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32 Diseases |  |
5 Trials |
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5 Trials |  |
1782 News |  |
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- | ribavirin / Generic mfg., Daklinza (daclatasvir) / BMS
Clinical, Journal, Real-world evidence: Safety and Efficacy of Sofosbuvir-Based DAA Regimens for Hepatitis C Virus Genotypes 1 - 4 and 6 in Myanmar: Real-world experience. (Pubmed Central) - May 26, 2018
DAA therapy ±PEG-IFN achieved high SVR rates. Genotype 6 patients had a low SVR to 12 weeks of LDV and SOF raising the need for other regimens, RBV or longer treatment duration in this population.
- || Daklinza (daclatasvir) / BMS
Trial completion date, Trial primary completion date: Study of Daclatasvir-based Therapy in Chinese Participants With Chronic Hepatitis C (CHC) (clinicaltrials.gov) - May 16, 2018
P=N/A, N=3000, Recruiting, Sponsor: Bristol-Myers Squibb
Genotype 6 patients had a low SVR to 12 weeks of LDV and SOF raising the need for other regimens, RBV or longer treatment duration in this population. Trial completion date: Aug 2021 --> Dec 2021 | Trial primary completion date: Aug 2021 --> Dec 2021
- ||| Daklinza (daclatasvir) / BMS
New trial: Study of Daclatasvir-based Therapy in Chinese Participants With Chronic Hepatitis C (CHC) (clinicaltrials.gov) - Apr 25, 2018
P=N/A, N=3000, Not yet recruiting, Sponsor: Bristol-Myers Squibb
- | Daklinza (daclatasvir) / BMS, Sovaldi (sofosbuvir) / Gilead
Clinical, Journal, Real-world evidence: Daclatasvir and sofosbuvir treatment of decompensated liver disease or post-liver transplant hepatitis C virus recurrence in patients with advanced liver disease/cirrhosis in a real-world cohort. (Pubmed Central) - Apr 8, 2018
Six patients died, 10 had adverse events leading to discontinuation, and 30 experienced serious adverse events.Daclatasvir plus sofosbuvir, with/without ribavirin, provided high SVR12 rates and was generally well tolerated in patients with life-threatening disease and high unmet needs. (2018;2:354-363).
- ||||| Arlansa (narlaprevir) / Merck (MSD)
New P2 trial: Efficacy and Safety of All-Oral Combination of Narlaprevir/Ritonavir and Daclatasvir in Treatment-Na?ve Patients With Chronic Hepatitis C Genotype 1b (clinicaltrials.gov) - Apr 2, 2018
P2, N=105, Active, not recruiting, Sponsor: R-Pharm
- | New P2/3 trial, Combination therapy: Role of Pegylated Interferon in Combination With DAAs to Cure Hepatitis C As Soon As Possible - Hepatitis C [ASAP-C] (clinicaltrials.gov) - Mar 29, 2018
P2/3, N=150, Recruiting, Sponsor: Johns Hopkins Bloomberg School of Public Health
- | Daklinza (daclatasvir) / BMS
Trial completion, Trial completion date: Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT2 Infected Patients (clinicaltrials.gov) - Mar 19, 2018
P4, N=112, Completed, Sponsor: Humanity and Health Research Centre
(2018;2:354-363). Recruiting --> Completed | Trial completion date: Dec 2017 --> Mar 2018
- | Sovaldi (sofosbuvir) / Gilead
Trial completion, Enrollment change, Trial completion date, Trial initiation date, Trial primary completion date: Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With Hepatitis C Infection (clinicaltrials.gov) - Mar 8, 2018
P4, N=10000, Completed, Sponsor: Tanta University
Recruiting --> Completed | Trial completion date: Dec 2017 --> Mar 2018 Recruiting --> Completed | N=6000 --> 10000 | Trial completion date: Dec 2018 --> Mar 2018 | Initiation date: Dec 2016 --> Jan 2015 | Trial primary completion date: Dec 2018 --> Jan 2018
- | Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta Pharma
Clinical Trial,Phase I, Clinical Trial,Phase II, Clinical Trial,Phase III, Journal: Glecaprevir-Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection. (Pubmed Central) - Feb 11, 2018
P3
Conclusions Once-daily treatment with glecaprevir-pibrentasvir for either 8 weeks or 12 weeks achieved high rates of sustained virologic response among patients with HCV genotype 1 or 3 infection who did not have cirrhosis. (Funded by AbbVie; ENDURANCE-1 and ENDURANCE-3 ClinicalTrials.gov numbers, NCT02604017 and NCT02640157 .).
