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Victrelis Medical Research Studies

Up-to-date List of Victrelis Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Victrelis Medical Research Studies

Rank Status Study
1 Recruiting Boceprevir/PegIFN α-2b/Riba in HCV+ Gt1 Menopausal Women, Nonresponders to PegIFN/Riba or Treatment-naives (MEN_BOC)
Conditions: Chronic Hepatitis C;   Menopause
Intervention: Drug: Pegylated Interferon, Ribavirin, Boceprevir
Outcome Measures: Improvement of sustained virological response in previous treatment failure or naive HCV-positive menopausal women.;   Early virological response
2 Recruiting The Effects of the Direct Acting Antiviral Agent Boceprevir on the Pharmacokinetics of Maraviroc in Healthy Volunteers
Condition: Healthy
Interventions: Drug: Maraviroc (5 days);   Drug: Maraviroc and boceprevir (14 days)
Outcome Measures: Change in maraviroc AUC;   Change in maraviroc Tmax;   Adverse events;   Change in maraviroc Cmax;   Change in maraviroc Cmin;   Change in maraviroc Cl/F;   Change in maraviroc Vd;   Change in maraviroc T1/2
3 Recruiting Comparative Effectiveness and Tolerability of Boceprevir vs Telaprevir
Conditions: Hepatitis C,;   Cirrhosis
Interventions: Drug: Telaprevir;   Drug: Boceprevir;   Drug: Peg-IFN;   Drug: Ribavirin
Outcome Measure: Safety/Adverse Event Outcome Measure
4 Not yet recruiting A Pilot Study of Boceprevir for the Treatment of Genotype 6 HCV
Condition: Chronic Hepatitis C
Interventions: Drug: Victrelis® (boceprevir) 800mg by mouth, TID (200 mg tablets);   Drug: Peg-Intron® (peginterferon-α-2b), 1.5ug/kg sc injection;   Drug: Rebetol® (ribavirin), 1000/1200mg by mouth daily
Outcome Measures: Early viral kinetics;   Rates of virological response;   Number of patients eligible for Response Guided Therapy;   Rates of virological breakthrough;   Rates of SVR12 and relapse;   Rates of anaemia on treatment
5 Recruiting Drug Utilization of Boceprevir and Clinical Management of Health Outcomes of Interest in Chronic Hepatitis C Participants (P08518)
Condition: Hepatitis C Chronic
Intervention:
Outcome Measures: Boceprevir utilization versus other therapies;   Clinical management of health outcomes of interest ([HOI], anemia, neutropenia, thrombocytopenia, or serious rash);   Incidence of anemia, neutropenia, thrombocytopenia, and serious skin rash
6 Not yet recruiting A Pilot Study to Treat Patients With Chronic Hepatitis C Virus (HCV) Genotype 1 and End-Stage Renal Disease (ESRD)
Conditions: Chronic Hepatitis C;   End Stage Renal Disease
Interventions: Drug: Ribavirin;   Drug: Peginterferon;   Drug: Boceprevir
Outcome Measures: Percentage of patients who achieve eRVR at treatment week 28;   Tolerability of treatment
7 Recruiting Boceprevir in End Stage Renal Disease (ESRD)
Conditions: Hepatitis C Infection;   End Stage Renal Disease
Interventions: Drug: Peginterferon alfa 2b;   Drug: Peginterferon alfa 2a;   Drug: Ribavirin;   Drug: Boceprevir
Outcome Measure: Proportion of patients who achieve sustained virologic response
8 Recruiting A Study to Evaluate the Efficacy and Safety of Boceprevir Added to Standard of Care Therapy in Previously Treated Participants With Chronic Hepatitis C Genotype 1 and Cirrhosis (MK-3034-105)
Condition: Hepatitis C
Interventions: Drug: boceprevir;   Biological: PegIFN-2b;   Drug: RBV
Outcome Measure: Number of participants who achieve sustained viral response (SVR) at 24 weeks after the end of all study treatment
9 Recruiting Individualized Triple-therapy Using Boceprevir in HIV-positive Patients With Hepatitis C
Conditions: Hepatitis C, Chronic;   HIV
Interventions: Drug: Pegylated interferon alpha-2a;   Drug: Ribavirin;   Drug: Boceprevir
