Trial · NCT00324961
Adefovir Dipivoxil Tablets (10mg) In Chinese Subjects With HBe Antigen Negative Chronic Hepatitis B
NCT00324961, Phase 4, Completed, GlaxoSmithKline; results first posted 2009-10-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Adefovir Dipivoxil Tablets (10mg) In Chinese Subjects With HBe Antigen Negative Chronic Hepatitis B. Trials, record NCT00324961. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00324961
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Adefovir Dipivoxil Tablets (10mg) In Chinese Subjects With HBe Antigen Negative Chronic Hepatitis B
- NCT number
- NCT00324961
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 533 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Chronic Hepatitis B
- Interventions
- adefovir dipivoxil tablets
- First posted
- 2006-05-11
- Last updated
- 2009-10-28
- Results first posted
- 2009-10-02
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Achieving HBV DNA ≤300 Copies/mL at Week 104 | Week 104 | Hepatitis B Virus (HBV) DNA level is tested in blood serum by real-time Polymerase Chain Reaction with the lower limit of detection (LLD) as 300 copies/milliliter in a central laboratory. |
| Secondary | Number of Participants Achieving Histological Improvement After the 104-week Treatment | Week 104 | Histological improvement (defined as ≥2 point reduction in the Knodell necroinflammation score without worsening fibrosis) was assessed by 2 independent pathologists in the HBeAg-negative participants who underwent 2 sequential liver biopsies at baseline and week 104/withdrawal. The Knodell/histological activity index (HAI) scoring system represents the sum of scores for periportal, bridging necrosis (0-10: none=0, multilobular necrosis=10), interlobular degeneration and focal necrosis (0-4: none=0, marked=4), portal inflammation (0-4: none=0, marked=4), and fibrosis (0-4: none=0, cirrhosis=4) |
| Secondary | Liver Histology Scores in HBeAg Negative Participants With Two Sequential Liver Biopsies During the Period of 104 Weeks | Baseline to Week 104 | The Knodell/histological activity index (HAI) scoring system that represents the sum of scores for periportal bridging necrosis (0-10: none=0, moderate piecemeal necrosis plus bridging necrosis=5, multilobular necrosis=10); interlobular degeneration and focal necrosis (0-4: none=0, marked=4); portal inflammation (0-4: none=0, marked=4) and fibrosis (0-4: none=0, fibrous portal expansion=1, bridging fibrosis=3, cirrhosis=4) was carried out by two independent pathologists in the HBeAg negative participants with 2 sequential liver biopsies during the period of 104 weeks. |
| Secondary | Change From Baseline in Median Serum HBV DNA Over Time | Baseline and Weeks 13, 26, 39, 52, 65, 78, 91, and 104 | The HBV DNA level was tested in blood serum by real-time PCR with the LLD as 300 copies/mL at baseline and Weeks 13, 26, 39, 52, 65, 78, 91, and 104 in a central laboratory. |
| Secondary | Number of Participants Achieving ALT Normalization at Week 104 | Week 104 | Serum alanine aminotransferase (ALT) normalization was defined as a serum ALT level at or below the upper limit of the normal (ULN) range after a baseline value above the ULN, as determined using central laboratory ranges. |
| Secondary | Number of Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 104 | Week 104 | HBsAg loss and HBsAg seroconversion (HBsAg loss and HBsAb detected) were assessed for all participants who were HBeAg negative at Weeks 0 and 104. Confirmed HBsAg loss was defined as undetectable HBeAg. |
| Secondary | Number of Participants With ADV-associated Resistance at Week 104 | Week 104 | Week 104 serum samples from participants who reached a HBV DNA breakthrough were assessed for the development of ADV (Adefovir dipivoxil) mutations (N236T and A181V) in the HBV polymerase. HBV DNA breakthrough was defined as an increase in HBV DNA level by 1 log10 copies/mL or more from the treatment nadir during Weeks 0 to 104. |
| Secondary | Number of Participants Achieving HBV DNA ≤300 Copies/mL Over Time | Weeks 13, 26, 39, 52, 65, 78, 91, and 104 | Hepatitis B Virus (HBV) DNA level is tested in blood serum by real-time Polymerase Chain Reaction with the lower limit of detection (LLD) as 300 copies/milliliter in a central laboratory. |
| Secondary | Number of Participants Achieving Complete Response at Week 104 | Week 104 | Complete response was defined as an HBV DNA level ≤ 300 copies/mL by the Roche COBAS AMPLICOR HBV MONITOR Test and ALT normalized for two consecutive visits at least 3 months apart. |
| Secondary | Time to Protocol-defined Complete Response Over a 104-week Treatment Period | Baseline to Week 104 | Time to response was defined as the time to participants achieving protocol-defined complete response at week 104 from baseline. Protocol-defined complete response was an HBV DNA level ≤ 300 copies/mL by Roche COBAS AMPLICOR HBV MONITOR Test and ALT normalized for two consecutive visits at least 3 months apart. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Achieving HBV DNA ≤300 Copies/mL at Week 104 | Week 104 | Intent-to-Treat (ITT) Population: all HBeAg participants who actually received the study medication at least once. Participants with missing data were not included in the analysis. | participants | NUMBER |
| SECONDARY | Number of Participants Achieving Histological Improvement After the 104-week Treatment | Week 104 | HBeAg negative chronic hepatitis B participants who underwent liver biopsy at Week 104 | participants | NUMBER |
