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- | Journal: The Role of CYPs and Transporters in the Biotransformation and Transport of the Anti-hepatitis C Antiviral Agents Asunaprevir, Daclatasvir, and Beclabuvir: Impact of Liver Disease, Race and Drug-drug Interactions on Safety and Efficacy. (Pubmed Central) - Mar 5, 2024
Conversely, there is also evidence that asunaprevir, daclatasvir and beclabuvir are perpetrators of drug interactions with coadministered rosuvastatin and dextromethorphan. Together, liver disease, pharmacogenomic variation and drug-drug interactions may disrupt.
- ||| Trial completion, Enrollment change, 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) - Feb 23, 2022
P=N/A, N=344, Completed, Sponsor: Bristol-Myers Squibb
Together, liver disease, pharmacogenomic variation and drug-drug interactions may disrupt. Active, not recruiting --> Completed | N=1000 --> 344
- | Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta
Journal, HEOR: A Cost-Effectiveness Analysis of Glecaprevir/Pibrentasvir Versus Existing Direct-Acting Antivirals to Treat Chronic Hepatitis C in Japan. (Pubmed Central) - Oct 7, 2020
In GT1 treatment-naïve non-cirrhotic patients GLE/PIB was a cost-effective strategy compared to other DAAs. When a pan-genotypic framework was used, the GLE/PIB portfolio dominated the SOF-based portfolio.
- || Ximency (daclatasvir/asunaprevir/beclabuvir) / BMS, beclabuvir (BMS-791325) / BMS, daclatasvir/asunaprevir (BMS-60032/BMS-790052) / BMS
Clinical, Journal: Exposure-Response Analysis for Efficacy of Daclatasvir, Asunaprevir, and Beclabuvir Combinations in HCV-Infected Patients. (Pubmed Central) - Aug 5, 2020
With the exception of the NS5A-Q30 substitution in genotype-1a subjects, statistically significant covariate effects had little impact on SVR12 rates. Overall, the E-R model was developed that captured the high SVR12 rates and the effect of covariates for the 3DAA regimen in HCV-infected patients.
- || Ximency (daclatasvir/asunaprevir/beclabuvir) / BMS, beclabuvir (BMS-791325) / BMS, daclatasvir/asunaprevir (BMS-60032/BMS-790052) / BMS
Clinical, PK/PD data, Journal: Population Pharmacokinetic Analysis of Daclatasvir, Asunaprevir, and Beclabuvir Combination in HCV-Infected Subjects. (Pubmed Central) - Jul 29, 2020
The effects of all covariates on daclatasvir PK were modest and not considered clinically significant. With the exception of race on asunaprevir and beclabuvir PK, no other parameters for daclatasvir, asunaprevir and beclabuvir population PK models were meaningfully impacted during the refinement with Japanese subjects.
- || Ximency (daclatasvir/asunaprevir/beclabuvir) / BMS
Clinical, Journal, Real-World Evidence: Real-world virological efficacy and safety of daclatasvir/asunaprevir/beclabuvir in patients with chronic hepatitis C virus genotype 1 infection in Japan. (Pubmed Central) - Jul 19, 2020
SVR rate was not as high as that in pre-approval clinical trial of this regimen in IFN-free DAA-naïve patients. In addition, most patients with a history of failure with IFN-free DAA therapy, particularly the DCV/ASV regimen, showed resistance to this regimen.
- || Ximency (daclatasvir/asunaprevir/beclabuvir) / BMS, beclabuvir (BMS-791325) / BMS, daclatasvir/asunaprevir (BMS-60032/BMS-790052) / BMS
Clinical, Journal: Safety Exposure-Response Analysis for Daclatasvir, Asunaprevir, and Beclabuvir Combinations in HCV-Infected Subjects. (Pubmed Central) - Jun 26, 2020
Subjects with F4 fibrosis score had a higher rate of Grade 3 or 4 Tbili elevation compared to subjects with F0 to F3 fibrosis score. Higher asunaprevir exposure was associated with increases in Grade 3 or 4 ALT and Tbili elevation rates; however, the impact on the ALT elevation was not clinically relevant and the effect on Tbili elevation was smaller than the other significant covariates.
