection Time Point From Baseline Through Week 156
Week 92, n=77
|
3.99 log 10 copies/mL
Standard Deviation 1.49
|
|
HBV DNA Levels at Each Collection Time Point From Baseline Through Week 156
Week 104, n=76
|
3.97 log 10 copies/mL
Standard Deviation 1.44
|
|
HBV DNA Levels at Each Collection Time Point From Baseline Through Week 156
Week 132, n=78
|
3.93 log 10 copies/mL
Standard Deviation 1.51
|
|
HBV DNA Levels at Each Collection Time Point From Baseline Through Week 156
Week 144, n=74
|
3.97 log 10 copies/mL
Standard Deviation 1.55
|
|
HBV DNA Levels at Each Collection Time Point From Baseline Through Week 156
Week 156, n=73
|
3.89 log 10 copies/mL
Standard Deviation 1.59
|
SECONDARY outcome
Timeframe: Week 104 and 156Population: All participants achieving viological response, defined as an HBV DNA level ≤ 300. Some participants were not tested at various weeks.
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.
Outcome measures
| Measure |
Adefovir Dipivoxil
n=77 Participants
Adefovir Dipivoxil 10 mg tablets once daily
|
|---|---|
|
Number of Participants With HBeAg Loss, HBeAg Seroconversion, HBsAg Loss and HBsAg Seroconversion at Week 104 & 156
Week 104 HBeAg loss, n=77
|
23 Participants
|
|
Number of Participants With HBeAg Loss, HBeAg Seroconversion, HBsAg Loss and HBsAg Seroconversion at Week 104 & 156
Week 104 HBeAg seroconversion, n=77
|
6 Participants
|
|
Number of Participants With HBeAg Loss, HBeAg Seroconversion, HBsAg Loss and HBsAg Seroconversion at Week 104 & 156
Week 104 HBsAg loss, n=77
|
0 Participants
|
|
Number of Participants With HBeAg Loss, HBeAg Seroconversion, HBsAg Loss and HBsAg Seroconversion at Week 104 & 156
Week 104 HBsAg seroconversion, n=77
|
0 Participants
|
|
Number of Participants With HBeAg Loss, HBeAg Seroconversion, HBsAg Loss and HBsAg Seroconversion at Week 104 & 156
Week 156 HBeAg loss, n=73
|
27 Participants
|
|
Number of Participants With HBeAg Loss, HBeAg Seroconversion, HBsAg Loss and HBsAg Seroconversion at Week 104 & 156
Week 156 HBeAg seroconversion, n=73
|
12 Participants
|
|
Number of Participants With HBeAg Loss, HBeAg Seroconversion, HBsAg Loss and HBsAg Seroconversion at Week 104 & 156
Week 156 HBsAg loss, n=73
|
1 Participants
|
|
Number of Participants With HBeAg Loss, HBeAg Seroconversion, HBsAg Loss and HBsAg Seroconversion at Week 104 & 156
Week 156 HBsAg seroconversion, n=73
|
0 Participants
|
SECONDARY outcome
Timeframe: Treatment Phase (Weeks 53-156)Population: ITT Population
The number of participants with a serious adverse event and an adverse event is reported. Refer to the adverse event section for details.
