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- | Levovir (clevudine) / Bukwang Pharma, Eisai
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: PET/CT in Evaluating Response to Chemotherapy in Patients With Breast Cancer (clinicaltrials.gov) - Aug 14, 2023
P=N/A, N=12, Terminated, Sponsor: University of Southern California
N=25 --> 12 | Trial completion date: Nov 2024 --> Nov 2022 | Recruiting --> Terminated | Trial primary completion date: Nov 2023 --> Nov 2022; Insufficient accrual
- || Levovir (clevudine) / Bukwang Pharma, Eisai, Vemlidy (tenofovir alafenamide) / Gilead, ATI-2173 / Antios Therap
Review, Journal: Active site polymerase inhibitor nucleotides (ASPINs): Potential agents for chronic HBV cure regimens. (Pubmed Central) - Nov 25, 2022
Thus, ATI-2173 is currently in clinical development as an agent for HBV cure. Here, we review the mechanism of action and preclinical and clinical profiles of clevudine and ATI-2173 to support the role of ASPINs as part of curative regimens for chronic HBV infection.
- | Levovir (clevudine) / Bukwang Pharma, Eisai
Journal: Protecting-group-free synthesis of clevudine (L-FMAU), a treatment of the hepatitis B virus. (Pubmed Central) - Nov 5, 2022
Starting from 2-deoxy-2-fluoro-D-galactopyranose, we developed the shortest and highest yield synthesis of this unnatural L-nucleoside. Key steps involve an iodine-promoted cyclization and oxidative cleavage to access the L-arabinofuranosyl scaffold.
- || ATI-2173 / Antios Therap
Clinical, P1 data, Journal: A Randomized Phase 1b Trial of the Active Site Polymerase Inhibitor Nucleotide ATI-2173 in Patients With Chronic Hepatitis B Virus Infection. (Pubmed Central) - Oct 7, 2022
P1
In this 28-day monotherapy study, ATI-2173 demonstrated safety and antiviral activity, with sustained off-treatment effects and substantially reduced systemic clevudine exposure. These results support evaluation of ATI-2173 with tenofovir disoproxil fumarate in phase 2 studies.
- | Levovir (clevudine) / Bukwang Pharma, Eisai
Enrollment open, Trial completion date, Trial primary completion date: PET/CT in Evaluating Response to Chemotherapy in Patients With Breast Cancer (clinicaltrials.gov) - Aug 9, 2022
P=N/A, N=25, Recruiting, Sponsor: University of Southern California
These results support evaluation of ATI-2173 with tenofovir disoproxil fumarate in phase 2 studies. Trial completion date: Nov 2022 --> Nov 2024 | Trial primary completion date: Nov 2021 --> Nov 2023 | Suspended --> Recruiting
- ||| Levovir (clevudine) / Bukwang Pharma, Eisai
Trial completion, Enrollment change: The Proof of Concept Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients With Mild and Moderate COVID-19 (clinicaltrials.gov) - Jul 23, 2022
P2, N=104, Completed, Sponsor: Bukwang Pharmaceutical
Trial completion date: Nov 2022 --> Nov 2024 | Trial primary completion date: Nov 2021 --> Nov 2023 | Suspended --> Recruiting Recruiting --> Completed | N=80 --> 104
- ||| Levovir (clevudine) / Bukwang Pharma, Eisai
Trial completion: The Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients With Moderate COVID-19 (clinicaltrials.gov) - Jul 23, 2022
P2, N=64, Completed, Sponsor: Bukwang Pharmaceutical
Recruiting --> Completed | N=80 --> 104 Recruiting --> Completed
- ATI-2173 / Antios Therap
Sustained 12 week off treatment antiviral efficacy of ATI-2173, a novel active site polymerase inhibitor nucleotide, combined with tenofovir disoproxil fumarate in chronic hepatitis B patients, a phase 2a clinical trial (Capital Suite 7) - May 12, 2022 - Abstract #EASLILC2022EASL_ILC_2286;
P2a
In the off-treatment period, ATI-2173 + TDF provided prolonged HBV DNA suppression, longer time to rebound, and absence of ALT flares compared toTDFalone. 24-week off-treatment data will be presented at the conference.