Outcome Measures: Sustained virologic response (SVR12);   Adverse events (AEs) and severe adverse events (SAEs);   Sustained virologic response (SVR24);   Anemia;   Thrombocytopenia;   Neutropenia;   Erythropoietin (EPO) and granulocyte colony-stimulating factor (G-CSF) analogues use;   Treatment discontinuation due to AEs;   Drop-outs
10 Recruiting Boceprevir-based Therapy to Rescue HCV Genotype 1/HBV Infected Patients Refractory to Combination Therapy
Condition: Hepatitis C, Chronic
Intervention: Drug: Stop trial intervention for boceprevir, PEG-IFN and RBV
Outcome Measures: Primary endpoint of this clinical trial-SVR and FAS for HCV RNA;   Key secondary endpoint of this clinical trial-SVR in mITT and HBV DNA surge
11 Recruiting Dutch Acute HCV in HIV Study (DAHHS)
Conditions: Hepatitis C;   Human Immunodeficiency Virus
Intervention: Drug: Boceprevir
Outcome Measures: Sustained Viral Responds(SVR) at 24 weeks of follow up after the end of all therapy for the Rapid Viral Response at week 4(RVR4) population.;   SVR 24 weeks after the end of all therapy in the entire study population (with or without RVR4).;   SVR 12 weeks after end of therapy in RVR4 population.;   SVR 24 weeks after end of therapy in patients with already a RVR at week 1.;   SVR 24 weeks after end of therapy in patients that started therapy ≤12weeks after the presumed HCV infection date versus those after 12 weeks.;   Alterations of biomarkers by therapy induced viral eradication: Viral sequencing, mutation analysis, gene expression analysis, and RNA analysis.;   Safety: Treatment related (serious) adverse events ((S)AE) and treatment discontinuation for (S)AE.
12 Unknown  A Drug Interaction Study of Boceprevir in Combination With Amlodipine or Diltiazem in Healthy Volunteers
Conditions: Hepatitis C;   Hypertension
Interventions: Drug: Amlodipine;   Drug: Diltiazem
Outcome Measures: pharmacokinetics;   number of participants with adverse events
13 Recruiting Short Duration Versus Standard Response-Guided Therapy With Boceprevir Combined With PegIntron and Ribavirin in Previously Untreated Non-Cirrhotic Asian Participants With Chronic HCV Genotype 1 (MK-3034-107)
Condition: Hepatitis C, Chronic
Interventions: Drug: Boceprevir;   Biological: Peg-interferon alfa-2b;   Drug: Ribavirin
Outcome Measures: Percentage of Participants With Undetectable HCV RNA at TW 8 Who Achieve Sustained Viral Response at Follow-up Week 12 (SVR12) [16-Week Arm vs. 28-Week Arm];   Percentage of Participants with Sustained Virologic Response at Follow-up Week 24 (SVR24);   Percentage of Participants with SVR12 By Virologic Response At End of Treatment;   Percentage of Participants With Relapse;   Percentage of Participants With Neutrophil Count <0.75 x10^9/L;   Percentage of Participants With Hemoglobin (Hgb) <10 g/dL;   Percentage of Participants With Dose Discontinuation/Modification Due to Adverse Events (AEs);   Percentage of Participants With Treatment-Related Serious AEs (SAEs)
14 Not yet recruiting A Study to Evaluate Safety and Efficacy of Boceprevir-response Guided Therapy in Controlled HIV Patients With Chronic Hepatitis C Genotype 1 Infection Who Failed Previously to Peginterferon /Ribavirin
Condition: HCV and HIV Seropositive Coinfection
Interventions: Drug: boceprevir;   Drug: Ribavirin;   Drug: Peginterferon alfa-2a;   Drug: Peginterferon alfa-2b
Outcome Measures: Achievement of sustained virological response (SVR) at week 24;   Achievement of sustained virological response at weeks 2,4,8,12.;   The proportion of subjects with undetectable HCV-RNA at FW 12.;   The proportion of subjects with undetectable HCV-RNA at 72 weeks after randomization.;   Number of adverse events;   Resistance of HCV after boceprevir (BOC) containing regimen