- ||| Daklinza (daclatasvir) / BMS
New trial: Study to Assess Clinical Outcomes in Chronic Hepatitis C Patients Previously Treated With Daclatasvir-Based Regimens (clinicaltrials.gov) - Dec 7, 2017
P=N/A, N=1000, Recruiting, Sponsor: Bristol-Myers Squibb
- | Sunvepra (asunaprevir) / BMS, daclatasvir/asunaprevir (BMS-60032/BMS-790052) / BMS, Daklinza (daclatasvir) / BMS
Journal: Daclatasvir Plus Asunaprevir for HCV Genotype 1b Infection in Patients With or Without Compensated Cirrhosis: A Pooled Analysis. (Pubmed Central) - Dec 1, 2017
P2, P3
This all-oral, interferon- and ribavirin-free combination is an effective and well-tolerated treatment option for patients with HCV GT1b infection and cirrhosis. Trial registrations numbers: Clinicaltrials.gov identifiers: NCT01012895; NCT01051414; NCT01581203; NCT01497834.
- | Sovaldi (sofosbuvir) / Gilead
Enrollment change: Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With Hepatitis C Infection (clinicaltrials.gov) - Nov 14, 2017
P4, N=6000, Recruiting, Sponsor: Tanta University
Trial registrations numbers: Clinicaltrials.gov identifiers: NCT01012895; NCT01051414; NCT01581203; NCT01497834. N=1000 --> 6000
- | ribavirin / Generic mfg., Daklinza (daclatasvir) / BMS
Review, Journal: Treat chronic hepatitis C virus infection in decompensated cirrhosis - pre- or post-liver transplantation? the ironic conundrum in the era of effective and well-tolerated therapy. (Pubmed Central) - Nov 3, 2017
Yet a contrarian view would be that not all patients have access to liver transplantation (LT), cannot bear the cost, have comorbidities or contraindications to LT. While the debate continues, it is essential that we develop robust predictors of improvement in liver function so that we can carefully select our patients for therapy in the context of liver transplantation.
- | Daklinza (daclatasvir) / BMS, Sovaldi (sofosbuvir) / Gilead
Journal: On-Treatment HCV RNA as a Predictor of Sustained Virologic Response in HCV Genotype 3-Infected Patients Treated With Daclatasvir and Sofosbuvir. (Pubmed Central) - Oct 22, 2017
While the debate continues, it is essential that we develop robust predictors of improvement in liver function so that we can carefully select our patients for therapy in the context of liver transplantation. On-treatment responses are not useful predictors of ultimate virological response to the daclatasvir + sofosbuvir regimen.
