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HEPSERA Post Marketing Surveillance (HEPSERA PMS)

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ClinicalTrials.gov Identifier: NCT01329419
Recruitment Status : Completed
First Posted : April 5, 2011
Results First Posted : April 5, 2011
Last Update Posted : July 5, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Hepatitis B
Intervention Drug: adefovir dipivoxil
Enrollment 4393
Recruitment Details The objective of this post-marketing surveillance (PMS) study was to monitor the safety and efficacy of Hepsera in the real clinical setting after launch.
Pre-assignment Details  
Arm/Group Title Hepsera 10 mg Once a Day
Hide Arm/Group Description Hepsera tablet containing 10 milligrams (mg) of adefovir dipivoxil administered once daily
Period Title: Overall Study
Started 4393
Completed 4158
Not Completed 235
Reason Not Completed
Protocol Violation             235
Arm/Group Title Hepsera 10 mg Once a Day
Hide Arm/Group Description Hepsera tablet containing 10 milligrams (mg) of adefovir dipivoxil administered once daily
Overall Number of Baseline Participants 4158
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4158 participants
43.9  (11)
[1]
Measure Description: Baseline characteristics were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants who had been administered the investigational drug at least once and had undergone all safety assessments.
Sex/Gender, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4158 participants
Female 874
Male 3280
Missing 4
[1]
Measure Description: Baseline characteristics were collected in members of the ITT Population, comprised of all participants who had been administered the investigational drug at least once and had undergone all safety assessments.
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4158 participants
Korean 4158
Not Korean 0
[1]
Measure Description: Baseline characteristics were collected in members of the ITT Population, comprised of all participants who had been administered the investigational drug at least once and had undergone all safety assessments.
1.Primary Outcome
Title Number of Participants With an Adverse Event
Hide Description 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.
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all participants who had been administered the investigational drug at least once and had undergone all safety assessments
Arm/Group Title Hepsera 10 mg Once a Day
Hide Arm/Group Description:
Hepsera tablet containing 10 milligrams (mg) of adefovir dipivoxil administered once daily
Overall Number of Participants Analyzed 4158
Measure Type: Number
Unit of Measure: participants
74
2.Secondary Outcome
Title Number of Participants With a Serious Adverse Event
Hide Description 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.
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Hepsera 10 mg Once a Day
Hide Arm/Group Description:
Hepsera tablet containing 10 mg of adefovir dipivoxil administered once daily
Overall Number of Participants Analyzed 4158
Measure Type: Number
Unit of Measure: participants
32
3.Secondary Outcome
Title Number of Participants With the Indicated Unexpected Adverse Events
Hide Description 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.
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Hepsera 10 mg Once a Day
Hide Arm/Group Description:
Hepsera tablet containing 10 mg of adefovir dipivoxil administered once daily
Overall Number of Participants Analyzed 4158
Measure Type: Number
Unit of Measure: participants
Sputum Increased 5
Hepatic Cirrhosis 4
Hepatic Encephalopathy 2
Hepatic Neoplasm 7
Hypoaesthesia 2
Hemoptysis 1
Azotaemia 1
Marrow Hyperplasia 1
Marrow Depression 1
Fracture 1
Fasciitis Necrotising 1
Skin Reaction Localised 1
Myalgia 1
Resistance 1
Proteinuria 1
Edema Peripheral 1
Dysuria 2
Pancytopenia 1
Ascites 3
Splenomegaly 1
Hernia Inguinal 1
Esophageal Varices 1
Urethral Disorder 1
Erythrocytes Abnormal 1
Vein Varicose 4
Hemorrhage Rectum 1
Gastric Ulcer Hemorrhagic 1
Hematemesis 1
Pneumonia 2
Pulmonary Carcinoma 1
Fatigue 3
Dyspnea 1
Jaundice 2
Melaena 1
Time Frame February 19, 2004 to February 18, 2010
