Clinical Trials: New treatments for hepatitis C that have been studied in humans, and various drugs that are in phase I, II and III development to treat hepatitis C

Pharmasset Announces the Continued Enrollment of the Phase 2b Clinical Trial of RG7128 for the Treatment of Hepatitis C

Nov 18
www.medicalnewstoday.com

Pharmasset, Inc. (Nasdaq: VRUS) announced that the enrollment of Cohort 2, led by its partner Roche (SWX: ROG.VX; RO.S, OTCQX: RHHBY), will continue for the remaining 300 genotype 1 and 4 patients in the ongoing phase 2b trial of RG7128, a first-in-class nucleoside analog polymerase inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. The decision was reached after a scheduled review by an independent Data Monitoring Committee (DMC) of all available safety data from the first cohort of approximately 100 patients completing 8 or 12 weeks of RG7128 or matching placebo in combination with pegylated interferon and ribavirin.

The DMC reviewed any potential drug discontinuations, incidence and details of adverse events, and selected laboratory assessments. No safety events in the DMC review were considered significantly different from those expected from HCV patients taking pegylated interferon and ribavirin treatment. The committee expressed no safety concerns that would preclude enrollment of the remaining 300 patients in the ongoing phase 2b study in the HCV positive genotype 1 and 4 population, and have not recommended modification of dose or duration of any RG7128 dosing regimens. Enrollment of these patients pre-screened for this Cohort in the fourth quarter 2009 has begun and is expected to be complete by the end of the first quarter of 2010.

"We welcome Roche's decision to open enrollment of Cohort 2 for the remaining 300 patients in the phase 2b trial," stated Michelle Berrey, MD, MPH, Pharmasset's Chief Medical Officer. "We are encouraged by the safety profile of RG7128 to date, which, when coupled with the higher barrier to resistance offered by nucleoside and nucleotide analog inhibitors has the potential to improve SVR rates over the current standard of care."

Additional RG7128 Studies
Pharmasset's development partner, Roche, plans to initiate a number of additional, longer duration phase 2b trials with RG7128 in the first half of 2010. An additional study in patients infected with HCV genotypes 2 and 3 is being planned to initiate later in 2010.

About the RG7128 Phase 2b Trial
The Phase 2b trial is anticipated to enroll a total of about 400 HCV-infected patients with genotypes 1 or 4 who have never received HCV treatment. The trial is evaluating the dose and duration of treatment with RG7128 in combination with Pegasys® plus Copegus®(ribavirin)The primary efficacy endpoint of the trial is the proportion of patients achieving an SVR, defined as serum HCV RNA below the limit of detection as measured by the Roche TaqMan assay 24 weeks after completion of treatment. Patients are equally randomized into one of 5 arms:

24 weeks of total treatment, with RG7128 500mg BID in combination with Pegasys and ribavirin for 12 weeks, followed by 12 weeks of Pegasys and ribavirin ("12+12")

24 weeks of total treatment, with RG7128 1000mg BID in combination with Pegasys and ribavirin for 12 weeks, followed by 12 weeks of Pegasys and ribavirin ("12+12")

24 weeks of total treatment, with RG7128 1000mg BID in combination with Pegasys and ribavirin for 8 weeks, followed by a further 16 weeks of Pegasys and ribavirin ("8+16")

48 weeks of total treatment, with RG7128 1000mg BID in combination with Pegasys and ribavirin for 12 weeks, followed by a further 36 weeks of Pegasys and ribavirin ("12+36")

A control arm with Pegasys and ribavirin for 48 weeks.

Patients randomized to the 24-week regimen will discontinue all treatment at week 24 if they have achieved a rapid virological response, defined as serum HCV RNA below the limit of detection at week 4, a strategy known as "RVR-guided" treatment. Patients who do not achieve an RVR will continue on the standard of care therapy (Pegasys and ribavirin) until week 48.

Source: Pharmasset, Inc

Oct

SciClone starts hepatitis C drug trial SCV-07

Oct 22

PHASE I TRIALS 2009

TMC435 trial for people who have previously failed treatment is still/will be recruiting

The reports on TMC435 Phase IIa trials looks very good, as good or better than Telaprevir and Boceprevir.

