Tenofovir Versus Tenofovir + Telbivudine for Chronic Hepatitis B (DUAL)
Open Label Study of Nucleus(t)Ide Treated Patients Randomised to Tenofovir, or Tenofovir + Telbivudine
Sponsor: National Medical Research Council (NMRC), Singapore
Listed as NCT02774837, this PHASE4 trial focuses on Chronic Hepatitis B and remains ongoing. Sponsored by National Medical Research Council (NMRC), Singapore, it has been updated 9 times since 2016, reflecting limited change activity. This study is part of the global effort to build evidence for infectious disease interventions.
Study Description(click to expand)Each subject must sign and date a study-specific informed consent form (ICF) prior to their participation in any screening activities. Prospective subjects should be screened no more than 28 days prior to administration of the first dose of study drug on Day 1. Screening evaluations will be used to determine eligibility of each candidate for study enrollment. Subjects meeting all of the inclusion criteria and none of the exclusion criteria as determined during screening will be eligible for the study. Candidates who fail to meet eligibility criteria by screening evaluations may be re-screened one time. Eligible patients at the end of screening will be randomised in a 1:1 ratio to experimental (combination) arm versus control (mono therapy) arm. Randomisation will be performed by computer generated random codes (performed by Singapore Clinical Research Institute) with a masked allocation sequence. There will be no blinding of therapy and the study will be conducted as an open label study since the outcomes are objectively measurable. After randomisation patients will be monitored 12 weekly for the first 24 weeks, then every 24 weekly until the last visit at 96 weeks. At each visit, patients will have a clinical evaluation and have a panel of...
Each subject must sign and date a study-specific informed consent form (ICF) prior to their participation in any screening activities. Prospective subjects should be screened no more than 28 days prior to administration of the first dose of study drug on Day 1. Screening evaluations will be used to determine eligibility of each candidate for study enrollment. Subjects meeting all of the inclusion criteria and none of the exclusion criteria as determined during screening will be eligible for the study. Candidates who fail to meet eligibility criteria by screening evaluations may be re-screened one time. Eligible patients at the end of screening will be randomised in a 1:1 ratio to experimental (combination) arm versus control (mono therapy) arm.
Randomisation will be performed by computer generated random codes (performed by Singapore Clinical Research Institute) with a masked allocation sequence. There will be no blinding of therapy and the study will be conducted as an open label study since the outcomes are objectively measurable.
After randomisation patients will be monitored 12 weekly for the first 24 weeks, then every 24 weekly until the last visit at 96 weeks.
At each visit, patients will have a clinical evaluation and have a panel of laboratory tests:
* Hematology: Full blood count, prothrombin time and international normalized ratio * Chemistry: Sodium, potassium, creatinine, albumin, alkaline phosphatase, -aspartate transaminase, alanine transaminase, lactate dehydrogenase, total bilirubin, creatine phosphokinase, alphafetoprotein, * Urinalysis: Urine dipstick (Appearance, color, leucocytes, nitrite, urobilinogen, protein, PH, specific gravity, ketone, bilirubin and glucose). * Viral serology: HBeAg, anti-HBe, HBsAg, qHBsAg and anti-HBs
Status Flow
Change History
9 versions recorded-
Jan 2026 — Present [monthly]
Unknown PHASE4
-
Sep 2024 — Present [monthly]
Unknown PHASE4
-
Jul 2024 — Sep 2024 [monthly]
Unknown PHASE4
Status: Unknown Status → Unknown
-
Oct 2021 — Jul 2024 [monthly]
Unknown Status PHASE4
Status: Active Not Recruiting → Unknown Status
-
Jan 2021 — Oct 2021 [monthly]
Active Not Recruiting PHASE4
▶ Show 4 earlier versions
-
Apr 2019 — Jan 2021 [monthly]
Active Not Recruiting PHASE4
Status: Unknown Status → Active Not Recruiting
-
Jan 2019 — Apr 2019 [monthly]
Unknown Status PHASE4
Status: Recruiting → Unknown Status
-
Jun 2018 — Jan 2019 [monthly]
Recruiting PHASE4
-
Jan 2017 — Jun 2018 [monthly]
Recruiting PHASE4
First recorded
Apr 2016
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- National Medical Research Council (NMRC), Singapore
- Seng Gee Lim
- Singapore Clinical Research Institute
For direct contact, visit the study record on ClinicalTrials.gov .