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2012 - Hepatitis Clinical Trials
Related:
2013-Updates
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
Clinical Trial Updates - ClinicalTrials.gov: updated in the last 30 days
The HCV clinical trials on this webpage are not a complete list; 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.
Center for Drug Evaluation and Research: www.fda.gov/cder
CenterWatch Web site: www.centerwatch.com
NIH Clinical Trials Web site: www.clinicaltrials.gov
In the news and trial updates;
Related:
2013-Updates
2012
Dec 15 2012
An Open Label Study of the Effect of Telaprevir in Combination With Ribavirin and
Peginterferon on HCV Infection in Stable Liver Transplant Patients
Sept 2012
An Open-Label Study of the Effect of Telaprevir in Combination With Peginterferon Alfa-2b and Ribavirin in Pediatric Subjects Infected With HCV
Thursday, September 27, 2012, 9:00:00 AM
Condition: Hepatitis C
Interventions: Drug: Telaprevir; Drug: Peginterferon alfa-2b; Drug: Ribavirin
Sponsors: Vertex Pharmaceuticals Incorporated; Vertex Pharmaceuticals Incorporated
Not yet recruiting - verified October 2012
Evaluation of Safety Tolerability and Antiviral Activity of ACH-0143102 Plus RBV Treatment Naive HCV GT1b Subjects
Tuesday, October 02, 2012, 9:00:00 AM
Condition: Chronic Hepatitis C Infection
Interventions: Drug: ACH-0143102; Drug: Ribavirin
Sponsors: Achillion Pharmaceuticals; Achillion Pharmaceuticals
Recruiting - verified October 2012
Safety and Efficacy of Sofosbuvir/GS-5885 Fixed-Dose Combination (FDC) +/-Ribavirin for the Treatment of
HCV
Tuesday, October 02, 2012, 9:00:00 AM
Condition: Chronic Hepatitis C Virus
Interventions: Drug: Sofosbuvir/GS-5885 400/90 mg; Drug: Ribavirin
Sponsors: Gilead Sciences; Gilead Sciences
Recruiting - verified October 2012
GS-7977 and Ribavirin in Patients With Chronic HCV With Cirrhosis and Portal Hypertension With or Without Liver
Decompensation
Source - http://clinicaltrials.gov/ct2/show/record/NCT01687257
This study is not yet open for participant recruitment
Verified September 2012 by Gilead Sciences
Sponsor: Gilead Sciences
Information provided by (Responsible Party): Gilead Sciences
ClinicalTrials.gov Identifier: NCT01687257
First received: September 12, 2012
Last updated: September 13, 2012
Last verified: September 2012
History of Changes
PurposeThis is a multicenter, Open-Label, Randomized Study to Investigate the Safety and Efficacy of GS-7977 and Ribavirin Administered for 24 weeks in Patients Infected with Chronic HCV with Cirrhosis and Portal Hypertension with or
without Liver Decompensation. Approximately 50 subjects (25 per group) will be randomized (1:1) to either receive study drug for 24 weeks or take part in an untreated observational arm for the first 24 weeks followed by study drug for another 24 weeks.
Estimated Enrollment: 50
Start Date: October 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date:
July 2013 (Final data collection date for primary outcome measure)
A Phase IIa Interferon Free Combination Hepatitis C Trial of Simeprevir (TMC435) and TMC647055 Will Commence Shortly
"This study is in line with Medivir's and Janssen's strategy to evaluate different combination possibilities with simeprevir for interferon-free HCV treatments. This will broaden our understanding of simeprevir, which we believe has the necessary characteristics to potentially become a key component of future hepatitis C treatment regimens, including combination with interferon and ribavirin as well as interferon-free therapies," comments Charlotte Edenius, Medivir's EVP of Research and Development....Read more
July 13 2012 - Source NATAP
Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With
HCV GT2 or GT3, and GT1
This study is currently recruiting participants.
Verified July 2012 by Gilead Sciences
Purpose
To assess safety and tolerability of PSI-7977 400 mg with and without ribavirin (RBV) and/or with and without pegylated interferon alfa-2a (PEG-IFN) in subjects with hepatitis C (HCV) genotypes 1, 2 or 3.
Phase 2
Drug: PSI-7977 in combination with RBV
Drug: PSI-7977 in combination with RBV and PEG-IFN
Drug: PSI-7977 monotherapy
Drug: PSI-7977 in combination with 800 mg RBV
Drug: PSI-7977 in combination with GS-5885 and RBV
Primary Outcome Measures:
· Safety and Tolerability [ Time Frame: 8 or 12 weeks ] Designated as safety issue: Yes ]
To assess the safety and tolerability of PSI-7977 400 mg for 8 or 12 weeks, administered with and without ribavirin
and/or pegylated interferon alfa-2a (PEG-IFN) and with and without GS-5885 in subjects with HCV genotypes 1, 2 or 3
Experimental: Arm 12: PSI-7977, RBV, GS-5885
PSI-7977 400 mg QD and weight-based RBV and GS-5885 for 12 weeks in GT-1 null responders
Experimental: Arm 13: PSI-7977, RBV, GS-5885
PSI-7977 400 mg QD, weight-based RBV and GS-5885 for 12 weeks in GT-1 treatment naive subjects
Experimental: Arm 7: PSI-7977 with RBV
PSI-7977 400 mg QD with weight-based RBV for 12 weeks in GT-1 null responders
Experimental: Arm 8: PSI-7977 and RBV
PSI-7977 400 mg QD and weight-based RBV for 12 weeks in GT-1 treatment naive subjects
Experimental: Arm 9: PSI-7977 and RBV
PSI-7977 400 mg QD and weight-based RBV for 12 weeks in GT 2/3 treatment experienced subjects
Links-
Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3
Drug Interaction Study of PSI-7977 and Antiretroviral Therapy(ART) Combinations in Human Immunodeficiency Virus and Hepatitis C Virus (HIV/HCV) Co-infected Patients.