Medivir: New Phase IIa Data On TMC435 In Patients With Hepatitis C Presented At The Ongoing EASL - Meeting
http://www.eurekalert.org/pub_releases/2008-11/zg-tpi110308.php

The purpose of this study is to determine the efficacy, safety and tolerability of different regimens of TMC435 with standard treatment compared to standard treatment alone in patients with chronic, genotype 1, hepatitis C who have failed previous treatment with pegylated interferon (Peg-INF) and ribavirin (RBV).

The company is Tibotec, it is a Phase IIb trial, double-blind. The trial has 5 arms: each receives SOC (standard of care) for 24 weeks. Arm 1 gets TMC435 (the trial drug) at 75mg for 12 weeks; Arm 2 gets it at 150mg for 12 weeks; Arm 3 gets 75mg for 24 weeks; and Arm 4 gets 150mg for 24 weeks. Arm 5 gets placebo and SOC. The patient will have an 80% chance of getting the trial drug.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00980330

Show 82 Study Locations

To learn how to participate in this trial please click here.

HCV/Phase 1 Trial of IMO-2125, a TLR9 Agonist, in Combination with Ribavirin

New HCV Oral Drug CTS-1027 Novel Approach To Treating Hepatitis C

Recruiting	CTS-1027 in Interferon-Naive Hepatitis C Patients

Recruiting

CTS-1027 in Interferon-Naive Hepatitis C Patients

Sept

MassBiologics Announces Phase 1 Study of Monoclonal Antibody Targeting HCV

Roche and InterMune Begin Phase 2b Trial of HCV Protease Inhibitor RG7227/ITMN-191
9-04-2009

Aug

We are recruiting patients for the following clinical trials at Rush University Hepatology:

1. Effect of Entecavir in Blacks/African Americans and Hispanics With Chronic Hepatitis B Virus (HBV) Infection
A study to develop observational clinical experience with the use of entecavir in patients who are either of Black/African-American race or of Hispanic ethnicity.

2. Study of TYZEKA in subjects of Black/African American or Hispanic/Latino origin with compensated chronic hepatitis B virus infection.

3. A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Evaluate the Efficacy, Safety and Tolerability of AST-120 (Spherical Carbon Adsorbent) for 8 Weeks in the Treatment of Mild Hepatic Encephalopathy
4. Randomised, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus (HCV) Infection Who Are Otherwise Eligible to Initiate Antiviral Therapy (Peginterferon Alfa-2a Plus Ribavirin)

Doris Yadav RN, BS
Senior Research Coordinator
Office: 312-563-3919
Fax: (312) 563-3920
Rush University Medical Center
1725 West Harrison Street
Suite 158 Professional Building
Chicago, Illinois 60612

Roche And InterMune Initiate Phase 2b Clinical Trial Of RG7227/ ITMN-191 In Patients With Chronic Hepatitis C

Eiger BioPharmaceuticals Announces Initiation Of CLEAN-1 HCV Phase 1b Trial
www.prnewswire.com

- Proof of Concept Study Investigating NS4B-RNA Binding Inhibitor

Eiger BioPharmaceuticals, Inc., a biotechnology company developing antiviral therapies, announced that the first patients have been dosed in an innovative clinical trial in patients chronically infected with the hepatitis C virus (HCV). The trial, run in centers in Australia and New Zealand, will investigate the antiviral effect of clemizole monotherapy in the absence of interferon.

CLEAN-1 will evaluate the safety and antiviral activity of clemizole, a first generation antihistamine, in 28 days of oral therapy in treatment-naive patients infected with HCV genotypes 1 and 2. This direct antiviral study represents an important first step in evaluating the therapeutic potential of inhibiting a new target in HCV -- small molecule inhibition of the interaction between NS4B and HCV-RNA that is required for HCV replication.

"This proof of concept study is an important first step in our comprehensive development strategy for clemizole and newly discovered NS4B-RNA binding inhibitors for the treatment of HCV," said David Cory, President and CEO of Eiger. "Inhibiting the NS4B-RNA interaction represents an exciting new approach toward developing interferon-free, virus-specific agents to treat HCV."

