Take the time to learn more about HCV agents currently in clinical trials by reviewing new research presented this month at the International Liver Congress 2014. Link to editorials, expert analysis, and slide presentations evaluating efficacy and safety of hepatitis C investigational interferon-free combinations with and without ribavirin.
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Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Chronic Hepatitis C Virus Infection Without Cirrhosis
Wednesday, April 02, 2014 12:00 PM
ClinicalTrials.gov Identifier: NCT02114177
Purpose
The purpose of the study is to evaluate the efficacy and safety of a treatment regimen of 12 weeks or 8 weeks of simeprevir in combination with sofosbuvir in chronic hepatitis C virus (HCV) genotype 1 infected men and women without cirrhosis who are HCV treatment-naïve or treatment-experienced.
Condition: Hepatitis C Virus Infection
Interventions: Drug: Simeprevir; Drug: Sofosbuvir
Sponsor: Janssen Infectious Diseases BVBA
Not yet recruiting - verified April 2014 - Please check back for future recruiting sites, or email JNJ.CT@sylogent.com
Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Genotype 1 Chronic Hepatitis C Virus Infection and Cirrhosis
Wednesday, April 02, 2014 12:00 PM
ClinicalTrials.gov Identifier: NCT02114151
Purpose
The purpose of the study is to investigate the efficacy and safety of 12 weeks of simeprevir (150 mg qd) in combination with sofosbuvir (400 mg qd) in chronic hepatitis C virus (HCV) genotype 1 infected men and women with cirrhosis who are HCV treatment-naïve or treatment-experienced.
Condition: Hepatitis C Virus Infection
Interventions: Drug: Simeprevir; Drug: Sofosbuvir
Sponsor: Janssen Infectious Diseases BVBA
Not yet recruiting - verified April 2014
Please check back for future recruiting sites, or email JNJ.CT@sylogent.com
Phase III Daclatasvir + Sofosbuvir in Cirrhotic Subjects and Subjects Post-liver Transplant (ALLY 1)
Verified March 2014 by Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02032875
Purpose
This trial is open to patients with cirrhosis due to chronic HCV, and to patients who have already received a liver transplant for chronic HCV. All subjects will be treated with Daclatasvir and Sofosbuvir for 12 weeks. Under certain conditions, the treatment duration may be extended for cirrhotic subjects. The study will test how well this combination of investigational drugs works to treat chronic HCV.
This study is currently recruiting participants
Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV (ALLY 3)
Verified March 2014 by Bristol-Myers Squibb
Sponsor: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02032901
Purpose To study the combination of Daclatasvir and Sofosbuvir for the treatment of HCV Genotype 3 infection
This study is currently recruiting participants
Phase III HIV/HCV Co-Infection Daclatasvir (DCV)+ Sofosbuvir (SOF) (ALLY 2)
Verified March 2014 by Bristol-Myers Squibb
Sponsor: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02032888
Purpose
To study the combination of Daclatasvir and Sofosbuvir for the treatment of HCV/ HIV Coinfection
This study is currently recruiting participants
Study of MK-5172 + MK-8742 + Ribavirin in Participants With Chronic Hepatitis C Who Failed Prior Direct-Acting Antiviral Therapy (MK-5172-048)
Wednesday, April 02, 2014 12:00 PM
ClinicalTrials.gov Identifier: NCT02105454
Purpose
Purpose
In this study, participants with hepatitis C
virus (HCV) genotype 1 (GT1) who failed prior direct-acting antiviral
(DAA) therapy will receive MK-5172 + MK-8742 + Ribavirin (RBV) to
evaluate sustained virologic response (SVR) using this drug combination.
Condition: Hepatitis C Virus
Interventions: Drug: MK-5172; Drug: MK-8742; Drug: RibavirinCondition: Hepatitis C Virus
Sponsor: Merck Sharp & Dohme Corp.
Not yet recruiting - verified April 2014
Study of Efficacy and Safety of MK-5172/MK-8742 Combination Regimen for Treatment-Naïve Participants With Chronic Hepatitis C Virus Genotypes 1, 4, 5, and 6 (MK-5172-060)
Wednesday, April 02, 2014 12:00 PM
ClinicalTrials.gov Identifier: NCT02105467
Purpose
This is an efficacy and safety study of MK-5172 in combination with MK-8742 in treatment-naive participants with chronic hepatitis C
virus (HCV) genotype (GT) 1, 4, 5, or 6 infection. Participants will be
randomly assigned (3:1 ratio) to immediate treatment or deferred
treatment (placebo control). The primary efficacy hypothesis is that the
proportion of participants receiving combination therapy in the
Immediate Treatment Arm who achieve sustained viral response at 12 weeks
after the end of study treatment (SVR12) will be superior to 73%.