- | Levovir (clevudine) / Bukwang Pharma, Eisai
Journal: Clevudine attenuates bleomycin-induced early pulmonary fibrosis via regulating M2 macrophage polarization. (Pubmed Central) - Mar 25, 2022
Less infiltration of M2 macrophages between α-SMA + cells was also found in clevudine treated mice. Our findings indicate a potential anti-fibrotic effect of clevudine by regulating macrophage polarization and might be meaningful in clinical settings.
- lamivudine HBV / Generic mfg.
[VIRTUAL] EARLY ON-TREATMENT HBV RNA AND HBCRAG PROFILES PREDICT FAVOURABLE HBsAg SUPPRESSION OR SEROCLEARANCE UPON LONG-TERM NUCLEOS(T)IDE ANALOGUE THERAPY IN CHRONIC HEPATITIS B INFECTION () - Oct 21, 2021 - Abstract #AASLD2021AASLD_944;
64 CHB patients (19 received lamivudine, 8 received adefovir, 16 received entecavir, 5 received telbivudine, and 16 received clevudine) were included... Early on-treatment changes of serum HBV RNA and HBcrAg as early as 4 weeks predict HBsAg seroclearance or ≤100 IU/mL in CHB patients put on NAs upon long term FU.
- | ATI-2173 / Antios Therap
Journal: ATI-2173, A Novel Liver-Targeted Non-Chain Terminating Nucleotide for HBV Cure Regimens. (Pubmed Central) - Jun 22, 2021
ATI-2173 activity was decreased by viral polymerase mutations associated with entecavir, lamivudine, and adefovir resistance, but not capsid inhibitor resistance mutations...Despite reduced plasma clevudine exposure, liver concentrations of the 5'-triphosphate were equivalent following ATI-2173 versus clevudine administration. By selectively delivering the 5'-monophosphate to the liver, while retaining the unique anti-HBV activity of the 5'-triphosphate, ATI-2173 may provide an improved pharmacokinetic profile for clinical use, reducing systemic exposure of clevudine and potentially eliminating skeletal myopathy.
- |||| Levovir (clevudine) / Bukwang Pharma, Eisai
New P2 trial: The Proof of Concept Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients With Mild and Moderate COVID-19 (clinicaltrials.gov) - May 17, 2021
P2, N=80, Recruiting, Sponsor: Bukwang Pharmaceutical
- | Levovir (clevudine) / Bukwang Pharma, Eisai
Trial completion date, Trial primary completion date: PET/CT in Evaluating Response to Chemotherapy in Patients With Breast Cancer (clinicaltrials.gov) - Apr 22, 2021
P=N/A, N=25, Suspended, Sponsor: University of Southern California
By selectively delivering the 5'-monophosphate to the liver, while retaining the unique anti-HBV activity of the 5'-triphosphate, ATI-2173 may provide an improved pharmacokinetic profile for clinical use, reducing systemic exposure of clevudine and potentially eliminating skeletal myopathy. Trial completion date: Nov 2021 --> Nov 2022 | Trial primary completion date: Nov 2020 --> Nov 2021
- ATI-2173 / Antios Therap
[VIRTUAL] Phase 1 results for ATI-2173, a novel active site polymerase inhibitor nucleotide, in HBV-infected subjects (Poster area) - Apr 9, 2021 - Abstract #EASLILC2021EASL_ILC_1142;
65% of ATI-2173 treated subjects were BLQ at EOT. Sustained off-treatment responses were noted 1- to 6-months post ATI-2173 discontinuation.
