A Phase 4 interventional study of Lamivudine and Entecavir in Hepatitis B, Chronic, sponsored by Bristol-Myers Squibb. Withdrawn. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2015-09-01.
Sponsored by Bristol-Myers Squibb · Phase 4, Interventional, and Treatment
Combination therapy with entecavir 1.0 mg plus adefovir 10 mg has superior antiviral activity compared with either entecavir monotherapy 1.0 mg or adefovir 10 mg plus lamivudine 100 mg in Chinese adults with lamivudine-resistant chronic hepatitis B infection
1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.
Browse Hepatitis B studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Lamivudine · Drug: Adefovir
Drug: Entecavir
Drug: Entecavir · Drug: Adefovir
Tablets, Oral, 100mg, once daily, 48-96 weeks depending on response
Also known as: Heptotin
Tablets, Oral, 1mg, once daily, 48-96 weeks depending on response
Also known as: Baraclude
Tablets, Oral, 10mg, once daily, 48-96 weeks depending on response
Also known as: Hepsera
The proportion of patients with HBV DNA < 50 IU/mL at W48
Time frame: Week 48
The proportion of patient with HBV DNA < 50 IU/mL at W 96
Time frame: Week 96
Mean reduction of HBV DNA at W 48 & 96
Time frame: Week 48 and 96
The proportion of subjects with ALT normalization at W 48 & 96
Time frame: Week 48 & Week 96
The proportion of subjects achieved HBeAg loss, seroconversion, HBsAg loss and seroconversion at W48 & 96
Time frame: Week 48 & 96
Safety
Time frame: Week 48 and Week 96
Resistance
Time frame: Week 48 & Week 96
No study locations are listed for this record.
This study is withdrawn, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.
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Bristol-Myers Squibb