- || daclatasvir+asunaprevir+BMS 791325 FDC / BMS, beclabuvir (BMS-791325) / BMS, daclatasvir/asunaprevir (BMS-60032/BMS-790052) / BMS
Clinical, Journal: Efficacy and safety of a fixed dose combination tablet of asunaprevir + beclabuvir + daclatasvir for the treatment of Hepatitis C. (Pubmed Central) - Feb 7, 2020
All these drawbacks considerably limit its effective commercial potential. However, it can be a therapeutic option against HCV in tailored approaches according to the needs of different markets across the world.Abbreviations AE: adverse event; ALT: alanine aminotransferase; AST: aspartate aminotransferase; ASV: asunaprevir; AUC: area under the curve; BCRP: Breast Cancer Resistance Protein; BCV: boceprevir; BID: bis in die; CI: confidence intervals; CLcr: creatinine clearance; DAA: direct acting antivirals; DCV: daclatasvir; EC50: Half maximal effective concentration; GT: genotype; HCV: Hepatitis C virus; IFN: Interferon; NHL: non-Hodgkin lymphoma; OATP: Organic anion transporting polypeptides; OR: odds ratio; P-gp: P-glycoprotein; PK: pharmacokinetics; QD: quo die; RAS: resistance-associated substitutions; SVR: sustained virological response; USD: Unites States dollar.
- || daclatasvir+asunaprevir+BMS 791325 FDC / BMS, beclabuvir (BMS-791325) / BMS, daclatasvir/asunaprevir (BMS-60032/BMS-790052) / BMS
Clinical, Journal, Combination therapy: Favorable outcome of retreatment by direct-acting antivirals for the hepatitis C patients with Daclatasvir plus Asunaprevir combination therapy failure. (Pubmed Central) - Nov 22, 2019
AASs were frequently observed in patients with DCV+ASV failure, but most patients achieved an SVR following re-treatment with DAAs. Although the spread of drug-resistant viruses due to unsuccessful DAA treatment was a matter of concern, most cases of DCV+ASV failure were overcome with additional treatment.
- | daclatasvir+asunaprevir+BMS 791325 FDC / BMS, beclabuvir (BMS-791325) / BMS, daclatasvir/asunaprevir (BMS-60032/BMS-790052) / BMS
Retrospective data, Journal: Pooled analysis of HCV genotype 1 resistance-associated substitutions in NS5A, NS3 and NS5B pre- and post-treatment with 12 weeks of daclatasvir, asunaprevir and beclabuvir. (Pubmed Central) - Oct 2, 2019
DCV+ASV+BCV±RBV was highly efficacious in HCV GT-1 infection, including HCV GT-1b with NS5A RAS. The fitness of treatment-emergent RAS post-treatment was NS5A > NS3 > NS5B; NS3 and NS5B RAS were generally replaced by wild-type sequence within 48 weeks.
- | daclatasvir+asunaprevir+BMS 791325 FDC / BMS, beclabuvir (BMS-791325) / BMS, daclatasvir/asunaprevir (BMS-60032/BMS-790052) / BMS
Clinical, Journal: Limitations of daclatasvir/asunaprevir plus beclabuvir treatment in cases of NS5A inhibitor treatment failure. (Pubmed Central) - Aug 9, 2019
Sustained virological response was achieved in a DAA-naïve patient and one of the DCV/ASV treatment failures through DCV/ASV/BCV therapy; however, HCV relapse occurred in the other patients with prior DCV/ASV and/or sofosbuvir/ledipasvir treatment failures. DCV/ASV/BCV therapy seems to have limited efficacy for patients with NS5A RAVs for whom prior DAA treatment has failed.
