Hepatitis C Clinical Trials

Learn the basics of clinical trials in hepatitis C and find out about clinical trials that you may be eligible for.

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How to Evaluate a Clinical Trial

Making Sense of Hepatitis C Research and Medical Literature

Clinical Trials are listed by Pharmaceutical Company at http://hcvadvocate.blogspot.ca/ and updated regularly

• To find a current clinical trial, click on one of the links to a pharmaceutical company in the columns at the beginning of our blog where it says: Drugs in Development / Clinical Trials—Updated .......
  
  
• If you would like more information about a study offered by a drug company we have listed, click on a study title on one of the drug company pages
  
  
• To find out even more about clinical trials for HCV medications you can go to:  www.clinicaltrials.gov or http://clinicaltrials.ifpma.org/clinicaltrials /no_cache /en/myportal/index.htm and type in ‘HCV’

ClinicalTrials.gov
Provides regularly updated information about federally and privately supported clinical research in human volunteers.

Centerwatch
Centerwatch list of hepatitis C clinical trials by state

Hep C Study Connect

The National Institute of Allergy and Infectious Diseases
Volunteer for NIAID Hepatitis C Clinical Research Studies

Study:  Newport Beach, CA

A Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy and Safety of the Combination of ABT-450/Ritonavir/ABT-267 and ABT-333 With and Without Ribavirin in Treatment Naïve Adults with Genotype 1a Chronic Hepatitis C Virus Infection

THIS IS A PEGINTERFERON-FREE TREATMENT, WITH OR WITHOUT RIBAVIRIN!

Key Inc/Exc:

Chronic HCV infection without cirrhosis Treatment naïve Genotype 1a

We are currently screening patients in our office in Newport Beach, CA (see address below). Enrollment will likely close in May, 2013.

Thanks, Kathy Kathy Shea, MPH Orange Coast Medical Group 496 Old Newport Blvd., Suite 4 Newport Beach, CA 92663 Telephone: (949) 574-2598 Fax: (949) 646-6972 .

Study:  San Francisco, CA

PEARL-IV (M14-002) trial, investigating a treatment without interferon (no injections)—Phase 3.

The study evaluates if ABT333 (Polymerase-Inhibitor), ABT450 (HCV-Protease Inhibitor) and ABT267 (NS5A Inhibitor) alone - or in conjunct with Ribavirin – is the better treatment option for GT1a (the most common GT in the US) Hepatitis C

In summary this is a

• 3 months treatment study
• Utilizing only tablets (no Interferon)
• Twice daily medications (total of 5 tabs)

The Phase 2 studies have had a  SVR (“cure”) rate between 86 and 100% depending of the population looked at (i.e. pretreatment or naïve, cirrhosis or no cirrhosis, different subtypes)

People qualifying for this trial need to be:

• Are chronically infected with Hep C, GT1a
• Have no cirrhosis
• Have no history of failure on previous treatments.

Fritz Bredeek, MD, PhD, FACP
Metropolis Medical
815 Hyde Street, Suite 301 , San Francisco, CA 94109
Phone 415.292-5477,
Fax 415 292-5490

Study:  Greater Cincinnati/Northern Kentucky

MCM Clinical Research is currently seeking participants for the Janssen sponsored ATTAIN study which is  a Phase III, double-blind trial to evaluate the efficacy, safety and tolerability of TMC435 vs. telaprevir, both in combination with PegIFN and ribavirin, in chronic hepatitis C genotype-1 infected subjects who were null or partial responders to prior pegylated IFN and ribavirin therapy.  All participants will receive active protease inhibitor therapy along with standard of care (Pegasys/Copegus).

Colleen M. Kennedy, PA-C
Sub-Investigator
MCM Clinical Research, LLC
7370 Turfway Road, Suite 300
Florence, Kentucky  41042
Phone:  (859) 594-4626
Direct: (859) 363-4005
Fax: (859) 594-4622

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