- ATI-2173 / Antios Therap
[VIRTUAL] Pharmacokinetics of ATI-2173, a novel active site polymerase inhibitor nucleotide, in a Phase 1b clinical trial (Poster area) - Apr 9, 2021 - Abstract #EASLILC2021EASL_ILC_1141;
ATI-2173 at doses of 10 to 50 mg orally per day had potent antiviral activity against chronic HBV with greatly decreased systemic exposure to the active nucleoside clevudine. The 25 and 50 mg doses of ATI-2173 have been advanced into a phase 2a study in combination with tenofovir in both HBV mono-infected and HBV/ HDV co-infected populations.
- || Levovir (clevudine) / Bukwang Pharma, Eisai
Trial completion date, Trial primary completion date: The Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients With Moderate COVID-19 (clinicaltrials.gov) - Jan 27, 2021
P2, N=60, Recruiting, Sponsor: Bukwang Pharmaceutical
The 25 and 50 mg doses of ATI-2173 have been advanced into a phase 2a study in combination with tenofovir in both HBV mono-infected and HBV/ HDV co-infected populations. Trial completion date: Dec 2020 --> Mar 2021 | Trial primary completion date: Sep 2020 --> Jan 2021
- | Levovir (clevudine) / Bukwang Pharma, Eisai
Journal: Biogenesis and molecular characteristics of serum hepatitis B virus RNA. (Pubmed Central) - Jan 8, 2021
In summary, serum HBV RNA is secreted in noninfectious virion-like particle as spliced and poly(A)-free pgRNA. Our study will shed light on the molecular biology of serum HBV RNA in HBV life cycle, and aid the development of serum HBV RNA as a novel biomarker for CHB diagnosis and treatment prognosis.
- lamivudine / Generic mfg., ATI-2173 / Antios Therap
[VIRTUAL] ATI-2173, a novel phosphoramidate nucleoside prodrug for HBV cure regimens (Poster Area) - May 30, 2020 - Abstract #EASLILCI2020EASL-ILC-I-1825;
ATI-2173 is a potent liver-targeted molecule that delivers the 5’-monophosphate of clevudine, enhancing the anti-HBV activity while significantly reducing systemic exposure to clevudine in the rat and monkey. ATI-2173 combined with TDF, ETV or other direct acting antivirals, could become an integral part of combination HBV cure regimens.
- ||| Levovir (clevudine) / Bukwang Pharma, Eisai
Enrollment open: The Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients With Moderate COVID-19 (clinicaltrials.gov) - May 10, 2020
P2, N=60, Recruiting, Sponsor: Bukwang Pharmaceutical
ATI-2173 combined with TDF, ETV or other direct acting antivirals, could become an integral part of combination HBV cure regimens. Not yet recruiting --> Recruiting
- |||| Levovir (clevudine) / Bukwang Pharma, Eisai
New P2 trial: The Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients With Moderate COVID-19 (clinicaltrials.gov) - Apr 14, 2020
P2, N=60, Not yet recruiting, Sponsor: Bukwang Pharmaceutical
- | Levovir (clevudine) / Bukwang Pharma, Eisai
Trial completion date, Trial primary completion date: PET/CT in Evaluating Response to Chemotherapy in Patients With Breast Cancer (clinicaltrials.gov) - Mar 27, 2020
P=N/A, N=25, Suspended, Sponsor: University of Southern California
Not yet recruiting --> Recruiting Trial completion date: Nov 2020 --> Nov 2021 | Trial primary completion date: Nov 2019 --> Nov 2020
- | Levovir (clevudine) / Bukwang Pharma, Eisai
Trial completion date, Trial primary completion date: PET/CT in Evaluating Response to Chemotherapy in Patients With Breast Cancer (clinicaltrials.gov) - Jan 25, 2019
