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Adefovir dipivoxil

Generic Name
Adefovir dipivoxil
Brand Names
Hepsera
Drug Type
Small Molecule
Chemical Formula
C20H32N5O8P
CAS Number
142340-99-6
Unique Ingredient Identifier
U6Q8Z01514
Background

Adefovir dipivoxil, previously called bis-POM PMEA, with trade names Preveon and Hepsera, is an orally-administered acyclic nucleotide analog reverse transcriptase inhibitor (ntRTI) used for treatment of hepatitis B. It is ineffective against HIV-1. Adefovir dipivoxil is the diester prodrug of adefovir.

Indication

Indicated for the treatment of chronic hepatitis B in adult patients with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease; this is based on histological, virological, biochemical, and serological responses in adult patients with HBeAg+ and HBeAg- chronic hepatitis B with compensated liver function, and in adult patients with clinical evidence of lamivudine-resistant hepatitis B virus with either compensated or decompensated liver function.

Associated Conditions
Chronic Hepatitis B Infection

A Double-Blind Randomized Clinical Trial Comparing the Safety and Antiviral Activity of 48-week Clevudine and Adefovir Dipivoxil in HBeAg(-) Chronic Hepatitis B With Compensated Liver Function

Phase 4
Completed
Conditions
HBeAg(-) Chronic Hepatitis B With Compensated Liver Function
Interventions
First Posted Date
2008-03-21
Last Posted Date
2012-04-25
Lead Sponsor
Bukwang Pharmaceutical
Target Recruit Count
43
Registration Number
NCT00641082
Locations
🇰🇷

Seoul National University Bundang Hospital, Bundang, Korea, Republic of

🇰🇷

Seoul National University Hospital, Seoul, Korea, Republic of

Efficacy and Safety of Telbivudine in Patients With Chronic Hepatitis B

Phase 4
Withdrawn
Conditions
Chronic Hepatitis B
Interventions
First Posted Date
2008-02-01
Last Posted Date
2012-05-02
Lead Sponsor
Novartis
Registration Number
NCT00606099
Locations
🇺🇸

Novartis, Sterling, Virginia, United States

A Randomized Study Comparing Lamivudine Versus Adefovir Dipivoxil for Prevention of zHBV Reactivation in HBsAg Seropositive Patients Undergoing Cytotoxic Chemotherapy

Not Applicable
Conditions
Hepatitis B
First Posted Date
2007-06-21
Last Posted Date
2010-07-07
Lead Sponsor
Hospital Authority, Hong Kong
Target Recruit Count
70
Registration Number
NCT00489151
Locations
🇨🇳

Queen Mary Hospital, Hong Kong, China

Adefovir Dipivoxil For The Treatment Of Chinese Compensated Chronic Hepatitis B(CHB)Patients

Phase 4
Completed
Conditions
Chronic Hepatitis B
Interventions
First Posted Date
2007-03-01
Last Posted Date
2009-10-20
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
1470
Registration Number
NCT00441974
Locations
🇨🇳

GSK Investigational Site, Tianjin, China

Study of Combination Therapy With LdT Plus Adefovir Versus Adefovir Alone

Phase 3
Terminated
Conditions
Hepatitis B
Interventions
First Posted Date
2006-09-14
Last Posted Date
2011-06-30
Lead Sponsor
Novartis
Target Recruit Count
43
Registration Number
NCT00376259
Locations
🇺🇸

Novartis, San Diego, California, United States

🇨🇳

Novarits, Kaohsuing, Taiwan

Adefovir Dipivoxil For The Treatment Of Patients With Chronic Hepatitis B Related Advanced Fibrosis Or Cirrhosis

Phase 4
Completed
Conditions
Hepatitis B, Chronic
Cirrhosis
Fibrosis
Chronic Hepatitis B
Interventions
First Posted Date
2006-07-04
Last Posted Date
2012-06-04
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
155
Registration Number
NCT00347009
Locations
🇻🇳

GSK Investigational Site, Ho Chi Minh City, Vietnam

Study Comparing the Safety of Switching From Lamivudine to Adefovir Dipivoxil Versus Overlapping Lamivudine and Adefovir Before Adefovir Dipivoxil Monotherapy in Patients With Chronic Hepatitis B

Phase 4
Completed
Conditions
Chronic Hepatitis B
Interventions
First Posted Date
2006-03-27
Last Posted Date
2021-11-12
Lead Sponsor
Thomas Jefferson University
Target Recruit Count
40
Registration Number
NCT00307242

Hepsera Versus Hepsera Plus Lamivudine for Treatment of Chronic Hepatitis B in Patients With Normal ALT

Phase 4
Completed
Conditions
Hepatitis B
Interventions
First Posted Date
2005-09-30
Last Posted Date
2007-11-15
Lead Sponsor
University of Washington
Target Recruit Count
19
Registration Number
NCT00230477
Locations
🇺🇸

Harborview Medical Center, Seattle, Washington, United States

Effect of Age on the Renal Clearance of Adefovir

Phase 4
Withdrawn
Conditions
Other Conditions That May Be A Focus of Clinical Attention
Interventions
First Posted Date
2005-09-16
Last Posted Date
2012-11-21
Lead Sponsor
University of California, San Francisco
Registration Number
NCT00187746
Locations
🇺🇸

San Francisco General Hospital, San Francisco, California, United States

Observational Study of the Durability of Seroconversion Chronic HBV Patients Who Seroconverted in a Previous Gilead-Sponsored Study of ADV.

Completed
Conditions
Hepatitis B
First Posted Date
2005-09-12
Last Posted Date
2014-01-07
Lead Sponsor
Gilead Sciences
Target Recruit Count
107
Registration Number
NCT00158717
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