- ||| Daklinza (daclatasvir) / BMS
Trial completion, Enrollment change, Trial primary completion date: A Retrospective, Observational Study on the Effectiveness of Daclatasvir-Containing Regimens in Patients in KSA, UAE and Qatar (clinicaltrials.gov) - Oct 10, 2017
P=N/A, N=182, Completed, Sponsor: Bristol-Myers Squibb
On-treatment responses are not useful predictors of ultimate virological response to the daclatasvir + sofosbuvir regimen. Active, not recruiting --> Completed | N=110 --> 182 | Trial primary completion date: Sep 2017 --> Jun 2017
- | Daklinza (daclatasvir) / BMS
Trial initiation date, Trial primary completion date: Determining the Sustained Virologic Response of Declatasvir in Egyptian Patients With Hepatitis C Virus Genotype 4 (clinicaltrials.gov) - Oct 10, 2017
P=N/A, N=250, Not yet recruiting, Sponsor: Zagazig University
Active, not recruiting --> Completed | N=110 --> 182 | Trial primary completion date: Sep 2017 --> Jun 2017 Initiation date: Jun 2016 --> Nov 2017 | Trial primary completion date: Dec 2016 --> Dec 2018
- | Daklinza (daclatasvir) / BMS
New P4 trial: Effect Of DAAs For Treatment Of HCV On Normal Kidney (clinicaltrials.gov) - Sep 28, 2017
P4, N=100, Not yet recruiting, Sponsor: Assiut University
- | Copegus (ribavirin) / Bausch Health, Daklinza (daclatasvir) / BMS
Journal: Concomitant use of direct-acting antivirals and chemotherapy in hepatitis C virus-infected patients with cancer. (Pubmed Central) - Aug 20, 2017
Hepatitis C virus-targeted antiviral therapy can be used concomitantly with selected anti-neoplastic agents under close monitoring for drug-drug interactions. This therapeutic intervention may prevent delay in the administration of chemotherapy in HCV-infected cancer patients.
- | Sunvepra (asunaprevir) / BMS, Daklinza (daclatasvir) / BMS
Journal: Rapid decrease in hepatitis C viremia by direct acting antivirals improves the natural killer cell response to IFNα. (Pubmed Central) - Jul 9, 2017
P1, P2
IFN-responsiveness can be improved by inhibiting HCV replication and reducing the HCV-induced activation of the innate immune response. This may provide a rationale for clinical trials of a brief period of direct acting antiviral therapy followed by PegIFN/RBV therapy to reduce the overall treatment costs in low-income and middle-income countries.
- Sunvepra (asunaprevir) / BMS, Daklinza (daclatasvir) / BMS
New trial: Early Post-marketing Study of Daclatasvir (Daklinza (clinicaltrials.gov) - Jul 4, 2017
P=N/A, N=30, Not yet recruiting, Sponsor: Bristol-Myers Squibb
- ||| Daklinza (daclatasvir) / BMS
New trial: A Retrospective, Observational Study on the Effectiveness of Daclatasvir-Containing Regimens in Patients in KSA, UAE and Qatar (clinicaltrials.gov) - Jul 2, 2017
P=N/A, N=110, Active, not recruiting, Sponsor: Bristol-Myers Squibb
- Daklinza (daclatasvir) / BMS
New trial: Early Post-marketing Study of Daclatasvir (Daklinza) in the Treatment of Chronic Hepatitis C (CHC) in Adults (clinicaltrials.gov) - Jun 7, 2017
P=N/A, N=10, Recruiting, Sponsor: Bristol-Myers Squibb
- | Daklinza (daclatasvir) / BMS, Sovaldi (sofosbuvir) / Gilead
New trial: hepatitisc: Hepatitis c and Vitamin D and Iron Status (clinicaltrials.gov) - May 25, 2017
P=N/A, N=87, Not yet recruiting, Sponsor: Eman Sayed Hassan Abd Allah
- ||| Sunvepra (asunaprevir) / BMS, Daklinza (daclatasvir) / BMS
Trial completion: Asunaprevir/Daclatasvir Safety Surveillance in Japanese Patients With Chronic Hepatitis C (clinicaltrials.gov) - Apr 14, 2017
P=N/A, N=2974, Completed, Sponsor: Bristol-Myers Squibb
This may provide a rationale for clinical trials of a brief period of direct acting antiviral therapy followed by PegIFN/RBV therapy to reduce the overall treatment costs in low-income and middle-income countries. Active, not recruiting --> Completed
- | Pegasys (pegylated interferon α -2a) / Roche, Daklinza (daclatasvir) / BMS, ledipasvir/sofosbuvir / Generic mfg.
