Switch From Adefovir to Tenofovir in Chronic Hepatitis B for Suboptimal Response to Adefovir-based Combination Therapy
Randomized Study Comparing Nucleoside Analogues Plus Tenofovir and Nucleoside Analogues Plus Adefovir in Chronic Hepatitis B Patients With Suboptimal Response to Adefovir-based Combination Therapy Due to Nucleoside Analogues Resistance
1 other identifier
interventional
124
1 country
1
Brief Summary
In Korea, the number of suboptimal responders to rescue combination therapy is also increasing. As a matter of fact, according to the investigations in Korea, HBV DNA undetectability at 48 weeks of adefovir and lamivudine combination rescue therapy for patients with lamivudine resistance was reported to be only 32.4%, which suggested that the appropriate another rescue therapy might be urgently required. However, there is no promising oral antiviral agents to control these patients in Asia-Pacific region, where tenofovir is not widely available. Tenofovir has a higher potent antiviral efficacy and a negligible drug resistance rate. The switch from adefovir to tenofovir in patients who have insufficient hepatitis B virus (HBV) suppression (HBV DNA ≥ 60 IU/mL by PCR) may lead to increased viral suppression or more HBeAg loss/seroconversion. Here, the investigators aimed to conduct a randomized study on evaluating the antiviral efficacy, safety, and tolerability of switching from adefovir to tenofovir in chronic hepatitis B patients who have suboptimal response to adefovir-based combination rescue therapy due to nucleoside analogues Resistance (SATIS study).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 11, 2012
CompletedFirst Posted
Study publicly available on registry
May 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedMay 10, 2012
May 1, 2012
1.9 years
March 11, 2012
May 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
number of patients with complete virologic response (HBV DNA < 60 IU/mL, approximately 300 copies/mL) at 48 weeks treatment
Complete virologic response (HBV DNA \< 60 IU/mL, approximately 300 copies/mL) at 48 weeks treatment
48 weeks
Secondary Outcomes (5)
number of patients with antiviral response at 48 weeks therapy
48 weeks
number of patients with biochemical response at 48 weeks therapy
48 weeks
number of patients with serologic response at 48 weeks therapy
48 weeks
number of patients with appearance of resistant mutant strain at 48 weeks
48 weeks
Number of Participants with Adverse Events
48 weeks
Study Arms (2)
Adefovir, nucleoside analogues
ACTIVE COMPARATORNucleoside analogues (Lamivudine 100mg, Telbivudine 600mg, Entecavir 1mg, or Clevudine 30mg) + Adefovir 10mg
Tenofovir, nucleoside analogues
EXPERIMENTALNucleoside analogues (Lamivudine 100mg, Telbivudine 600mg, Entecavir 1mg, or Clevudine 30mg) + Tenofovir 300mg
Interventions
active comparator: Nucleoside analogues (Lamivudine 100mg, Telbivudine 600mg, Entecavir 1mg, or Clevudine 30mg/day) + Adefovir 10mg/day Experimental: Nucleoside analogues (Lamivudine 100mg, Telbivudine 600mg, Entecavir 1mg, or Clevudine 30mg/day) + Tenofovir 300mg/day
Eligibility Criteria
You may qualify if:
- subjects with age \>= 20 years
- subjects with chronic hepatitis B
- subjects treated with nucleoside analogues plus adefovir for at least 6 months due to resistance to nucleoside analogues (Lamivudine, Telbivudine, Entecavir, or Clevudine)
- subjects with partial virologic response to nucleoside analogues plus adefovir HBV DNA ≥ 60 IU/mL)
- subjects with ALT less than 5 times of upper limit of normal
- subjects who agreed to participate in the clinical trials and signed the informed consents
You may not qualify if:
- subjects with decompensate liver cirrhosis Child-Pugh B, C)
- subjects with Adefovir mutation
- subjects with HCV, HDV, or HIV infection
- pregnant or lactating women
- women of childbearing age who do not use the appropriate contraception method
- subjects who have the abnormal lesion suspected of hepatocellular carcinoma on imaging modalities
- subjects with other liver diseases such as hemochromatosis, Wilson's disease, alcoholic liver disease, nonalcoholic liver disease, alpha-1 antitrypsin deficiency
- subjects with hypersensitivity for study drugs
- subjects who participated in other clinical trials 60 days before the current recruitment
- subjects who are judged as inappropriate by investigators
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Internal Medicine, Yonsei University College of Medicine
Seoul, 120-752, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sang Hoon Ahn, MD, PhD.
Department of Internal Medicine, Yonsei University College of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 11, 2012
First Posted
May 10, 2012
Study Start
March 1, 2012
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
May 10, 2012
Record last verified: 2012-05