Trial · NCT01023217
Entecavir Plus Adefovir in Lamivudine-Resistant Chronic Hepatitis B Patients Who Fail Lamivudine Plus Adefovir
NCT01023217, Phase 4, Completed, Asan Medical Center; results first posted 2014-01-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Entecavir Plus Adefovir in Lamivudine-Resistant Chronic Hepatitis B Patients Who Fail Lamivudine Plus Adefovir. Trials, record NCT01023217. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01023217
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Entecavir Plus Adefovir in Lamivudine-Resistant Chronic Hepatitis B Patients Who Fail Lamivudine Plus Adefovir
- NCT number
- NCT01023217
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 90 participants, actual
- Lead sponsor
- Asan Medical Center
- Conditions
- Hepatitis B, Chronic
- Interventions
- Adefovir, Entecavir, Lamivudine
- First posted
- 2009-12-02
- Last updated
- 2014-02-10
- Results first posted
- 2014-01-13
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Virologic Response (CVR, Serum HBV DNA Undetectable by PCR or Less Than 60 IU/mL) | at week 52 from randomization | |
| Secondary | Reduction in Serum HBV DNA Levels | at week 52 and at week 104 from randomization | |
| Secondary | Genotypic Resistance to ADV or ETV | at week 52 and at week 104 from randomization | |
| Secondary | Normalization of ALT Level | at week 52 and at week 104 from randomization | |
| Secondary | Complete Virologic Response (CVR, Serum HBV DNA Undetectable by PCR or Less Than 60 IU/mL) | at week 104 from randomization |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Virologic Response (CVR, Serum HBV DNA Undetectable by PCR or Less Than 60 IU/mL) | at week 52 from randomization | participants | NUMBER | |
| SECONDARY | Reduction in Serum HBV DNA Levels | at week 52 and at week 104 from randomization | |||
| SECONDARY | Genotypic Resistance to ADV or ETV | at week 52 and at week 104 from randomization | |||
| SECONDARY | Normalization of ALT Level | at week 52 and at week 104 from randomization | |||
| SECONDARY | Complete Virologic Response (CVR, Serum HBV DNA Undetectable by PCR or Less Than 60 IU/mL) | at week 104 from randomization |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Virologic Response (CVR, Serum HBV DNA Undetectable by PCR or Less Than 60 IU/mL) | Adefovir Plus Entecavir | 13 | participants | ||
| Complete Virologic Response (CVR, Serum HBV DNA Undetectable by PCR or Less Than 60 IU/mL) | Adefovir Plus Lamivudine | 2 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Adefovir Plus Lamivudine | 45 | |
| Overall Study | STARTED | Adefovir Plus Entecavir | 45 | |
| Overall Study | COMPLETED | Adefovir Plus Lamivudine | 44 | |
| Overall Study | COMPLETED | Adefovir Plus Entecavir | 45 | |
| Overall Study | NOT COMPLETED | Adefovir Plus Lamivudine | 1 | |
| Overall Study | NOT COMPLETED | Adefovir Plus Entecavir | 0 |
Source ClinicalTrials.gov
Adverse events10
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 | URI | Respiratory, thoracic and mediastinal disorders | Adefovir Plus Entecavir | 5 | 45 | 5 |
| other | URI | Respiratory, thoracic and mediastinal disorders | Adefovir Plus Lamivudine | 5 | 45 | 5 |
| serious | Hearing loss | Ear and labyrinth disorders | Adefovir Plus Entecavir | 1 | 45 | 1 |
| serious | Hearing loss | Ear and labyrinth disorders | Adefovir Plus Lamivudine | 0 | 45 | 0 |
| serious | Thyroid cancer | Endocrine disorders | Adefovir Plus Entecavir | 1 | 45 | 1 |
| serious | Thyroid cancer | Endocrine disorders | Adefovir Plus Lamivudine | 0 | 45 | 0 |
| serious | Intervertebral disc herniation | Musculoskeletal and connective tissue disorders | Adefovir Plus Entecavir | 0 | 45 | 0 |
| serious | Intervertebral disc herniation | Musculoskeletal and connective tissue disorders | Adefovir Plus Lamivudine | 1 | 45 | 1 |
| serious | rib fracture | Musculoskeletal and connective tissue disorders | Adefovir Plus Entecavir | 0 | 45 | 0 |
| serious | rib fracture | Musculoskeletal and connective tissue disorders | Adefovir Plus Lamivudine | 1 | 45 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Adefovir Plus Entecavir | ||
| Total, all-cause mortality | Adefovir Plus Lamivudine | ||
| Total, other adverse events | Adefovir Plus Entecavir | 5 | 45 |
| Total, other adverse events | Adefovir Plus Lamivudine | 5 | 45 |
| Total, serious adverse events | Adefovir Plus Entecavir | 2 | 45 |
| Total, serious adverse events | Adefovir Plus Lamivudine | 2 | 45 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23650172 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Adefovir Plus Entecavir vs Adefovir Plus Lamivudine: Complete Virologic Response (CVR, Serum HBV DNA Undetectable by PCR or Less Than 60 IU/mL) | Trial comparisons |
| Adefovir Plus Entecavir vs Adefovir Plus Lamivudine: serious adverse events | Trial comparisons |
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01023217
GET https://conductscience.org/api/trials/v1/NCT01023217/registered