Journal: Hepatitis C virus genotype 3: Meta-analysis on sustained virologic response rates with currently available treatment options. (Pubmed Central) - Apr 12, 2017
Active, not recruiting --> Completed Lastly, SOF + DCV combination is probably the best oral therapy option and the addition of RBV does not appear to be needed to increase SVR rates substantially.
- ||||| peginterferon lambda-1a (BMS-914143) / Eiger, Stanford University, Daklinza (daclatasvir) / BMS
Enrollment change, Combination therapy: DIMENSION: Efficacy and Safety Study of Pegylated Interferon Lambda-1a With Ribavirin and Daclatasvir, to Treat na (clinicaltrials.gov) - Mar 23, 2017
P3, N=453, Completed, Sponsor: Bristol-Myers Squibb
Lastly, SOF + DCV combination is probably the best oral therapy option and the addition of RBV does not appear to be needed to increase SVR rates substantially. N=300 --> 453
- ||| Daklinza (daclatasvir) / BMS
Trial completion: Comparative Assessment of Utilization of Antiviral Therapies in Hepatitis C and Effectiveness of Daclatasvir-containing Regimens in Real-life Clinical Care in Europe (CMPASS-EU) (clinicaltrials.gov) - Mar 7, 2017
P=N/A, N=920, Completed, Sponsor: Bristol-Myers Squibb
N=300 --> 453 Active, not recruiting --> Completed
- ||| New trial, Real-world evidence, Adverse drug reaction, Real-world: Real-world Incidence Proportion of Hepatic Toxicity and All Adverse Drug Reactions (ADRs) in Japanese Patients Receiving Daclatasvir (DCV) Trio Therapy (clinicaltrials.gov) - Mar 5, 2017
P=N/A, N=1000, Recruiting, Sponsor: Bristol-Myers Squibb
- | ribavirin / Generic mfg., Pegasys (pegylated interferon α -2a) / Roche, Daklinza (daclatasvir) / BMS
Journal: Daclatasvir and Peginterferon/Ribavirin for Black/African-American and Latino Patients with HCV infection. (Pubmed Central) - Mar 1, 2017
SVR12 rates for black/AA (50.8%) and Latino (58.9%) cohorts treated with daclatasvir plus pegIFN alfa-2a/RBV and the lower bound of the 95% CIs were higher than the estimated historical control (black/AA, 26% SVR; Latino, 36% SVR) treated with pegIFN alfa-2a/RBV. These data support daclatasvir use in all-oral direct-acting antiviral combinations.
- | Daklinza (daclatasvir) / BMS, ledipasvir/sofosbuvir / Generic mfg.
Review, Journal: Developing therapies to treat hepatitis C infection in post-liver transplant recipients. (Pubmed Central) - Mar 1, 2017
Expert Opinion: While there are many potential available therapies for HCV recurrence in the post-liver transplant setting, daclatasvir/sofosbuvir and ledipasvir/sofosbuvir have been the most extensively studied. Newer, pangenotypic generation drugs require more evidence before routine utilization in post-liver transplant recipients.
- ||||||| Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta Pharma
Trial completion: ENDURANCE-3: A Study Comparing Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Dosed With Daclatasvir in Adults With HCV Genotype 3 Infection (clinicaltrials.gov) - Feb 9, 2017
P3, N=506, Completed, Sponsor: AbbVie
Newer, pangenotypic generation drugs require more evidence before routine utilization in post-liver transplant recipients. Active, not recruiting --> Completed
- | Journal: Daclatasvir vs telaprevir plus peginterferon alfa/ribavirin for hepatitis C virus genotype 1. (Pubmed Central) - Jan 25, 2017
Active, not recruiting --> Completed Daclatasvir plus pegIFN/RBV demonstrated noninferiority to telaprevir plus pegIFN/RBV for SVR12 and was well-tolerated in treatment-naive GT1b-infected patients, supporting the use of daclatasvir with other direct-acting antivirals.
