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Hepatitis Clinical Trials
Treatment Action Group publishes Guide to Clinical Trials for People With Hepatitis C
There are many new hepatitis C drugs being studied in clinical trials. People with hepatitis C have many options to choose from. Whether you have hepatitis C or another medical condition, deciding to participate in a clinical trial can be complicated. Having more information can help you decide whether or not to participate in a clinical trial, and which trial, or trials, may be right for you.
Links;
Clinical Trials
To learn more about Hepatitis C virus clinical trials or to find out if a study is enrolling patients
in your area, please click here.
Clinical Trials Listed On The Blog; See Label Clinical Trials
Clinical Connections;
International Search
US Clincal Connections
Center for Drug Evaluation and Research: www.fda.gov/cder
CenterWatch Web site: www.centerwatch.com
NIH Clinical Trials Web site: www.clinicaltrials.gov
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In The News;
May
Hepatitis C-ACH-3102 Receives Fast Track Designation From the FDA
Achillion Pan-Genotypic ACH-3102 begins dosing in a Phase 1clinical trial
Pegylated Interferon, Ribavirin, Telaprevir in Hepatitis C Virus Infection in Orthotopic
Liver Transplant Recipients
This study is currently recruiting participants.
Verified May 2012 by University of Chicago
First Received on April 27, 2012.Last Updated on May 2, 2012
Mar
TMC435-New Studies in Phase III Program
Dec
Phase III BMS-790052 Add-On to Peg-Interferon Alfa-2a and Ribavirin in Naive Hepatitis C This study is currently recruiting participants.
Verified December 2011 by Bristol-Myers Squibb
New HCV Clinical Trial To Evaluate Merck’s-VICTRELIS with Roche's Mericitabine Plus SOC
Merck Announces Initiation of Clinical Development Collaboration with Roche To Evaluate Investigational Combination Regimens for the Treatment of Chronic Hepatitis C Genotype 1 Infection
The first trial is designed to provide clinical data on the use of VICTRELIS (boceprevir), an oral HCV NS3/4A protease inhibitor, in combination with mericitabine (RO5024048), Roche's investigational oral HCV NS5B nucleoside polymerase inhibitor, Pegasys® (pegylated interferon alfa-2a) and Copegus® (ribavirin), in adult patients with chronic HCV genotype 1 infection who had a null response to prior peginterferon alfa and ribavirin therapy (less than a 2 log HCV-RNA decline at treatment week 12). The Phase II study, called DYNAMO 1, plans to recruit patients at 25 sites globally.
Experimental Hepatitis C Drug PSI-938 Halted In Clinical Trial
--Use of PSI-938 halted in clinical trial due to liver-related abnormalities
--Studies of lead hepatitis C candidate, PSI-7977, continue
BI 201335-Boehringer announced final patient entry for Phase III Trial
Initiation of ALS-2200/ALS-2158 in clinical studies this data may enable initiation study of interferon-free combination by Vertex and Alios BioPharma
Nov 3
PSI-7977 and Daclatasvir (BMS-790052) 12 wk Interferon-Free Tx Arms Added-Genotype 1
Nov 1
Pharmasset All-Oral Therapy By 2013?
Pharmasset Announces the Initiation of an Interferon-Free Phase 3 Program with PSI-7977 for HCV
Three pivotal studies planned to evaluate PSI-7977 400 mg QD plus ribavirin for 12 weeks in patients with HCV
Anticipated US and EU marketing submissions in second half of 2013
PRINCETON, N.J., Nov. 1, 2011 /PRNewswire/ -- Pharmasset, Inc. (Nasdaq: VRUS) today announced the initiation of a Phase 3 program with the hepatitis C virus (HCV) nucleotide analog, PSI-7977. This pivotal program will evaluate a 12-week, all-oral, interferon-free regimen of PSI-7977 and ribavirin in patients with HCV, independent of viral genotype or their ability to take interferon therapy.
"After recent discussions with Health Authorities, we are excited to be initiating the first of a series of pivotal studies to explore an interferon-free regimen of PSI-7977 in broad populations of individuals with HCV," said Michael Rogers, Ph.D., Pharmasset's Chief Development Officer.