Condition: Chronic Hepatitis C VirusInterventions: Drug: MK-5172 100mg/MK-8742 50 mg fixed-dose combination; Drug: Placebo to MK-5172 + MK-8742 fixed-dose combination
Sponsor: Merck Sharp & Dohme Corp.
Not yet recruiting - verified April 2014
An Efficacy and Safety Study of MK-5172 + MK-8742 in the Treatment of Chronic Hepatitis C Virus in Participants Who Are Co-Infected With Human Immunodeficiency Virus (C-EDGE COINFECTION) (MK-5172-061)
Wednesday, April 02, 2014 12:00 PM
ClinicalTrials.gov Identifier: NCT02105662
Purpose
The purpose of this study is to assess the efficacy and safety of
MK-5172 100 mg in combination with MK-8742 50 mg in the treatment of
chronic hepatitis C virus (HCV) in
participants who are co-infected with human immunodeficiency virus
(HIV). The primary hypothesis is that the percentage of participants who
receive MK-5172 + MK-8742 and achieve Sustained Virologic Response
after 12 weeks of therapy (SVR12) will be greater than 70%.Purpose
Condition: Chronic Hepatitis C
Intervention: Drug: MK-5172 100 mg/MK-8742 50 mg fixed-dose combination tablets
Sponsor: Merck Sharp & Dohme Corp.
Not yet recruiting - verified April 2014
An Efficacy and Safety Study of MK-5172 + MK-8742 in the Treatment of Chronic Hepatitis C Virus Genotype 1, 4, 5 or 6 Infection in Treatment-Naïve Participants Who Are on Opiate Substitution Therapy (C-EDGE RECOVERY)(MK-5172-062)
Wednesday, April 02, 2014 12:00 PM
ClinicalTrials.gov Identifier: NCT02105688
Purpose
The purpose of this study is to assess the efficacy and safety of
MK-5172 100 mg in combination with MK-8742 50 mg in the treatment of
chronic hepatitis C virus (HCV) genotype 1
(GT1), GT4, GT5 or GT6 infection in treatment-naïve participants who are
on opiate substitution therapy (OST). The primary hypothesis is that
the percentage of participants who receive MK-5172+MK-8742 and achieve a
Sustained Virologic Response 12 weeks after the end of all study
therapy (SVR12) will be superior to 67%.
Condition: Chronic Hepatitis C
Intervention: Drug: MK-5172 100 mg/MK-8742 50 mg fixed-dose combination tabletsCondition: Chronic Hepatitis C
Sponsor: Merck Sharp & Dohme Corp.
Not yet recruiting - verified April 2014
Study of Efficacy and Safety of MK-5172 + MK-8742 With or Without Ribavirin for Participants With Hepatitis C Genotype 1, 4, 5, or 6 Infections Who Have Failed Prior Treatment With Pegylated Interferon + Ribavirin (MK-5172-068)
Wednesday, April 02, 2014 12:00 PM
ClinicalTrials.gov Identifier: NCT02105701
Purpose
Purpose
This is an efficacy and safety study of MK-5172 in combination with
MK-8742 with or without ribavirin (RBV) in participants with chronic hepatitis C
virus (HCV) genotype (GT) 1, 4, 5, or 6 infections who have failed
prior therapy with pegylated interferon and RBV. The primary study
hypothesis is that in at least one of the study arms, the percentage of
participants achieving sustained viral response 12 weeks after the end
of all study treatment (SVR12) will be superior to 58%.
Condition: Hepatitis C Infection
Interventions: Drug: MK-5172 + MK-8742; Drug: RBVCondition: Hepatitis C Infection
Sponsor: Merck Sharp & Dohme Corp.
Not yet recruiting - verified April 2014
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)
Monday, March 31, 2014 12:00 PM
ClinicalTrials.gov Identifier: NCT02107365
Purpose
Purpose
Success rates, after retreatment with Peg-Interferon/Ribavirin bitherapy, in patients infected with HCV (hepatitis C
virus) genotype 4 and non-responders to a first standard treatment, are
disappointing. The association of Asunaprevir and Daclatasvir in
combination with the standard-of-care bitherapy has been shown to
increase the efficacy of the treatment in non-responders genotype
1-infected patients.
Given the absence of
current solutions and urgent therapeutic needs for HCV genotype
4-infected patients previously treated with pegylated
Interferon/Ribavirin, this pilot study aims to evaluate the efficacy and
safety of a quadritherapy associating Asunaprevir, Daclatasvir,
pegylated Interferon alpha-2a and Ribavirin, in this very difficult to
treat population.
60 subjects will be enrolled.
The primary endpoint will
be the rate of sustained virological response (SVR), defined by an
undetectable HCV RNA, at Week 36 (12 weeks after the end of a 24 weeks
quadritherapy).