- | daclatasvir+asunaprevir+BMS 791325 FDC / BMS
Clinical, Journal: Potent viral suppression and improvements in alpha-fetoprotein and measures of fibrosis in Japanese patients receiving a daclatasvir/asunaprevir/beclabuvir fixed-dose combination for the treatment of HCV genotype-1 infection. (Pubmed Central) - Jul 13, 2019
DCV/ASV/BCV therapy seems to have limited efficacy for patients with NS5A RAVs for whom prior DAA treatment has failed. DCV-TRIO administered for 12 weeks to Japanese patients with primarily GT-1b infection achieved a high SVR12 rate and resulted in improved measures of hepatic fibrosis and serum AFP that may reduce the risk of future liver disease progression and hepatocellular carcinoma, particularly in those with compensated cirrhosis.
- | daclatasvir+asunaprevir+BMS 791325 FDC / BMS, beclabuvir (BMS-791325) / BMS, daclatasvir/asunaprevir (BMS-60032/BMS-790052) / BMS
Journal, Combination therapy: Association between alanine aminotransferase elevation and UGT1A1*6 polymorphisms in daclatasvir and asunaprevir combination therapy for chronic hepatitis C. (Pubmed Central) - May 30, 2019
Through the analysis we suggest that the A allele in UGT1A1 rs4148323 (UGT1A1*6), which is highly prevalent in the Japanese population, should be considered a risk for the development of DCV/ASV therapy-induced ALT elevation. Pretreatment SNP testing of UGT1A1*6 might be beneficial for the prediction of liver damage induced by DCV/ASV or even by DCV/ASV plus beclabuvir.
- | daclatasvir+asunaprevir+BMS 791325 FDC / BMS, beclabuvir (BMS-791325) / BMS, daclatasvir/asunaprevir (BMS-60032/BMS-790052) / BMS
Retrospective data, Review, Journal, Combination therapy: Beclabuvir in combination with asunaprevir and daclatasvir for hepatitis C virus genotype 1 infection: A systematic review and meta-analysis. (Pubmed Central) - Apr 3, 2019
Daclatasvir, asunaprevir (ASV), and beclabuvir (BCV) are direct-acting antivirals (DAAs) for patients with hepatitis C virus genotype 1 infection...The three-drug combination showed a high response rate in naïve patients with sustained virologic response at week-12 posttreatment (SVR ) rate = 95.7% (95%CI [93.8-97.1]) and no difference detected by adding ribavirin (RBV) (the pooled RR = 0.98, 95%CI [0.90-1.08], P = 0.70) or comparing with interferon-experienced patients (RR = 1.02, 95%CI [0.98-1.07], P = 0.31) regardless the genotype 1 subtypes or IL28B genotype...Increasing the dose or the duration did not show a significant increase in the efficacy. In conclusion, this analysis showed high response rates in HCV genotype 1-infected patients treated with daclatasvir, asunaprevir, and beclabuvir irrespective of ribavirin use, prior interferon-based therapy, or restriction on non-cirrhotic patients, IL28B genotype, or baseline resistance-associated variants.
- || Enrollment closed, 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) - Jan 30, 2019
P=N/A, N=1000, Active, not recruiting, Sponsor: Bristol-Myers Squibb
In conclusion, this analysis showed high response rates in HCV genotype 1-infected patients treated with daclatasvir, asunaprevir, and beclabuvir irrespective of ribavirin use, prior interferon-based therapy, or restriction on non-cirrhotic patients, IL28B genotype, or baseline resistance-associated variants. Recruiting --> Active, not recruiting
- | Clinical, Journal: Multitarget Direct-Acting Antiviral Therapy Is Associated With Superior Immunologic Recovery in Patients Coinfected With Human Immunodeficiency Virus and Hepatitis C Virus. (Pubmed Central) - Dec 18, 2018
We analyzed peripheral blood mononuclear cells (PBMCs) at baseline and at the time of sustained viral response (SVR) from subjects treated with three different combination DAA regimens: daclatasvir (DCV) and asunaprevir (ASV) for 24 weeks (CONQUER 2-DAA), DCV/ASV/beclabuvir (BCV) for 12 weeks (CONQUER 3-DAA), and sofosbuvir (SOF) and ledipasvir (LDV) for 12 weeks (ERADICATE study)...We showed that different DAA-based therapies have different immunologic outcomes after successful HCV treatment in patients coinfected with HIV/HCV. This information will be beneficial for providers when selecting the regimens for patients coinfected with HIV/HCV.