The first trial, FISSION, will enroll approximately 500 treatment-naive patients with HCV genotype 2 or 3, and will evaluate the safety and efficacy of a 12-week interferon-free regimen of PSI-7977 and ribavirin compared to 24 weeks of pegylated interferon and ribavirin. The primary endpoint of the study is sustained virologic response 12 weeks after the completion of treatment (SVR12).
Pharmasset plans to initiate a second 12-week duration, interferon-free Phase 3 trial, POSITRON, in early 2012. This trial will enroll approximately 225 patients with HCV genotype 2 or 3 who cannot take interferon.
In mid-2012, Pharmasset intends to initiate a third 12-week duration, interferon-free Phase 3 trial, NEUTRINO. This trial will enroll patients who cannot take interferon, and will include patients with HCV regardless of viral genotype, including those with HCV genotype 1. The final study design will be based on emerging data from ELECTRON and from PSI-7977 plus RBV-containing arms in the ongoing QUANTUM study.
"Based on encouraging results to date, we have selected an IFN-free regimen of PSI-7977/RBV for our registrational program," said Michelle Berrey, MD, MPH, Pharmasset's Chief Medical Officer. "We continue to believe that interferon remains the greatest impediment to care for a majority of the millions of individuals living with HCV. PSI-7977 has demonstrated high cure rates, without viral resistance, and across HCV genotypes; we hope to confirm these benefits in these registrational studies."
About FISSON
FISSION will be conducted at more than 100 centers in the US, Europe and other territories. The trial will enroll approximately 500 treatment-naive patients with HCV genotype 2 or 3 into one of two open-label regimens:
- PSI-7977 400 mg QD with ribavirin for 12 weeks
- the current standard-of-care for HCV GT2/3, pegylated interferon and ribavirin for 24 weeks
POSITRON will be conducted at more than 100 centers in the US, Europe and other territories. The trial will enroll patients with HCV genotype 2 or 3 who cannot take interferon into one of two blinded regimens:
- PSI-7977 400 mg QD with ribavirin for 12 weeks
- placebo PSI-7977 and placebo ribavirin
POSITRON will enroll approximately 225 patients with or without cirrhosis. The primary endpoint of the trial will be SVR12. Enrollment is anticipated to begin in the first quarter of 2012.
About NEUTRINO
NEUTRINO will enroll approximately 280 patients who cannot take interferon. The study will be conducted at more than 100 centers in the US, Europe and other territories. The final design of the trial will be based on emerging data from ongoing studies, including ELECTRON and QUANTUM. We anticipate the study will enroll patients with HCV regardless of viral genotype, and including those with HCV GT1. Enrollment is anticipated to begin in mid-2012.
Pharmasset anticipates submitting data from all three phase 3 trials in the second half of 2013 to support the marketing approval of PSI-7977 in the US and European Union.
Conference Call and Webcast
Members of Pharmasset's management team will host a conference call today, November 1, 2011, at 8:00 a.m. ET to discuss the initiation of the PSI-7977 Phase 3 program. Investors may listen to the webcast of the conference call live on the "Events & Presentations" section of Pharmasset's website, www.pharmasset.com. Alternatively, investors may listen to the call by dialing 877-640-9867 from locations in the U.S. and 914-495-8546 from outside the U.S. The webcast replay will be available for at least 72 hours following the call.
About Pharmasset
Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing, and commercializing novel drugs to treat viral infections. Pharmasset's primary focus is the development of oral therapeutics for the treatment of hepatitis C virus (HCV) infection. Our research and development efforts are focused on nucleoside/tide analogs, a class of compounds which act as alternative substrates for the viral polymerase, thus inhibiting viral replication. We currently have three clinical-stage product candidates advancing in trials in various populations. Our pyrimidine, PSI-7977, an unpartnered uracil nucleotide analog, is initiating an interferon-free, Phase 3 program in patients with HCV genotypes 1, 2 and 3 and continues to be evaluated in five Phase 2b trials in patients with all HCV genotypes. Our purine, PSI-938, an unpartnered guanosine nucleotide analog, is being studied in QUANTUM, a Phase 2b interferon-free trial of PSI-7977 and/or PSI-938 in patients with all HCV genotypes. Mericitabine (RG7128) continues in development through a strategic collaboration with Roche.
Contact
Richard E. T. Smith, Ph.D.