- |||| Sunvepra (asunaprevir) / BMS, Daklinza (daclatasvir) / BMS
Trial completion, Trial primary completion date: Therapy With Asunaprevir, Daclatasvir, Ribavirin and Pegylated Interferon Alpha-2a in HCV Genotype 4-infected Patients Who Have Failed to a Previous Therapy With Peg-Interferon/Ribavirin (ANRS HC32 QUATTRO) (clinicaltrials.gov) - Jan 24, 2017
P2, N=60, Completed, Sponsor: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Daclatasvir plus pegIFN/RBV demonstrated noninferiority to telaprevir plus pegIFN/RBV for SVR12 and was well-tolerated in treatment-naive GT1b-infected patients, supporting the use of daclatasvir with other direct-acting antivirals. Active, not recruiting --> Completed | Trial primary completion date: Jul 2015 --> Feb 2015
- Daklinza (daclatasvir) / BMS
Trial primary completion date: Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT2 Infected Patients (clinicaltrials.gov) - Jan 18, 2017
P4, N=120, Recruiting, Sponsor: Humanity & Healthy GI and Liver Centre
Active, not recruiting --> Completed | Trial primary completion date: Jul 2015 --> Feb 2015 Trial primary completion date: Dec 2016 --> Dec 2017
- || Sunvepra (asunaprevir) / BMS, Daklinza (daclatasvir) / BMS
Trial primary completion date: Asunaprevir/Daclatasvir Safety Surveillance in Japanese Patients With Chronic Hepatitis C (clinicaltrials.gov) - Jan 18, 2017
P=N/A, N=2974, Active, not recruiting, Sponsor: Bristol-Myers Squibb
Trial primary completion date: Dec 2016 --> Dec 2017 Trial primary completion date: Nov 2016 --> Feb 2017
- | Sovaldi (sofosbuvir) / Gilead
New P4 trial: Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With Hepatitis C Infection (clinicaltrials.gov) - Dec 14, 2016
P4, N=1000, Recruiting, Sponsor: Tanta University
- Trial primary completion date: GEHEP: Efficacy and Safety of Therapy Against HCV Based on Direct-acting Antivirals in Real-life Conditions (clinicaltrials.gov) - Oct 17, 2016
P=N/A, N=1000, Recruiting, Sponsor: Valme University Hospital
Trial primary completion date: Nov 2016 --> Feb 2017 Trial primary completion date: Nov 2017 --> Nov 2020
- || Sunvepra (asunaprevir) / BMS, Daklinza (daclatasvir) / BMS
Enrollment closed, Trial primary completion date: Asunaprevir/Daclatasvir Safety Surveillance in Japanese Patients With Chronic Hepatitis C (clinicaltrials.gov) - Sep 1, 2016
P=N/A, N=3000, Active, not recruiting, Sponsor: Bristol-Myers Squibb
Trial primary completion date: Nov 2017 --> Nov 2020 Recruiting --> Active, not recruiting | Trial primary completion date: May 2016 --> Nov 2016
- Daklinza (daclatasvir) / BMS
Trial primary completion date: Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT2 Infected Patients (clinicaltrials.gov) - Aug 22, 2016
P4, N=120, Recruiting, Sponsor: Humanity & Healthy GI and Liver Centre
Recruiting --> Active, not recruiting | Trial primary completion date: May 2016 --> Nov 2016 Trial primary completion date: Jun 2016 --> Dec 2016
- ||||| Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta Pharma
Trial initiation date: ENDURANCE-3: A Study Comparing Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Dosed With Daclatasvir in Adults With HCV Genotype 3 Infection (clinicaltrials.gov) - Jul 19, 2016
P3, N=460, Active, not recruiting, Sponsor: AbbVie
Trial primary completion date: Jun 2016 --> Dec 2016 Initiation date: Jan 2015 --> Dec 2015
- | Daklinza (daclatasvir) / BMS