P=N/A, N=25, Suspended, Sponsor: University of Southern California
Trial completion date: Nov 2020 --> Nov 2021 | Trial primary completion date: Nov 2019 --> Nov 2020 Trial completion date: Nov 2019 --> Nov 2020 | Trial primary completion date: Nov 2018 --> Nov 2019
- | Levovir (clevudine) / Bukwang Pharma, Eisai
Trial primary completion date: PET/CT in Evaluating Response to Chemotherapy in Patients With Breast Cancer (clinicaltrials.gov) - Dec 20, 2017
P=N/A, N=25, Suspended, Sponsor: University of Southern California
Trial completion date: Nov 2019 --> Nov 2020 | Trial primary completion date: Nov 2018 --> Nov 2019 Trial primary completion date: Nov 2017 --> Nov 2018
- | Levovir (clevudine) / Bukwang Pharma, Eisai
Trial initiation date, Trial primary completion date: PET/CT in Evaluating Response to Chemotherapy in Patients With Breast Cancer (clinicaltrials.gov) - Apr 11, 2017
P=N/A, N=25, Suspended, Sponsor: University of Southern California
Trial primary completion date: Nov 2017 --> Nov 2018 Initiation date: Oct 2012 --> Nov 2013 | Trial primary completion date: Oct 2016 --> Nov 2017
- Levovir (clevudine) / Bukwang Pharma, Eisai
Phase classification: Durability of Antiviral Activity in Chronic HBV Patients Who Showed Complete Response in L-FMAU-301,302 or 303 Trial (clinicaltrials.gov) - Feb 1, 2017
P=N/A, N=0, Completed, Sponsor: Bukwang Pharmaceutical
Initiation date: Oct 2012 --> Nov 2013 | Trial primary completion date: Oct 2016 --> Nov 2017 Phase classification: P3 --> P=N/A
- Levovir (clevudine) / Bukwang Pharma, Eisai
Trial primary completion date: PET/CT in Evaluating Response to Chemotherapy in Patients With Breast Cancer (clinicaltrials.gov) - Apr 9, 2016
P=N/A, N=25, Suspended, Sponsor: University of Southern California
Phase classification: P3 --> P=N/A Trial primary completion date: Oct 2015 --> Oct 2016
- Levovir (clevudine) / Bukwang Pharma, Eisai
Trial primary completion date: A Study to Evaluate the Efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period (clinicaltrials.gov) - Aug 13, 2015
P4, N=200, Terminated, Sponsor: Bukwang Pharmaceutical
Trial primary completion date: Oct 2015 --> Oct 2016 Trial primary completion date: Nov 2013 --> Nov 2014
- Levovir (clevudine) / Bukwang Pharma, Eisai
Trial suspension: PET/CT in Evaluating Response to Chemotherapy in Patients With Breast Cancer (clinicaltrials.gov) - Aug 13, 2015
P=N/A, N=25, Suspended, Sponsor: University of Southern California
Trial primary completion date: Nov 2013 --> Nov 2014 Recruiting --> Suspended
- | Levovir (clevudine) / Bukwang Pharma, Eisai
Trial termination, Trial primary completion date: A Study to Compare and Evaluate Intrahepatic cccDNA Reduction After Administrating Clevudine or Entecavir in the Chronic HBV Patients (clinicaltrials.gov) - Dec 19, 2014
P4, N=75, Terminated, Sponsor: Bukwang Pharmaceutical
Recruiting --> Suspended Active, not recruiting --> Terminated | Trial primary completion date: Aug 2012 --> Aug 2013
- | Levovir (clevudine) / Bukwang Pharma, Eisai
Trial termination, Monotherapy: A Study With Clevudine Monotherapy or Adefovir and Clevudine Combination in Patients With Chronic Hepatitis B (clinicaltrials.gov) - Dec 19, 2014
P4, N=200, Terminated, Sponsor: Bukwang Pharmaceutical
Active, not recruiting --> Terminated | Trial primary completion date: Aug 2012 --> Aug 2013 Active, not recruiting --> Terminated