- ||| 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
- beclabuvir (BMS-791325) / BMS
Trial completion, Trial primary completion date: Safety, Tolerability, and Efficacy of Asunaprevir and Daclatasvir in Subjects Coinfected With HIV-HCV (clinicaltrials.gov) - Nov 18, 2016
P2, N=39, Completed, Sponsor: National Institutes of Health Clinical Center (CC)
This information will be beneficial for providers when selecting the regimens for patients coinfected with HIV/HCV. Active, not recruiting --> Completed | Trial primary completion date: Nov 2016 --> Mar 2016
- Ximency (daclatasvir/asunaprevir/beclabuvir) / BMS, beclabuvir (BMS-791325) / BMS
Enrollment change, Trial withdrawal: HEPCOG-II: Impact of HCV Treatment on Neurocognitive Functions and Brain Metabolism (clinicaltrials.gov) - Jun 5, 2016
P4, N=0, Withdrawn, Sponsor: Kirby Institute
Active, not recruiting --> Completed | Trial primary completion date: Nov 2016 --> Mar 2016 N=35 --> 0 | Not yet recruiting --> Withdrawn
- | Ximency (daclatasvir/asunaprevir/beclabuvir) / BMS, beclabuvir (BMS-791325) / BMS
Trial completion, Enrollment change, Trial primary completion date: RHACE 1: Rapid Hepatitis C Elimination Trial- A Pilot Study of Daclatasvir/Asunaprevir/BMS-791325 With or Without Ribavirin To Treat Hepatitis C Virus (clinicaltrials.gov) - Apr 19, 2016
P=N/A, N=25, Completed, Sponsor: Timothy Morgan, MD
N=35 --> 0 | Not yet recruiting --> Withdrawn Recruiting --> Completed | N=60 --> 25 | Trial primary completion date: Apr 2015 --> Feb 2016
- Enrollment change, Trial withdrawal: QUATTROTURBO: Pilot Study to Assess Efficacy and Safety of a Triple Therapy With Asunaprevir, Daclatasvir, and BMS-791325 in HCV Genotype 4-infected Patients After Failure of Pegylated Interferon-Ribavirin Regimen (clinicaltrials.gov) - Feb 2, 2016
P2, N=0, Withdrawn, Sponsor: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Recruiting --> Completed | N=60 --> 25 | Trial primary completion date: Apr 2015 --> Feb 2016 N=60 --> 0 | Not yet recruiting --> Withdrawn
- | Ximency (daclatasvir/asunaprevir/beclabuvir) / BMS, beclabuvir (BMS-791325) / BMS
Trial completion, Combination therapy: Short Duration Combination Therapy With Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir in Subjects Infected With Chronic Hepatitis-C (FOURward Study) (clinicaltrials.gov) - Jan 11, 2016
P2, N=28, Completed, Sponsor: Bristol-Myers Squibb
N=60 --> 0 | Not yet recruiting --> Withdrawn Active, not recruiting --> Completed
- beclabuvir (BMS-791325) / BMS
Enrollment closed, Enrollment change, Trial primary completion date: Safety, Tolerability, and Efficacy of Asunaprevir and Daclatasvir in Subjects Coinfected With HIV-HCV (clinicaltrials.gov) - Dec 10, 2015
P2, N=39, Active, not recruiting, Sponsor: National Institutes of Health Clinical Center (CC)
Active, not recruiting --> Completed Recruiting --> Active, not recruiting | N=60 --> 39 | Trial primary completion date: Jan 2016 --> Nov 2016
- ||||||| Ximency (daclatasvir/asunaprevir/beclabuvir) / BMS
Trial completion: UNITY 4: A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1 (clinicaltrials.gov) - Oct 6, 2015
P3, N=169, Completed, Sponsor: Bristol-Myers Squibb
Recruiting --> Active, not recruiting | N=60 --> 39 | Trial primary completion date: Jan 2016 --> Nov 2016 Active, not recruiting --> Completed