VP, Investor Relations and Corporate Communications
Office +1 (609) 865-0693
Oct 24
Vertex Initiates Phase 3b CONCISE-Study Incivek w-peg/riba
Vertex Pharmaceuticals Incorporated today announced the initiation of a Phase 3b study called CONCISE that will evaluate the potential for treatment with INCIVEK™ (telaprevir) combination therapy to be shortened to 12 weeks in people with genotype 1 chronic hepatitis C who have the ‘CC' variation near the IL28B gene.
INCIVEK (in-SEE-veck) is administered in combination with pegylated-interferon and ribavirin. Approximately one-third of people with hepatitis C have the ‘CC' genotype, which has been associated with higher sustained viral response (SVR, or viral cure) rates and faster response to interferon-based treatment. In this study, INCIVEK will be taken twice a day. The study is expected to enroll 350 people in the United States and Europe who are new to treatment or who have relapsed after at least one prior course of treatment with pegylated-interferon and ribavirin alone. The primary endpoint of the study is the proportion of patients who achieve a sustained viral response 12 weeks after the last planned dose of study drug (SVR12).
Oct 17
DEBO25 vs Boceprevir New Study in African-Americans -
This study will assess the safety and efficacy of alisporivir plus pegylated interferon alfa2a and Ribavirin as well as boceprevir plus pegylated interferon alfa2a and Ribavirin in African American chronic hepatitis C genotype 1 patients that have never received treatment for their hepatitis C.
UC San Diego School of Medicine Launches Hepatitis C Clinical Trials
Oct 11
Pharmasset Adds New Study Arm-PSI-7977
Press Release; Medivir - The Phase 3 Program for TMC435 in Treatment-Naive Patients and Patients who Have Relapsed After Prior Interferon-Based Treatment
Click Here For Locations and Trial Information
PSI-7977 Genotypes 1,4,5,6
Press Release; Hepatitis C Phase 2b ATOMIC Trial of PSI-7977 for Multiple HCV Genotypes
Click here for Locations and Trial Information
PSI-7977 Genotypes 2 and 3
Click Here For Locations and Trial Information;
Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3
Press Release; Hepatitis C compound BI 201335 moves into Phase III clinical trials
Click Here for Locations and Trial Information
BMS Phase 2B Study including 4 drug regimen of NS5A BMS-790052 + protease BMS-650032 + Peglambda/Rbv
Click Here For Locations and Trial Information;
Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin
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Click here to search for all HCV trials http://www.clinicalconnection.com
TMC125IFD1001 - Drug-Drug Interaction of Etravirine With Telaprevir and TMC278 With Telaprevir. Conditions: Hepatitis C; HIV Interventions: Drug: telaprevir/TMC278; Drug: telaprevir/ETR; Drug: TMC278/telaprevir; Drug: ETR/telaprevir
VX-950HEP1001 - Drug-drug Interaction Study Between Telaprevir and RaltegravirConditions: Hepatitis C
1 Location available
Virology Follow up Study in Subjects Previously Treated With TelaprevirConditions: Hepatitis C
25 Locations available
Intrahepatic HCV RNA and Telaprevir Kinetics in Hepatitis C Virus (HCV)Conditions: Hepatitis C
1 Location available
A Safety and Efficacy Study of the Combination of VX-222 and Telaprevir in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus InfectioConditions: Chronic Hepatitis C Virus Infection
12 Locations available
VX-950-C211 - A Dosing Regimen Study (Twice Daily Versus Every 8 Hours) of Telaprevir in Treatment-naive Patients With Genotype 1 Chronic Hepatitis C Conditions: Genotype 1 Chronic Hepatitis C - Treatment Naive
36 Locations available
Placebo-Controlled, Dose-Escalation Study of the Safety of IMO-2125 in Hepatitis C-Infected PatientsConditions: Hepatitis C
6 Locations available
Safety, Tolerability and Antiviral Activity of ACH-0141625 or Placebo in Combination With Peginterferon and Ribavirin in HCV Positive SubjectsConditions: Hepatitis C
9 Locations available
Ph IIA Study (SOC +/- NS5B)Conditions: Hepatitis C Virus