- | Levovir (clevudine) / Bukwang Pharma, Eisai
Trial termination, Trial primary completion date: A Study to Evaluate the Efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period (clinicaltrials.gov) - Dec 19, 2014
P4, N=200, Terminated, Sponsor: Bukwang Pharmaceutical
Active, not recruiting --> Terminated Active, not recruiting --> Terminated | Trial primary completion date: Jun 2013 --> Nov 2013; Enrollment
- |||| Levovir (clevudine) / Bukwang Pharma, Eisai
Trial completion, Trial primary completion date: A Study to Evaluate the Efficacy and Safety of Clevudine and Peg-interferon in Sequence Compared With Clevudine Alone in the Patients With HBeAg(+) Chronic Hepatitis B or Clevudine and Peg-interferon Sequential Treatment in Patients With Chronic Hepatitis B Who Have HBeAg(+) (clinicaltrials.gov) - Dec 19, 2014
P4, N=60, Completed, Sponsor: Bukwang Pharmaceutical
Active, not recruiting --> Terminated | Trial primary completion date: Jun 2013 --> Nov 2013; Enrollment Recruiting --> Completed | Trial primary completion date: Feb 2013 --> Aug 2013
- |||| Levovir (clevudine) / Bukwang Pharma, Eisai
Trial completion, Monotherapy: An Open Study to Evaluate the Efficacy, Safety of Clevudine Monotherapy or Adefovir and Clevudine Combination in Patients With Chronic Hepatitis B (clinicaltrials.gov) - Dec 19, 2014
P4, N=60, Completed, Sponsor: Bukwang Pharmaceutical
Recruiting --> Completed | Trial primary completion date: Feb 2013 --> Aug 2013 Active, not recruiting --> Completed
- | Levovir (clevudine) / Bukwang Pharma, Eisai
Trial completion, Trial primary completion date, Monotherapy: A Study With Clevudine Monotherapy or Adefovir and Clevudine Combination in Proportion to Roadmap Concept in Patients With HBV Associated-HCC (clinicaltrials.gov) - Dec 19, 2014
P4, N=33, Completed, Sponsor: Bukwang Pharmaceutical
Active, not recruiting --> Completed Active, not recruiting --> Completed | Trial primary completion date: Dec 2013 --> Jan 2013
- ||||||| Levovir (clevudine) / Bukwang Pharma, Eisai
Trial completion: A Pilot Study to Evaluate the Safety and Efficacy of Clevudine or Adefovir Patients With LC-B (clinicaltrials.gov) - Dec 19, 2014
P3, N=102, Completed, Sponsor: Bukwang Pharmaceutical
Active, not recruiting --> Completed | Trial primary completion date: Dec 2013 --> Jan 2013 Active, not recruiting --> Completed
- Levovir (clevudine) / Bukwang Pharma, Eisai
Trial primary completion date: PET/CT in Evaluating Response to Chemotherapy in Patients With Breast Cancer (clinicaltrials.gov) - Sep 10, 2014
P=N/A, N=25, Recruiting, Sponsor: University of Southern California
Active, not recruiting --> Completed Trial primary completion date: Oct 2014 --> Oct 2015
- Levovir (clevudine) / Bukwang Pharma, Eisai
Enrollment open: PET/CT in Evaluating Response to Chemotherapy in Patients With Breast Cancer (clinicaltrials.gov) - Jan 26, 2014
P=N/A, N=25, Recruiting, Sponsor: University of Southern California
Trial primary completion date: Oct 2014 --> Oct 2015 Suspended --> Recruiting
- | Levovir (clevudine) / Bukwang Pharma, Eisai
Trial completion: A Clinical Trial to Investigate the Pharmacokinetic Drug-drug Interaction of Clevudine and Adefovir Dipivoxil After Oral Administration in Healthy Male Subjects (clinicaltrials.gov) - Sep 15, 2012
P1, N=42, Completed, Sponsor: Bukwang Pharmaceutical
Suspended --> Recruiting Recruiting --> Completed