- ||||||| Ximency (daclatasvir/asunaprevir/beclabuvir) / BMS, beclabuvir (BMS-791325) / BMS
Trial completion: UNITY 3: A Japanese Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 in Subjects With Genotype 1 Chronic Hepatitis C (clinicaltrials.gov) - Sep 4, 2015
P3, N=297, Completed, Sponsor: Bristol-Myers Squibb
Active, not recruiting --> Completed Active, not recruiting --> Completed
- | Ximency (daclatasvir/asunaprevir/beclabuvir) / BMS, beclabuvir (BMS-791325) / BMS
Trial initiation date, Trial primary completion date: HEPCOG-II: Impact of HCV Treatment on Neurocognitive Functions and Brain Metabolism (clinicaltrials.gov) - Apr 30, 2015
P4, N=35, Not yet recruiting, Sponsor: Kirby Institute
Active, not recruiting --> Completed Initiation date: Mar 2015 --> Jun 2015 | Trial primary completion date: Feb 2016 --> Jun 2016
- ||||| Ximency (daclatasvir/asunaprevir/beclabuvir) / BMS
Enrollment closed: UNITY 4: A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1 (clinicaltrials.gov) - Mar 18, 2015
P3, N=160, Active, not recruiting, Sponsor: Bristol-Myers Squibb
Initiation date: Mar 2015 --> Jun 2015 | Trial primary completion date: Feb 2016 --> Jun 2016 Recruiting --> Active, not recruiting
- |||| Ximency (daclatasvir/asunaprevir/beclabuvir) / BMS
Trial primary completion date: UNITY 4: A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1 (clinicaltrials.gov) - Feb 23, 2015
P3, N=160, Recruiting, Sponsor: Bristol-Myers Squibb
Recruiting --> Active, not recruiting Trial primary completion date: Mar 2015 --> Jun 2015
- | Ximency (daclatasvir/asunaprevir/beclabuvir) / BMS, beclabuvir (BMS-791325) / BMS
Trial completion: Study of Drug Combination on Pharmacokinetics in Healthy Volunteers (clinicaltrials.gov) - Feb 10, 2015
P1, N=41, Completed, Sponsor: Bristol-Myers Squibb
Trial primary completion date: Mar 2015 --> Jun 2015 Not yet recruiting --> Completed
- ||||||| Ximency (daclatasvir/asunaprevir/beclabuvir) / BMS, beclabuvir (BMS-791325) / BMS
Trial completion: UNITY 1: A Study of an Investigational Treatment Regimen of Daclatasvir (DCV) + Asunaprevir (ASV) + BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) for 12 Weeks for the Treatment of Chronic Hepatitis C Virus (HCV) Genotype 1 Infection in Non-cirrhotic Subjects (clinicaltrials.gov) - Dec 9, 2014
P3, N=416, Completed, Sponsor: Bristol-Myers Squibb
Not yet recruiting --> Completed Active, not recruiting --> Completed
- ||||||| Ximency (daclatasvir/asunaprevir/beclabuvir) / BMS, beclabuvir (BMS-791325) / BMS
Trial completion: UNITY 2: A Study of an Investigational Treatment Regimen of DCV+ASV+BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) With or Without RBV for 12 Weeks for the Treatment of Chronic Hepatitis C Virus(HCV)Genotype 1 Infection in Subjects With Compensated Cirrhosis (clinicaltrials.gov) - Dec 9, 2014
P3, N=202, Completed, Sponsor: Bristol-Myers Squibb
Active, not recruiting --> Completed Active, not recruiting --> Completed
- ||||| New P2 trial: QUATTROTURBO: Pilot Study to Assess Efficacy and Safety of a Triple Therapy With Asunaprevir, Daclatasvir, and BMS-791325 in HCV Genotype 4-infected Patients After Failure of Pegylated Interferon-Ribavirin Regimen (clinicaltrials.gov) - Dec 6, 2014