Eiger BioPharmaceuticals recently announced the acquisition of the exclusive license to this novel HCV technology, discovered in the labs of Stanford scientist and Eiger Founder, Dr. Jeffrey Glenn, M.D., Ph.D. and colleagues. Clemizole targets a non-structural protein found in the HCV genome, NS4B, which binds to HCV-RNA and is required for virus replication. Disrupting the function of this protein represents a new approach to treat HCV infection and may be associated with less drug resistance than polymerase and protease inhibitors in development.

About NS4B and Clemizole
Binding of the non-structural protein NS4B to the 3' terminus of the HCV negative RNA strand is a recently identified target for drug intervention. The requirement of this target for viral replication has been genetically validated. The two component nature of this target, involving interaction between NS4B and HCV-RNA, creates mutational constraints that should decrease resistance to pharmacologic inhibitors, compared to agents designed against a single component target such as the NS3 protease. Clemizole hydrochloride was identified as a specific inhibitor of NS4B-RNA binding. Clemizole, a first generation antihistamine, was widely used in Europe and in the U.S. beginning in the late 1950's, marketed under various brand names, for the management of allergic disorders and various dermatological conditions. Clemizole is no longer marketed as a single agent antihistamine anywhere in the world.

"In the process of studying clemizole's newly discovered anti-HCV activity, we have found that it not only has several unique and remarkable features of its own that can make it ideal for hepatitis C, but clemizole also appears to be able to significantly increase the efficacy of other agents in clinical development," said Jeffrey Glenn, Founder of Eiger. "Together this suggests that clemizole has the potential to be an ideal component of all future anti-HCV cocktails."

About Eiger BioPharmaceuticals, Inc
Eiger is focused on the discovery and development of new antiviral agents against novel targets for the treatment of hepatitis virus infections. Eiger's pipeline includes repurposed clinical stage therapeutic agents as well as preclinical NCEs from discovery that exhibit antiviral activity against Hepatitis C, Hepatitis D, and other viruses.

Source: Eiger BioPharmaceuticals, Inc.

Telaprevir

United States, New York Weill Cornell Medical College

New York, New York, United States, 10065

Not yet recruiting

Est Enrollment 20

Intrahepatic HCV RNA and Telaprevir Kinetics in Hepatitis C Virus (HCV)

Condition:	Hepatitis C
Intervention:	Drug: Telaprevir

More Trials Telaprevir

Search Studies Below

Previous Page (1-20) Studies Shown (21-40) Next Page (41-60

July-June

Albumin Interferon (Albuferon) and HCV Polymerase Inhibitor PSI-7851 Advance in Clinical Trials

Click here for additional trials

Time-Released Interferon Locteron Study Enrollment Completed

Virco and Siemens Diagnostics Sign Licensing Agreement Allowing Virco to Develop New Platform for Use in Development of New Therapies for Hepatitis C

Pharmasset Initiates Phase 1b Multiple Ascending Dose Clinical Trial of PSI-7851 in Chronic Hepatitis C Patients

Champion Study

If you have hepatitis C, you’re invited to see if you may qualify for a medical research study to determine if an investigational oral medication in combination with standard, approved treatments may help in managing hepatitis C.

Each individual will be evaluated to determine his or her eligibility. If you qualify, you will receive study medications, medical exams and lab tests for 4 weeks at no charge, as well as an additional 44 weeks of approved treatment after the study ends. Beyond that, financial compensation is also available. To learn more, visit www.ChampionStudy.com.

For more technical details on this study please click here

May

Roche and Pharmasset Initiate Phase IIb Clinical Trial of R7128, Most Advanced Nucleoside Polymerase Inhibitor in Development for Chronic Hepatitis C

OPERA-1 trial (Study TMC435-C201): interim analysis of safety and antiviral activity of TMC435 in treatment-naÏve genotype-1 HCV patients -

April-March

Pharmasset Initiates First Clinical Trial of Second-generation HCV Polymerase Inhibitor PSI-7851

Review Finds Albumin Interferon for Chronic Hepatitis C Is Effective and Well-tolerated; Phase 3 Results Show Non-inferiority to Pegylated Interferon

ISHLVD: TMC435 HCV Protease Inhibitor Safety/antiviral activity OPERA Study doses 25 & 75 mg once daily -

(03/30/09)

Recruiting

TMC435350-TiDP16-C202: A Study to Assess the Activity of TMC435 on Hepatitis C Virus in Patients Who Have Never Received Treatment for Their Hepatitis C Infection.