| SECONDARY | Liver Histology Scores in HBeAg Negative Participants With Two Sequential Liver Biopsies During the Period of 104 Weeks | Baseline to Week 104 | HBeAg negative chronic hepatitis B participants who underwent liver biopsy at Week 48 | Points on a scale | MEAN |
| SECONDARY | Change From Baseline in Median Serum HBV DNA Over Time | Baseline and Weeks 13, 26, 39, 52, 65, 78, 91, and 104 | Intent-to-Treat (ITT) Population: all HBeAg negative participants who actually received the study medication at least once. | log10 copies/mL | MEDIAN |
| SECONDARY | Number of Participants Achieving ALT Normalization at Week 104 | Week 104 | Intent-to-Treat (ITT) Population: all HBeAg negative participants who actually received the study medication at least once. A total of 435 participants had a baseline ALT value above the ULN. | participants | NUMBER |
| SECONDARY | Number of Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 104 | Week 104 | Intent-to-Treat (ITT) Population: all HBeAg negative participants who actually received the study medication at least once | participants | NUMBER |
| SECONDARY | Number of Participants With ADV-associated Resistance at Week 104 | Week 104 | Intent-to-Treat (ITT) Population: all participants who actually received the study medication at least once. | participants | NUMBER |
| SECONDARY | Number of Participants Achieving HBV DNA ≤300 Copies/mL Over Time | Weeks 13, 26, 39, 52, 65, 78, 91, and 104 | Intent-to-Treat (ITT) Population: all participants who actually received the study medication at least once. Missing data were not included in statistical analysis. | participants | NUMBER |
| SECONDARY | Number of Participants Achieving Complete Response at Week 104 | Week 104 | Intent-to-Treat (ITT) Population: all participants who actually received the study medication at least once. | participants | NUMBER |
| SECONDARY | Time to Protocol-defined Complete Response Over a 104-week Treatment Period | Baseline to Week 104 | Intent-to-Treat (ITT) Population: all participants who actually received the study medication at least once. | days | MEAN |
Source ClinicalTrials.gov
Results by group35
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Achieving HBV DNA ≤300 Copies/mL at Week 104 | HBeAg- at Baseline | HBV DNA ≤300 cp/mL | 85 | participants | |
| Number of Participants Achieving HBV DNA ≤300 Copies/mL at Week 104 | HBeAg- at Baseline | HBV DNA > 300 cp/mL | 403 | participants | |
| Number of Participants Achieving Histological Improvement After the 104-week Treatment | HBeAg- at Baseline | Histological improvement | 21 | participants | |
| Number of Participants Achieving Histological Improvement After the 104-week Treatment | HBeAg- at Baseline | No histological change | 17 | participants | |
| Number of Participants Achieving Histological Improvement After the 104-week Treatment | HBeAg- at Baseline | Histological worsening | 13 | participants | |
| Liver Histology Scores in HBeAg Negative Participants With Two Sequential Liver Biopsies During the Period of 104 Weeks | HBeAg- at Baseline | Knodell score at baseline | 8.0 | Standard Deviation 3.8 | Points on a scale |
| Liver Histology Scores in HBeAg Negative Participants With Two Sequential Liver Biopsies During the Period of 104 Weeks | HBeAg- at Baseline | Knodell score at week 104/withdrawal | 5.4 | Standard Deviation 2.8 | Points on a scale |
| Liver Histology Scores in HBeAg Negative Participants With Two Sequential Liver Biopsies During the Period of 104 Weeks | HBeAg- at Baseline | Necroinflammation score at baseline | 6.3 | Standard Deviation 3.0 | Points on a scale |
| Liver Histology Scores in HBeAg Negative Participants With Two Sequential Liver Biopsies During the Period of 104 Weeks | HBeAg- at Baseline | Necroinflammation score at week 104/withdrawal | 3.2 | Standard Deviation 2.0 | Points on a scale |
| Liver Histology Scores in HBeAg Negative Participants With Two Sequential Liver Biopsies During the Period of 104 Weeks | HBeAg- at Baseline | Fibrosis score at baseline | 1.6 | Standard Deviation 0.9 | Points on a scale |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 10 mg Adefovir Dipivoxil (ADV) | 533 | |
| Overall Study | COMPLETED | 10 mg Adefovir Dipivoxil (ADV) | 490 | |
| Overall Study | NOT COMPLETED | 10 mg Adefovir Dipivoxil (ADV) | 43 |
Source ClinicalTrials.gov
Adverse events7
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | 10 mg Adefovir Dipivoxil (ADV) | 38 | 533 | |
| serious | Hepatitis B | Infections and infestations | 10 mg Adefovir Dipivoxil (ADV) | 1 | 533 | |
| serious | Alanine aminotransferase increased | Investigations | 10 mg Adefovir Dipivoxil (ADV) | 1 | 533 | |
| serious | Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 10 mg Adefovir Dipivoxil (ADV) | 1 | 533 | |
| serious | Neurilemmoma | Nervous system disorders | 10 mg Adefovir Dipivoxil (ADV) | 1 | 533 | |
| serious | Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | 10 mg Adefovir Dipivoxil (ADV) | 1 | 533 | |
| serious | Cerebral hemorrhage | Vascular disorders | 10 mg Adefovir Dipivoxil (ADV) | 1 | 533 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 10 mg Adefovir Dipivoxil (ADV) | ||
| Total, other adverse events | 10 mg Adefovir Dipivoxil (ADV) | 38 | |
| Total, serious adverse events | 10 mg Adefovir Dipivoxil (ADV) | 5 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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