A Phase 4 interventional study of adefovir dipivoxil 10mg in Hepatitis B, Chronic and Chronic Hepatitis B, sponsored by GlaxoSmithKline. Completed at 1 site in South Korea. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-12-15.
Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Treatment
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.
954 studies on the registry are indexed under Hepatitis B, Chronic; 147 are open to participants now.
This study's enrollment of 80 is below the median of 100 across 692 interventional studies indexed under Hepatitis B, Chronic.
Browse Hepatitis B, Chronic studies →GlaxoSmithKline is the lead sponsor of 3,647 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 239 (91%) have results posted.
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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.
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.
Time frame: Baseline, Week 156
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.
Time frame: Week 104, Week 156
Number of Participants Achieving Virological Response at Week 104 & 156
Virological response is defined as HBV DNA level\<300 copies/ml
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Treatment Phase (Weeks 53-156)
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.
| Milestone | Adefovir Dipivoxil |
|---|---|
| Started | 104 |
| Completed | 102 |
| Not completed | 2 |
| Withdrew: Lost to follow-up | 2 |
| Milestone | Adefovir Dipivoxil |
|---|---|
| Started | 80 |
| Completed | 74 |
| Not completed | 6 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Hbv dna mutation positive | 4 |
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.
| log10 copies/mL | Adefovir Dipivoxil |
|---|---|
| Baseline, n=104 | 7.94 ± 1.66 |
| Week 156, n=74 | 3.89 ± 1.59 |
| Change from Baseline | -4.16 ± 1.79 |
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.
| Participants | Adefovir Dipivoxil |
|---|---|
| Week 104, n=77 | 63 |
| Week 156, n=73 | 65 |
Virological response is defined as HBV DNA level\<300 copies/ml
| Participants | Adefovir Dipivoxil |
|---|---|
| Week 104, n=77 | 20 |
| Week 156, n=73 | 24 |
Serum HBV DNA. Baseline is defined as the first day of study ADF103814, of which Study 108005 is an extension.
| log 10 copies/mL | Adefovir Dipivoxil |
|---|---|
| Baseline, n=104 | 7.94 ± 1.66 |
| Week 68, n=74 | 3.90 ± 1.37 |
| Week 80, n=73 | 3.79 ± 1.36 |
| Week 92, n=77 | 3.99 ± 1.49 |
| Week 104, n=76 | 3.97 ± 1.44 |
| Week 120, n=76 | 3.88 ± 1.44 |
| Week 132, n=78 | 3.93 ± 1.51 |
| Week 144, n=74 | 3.97 ± 1.55 |
| Week 156, n=73 | 3.89 ± 1.59 |
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.
| Participants | Adefovir Dipivoxil |
|---|---|
| Week 104 HBeAg loss, n=77 | 23 |
| Week 104 HBeAg seroconversion, n=77 | 6 |
| Week 104 HBsAg loss, n=77 | 0 |
| Week 104 HBsAg seroconversion, n=77 | 0 |
| Week 156 HBeAg loss, n=73 | 27 |
| Week 156 HBeAg seroconversion, n=73 | 12 |
| Week 156 HBsAg loss, n=73 | 1 |
| Week 156 HBsAg seroconversion, n=73 | 0 |
The number of participants with a serious adverse event and an adverse event is reported. Refer to the adverse event section for details.
| participants | Adefovir Dipivoxil |
|---|---|
| Serious adverse event | 2 |
| Adverse event | 43 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adefovir Dipivoxil | — | 2/80 (2.5%) | 43/80 (53.8%) |
| Event | Adefovir Dipivoxil |
|---|---|
| Acute pancreatitisGastrointestinal disorders | 1/80 |
| Nasal bone fractureMusculoskeletal and connective tissue disorders | 1/80 |
| CholangitisHepatobiliary disorders | 1/80 |
| CholecystitisHepatobiliary disorders | 1/80 |
| Pancreatic cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/80 |
| Event | Adefovir Dipivoxil |
|---|---|
| Alanine aminotransferase increasedInvestigations | 10/80 |
| Aspartate aminotransferase increasedInvestigations | 7/80 |
| HeadacheNervous system disorders | 5/80 |
| Common coldRespiratory, thoracic and mediastinal disorders | 4/80 |
| FatigueGeneral disorders | 3/80 |
| Abdominal painGastrointestinal disorders | 2/80 |
| DiarrhoeaGastrointestinal disorders | 2/80 |
| Retinopathy diabeticEndocrine disorders | 1/80 |
| XerophthalmiaEye disorders | 1/80 |
| Epigastric discomfortGastrointestinal disorders | 1/80 |
| Age Continuous(years) | Adefovir Dipivoxil |
|---|---|
| Mean | 35.3 ± 10.4 |
| Sex: Female, Male(Participants) | Adefovir Dipivoxil |
|---|---|
| Female | 21 |
| Male | 83 |
| Race/Ethnicity, Customized(Participants) | Adefovir Dipivoxil |
|---|---|
| Number | 104 |
This study is completed, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Adefovir dipivoxil