Trial · NCT01329419

HEPSERA Post Marketing Surveillance

NCT01329419, Completed, GlaxoSmithKline; results first posted 2011-04-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. HEPSERA Post Marketing Surveillance. Trials, record NCT01329419. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01329419

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: HEPSERA Post Marketing Surveillance
NCT number: NCT01329419
Status: Completed
Enrollment: 4,393 participants, actual
Lead sponsor: GlaxoSmithKline
Conditions: Hepatitis B
Interventions: adefovir dipivoxil
First posted: 2011-04-05
Last updated: 2017-07-05
Results first posted: 2011-04-05

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With an Adverse Event	12 weeks	An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all adverse events occurring during the course of the study, please see the table entitled "Other (non-serious) adverse events" in the Adverse Event section of the results record.
Secondary	Number of Participants With a Serious Adverse Event	12 weeks	A serious adverse event is any untoward medical occurrence that, at any dose: results in death /is life-threatening; requires hospitalization or prolongation of exixting hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is another medically significant event. For a list of all serious adverse events occurring during the course of the study, please see the table entitled "Serious Adverse Events" in the Adverse Event section of the results record.
Secondary	Number of Participants With the Indicated Unexpected Adverse Events	12 weeks	An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With an Adverse Event	12 weeks	Intent-to-Treat (ITT) Population: all participants who had been administered the investigational drug at least once and had undergone all safety assessments	participants	NUMBER
SECONDARY	Number of Participants With a Serious Adverse Event	12 weeks	ITT Population	participants	NUMBER
SECONDARY	Number of Participants With the Indicated Unexpected Adverse Events	12 weeks	ITT Population	participants	NUMBER

Source ClinicalTrials.gov

Results by group36

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants With an Adverse Event	Hepsera 10 mg Once a Day		74	participants
Number of Participants With a Serious Adverse Event	Hepsera 10 mg Once a Day		32	participants
Number of Participants With the Indicated Unexpected Adverse Events	Hepsera 10 mg Once a Day	Sputum Increased	5	participants
Number of Participants With the Indicated Unexpected Adverse Events	Hepsera 10 mg Once a Day	Hepatic Cirrhosis	4	participants
Number of Participants With the Indicated Unexpected Adverse Events	Hepsera 10 mg Once a Day	Hepatic Encephalopathy	2	participants
Number of Participants With the Indicated Unexpected Adverse Events	Hepsera 10 mg Once a Day	Hepatic Neoplasm	7	participants
Number of Participants With the Indicated Unexpected Adverse Events	Hepsera 10 mg Once a Day	Hypoaesthesia	2	participants
Number of Participants With the Indicated Unexpected Adverse Events	Hepsera 10 mg Once a Day	Hemoptysis	1	participants
Number of Participants With the Indicated Unexpected Adverse Events	Hepsera 10 mg Once a Day	Azotaemia	1	participants
Number of Participants With the Indicated Unexpected Adverse Events	Hepsera 10 mg Once a Day	Marrow Hyperplasia	1	participants

1 to 10 of 36Source ClinicalTrials.gov

See all 36 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Hepsera 10 mg Once a Day	4,393
Overall Study	COMPLETED	Hepsera 10 mg Once a Day	4,158
Overall Study	NOT COMPLETED	Hepsera 10 mg Once a Day	235

Source ClinicalTrials.gov

Adverse events73

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
other	Abdominal Pain	Gastrointestinal disorders	Hepsera 10 mg Once a Day	6	4,158
other	Dyspepsia	Gastrointestinal disorders	Hepsera 10 mg Once a Day	5	4,158
other	Gagging	Gastrointestinal disorders	Hepsera 10 mg Once a Day	4	4,158
other	Flatulence	Gastrointestinal disorders	Hepsera 10 mg Once a Day	4	4,158
other	Diarrhea	General disorders	Hepsera 10 mg Once a Day	2	4,158
other	Esophageal Varices	Gastrointestinal disorders	Hepsera 10 mg Once a Day	1	4,158
other	Hemorrhage Rectum	Gastrointestinal disorders	Hepsera 10 mg Once a Day	1	4,158
other	Gastric Ulcer Hemorrhagic	Gastrointestinal disorders	Hepsera 10 mg Once a Day	1	4,158
other	Hematemesis	Gastrointestinal disorders	Hepsera 10 mg Once a Day	1	4,158
other	Melaena	Gastrointestinal disorders	Hepsera 10 mg Once a Day	1	4,158

1 to 10 of 73Source ClinicalTrials.gov

See all 73 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Hepsera 10 mg Once a Day
Total, other adverse events	Hepsera 10 mg Once a Day	74	4,158
Total, serious adverse events	Hepsera 10 mg Once a Day	32	4,158

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01329419

GET https://conductscience.org/api/trials/v1/NCT01329419/results?page=2

API reference For AI assistants