Interventions: Drug: Asunaprevir; Drug: Daclatasvir; Drug: Ribavirin; Drug: Pegylated Interferon alpha-2a
Sponsors: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS); Bristol-Myers Squibb
This study is currently recruiting participants - verified March 2014
A Multicenter Compassionate Use Protocol of Daclatasvir (BMS-790052) in Combination With Sofosbuvir With or Without Ribavirin for the Treatment of Subjects With Chronic Hepatitis C
Tuesday, March 25, 2014 12:00 PM
Condition: Chronic Hepatitis C
ClinicalTrials.gov Identifier: NCT02097966
Purpose
The primary objective of this program is to provide Daclatasvir in
combination with Sofosbuvir with or without ribavirin to subjects with
chronic hepatitis C who are at a high risk
of liver decompensation or death within 12 months if left untreated and
who have no available therapeutic options.Purpose
Interventions: Drug: Daclatasvir; Drug: Sofosbuvir; Drug: Ribavirin
Sponsor: Bristol-Myers Squibb
Available - verified April 2014
Expanded access is currently available for this treatment.
A Study to Evaluate the Safety and Antiviral Effect of Multiple Doses of ABT-493 and ABT-530 in Adults With Genotype 1 Hepatitis C Virus (HCV)
Verified March 2014 by AbbVie
ClinicalTrials.gov Identifier: NCT01995071
Purpose
The purpose of this study is to evaluate the safety and antiviral effect
of multiple doses of ABT-493 and ABT-530 in adults with genotype 1 HCV.Conditions: Chronic Hepatitis C; Hepatitis C Virus; Compensated Cirrhosis
Interventions: Drug: ABT-493; Drug: ABT-530; Drug: ABT-450/r/ABT-267; Drug: ABT-333; Drug: Ribavirin (RBV)
Sponsor: AbbVie
This study is currently recruiting participants
A Study of Pharmacokinetics, Efficacy, Safety, Tolerability, of the Combination of Simeprevir (TMC435), Daclatasvir (BMS-790052), and Ribavirin (RBV) in Patients With Recurrent Chronic Hepatitis C Genotype 1b Infection After Orthotopic Liver Transplantation
Verified April 2014 by Janssen R&D Ireland
ClinicalTrials.gov Identifier: NCT01938625
Purpose
The purpose of the study is to evaluate effect of steady-state (when the
amount of drug administered (in a given time period) is equal to the
amount of drug eliminated in that same period) simeprevir and
daclatasvir on the steady-state pharmacokinetics (what a medication does
to the body) of cyclosporine and tacrolimus when administered as a
combinational regimen in post-orthotopic liver transplantation (OLT)
participants with recurrent hepatitis C
virus (HCV) genotype 1b infection and effectiveness of a 24-week
treatment regimen containing simeprevir, daclatasvir, and ribavarin
(RBV) with respect to the proportion of HCV genotype 1b infected
post-OLT participants achieving sustained virologic response 12 weeks
after end of treatment.Condition: Hepatitis C, Chronic
Interventions: Drug: Simprenavir; Drug: Daclatasvir; Drug: Ribavarin
Sponsor: Janssen R&D Ireland
This study is currently recruiting participants
Study of A Combination Pill With GS-7977 and GS-5885 for Hepatitis C in People With HIV
Verified June 2013 by National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01878799
Background:
- Present treatment for
hepatitis C includes the use of a weekly injection and two different
pills. This treatment is associated with serious side effects. Drugs
that can be taken by mouth and cure HCV infection without serious side
effects would be a great help to the large number of people infected
with HCV. GS-7977 and GS-5885 are new medications being developed to
treat the hepatitis C virus (HCV) infection. They are still being
researched and are not approved by the Food and Drug Administration.
They are being developed as treatment for hepatitis C as a single pill
taken once a day.
Objectives:
- To determine whether a
combination of the two study drugs can safely and effectively treat HCV
infection in people with HIV infection and who do not have cirrhosis of
the liver.
Eligibility:
- Individuals who have HIV infection and have liver disease caused by infection with HCV.
Design:
- Participants will be screened with a physical exam and medical history. Blood samples will be collected. Urine samples will be collected from participants who might become pregnant. If a participant has not had a liver biopsy in the past 3 years, one will be required.
- Participants will take one pill daily for 12 weeks. This pill will be a combination of the two study drugs.
- Treatment will be monitored with frequent clinic visits and blood tests over a total of 60 weeks.
Conditions: Hepatitis C, Chronic; Co-Infection
Intervention: Drug: Fixed Dose GS-7997 / GS-5885
Sponsors: National Institutes of Health Clinical Center (CC); National Institute of Allergy and Infectious Diseases (NIAID)This study is currently recruiting participants
Links
Center for Drug Evaluation and Research: www.fda.gov/cder
CenterWatch Website: www.centerwatch.com
NIH Clinical Trials Website: www.clinicaltrials.gov
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