- | Levovir (clevudine) / Bukwang Pharma, Eisai
Enrollment change: An Open Study to Evaluate the Sustained Effect in Patients Showing Virological Responses With Muscle-related Symptom of Chronic Hepatitis B Patients Who Received Clevudine (clinicaltrials.gov) - Jul 23, 2012
P4, N=37, Completed, Sponsor: Bukwang Pharmaceutical
Recruiting --> Completed N=102 --> 37
- ||| Levovir (clevudine) / Bukwang Pharma, Eisai
Enrollment closed, Monotherapy: A Study With Clevudine Monotherapy or Adefovir and Clevudine Combination in Patients With Chronic Hepatitis B (clinicaltrials.gov) - Jul 23, 2012
P4, N=200, Active, not recruiting, Sponsor: Bukwang Pharmaceutical
N=102 --> 37 Recruiting --> Active, not recruiting
- ||||| Levovir (clevudine) / Bukwang Pharma, Eisai
Enrollment closed: A Pilot Study to Evaluate the Safety and Efficacy of Clevudine or Adefovir Patients With LC-B (clinicaltrials.gov) - Jul 23, 2012
P3, N=102, Active, not recruiting, Sponsor: Bukwang Pharmaceutical
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- | Levovir (clevudine) / Bukwang Pharma, Eisai
Trial completion: An Open Study to Evaluate the Sustained Effect in Patients Showing Virological Responses With Muscle-related Symptom of Chronic Hepatitis B Patients Who Received Clevudine (clinicaltrials.gov) - Jul 23, 2012
P4, N=37, Completed, Sponsor: Bukwang Pharmaceutical
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- |||| Levovir (clevudine) / Bukwang Pharma, Eisai
Trial completion: Long-term Study With Clevudine (clinicaltrials.gov) - Jul 23, 2012
P4, N=150, Completed, Sponsor: Bukwang Pharmaceutical
Active, not recruiting --> Completed Active, not recruiting --> Completed
- |||| Levovir (clevudine) / Bukwang Pharma, Eisai
Trial completion: Switching Study From Lamivudine to Clevudine in the Chronic Hepatitis B Patients (clinicaltrials.gov) - Jul 23, 2012
P4, N=100, Completed, Sponsor: Bukwang Pharmaceutical
Active, not recruiting --> Completed Recruiting --> Completed
- ||||||| Levovir (clevudine) / Bukwang Pharma, Eisai
Trial completion: Compare the Efficacy and Safety of 48-week Treatment With Clevudine 30mg Versus Lamivudine 100mg for CHB Infection (clinicaltrials.gov) - Jul 23, 2012
P3, N=92, Completed, Sponsor: Bukwang Pharmaceutical
Recruiting --> Completed Active, not recruiting --> Completed
- | Levovir (clevudine) / Bukwang Pharma, Eisai
Enrollment change: A Double-Blind Randomized Clinical Trial Comparing the Safety and Antiviral Activity of 48-week Clevudine and Adefovir Dipivoxil in HBeAg(-) Chronic Hepatitis B With Compensated Liver Function (clinicaltrials.gov) - Apr 23, 2012
P4, N=43, Completed, Sponsor: Bukwang Pharmaceutical
Active, not recruiting --> Completed N=72 --> 43
- | Levovir (clevudine) / Bukwang Pharma, Eisai
Trial completion: A Double-Blind Randomized Clinical Trial Comparing the Safety and Antiviral Activity of 48-week Clevudine and Adefovir Dipivoxil in HBeAg(-) Chronic Hepatitis B With Compensated Liver Function (clinicaltrials.gov) - Apr 23, 2012
P4, N=43, Completed, Sponsor: Bukwang Pharmaceutical
N=72 --> 43 Recruiting --> Completed
- | Levovir (clevudine) / Bukwang Pharma, Eisai
New P1 trial: A Clinical Trial to Investigate the Pharmacokinetic Drug-drug Interaction of Clevudine and Adefovir Dipivoxil After Oral Administration in Healthy Male Subjects (clinicaltrials.gov) - Apr 18, 2012
P1, N=42, Completed, Sponsor: Bukwang Pharmaceutical