Locations

Belgium

Bruxelles, Belgium

Leuven, Belgium

Gent, Belgium

Brugge, Belgium

Brussels, Belgium

Germany

Berlin, Germany

Hannover, Germany

Freiburg, Germany

Frankfurt N/A, Germany

Thailand

Bangkok, Thailand

Chiang Mai, Thailand

Conditions:	Hepatitis C; Hepatitis C, Chronic; Infection
Intervention:	Drug: TMC435

Guide to Understanding Clinical Trials and Medical Research in Hepatitis C

Vertex Acquires VCH-222 and VCH-759, Two Experimental Oral HCV Polymerase Inhibitors

FDA Approves New Indication for PegIntron plus Ribavirin for Certain Patients Who Failed Prior Hepatitis C Treatment

Feb/Jan

Phase 1 OPTIMA Trial Finds Controlled-release Nitazoxanide Improves Response to Pegylated Interferon plus Ribavirin - 2/27/09
Abbott and Enanta Announce First Clinical Trial of Oral HCV Protease Inhibitor ABT-450 - 2/20/2009
iTherX Pharmaceuticals Announces Phase 2a Proof-of-concept Trial of First Hepatitis C Virus Entry Inhibitor - 2/13/2009

Debiopharm Begins Randomization of Participants in Phase 2b Trial of Cyclophilin Inhibitor Debio 025 for Chronic Hepatitis C

Schering-Plough Completes Enrollment of Boceprevir Registration Studies in Treatment-Naive and Treatment-Experienced HCV Patients -

Clinical Update - Debio 025 in Hepatitis C - Debiopharm starts phase IIb triple therapy study, a promising therapeutic avenue -

Schering-Plough Completes Enrollment of Phase 3 Trial of HCV Protease Inhibitor Boceprevir

New Hepatitis C Treatment Trials: HCV Polymerase Inhibitor R7128, Nucleotide Prodrug IDX184, and Albumin Interferon (Albuferon)

Albumin Interferon (Albuferon) Works as Well as Pegylated Interferon in ACHIEVE 2/3 Trial

New Genetic Test May Help Predict Response to Hepatitis C Treatment -

Find A Trial In Your State

World [map]

Region Name	Number of Studies
North America	66
United States	57	[studies]
Alabama	9	[studies]
Arizona	9	[studies]
Arkansas	2	[studies]
California	28	[studies]
Colorado	12	[studies]
Connecticut	10	[studies]
District of Columbia	6	[studies]
Florida	22	[studies]
Georgia	10	[studies]
Hawaii	7	[studies]
Illinois	10	[studies]
Indiana	8	[studies]
Iowa	3	[studies]
Kansas	2	[studies]
Kentucky	5	[studies]
Louisiana	6	[studies]
Maine	1	[studies]
Maryland	28	[studies]
Massachusetts	13	[studies]
Michigan	9	[studies]
Minnesota	7	[studies]
Mississippi	6	[studies]
Missouri	14	[studies]
Nebraska	2	[studies]
New Hampshire	3	[studies]
New Jersey	12	[studies]
New Mexico	3	[studies]
New York	24	[studies]
North Carolina	15	[studies]
Ohio	11	[studies]
Oklahoma	9	[studies]
Oregon	11	[studies]
Pennsylvania	15	[studies]
Rhode Island	3	[studies]
South Carolina	4	[studies]
Tennessee	9	[studies]
Texas	30	[studies]
Utah	6	[studies]
Vermont	1	[studies]
Virginia	20	[studies]
Washington	5	[studies]
Wisconsin	3	[studies]

NOV

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.

Vertex clinical trials hotline at 617-444-6777

Trials HCV

2008

New Study: Telaprevir in Treatment Experienced Patients

New Study: Telaprevir in Treatment Experienced Patients
—Alan Franciscus, Editor-in-Chief

On October 15, 2008 Tibotec announced that it will begin screening patients for a large phase III study to evaluate the combination of telaprevir, pegylated interferon plus ribavirin in treatment experienced patients who did not achieve a sustained virological response to a previous course of treatment with pegylated interferon plus ribavirin. Tibotec is Vertex’s commercial partner that is conducting clinical trials outside of the United States, Canada and Mexico.