June 29
Press Release - TMC435 and daclatasvir interferon free Phase II trial to Commence Shortly
For additional information from these recently updated studies, please see Study of Daclatasvir and TMC435 for Subjects With Genotype 1 Chronic Hepatitis C @ http://www.clinicaltrials.gov.
June 2012
This study has been suspended
Phase 2b Study of BMS-986094 and Daclatasvir, With or Without Ribavirin for the Treatment of Patients With Chronic Hepatitis C
Press Release
BMS halts the development of BMS-986094 due to patient death
Open-Label Study of GS-7977 + Ribavirin Pre-Transplant
An Open-Label Study to Explore the Clinical Efficacy of GS 7977 With Ribavirin Administered Pre-Transplant in Preventing
Hepatitis C Virus (HCV) Recurrence Post-Transplant
This study is currently recruiting participants.
Verified April 2012 by Gilead Sciences
Purpose
The primary objective is to determine if the administration of a combination of GS 7977 and ribavirin to HCV-infected subjects with hepatocellular carcinoma (HCC) meeting the MILAN criteria prior to undergoing liver transplantation for up to 24 weeks can prevent post-transplant re-infection as determined by a sustained post-transplant virological response (HCV RNA < LLoQ) at 12 weeks post-transplant.
Estimated Enrollment: 40
Study Start Date: March 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Open-Label Study of GS-7977+ Ribavirin for 12 Weeks in Subjects With Chronic HCV Infection
This study is not yet open for participant recruitment.
Verified June 2012 by Gilead Sciences
First Received on June 7, 2012.
Last Updated on June 19, 2012 History of Changes
Intervention:
Drug: GS-7977 in combination with ribavirin
June 7, 2012
Safety and Efficacy Study of Pegylated Interferon Lambda With and Without Daclatasvir, Compared to Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C Genotype 2 and 3
This study is not yet open for participant recruitment.
Verified June 2012 by Bristol-Myers Squibb
First Received on June 7, 2012. No Changes Posted
Interventions:
Biological: Pegylated interferon lambda (pegIFNλ); Biological: Pegylated interferon alfa-2a (pegIFNα-2a); Drug:
Ribavirin; Drug: Daclatasvir; Drug: Placebo matching Daclatasvir
Gilead HCV SVR Registries
Gilead Sustained Virologic Response (SVR) Registry
Purpose
This Registry is designed to provide long term clinical and virologic follow up in subjects who have achieved sustained
virologic response (SVR) while participating in a previous Gilead sponsored Hepatitis C Virus (HCV) study.
A Gilead Sequence Registry of Subjects Who Did Not Achieve Sustained Virologic Response
Purpose
This Registry is designed to obtain long term data on subject who have failed to achieve sustained virologic response (SVR)
while receiving at least one Gilead oral antiviral agent (OAV) in a previous Gilead-sponsored hepatitis C study.
BMS-790052 (Daclatasvir) - Bristol Hep C Trial Change Has Big Implications
Is a promising new class of drugs for treating hepatitis C going to be limited because patients with the most common
genotype of the virus are likely to develop resistance to the medications? This is the possibility raised by a Wall Street analyst after learning that Bristol-Myers Squibb last week altered the protocol for a clinical trial for its daclatasvir antiviral, which is believed to be the most potent in the forthcoming NS5a class of hepatitis c treatments. According to ClinicalTrials.gov, the drugmaker changed the protocol to its COMMAND-3 trial, which compares its drug in combination with interferon and ribavirin to Incivek, a protease inhibitor sold by Vertex Pharmaceuticals, along with interferon and ribavarin. What was the change?
Bristol-Myers restricted future enrollment to patients who have only genotype 1b HCV, rather than all genotype 1 patients (see this and this)......
Continue Reading @ Pharmalot
Verified June 2012
A Phase III Study of BI201335 in Treatment-naive and Prior Relapser Patients With Chronic Hepatitis C Infection
Last Updated on June 1, 2012 History of Changes
Interventions: Drug: PegIFN/RBV; Drug: PegIFN/RBV;
Drug: BI 201335; Drug: BI 201335; Drug: BI 201335
Sponsors:
Boehringer Ingelheim Pharmaceuticals; Boehringer Ingelheim Pharmaceuticals
Not yet recruiting - verified June 2012
A Multiple Dose Study to Evaluate the Safety and Efficacy of MK-2748 in Hepatitis C-Infected Participants
(MK-2748-002)
Friday, May 04, 2012, 9:00:00 AM
Interventions: Drug: MK-2748; Drug: Placebo
Sponsors: Merck; Merck
Recruiting - verified June 2012
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 2011
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 2011
PSI-7977 and Daclatasvir (BMS-790052) 12 wk Interferon-Free Tx Arms Added-Genotype 1
Nov 1 2011
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 2011
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 2011
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 2011
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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