15 Not yet recruiting Study of Combining Boceprevir With Peginterferon Alfa-2b and Ribavirin in the Treatment-naive Patients Infected With Genotype 4 Chronic Hepatitis C Infection
Condition: Genotype 4 Chronic Hepatitis C Infection
Interventions: Drug: Boceprevir;   Drug: Peginterferon alfa-2b;   Drug: ribavirin
Outcome Measures: Efficacy;   Week 8 Response;   12 Weeks response;   IL-28B polymorphism
16 Not yet recruiting An Observational Study Examining the Use of Triple Combination Therapy With Boceprevir, Pegasys and Ribivarin in the Re-Treatment of Chronic Hepatitis C Patients
Condition: Hepatitis C, Chronic
Intervention:
Outcome Measures: Sustained virological response 24 (SVR24), defined as percentage of patients with HCV RNA < 15 IU/mL after the 24-week follow-up;   Virological response (HCV RNA < 15 IU/mL);   Virological breakthrough, defined as either HCV RNA >/= 15 IU/mL in patients with prior virological response or as an increase in RCV RNA >/= 1 log10 above nadir;   Virological relapse defined as HCV RNA >/= 15 IU/mL during the treatment free follow-up period in patients with virological response at the end of treatment;   Incidence of treatment discontinuation due to futility, defined as: HCV RNA drop < 3 log10 at Week 8, HCV RNA >/= 100 IU/mL at Week 12, or HCV RNA >/= 15 IU/mL at Week 24;   Incidence of treatment discontinuation;   Incidence of adverse events;   Predictive value of patient demographics;   Predictive value of liver fibrosis;   Predictive value of HCV disease characteristics;   Predictive value of previous virological response (null-response, partial response, or relapse)
17 Recruiting Register of Telaprevir and Boceprevir in Routine Clinical Practice
Condition: Hepatitis C
Intervention:
Outcome Measures: Effectiveness of current treatment of hepatitis C virus, genotype 1, for patients who have never been treated and for patients who have been previously treated;   Safety of current treatment of hepatitis C virus, genotype 1, for patients who have never been treated and for patients who have been previously treated
18 Recruiting Study of Quadruple Therapy With Eltrombopag for Chronic Hepatitis C
Conditions: Thrombocytopenia;   Hepatitis C
Intervention: Drug: Eltrombopag
Outcome Measure: Percentage of study patients completing antiviral therapy, as per boceprevir prescribing guidelines.
19 Recruiting Real-life Security and Efficacy of DAA-based Therapy in HCV/HIV-Coinfected Patients
Conditions: Hepatitis C, Chronic;   Human Immunodeficiency Virus
Intervention: Drug: DAA against HCV
Outcome Measures: Number of patients who achieve SVR to DAA-based therapy as measure of efficacy;   Number of patients who develop severe adverse events as measure of safety;   Number of patients who achieve SVR to a BOC-based regimen as compared to numbers of patients who achieve SVR to a TVR-based regimen.;   Number of patients who reach undetectable HCV-RNA at week 4 of PI-based therapy as a measure of on-treatment response to therapy.;   Number of patients who develop adverse events during a BOC-based regimen as compared to numbers of patients who develop adverse events during a TVR-based regimen.
20 Not yet recruiting Technology-Based Application To Improve The Triple Therapy Adherence Rate In Subjects With Hepatitis C Infection
Condition: Hepatitis C
Intervention: Other: On Plan
Outcome Measures: Treatment Completion;   Virologic response

These studies may lead to new treatments and are adding insight into Victrelis etiology and treatment.

A major focus of Victrelis research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.


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