P2, N=60, Not yet recruiting, Sponsor: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
- | Ximency (daclatasvir/asunaprevir/beclabuvir) / BMS, beclabuvir (BMS-791325) / BMS
New P4 trial: HEPCOG-II: Impact of HCV Treatment on Neurocognitive Functions and Brain Metabolism (clinicaltrials.gov) - Nov 18, 2014
P4, N=35, Not yet recruiting, Sponsor: Kirby Institute
- | Ximency (daclatasvir/asunaprevir/beclabuvir) / BMS, beclabuvir (BMS-791325) / BMS
Enrollment closed, Combination therapy: Short Duration Combination Therapy With Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir in Subjects Infected With Chronic Hepatitis-C (FOURward Study) (clinicaltrials.gov) - Oct 31, 2014
P2, N=30, Active, not recruiting, Sponsor: Bristol-Myers Squibb
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- ||| beclabuvir (BMS-791325) / BMS
Enrollment change: Safety, Tolerability, and Efficacy of Asunaprevir and Daclatasvir in Subjects Coinfected With HIV-HCV (clinicaltrials.gov) - Oct 23, 2014
P2, N=60, Recruiting, Sponsor: National Institutes of Health Clinical Center (CC)
Recruiting --> Active, not recruiting N=40 --> 60
- |||||| Ximency (daclatasvir/asunaprevir/beclabuvir) / BMS
Enrollment open: UNITY 4: A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1 (clinicaltrials.gov) - Sep 30, 2014
P3, N=160, Recruiting, Sponsor: Bristol-Myers Squibb
N=40 --> 60 Active, not recruiting --> Recruiting
- ||||| Ximency (daclatasvir/asunaprevir/beclabuvir) / BMS
Enrollment closed: UNITY 4: A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1 (clinicaltrials.gov) - Sep 19, 2014
P3, N=160, Active, not recruiting, Sponsor: Bristol-Myers Squibb
Active, not recruiting --> Recruiting Suspended --> Active, not recruiting
- || Ximency (daclatasvir/asunaprevir/beclabuvir) / BMS
Trial suspension: UNITY 4: A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1 (clinicaltrials.gov) - Aug 15, 2014
P3, N=160, Suspended, Sponsor: Bristol-Myers Squibb
Suspended --> Active, not recruiting Not yet recruiting --> Suspended
- | Ximency (daclatasvir/asunaprevir/beclabuvir) / BMS, beclabuvir (BMS-791325) / BMS
Enrollment open, Combination therapy: Short Duration Combination Therapy With Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir in Subjects Infected With Chronic Hepatitis-C (FOURward Study) (clinicaltrials.gov) - Aug 15, 2014
P2, N=30, Recruiting, Sponsor: Bristol-Myers Squibb
Not yet recruiting --> Suspended Not yet recruiting --> Recruiting
- | Ximency (daclatasvir/asunaprevir/beclabuvir) / BMS, beclabuvir (BMS-791325) / BMS
Trial completion: Drug Interaction Study of an OCP (Norethindrone (ND) Acetate and Ethinyl Estradiol (EE))With a Combination of Daclatasvir (DCV) Asunaprevir (ASV) and BMS-791325 (clinicaltrials.gov) - Aug 15, 2014
P1, N=20, Completed, Sponsor: Bristol-Myers Squibb
Not yet recruiting --> Recruiting Not yet recruiting --> Completed
- | Ximency (daclatasvir/asunaprevir/beclabuvir) / BMS, beclabuvir (BMS-791325) / BMS
Trial completion, Combination therapy: Drug Interaction Between Daclatasvir/Asunaprevir/BMS-791325 and Rosuvastatin (clinicaltrials.gov) - Jul 18, 2014
P1, N=18, Completed, Sponsor: Bristol-Myers Squibb
Not yet recruiting --> Completed Not yet recruiting --> Completed
