2009
HCV Drugs in Development
ClinicalTrials.gov
Provides regularly updated information about federally and privately
supported clinical research in human volunteers.
Search Studies Below
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)
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
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
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
Vertex Hep C treatment enters late-stage trials
Vertex Pharmaceuticals to Begin Phase 3 Development of Telaprevir,
Investigational Hepatitis C Protease Inhibitor
DIRECT
is a randomized, open-label, phase III investigational research study
that will evaluate the safety and efficacy of daily administration of
subcutaneous interferon alfacon-1 plus ribavirin versus no treatment in
HCV patients who have not responded to previous combination therapy with
pegylated interferon alfa plus ribavirin.
Albuferon Dose in Ongoing Trials is Lowered Due to
Safety Concerns
InterMune Announces Continuing Progress on HCV Protease Inhibitor
ITMN-191 (R7227)
HCV New Drug Pipeline
Continue reading "Trial to Test Potential HCV
Triple Combination Therapy"
Roche responds to announcement of 'IDEAL'
hepatitis C trial results
SCHERING-PLOUGH REPORTS TOP-LINE RESULTS OF THE
IDEAL STUDY First Large Study Comparing Leading Hepatitis C Therapies
Shows Similar Sustained Response Rates; Fewer Patients Relapsed
Following PEGINTRON Combination Therapy
-
IDEAL Study COMMENTARY- Doug Dieterich MD A
Healthy Dose of Curiosity Clinical trial results require careful
interpretation
Pharmasset Announces R7128 Achieves 85% Rapid
Virologic Response in a 4-week Combination Study for the Treatment of
Chronic Hepatitis C -
2007
HCV-796 Dosing Discontinued
Romark Initiates Phase II Clinical Trial of
Nitazoxanide (Alinia) for Chronic Hepatitis C
-
Triphasic Decline of Hepatitis C Virus RNA during
Interferon-based Antiviral Therapy
Idenix Suspends Testing of HCV Polymerase Inhibitor
Valopicitabine (NM283)
HCV Drug Pipeline
Hepatitis C Clinical Trials
DDW 2007 Highlights:
Part 2
DDW 2007 Highlights
Part 1
2006
Largest U.S. Hepatitis C Trial Provides Insight
Into Optimizing Treatment For Patients
HCV Drug Pipeline
Fast Track for ACTILON
Novartis strengthens infectious disease portfolio
by acquiring rights to Albuferon(TM), a hepatitis C interferon drug set
to enter Phase III trials
From DDW JUNE 2006
Clinical Trials Preliminary Results
-
ID# 1 – Antiviral Activity of the Non-Nucleoside Polymerase Inhibitor,
HCV-796, in Patients With Chronic Hepatitis C Virus: Preliminary
Results From a Randomized, Double-Blind, Placebo-Controlled, Ascending
Multiple Dose Study
-
ID# 4 – Valopicitabine (NM283), Alone or with Peg-Interferon, Compared
to Peg Interferon/Ribavirin (pegIFN/RBV) Retreatment in Hepatitis C
Patients with Prior Non-Response to PegIFN/RBV: Week 24 Results
-
Abstract S1057 – Stronger Baseline HCV-Specific Immunity Is Associated
With A Higher Likelihood Of A Sustained Virological Response to
Combination Antiviral Therapy Of Chronic Hepatitis C
(Updated
May 21, 2006)
-
Abstract S1058 – The impact of growth factors on Peg-Intron and
Rebetol dose reduction in patients treated for genotype 1 chronic
hepatitis C
(Updated May 21, 2006)
-
Abstract S1059 – Results of a Phase II dose ranging study of orally
administered celgosivir as monotherapy in chronic hepatitis C
genotype-1 patients.
(Updated May 25, 2006)
-
Abstract S1060 – Comparison of Daily Consensus Interferon versus
Peginterferon alfa 2a Extended Therapy of 72 Weeks for Peginterferon /
Ribavirin Relapse Patients with Chronic Hepatitis C
-
Abstract S1061 – Higher Susceptibility of Peginterferon alfa 2a versus
Peginterferon alfa 2b Nonresponder Patients with Chronic Hepatitis C
to Retreatment with Consensus Interferon Daily Dosing and Ribavirin
-
Abstract S1062 – Early viral response to CPG 10101, a new
investigational antiviral TLR9 agonist, in combination with pegylated
interferon and/or ribavirin, in prior relapse HCV responders:
preliminary report of a randomized Phase 1 study
(Updated
May 25, 2006)
-
Abstract S1063 – The usefulness of sPECAM-1 and sVCAM-1 serum
concentrations measurement in the assessment of fibrosis, inflammatory
activity and antiviral therapy effectiveness in chronic hepatitis C
Open Clinical Trial of New PI SCH 503034 Plus
PegIntron in HCV Patients Nonresponsive to Prior Treatment with
Peginterferon Plus Ribavirin
(Feb 7 06)
Phase III Trial Shows Zadaxin Ineffective for
Treatment of Hepatitis C among Nonresponders to Prior Treatment with
Interferon
FDA Grants Fast Track Review to Schering-Plough's
New Oral HCV Protease Inhibitor SCH 503034
Hepatitis C Clinical Trials 2006
2005
Hepatitis C Treatments in Current Clinical
Development
(06/02/05)
HCV Drug NM283 Trial Fully Enrolled
(06/02/05)
New HCV Drug Albuferon Starts Study in Genotype 1
Naives
(06/02/05)
How Ideal Is the
IDEAL Trial?
June 2004
New Pegasys Study for HCV+ Untreated Patients with
Genotype 1, High Weight & High Viral Load
June 30 2004
New Pegasys Trial to Enroll Hepatitis C Patients Not Helped by PEG-Intron
(repeat study)
Nation's Top
Medical Centers Seek Participants for Largest Study Comparing Leading
Hepatitis C Treatments
Thursday May 13, 8:59 am ET
InterMune
Initiates Phase II Clinical Trial of Daily Infergen Plus Actimmune for
the Treatment of Hepatitis C Nonresponders