New P1 trial: Bioequivalence Study of Daclatasvir From Prodactariv 60 mg Film Coated Tablets (International Drug Agency for Pharmaceutical Industry (IDI), Egypt) and Clatazev 60 mg Tablets (Bristol-Myers Squibb Pharma, UK) (clinicaltrials.gov) - May 23, 2016
P1, N=24, Completed, Sponsor: Genuine Research Center, Egypt
- ||||| Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta Pharma
Enrollment closed: ENDURANCE-3: A Study Comparing Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Dosed With Daclatasvir in Adults With HCV Genotype 3 Infection (clinicaltrials.gov) - May 18, 2016
P3, N=460, Active, not recruiting, Sponsor: AbbVie
Initiation date: Jan 2015 --> Dec 2015 Recruiting --> Active, not recruiting
- Daklinza (daclatasvir) / BMS
New trial: Determining the Sustained Virologic Response of Declatasvir in Egyptian Patients With Hepatitis C Virus Genotype 4 (clinicaltrials.gov) - May 13, 2016
P=N/A, N=250, Not yet recruiting, Sponsor: Zagazig University
- || Olysio (simeprevir) / J&J, Medivir, Daklinza (daclatasvir) / BMS
New P3 trial: FRI-STC: Impact of Interferon Free Regimens in Patients With Chronic HCV and Successfully Treated HCC (clinicaltrials.gov) - May 13, 2016
P3, N=150, Recruiting, Sponsor: National Hepatology & Tropical Medicine Research Institute
- |||| Olysio (simeprevir) / J&J, Medivir
Trial completion: COMMIT: A Study to Assess the Efficacy and Safety of the Combination of Simeprevir and Daclatasvir in Chronic Hepatitis C Genotype 1b-Infected Participants (clinicaltrials.gov) - May 5, 2016
P2, N=106, Completed, Sponsor: Janssen-Cilag International NV
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- ||| Daklinza (daclatasvir) / BMS
Trial completion: Effectiveness Of Daclatasvir-Based Regimens In Patients With Chronic Hepatitis C Infection In Europe: Experience From Named Patient Program And From Early Post-Marketing Authorization Period (clinicaltrials.gov) - May 4, 2016
P=N/A, N=300, Completed, Sponsor: Bristol-Myers Squibb
Active, not recruiting --> Completed Active, not recruiting --> Completed
- | Daklinza (daclatasvir) / BMS
New P1 trial: Bioequivalence Study of Daclatasvir From Daclatasvir Zeta 60 mg Film Coated Tablets (Zeta Pharm Pharmaceutical Industries, Egypt) and Clatazev 60 mg Tablets (Bristol-Myers Squibb Pharma, UK) (clinicaltrials.gov) - May 2, 2016
P1, N=24, Completed, Sponsor: Genuine Research Center, Egypt
- || Daklinza (daclatasvir) / BMS
Enrollment closed: Comparative Assessment of Utilization of Antiviral Therapies in Hepatitis C and Effectiveness of Daclatasvir-containing Regimens in Real-life Clinical Care in Europe (CMPASS-EU) (clinicaltrials.gov) - Apr 27, 2016
P=N/A, N=920, Active, not recruiting, Sponsor: Bristol-Myers Squibb
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- Daklinza (daclatasvir) / BMS
Trial completion: DATE-3: A Drug-drug Interaction Study Between Daclatasvir and Metformin (clinicaltrials.gov) - Apr 7, 2016
P1, N=20, Completed, Sponsor: Radboud University
Recruiting --> Active, not recruiting Not yet recruiting --> Completed
- ||||| Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta Pharma
Enrollment change, Trial initiation date: ENDURANCE-3: A Study Comparing Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Dosed With Daclatasvir in Adults With HCV Genotype 3 Infection (clinicaltrials.gov) - Mar 15, 2016
P3, N=460, Recruiting, Sponsor: AbbVie
Not yet recruiting --> Completed N=345 --> 460 | Initiation date: Nov 2015 --> Jan 2015