10 Locations available
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination WithConditions: Hepatitis C - HCV - Chronic Hepatitis C - Hepatitis C Genotype 1
4 Locations
Safety and Efficacy of ANA598 Administered With Pegylated Interferon and Ribavirin in Genotype-1 Patients With Chronic HCV InfectionConditions: Hepatitis C
30 Locations available
Efficacy and Safety of BI201335 in Combination With Pegylated Interferon Alpha and Ribavirin in Treatment Naive Genotype 1 Hepatitis C Infected PatienConditions: Hepatitis C
6 Locations available
Sustained Virological Response (SVR) to Antiviral Treatment of Liver Transplant Recipients With Recurrent Hepatitis CConditions: Hepatitis C - Liver Transplantation
7 Locations available
A Pilot Study to Examine the Role of Nitazoxanide to Prevent Recurrence of Hepatitis C After TransplantationConditions: Hepatitis C Recurrence
1 Location available
Efficacy and Safety Study of PEG-rIL-29 Plus Ribavirin to Treat Chronic Hepatitis C Virus InfectionConditions: Hepatitis C, Chronic
13 Locations available
A Study on The Combination of RO5024048 And Ritonavir-Boosted Danoprevir With And Without Copegus (Ribavirin) in Interferon-Naïve Patients With ChroniConditions: Hepatitis C, Chronic
5 Locations available
A Study of Danoprevir Boosted With Low Dose Ritonavir in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C VirConditions: Hepatitis C, Chronic
3 Locations available
TMC435HPC3007 - Phase III Trial of TMC435 in Genotype 1 Hepatitis C-infected Patients Who Relapsed After Previous TherapyConditions: Hepatitis C
11 Locations available
TMC435-TiDP16-C216 - Phase III Trial of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected PatientsConditions: Hepatitis C
10 Locations available
TMC435-TiDP16-C208 - Phase III Trial of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected PatientsConditions: Hepatitis C
10 Locations available
A Study of Vaniprevir (MK-7009) in Patients With Chronic Hepatitis C Infection After Participation in Other Vaniprevir Studies (MK-7009-028 AM4)Conditions: Hepatitis C, Chronic
5 Locations available
Study of BMS-650032 With Peginterferon Alfa-2a Plus RibavirinConditions: Hepatitis C Virus
14 Locations available
GS 5885 Administered Concomitantly With GS-9451, Tegobuvir and Ribavirin (RBV) in Chronic Genotype 1 Hepatitis C Virus (HCV) InfectionConditions: Hepatitis C, Chronic
2 Locations available
GS-5885 Alone or in Combination With GS-9451 With Peginterferon Alfa 2a and Ribavirin in Treatment Chronic Genotype 1 Hepatitis C VirusConditions: Hepatitis C, Chronic
7 Locations available
Safety and Efficacy of the Therapeutic Vaccine GI-5005 Combined With Pegylated Interferon Plus Ribavirin Standard of Care Therapy Versus Standard of CConditions: Genotype 1 Chronic Hepatitis C
23 Locations available
A Study of Response-Guided Duration of Combination Therapy With GS-9451, Pegasys® and Copegus® With and Without Tegobuvir (GS-9190) in Previously UntrConditions: Hepatitis C, Chronic
43 Locations available
Study of SCY-635, Pegasys and Copegus in Hepatitis CConditions: Hepatitis C
2 Locations available
Efficacy and Safety Study of DEB025/Alisporivir Combined to Standard Therapy (Peg-IFN and Ribavirin) in Chronic Hepatitis C Genotype 1 naïve PatientsConditions: Hepatitis C, Chronic
24 Locations available
Efficacy and Safety of DEB025 Combined With Peg-IFN Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Relapsers and Non-respondersConditions: Hepatitis C Chronic
8 Locations available
Efficacy and Safety of DEB025 Alone or Combined With Either Ribavirin or Peg-IFN α2a in Chronic Hepatitis C Genotype 2 and 3 naïve PatientsConditions: Hepatitis C - Chronic Pain
1 Location available
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) When Given Together With ABT-333 and Ribavirin (RConditions: Chronic Hepatitis C, Hepatitis C, Hepatitis C Virus (HCV)
1 Location available
PSI-7977 With Pegylated Interferon and Ribavirin Hepatitis C Virus (HCV) Genotypes 1,4,5,6Conditions: Hepatitis C, Chronic
18 Locations available