- ||| Ximency (daclatasvir/asunaprevir/beclabuvir) / BMS, beclabuvir (BMS-791325) / BMS
Enrollment open: RHACE 1: Rapid Hepatitis C Elimination Trial- A Pilot Study of Daclatasvir/Asunaprevir/BMS-791325 With or Without Ribavirin To Treat Hepatitis C Virus (clinicaltrials.gov) - Jul 14, 2014
P=N/A, N=60, Recruiting, Sponsor: Timothy Morgan, MD
Not yet recruiting --> Completed Not yet recruiting --> Recruiting
- ||||| Ximency (daclatasvir/asunaprevir/beclabuvir) / BMS, beclabuvir (BMS-791325) / BMS
Enrollment closed, Trial primary completion date: UNITY 3: A Japanese Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 in Subjects With Genotype 1 Chronic Hepatitis C (clinicaltrials.gov) - Jul 12, 2014
P3, N=286, Active, not recruiting, Sponsor: Bristol-Myers Squibb
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting | Trial primary completion date: Oct 2015 --> Dec 2014
- | beclabuvir (BMS-791325) / BMS
Trial completion: To Assess the Effect of Renal Impairment on the Blood Levels of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325 After Multiple Doses of a Fixed Dose Combination Tablet (clinicaltrials.gov) - Jul 12, 2014
P1, N=41, Completed, Sponsor: Bristol-Myers Squibb
Recruiting --> Active, not recruiting | Trial primary completion date: Oct 2015 --> Dec 2014 Recruiting --> Completed
- | Ximency (daclatasvir/asunaprevir/beclabuvir) / BMS
Trial completion: Food Effect of a Fixed Dose Combination of Daclatasvir, Asunaprevir and BMS-791325 (clinicaltrials.gov) - Jul 12, 2014
P1, N=24, Completed, Sponsor: Bristol-Myers Squibb
Recruiting --> Completed Recruiting --> Completed
- |||| Ximency (daclatasvir/asunaprevir/beclabuvir) / BMS, beclabuvir (BMS-791325) / BMS
Trial primary completion date: UNITY 3: A Japanese Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 in Subjects With Genotype 1 Chronic Hepatitis C (clinicaltrials.gov) - Jun 27, 2014
P3, N=286, Recruiting, Sponsor: Bristol-Myers Squibb
Recruiting --> Completed Trial primary completion date: Feb 2015 --> Oct 2015
- | Ximency (daclatasvir/asunaprevir/beclabuvir) / BMS, beclabuvir (BMS-791325) / BMS
New P2 trial, Combination therapy: Short Duration Combination Therapy With Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir in Subjects Infected With Chronic Hepatitis-C (FOURward Study) (clinicaltrials.gov) - Jun 27, 2014
P2, N=30, Not yet recruiting, Sponsor: Bristol-Myers Squibb
- |||||| Ximency (daclatasvir/asunaprevir/beclabuvir) / BMS, beclabuvir (BMS-791325) / BMS
Enrollment open: UNITY 3: A Japanese Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 in Subjects With Genotype 1 Chronic Hepatitis C (clinicaltrials.gov) - Jun 27, 2014
P3, N=286, Recruiting, Sponsor: Bristol-Myers Squibb
Trial primary completion date: Feb 2015 --> Oct 2015 Not yet recruiting --> Recruiting
- | Ximency (daclatasvir/asunaprevir/beclabuvir) / BMS, beclabuvir (BMS-791325) / BMS
New P1 trial: Study of Drug Combination on Pharmacokinetics in Healthy Volunteers (clinicaltrials.gov) - Jun 26, 2014
P1, N=41, Not yet recruiting, Sponsor: Bristol-Myers Squibb
- |||||||||| Ximency (daclatasvir/asunaprevir/beclabuvir) / BMS
New P3 trial: UNITY 4: A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1 (clinicaltrials.gov) - Jun 24, 2014
P3, N=160, Not yet recruiting, Sponsor: Bristol-Myers Squibb