This worldwide study will enroll about 650 HCV patients. According to the company press release the U.S. centers have begun screening patients, and other global study centers are expected to begin the screening process within the next couple of weeks. The study will include null responders, partial responders and relapsers.

The REALIZE Study

The study will include 3 arms:

1. Telaprevir dosed at 750 mg q8h (every eight hours) for 12 weeks in combination with standard doses of pegylated interferon plus ribavirin, followed by 36 weeks of treatment with pegylated interferon plus ribavirin alone;

2. Delayed start arm – 4 weeks of treatment with pegylated interferon plus ribavirin, followed by telaprevir dosed at 750 mg q8h for 12 weeks in combination with standard doses of pegylated interferon and ribavirin, followed by another 32 weeks of pegylated interferon and ribavirin alone;

3. Control Arm – standard doses of pegylated interferon plus ribavirin dosed for 48 weeks.

The study has been named REALIZE (Re-treatment of Patients with Telaprevir-based Regimen to Optimize Outcomes).

Currently, Vertex is conducting another large phase III study of telaprevir in combination with pegylated interferon plus ribavirin for the treatment of genotype 1 treatment naïve patients called the ADVANCE trial. The ADVANCE trial is expected to enroll about 1050 patients in the U.S., Europe and certain other countries. It is expected that the results from the ADVANCE study will be used to apply to the Food and Drug Administration for marketing approval of telaprevir in the U.S.

For more information about the ADVANCE and REALIZE studies visit www.clinicaltrials.gov.

Source: Company Press Release

Vertex Pharmaceuticals Highlights HCV - Telaprevir Development Program

Tibotec Begins Enrollment for Phase III Study of Telaprevir, an Investigational Agent, in HCV Patients Who Failed Prior Treatment -

(10/15/08)

High-Dose Ribavirin and Peginterferon to Treat Chronic Hepatitis C Genotype 1

Interest of Ribavirin in the Maintenance Treatment of Liver Fibrosis Using Low Dose Pegylated Interferon alpha2b in Patients With Chronic Hepatitis C Non Responders to Previous Antiviral Therapy.

Pegylated-Interferon and Ribavirin in Hepatitis C Patients With Persistently Normal Alanine Aminotransferase Levels

VX-950-TiDP24-C210: A Study to Assess the Activity of Telaprevir on Hepatitis C Virus in Treatment naïve Patients Who Are Chronically Infected With Hepatitis C Genotype 4 Infection.

More HCV Trials

Attention: All Relapsers & Non Responders

If you had at least a 2 log drop by week 12 but never cleared, OR you relapsed during Tx or you Cleared, stayed clear, but were detectible again by 6 months Post Tx, You are ELIGIBLE for this New Trial by Schering Posted below. There is a Tx Arm that includes the new Boceprevir Protease Inhibitor If you can get in this study you won't have to wait for 2-3-or more years for this or the other PI (Telepiver) to hit the streets with FDA approval.

Thanks Marcus

Schering-Plough To Initiate Phase III Studies With HCV Protease Inhibitor Boceprevir in Previously Untreated Hepatitis C Patients and Those Who Failed Prior Treatment -

InterMune Announces Start of 14-Day Triple Combination Study of ITMN-191 in Patients With Chronic Hepatitis C

Schering starts hepatitis C trials, Vertex falls

Trial HCV

VX-950-TiDP24-C210: A Study to Assess the Activity of Telaprevir on Hepatitis C Virus in Treatment naïve Patients Who Are Chronically Infected With Hepatitis C Genotype 4 Infection

Peginterferon and Ribavirin on Virologic and Immunologic Parameters in Hepatitis C Mono- and Coinfected Patient (PRIVICOP)

Low-Dose Peginterferon and Ribavirin to Treat Chronic Hepatitis C in Patients Infected With HCV Genotype 2 or 3

Pegylated Interferon and Ribavirin to Treat Chronic Hepatitis C With and Without Kidney Disease

Pegylated-Interferon and Ribavirin in Hepatitis C Patients With Persistently Normal Alanine Aminotransferase Levels

Retreatment of Chronic Hepatitis C Non-Responders With Pegylated Interferon Alpha + Ribavirin + Pioglitazone

Insulin Resistance Associated With Chronic Hepatitis C (CHC) and the Effect of Antiviral Therapy