Adverse Event Reporting Description Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
 
Arm/Group Title Hepsera 10 mg Once a Day
Hide Arm/Group Description Hepsera tablet containing 10 milligrams (mg) of adefovir dipivoxil administered once daily
All-Cause Mortality
Hepsera 10 mg Once a Day
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Hepsera 10 mg Once a Day
Affected / at Risk (%)
Total   32/4158 (0.77%) 
Blood and lymphatic system disorders   
Vein Varicose  1  3/4158 (0.07%) 
Pancytopenia  1  1/4158 (0.02%) 
Gastrointestinal disorders   
Gastric Ulcer Hemorrhagic  1  1/4158 (0.02%) 
Melaena  1  1/4158 (0.02%) 
Hematemesis  1  1/4158 (0.02%) 
Abdominal Pain  1  2/4158 (0.05%) 
General disorders   
Fever  1  1/4158 (0.02%) 
Ascites  1  1/4158 (0.02%) 
Hepatobiliary disorders   
Hepatic Failure  1  9/4158 (0.22%) 
Hepatic Cirrhosis  1  4/4158 (0.10%) 
Hepatic Encephalopathy  1  2/4158 (0.05%) 
Jaundice  1  2/4158 (0.05%) 
Alanine Transaminase/Aspartate Aminotransferase Increased  1  1/4158 (0.02%) 
Musculoskeletal and connective tissue disorders   
Myalgia  1  1/4158 (0.02%) 
Fracture  1  1/4158 (0.02%) 
Fasciitis Necrotising  1  1/4158 (0.02%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Hepatic Neoplasm  1  7/4158 (0.17%) 
Pulmonary Carcinoma  1  1/4158 (0.02%) 
Nervous system disorders   
Hypoaesthesia  1  1/4158 (0.02%) 
Reproductive system and breast disorders   
Hernia Inguinal  1  1/4158 (0.02%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/4158 (0.02%) 
Pneumonia  1  2/4158 (0.05%) 
Skin and subcutaneous tissue disorders   
Rash  1  1/4158 (0.02%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, WHOART
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Hepsera 10 mg Once a Day
Affected / at Risk (%)
Total   74/4158 (1.78%) 
Blood and lymphatic system disorders   
Vein Varicose  1  4/4158 (0.10%) 
Red Blood Cell Abnormality  1  1/4158 (0.02%) 
Marrow Hyperplasia  1  1/4158 (0.02%) 
Marrow Depression  1  1/4158 (0.02%) 
Pancytopenia  1  1/4158 (0.02%) 
Splenomegaly  1  1/4158 (0.02%) 
Gastrointestinal disorders   
Abdominal Pain  1  6/4158 (0.14%) 
Dyspepsia  1  5/4158 (0.12%) 
Gagging  1  4/4158 (0.10%) 
Flatulence  1  4/4158 (0.10%) 
Esophageal Varices  1  1/4158 (0.02%) 
Hemorrhage Rectum  1  1/4158 (0.02%) 
Gastric Ulcer Hemorrhagic  1  1/4158 (0.02%) 
Hematemesis  1  1/4158 (0.02%) 
Melaena  1  1/4158 (0.02%) 
General disorders   
Diarrhea  1  2/4158 (0.05%) 
Asthenia  1  5/4158 (0.12%) 
Ascites  1  3/4158 (0.07%) 
Fatigue  1  3/4158 (0.07%) 
Tolerance  1  1/4158 (0.02%) 
Edema Peripheral  1  1/4158 (0.02%) 
Fever  1  1/4158 (0.02%) 
Hepatobiliary disorders   
Hepatic Failure  1  9/4158 (0.22%) 
Hepatic Cirrhosis  1  4/4158 (0.10%) 
Alanine Transaminase/Aspartate Aminotransferase Increased  1  2/4158 (0.05%) 
Hepatic Encephalopathy  1  2/4158 (0.05%) 
Hepatitis Chronic Active Aggrava  1  2/4158 (0.05%) 
Jaundice  1  2/4158 (0.05%) 
Musculoskeletal and connective tissue disorders   
Fracture  1  1/4158 (0.02%) 
Fasciitis Necrotising  1  1/4158 (0.02%) 
Myalgia  1  1/4158 (0.02%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Hepatic Neoplasm  1  7/4158 (0.17%) 
Pulmonary Carcinoma  1  1/4158 (0.02%) 
Nervous system disorders   
Hypoaesthesia  1  2/4158 (0.05%) 
Headache  1  1/4158 (0.02%) 
Renal and urinary disorders   
Dysuria  1  2/4158 (0.05%) 
Azotaemia  1  1/4158 (0.02%) 
Proteinuria  1  1/4158 (0.02%) 
Urethral Disorder  1  1/4158 (0.02%) 
Hematuria  1  1/4158 (0.02%) 
Hernia Inguinal  1  1/4158 (0.02%) 
Respiratory, thoracic and mediastinal disorders   
Coughing  1  7/4158 (0.17%) 
Sputum Increased  1  5/4158 (0.12%) 
Pneumonitis  1  2/4158 (0.05%) 
Hemoptysis  1  1/4158 (0.02%) 
Pharyngitis  1  1/4158 (0.02%) 
Dyspnea  1  1/4158 (0.02%) 
Skin and subcutaneous tissue disorders   
Rash  1  3/4158 (0.07%) 
Pruritus  1  1/4158 (0.02%) 
Skin Reaction Localised  1  1/4158 (0.02%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, WHOART
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01329419     History of Changes
Other Study ID Numbers: 105711
First Submitted: March 10, 2011
First Posted: April 5, 2011
Results First Submitted: March 10, 2011
Results First Posted: April 5, 2011
Last Update Posted: July 5, 2017