- |||||||||| Tyzeka (telbivudine) / Novartis
Clinical, Journal: A case of telbivudine-related fatal lactic acidosis and multiple organ dysfunction syndrome (Pubmed Central) - Jul 20, 2019 Telbivudine was discontinued, and tenofovir disoproxil fumarate and liver protective drug were used...Such patients are easily misdiagnosed as neuromuscular diseases in the early stage, which might delay the treatment and worsen medical conditions. Clinicians need to be cautious and obtain an early identification to avoid misdiagnosis.
- |||||||||| Baraclude (entecavir) / BMS, Tyzeka (telbivudine) / Novartis
Clinical, Journal: Efficacy and safety of long-term therapy with nucleos(t)ide analogues in chronic hepatitis B. (Pubmed Central) - Jul 3, 2019 In addition, given that maternal biochemical flare occurred in 18% of mothers, re-administration of antiviral agents might be required. Entecavir and tenofovir might be recommended for the treatment of chronic hepatitis B because of having potent antiviral effect, high genetic barriers against resistance and good safety.
- |||||||||| Vemlidy (tenofovir alafenamide) / Gilead
Clinical, Review, Journal: Review article: long-term safety of oral anti-viral treatment for chronic hepatitis B. (Pubmed Central) - Jun 15, 2019 Long-term safety profile of nucleoside analogues is now better defined with more data from large real-life cohorts and clinical trials with long-term follow-up. The new nucleotide analogue, TAF is now available with favourable renal and bone safety profiles.
- |||||||||| Tyzeka (telbivudine) / Novartis
Enrollment closed, Trial completion date, Trial primary completion date: Tenofovir Versus Tenofovir + Telbivudine for Chronic Hepatitis B (clinicaltrials.gov) - Mar 18, 2019 P4, N=146, Active, not recruiting, Tenofovir maintains sensitivity in 100% of patients with resistance mutations, so it should be considered the treatment of choice. Recruiting --> Active, not recruiting | Trial completion date: Dec 2018 --> Jul 2020 | Trial primary completion date: Jun 2018 --> Jul 2020
- |||||||||| Tyzeka (telbivudine) / Novartis
Trial completion, Enrollment change, Trial completion date, Trial initiation date, Trial primary completion date: The Safety of Anti-viral Therapy in Preventing HBV MTCT in Pregnant Women After Discontinuation (clinicaltrials.gov) - Aug 29, 2018 P4, N=111, Completed, Trial completion date: Dec 2019 --> Jan 2019 | Trial primary completion date: Dec 2019 --> Jan 2019 Not yet recruiting --> Completed | N=200 --> 111 | Trial completion date: Dec 2020 --> Dec 2017 | Initiation date: Apr 2018 --> Jun 2015 | Trial primary completion date: Dec 2020 --> Dec 2017
- |||||||||| Tyzeka (telbivudine) / Novartis
Trial completion, Combination therapy: TDF and LdT in Immune-tolerant CHB Patients Awaiting Assisted Reproduction (clinicaltrials.gov) - May 2, 2018 P1/2, N=120, Completed, Not yet recruiting --> Completed | N=200 --> 111 | Trial completion date: Dec 2020 --> Dec 2017 | Initiation date: Apr 2018 --> Jun 2015 | Trial primary completion date: Dec 2020 --> Dec 2017 Active, not recruiting --> Completed
- |||||||||| Tyzeka (telbivudine) / Novartis
Trial initiation date, Trial primary completion date: STEN: A Two-year Study of Telbivudine in HBeAg Negative Hepatitis (clinicaltrials.gov) - Oct 24, 2017 P4, N=360, Completed, Active, not recruiting --> Completed Initiation date: Sep 2011 --> Jan 2011 | Trial primary completion date: Feb 2013 --> Feb 2014
- |||||||||| Tyzeka (telbivudine) / Novartis
New P4 trial: EFFORT Further Extension Study (clinicaltrials.gov) - Jul 7, 2016 P4, N=130, Active, not recruiting,
- |||||||||| Tyzeka (telbivudine) / Novartis
Trial completion, Post-transplantation: Replacement of Lamivudine by Telbivudine to Improve Renal Function (clinicaltrials.gov) - Apr 8, 2016 P2/3, N=120, Completed, N=20 --> 0 | Recruiting --> Withdrawn | Trial primary completion date: Jun 2019 --> Jun 2015 Enrolling by invitation --> Completed
- |||||||||| Tyzeka (telbivudine) / Novartis
Trial completion, Enrollment change, Trial primary completion date: Study of Telbivudine in Chronic Hepatitis B (clinicaltrials.gov) - Feb 29, 2016 P=N/A, N=160, Completed, Withdrawn --> Completed | Trial primary completion date: Apr 2015 --> Apr 2014 Recruiting --> Completed | N=200 --> 160 | Trial primary completion date: Jan 2012 --> Jan 2016
- |||||||||| Tyzeka (telbivudine) / Novartis
Enrollment closed: EFFORT-Ex: EFFORT Extension Study (clinicaltrials.gov) - Jun 19, 2014 P4, N=576, Active, not recruiting, Recruiting --> Active, not recruiting | Trial primary completion date: Mar 2014 --> Oct 2014 Recruiting --> Active, not recruiting
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