Outcome measures
| Measure |
Adefovir Dipivoxil
n=80 Participants
Adefovir Dipivoxil 10 mg tablets once daily
|
|---|---|
|
Safety Assessment: Number of Participants With a Serious Adverse Event and an Adverse Event
Serious adverse event
|
2 participants
|
|
Safety Assessment: Number of Participants With a Serious Adverse Event and an Adverse Event
Adverse event
|
43 participants
|
Adverse Events
Adefovir Dipivoxil
Serious adverse events
| Measure |
Adefovir Dipivoxil
n=80 participants at risk
Adefovir Dipivoxil 10 mg tablets once daily
|
|---|---|
|
Gastrointestinal disorders
Acute pancreatitis
|
1.2%
1/80
|
|
Musculoskeletal and connective tissue disorders
Nasal bone fracture
|
1.2%
1/80
|
|
Hepatobiliary disorders
Cholangitis
|
1.2%
1/80
|
|
Hepatobiliary disorders
Cholecystitis
|
1.2%
1/80
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic cancer
|
1.2%
1/80
|
Other adverse events
| Measure |
Adefovir Dipivoxil
n=80 participants at risk
Adefovir Dipivoxil 10 mg tablets once daily
|
|---|---|
|
Endocrine disorders
Retinopathy diabetic
|
1.2%
1/80
|
|
Eye disorders
Xerophthalmia
|
1.2%
1/80
|
|
Gastrointestinal disorders
Abdominal pain
|
2.5%
2/80
|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
2/80
|
|
Gastrointestinal disorders
Epigastric discomfort
|
1.2%
1/80
|
|
Gastrointestinal disorders
Epigastric hunger pain
|
1.2%
1/80
|
|
Gastrointestinal disorders
Epigastric pain
|
1.2%
1/80
|
|
Gastrointestinal disorders
Gastritis
|
1.2%
1/80
|
|
Gastrointestinal disorders
Heartburn
|
1.2%
1/80
|
|
Gastrointestinal disorders
Indigestion
|
1.2%
1/80
|
|
Gastrointestinal disorders
Mouth dry
|
1.2%
1/80
|
|
Gastrointestinal disorders
Oral submucous fibrosis
|
1.2%
1/80
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
1.2%
1/80
|
|
Gastrointestinal disorders
Umbrical cord area pain
|
1.2%
1/80
|
|
General disorders
Chest pain
|
1.2%
1/80
|
|
General disorders
Fatigue
|
3.8%
3/80
|
|
General disorders
Fever
|
1.2%
1/80
|
|
General disorders
Weakness generalized
|
1.2%
1/80
|
|
Hepatobiliary disorders
Liver fatty
|
1.2%
1/80
|
|
Infections and infestations
Ascites
|
1.2%
1/80
|
|
Infections and infestations
Bronchitis
|
1.2%
1/80
|
|
Infections and infestations
Broncitis aggravated
|
1.2%
1/80
|
|
Infections and infestations
Bronchitis chronic
|
1.2%
1/80
|
|
Infections and infestations
Folliculitis
|
1.2%
1/80
|
|
Infections and infestations
Herpes zoster
|
1.2%
1/80
|
|
Infections and infestations
Pharyngitis
|
1.2%
1/80
|
|
Investigations
Alpha-fetoprotein increased
|
1.2%
1/80
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
10/80
|
|
Investigations
Aspartate aminotransferase increased
|
8.8%
7/80
|
|
Investigations
Creatine phosphokinase increased
|
1.2%
1/80
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.2%
1/80
|
|
Musculoskeletal and connective tissue disorders
Finger sprain
|
1.2%
1/80
|
|
Musculoskeletal and connective tissue disorders
Lipoma
|
1.2%
1/80
|
|
Musculoskeletal and connective tissue disorders
Left wrist pain
|
1.2%
1/80
|
|
Musculoskeletal and connective tissue disorders
Left knee pain
|
1.2%
1/80
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.2%
1/80
|
|
Musculoskeletal and connective tissue disorders
Pain neck/shoulder
|
1.2%
1/80
|
|
Musculoskeletal and connective tissue disorders
Right middle finger pain
|
1.2%
1/80
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Epidermal cyst
|
1.2%
1/80
|
|
Nervous system disorders
Dizziness
|
1.2%
1/80
|
|
Nervous system disorders
Headache
|
6.2%
5/80
|
|
Nervous system disorders
Numbness
|
1.2%
1/80
|
|
Nervous system disorders
Tingling skin
|
1.2%
1/80
|
|
Nervous system disorders
Vertigo
|
1.2%
1/80
|
|
Respiratory, thoracic and mediastinal disorders
Common cold
|
5.0%
4/80
|
|
Respiratory, thoracic and mediastinal disorders
Coughing
|
1.2%
1/80
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER