A Phase 4 interventional study of telbivudine and telbivudine in Hepatitis B, Chronic, sponsored by Nanfang Hospital, Southern Medical University. Completed at 24 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-01-31.
Sponsored by Nanfang Hospital, Southern Medical University · Phase 4, Interventional, and Treatment
The purpose of this trial is to prove that the strategy of treatment adjustment at W24 according to virological response based on ROADMAP concept is better than standard of care strategy.
954 studies on the registry are indexed under Hepatitis B, Chronic; 147 are open to participants now.
This study's enrollment of 606 is above the median of 100 across 692 interventional studies indexed under Hepatitis B, Chronic.
Browse Hepatitis B, Chronic studies →Nanfang Hospital, Southern Medical University is the lead sponsor of 488 studies on the registry; 213 are open to participants now.
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Exclusion Criteria:
Patients were to take telbivudine 600 mg orally daily from Baseline.At Week 24, patients in Group I were split into Group I-A or Group I-B based on their virologic load: * Group I-A: This group of patients was those with HBV DNA ≥300 copies/mL at Week 24 and adefovir was to be added at Week 28; * Group I-B: This group of patients was those with HBV DNA \<300 copies/mL at Week 24. Telbivudine monotherapy was to be continued until there was a viral breakthrough (confirmed by two examinations with at least 1 month interval with compliance factor excluded) and then adefovir was to be added; The total treatment duration was 104 weeks.
Drug: telbivudine
patients were to take telbivudine 600 mg monotherapy from Baseline until Week 104. If viral breakthrough (defined as HBV DNA 1 log10 above nadir) was confirmed (by two examinations with at least a 1 month interval with compliance factor excluded), adefovir 10 mg daily was to be added.
Drug: telbivudine
telbivudine, 600mg, oral, daily
Also known as: Sebivo®
telbivudine, 600mg, oral, daily
Also known as: Sebivo®
To demonstrate the percentage of patients achieving HBV DNA< 300copies/mL at Week 104 in Group I is superior than that in Group II
Time frame: Week 104
Percentage of patients achieving HBV DNA <60IU/mL (300copies/mL) at Week 52
Time frame: week 52
Serum HBV DNA reduction from baseline at week 104
Time frame: week 104
Percentage of patients with HBeAg loss & HBeAg seroconversion at week104 in patients with HBeAg positive at baseline
Time frame: week 104
Percentage of patients with HBV DNA<300copies/mL AND HBeAg loss or seroconversion at Week 104 in patients with positive HBeAg at baseline
Time frame: week 104
Serum HBV DNA reduction from baseline at week 52
Time frame: week 52
The record gives a start of Aug 2009, a primary completion of Apr 2012 and a completion of Aug 2012. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Telbivudine
Nanfang Hospital, Southern Medical University →