ClinicalTrials.Gov Identifier:  NCT00606086

This study is currently closed.

Summary

This study in patients with chronic genotype 1 hepatitis C infection has two primary arms. Patients randomized to Arm1 will receive pegylated interferon/ribavirin [Standard of Care] plus the GI-5005 Tarmogen. Patients randomized to Arm 2 will receive Standard of Care alone. Patients will be monitored for viral load decreases, improvement in biochemical markers, safety and immune responses related to treatment.

Patients randomized to Arm1 will receive five weekly, followed by up to 17 monthly doses of GI-5005. GI-5005 is injected under the skin (subcutaneous injection).

Official Title:

A Phase 2 Randomized, Open Label, Multi-center, Therapeutic Trial of the Efficacy, Immunogenicity, and Safety of GI-5005; an Inactivated Recombinant Saccharomyces cerevisiae Expressing a Hepatitis C Virus NS3-Core Fusion Protein, Combined with Pegylated Interferon plus Ribavirin Standard of Care Therapy versus Standard of Care Alone, and GI-5005 Salvage of Standard of Care Failures, in Patients with Genotype 1 Chronic Hepatitis C Infection.

Study Details:

This study will be a randomized, open label, multi-arm, multi-center, therapeutic trial comparing pegylated interferon plus ribavirin (Standard of Care), versus the subcutaneous administration of multiple doses of GI-5005 in combination with pegylated interferon plus ribavirin in patients with chronic genotype 1 hepatitis C infection who are either treatment naïve or non-responders to a prior interferon based regimen using pegylated or non-pegylated interferon alpha with ribavirin. GI-5005 salvage of in-study Standard of Care failures will also be explored in this trial. This study is designed to enroll 120 evaluable patients randomized 1:1 in 2 arms at approximately 20-30 active centers in the U.S, and up to 10 active centers internationally.

Eligibility

Inclusion Criteria:

• Chronic hepatitis C infection with genotype 1 based on serum positivity for HCV RNA or a positive test for serum anti-HCV antibody for at least 6 months.
• If female of childbearing potential, negative pregnancy test.
• Age: 18 years or older
• Patients can be either treatment-naïve or a non-responder to prior combination therapy with pegylated or non-pegylated interferon plus ribavirin.

Exclusion Criteria:

• Patients with cirrhosis of the liver
• History of significant non-HCV chronic liver disease, i.e. alcoholic hepatitis, autoimmune hepatitis
• Patients treated with more than 1 complete hepatitis C regimen (subjects with a history of 1 complete prior regimen and a second incomplete prior regimen may be eligible upon discussion with and approval of the medical monitor)
• Treatment for HCV infection within 28 days before screening

Location and Contact Information:

UNITED STATES

Alabama

Arizona

University of Arizona
Department of Surgery
1501 N. Campbell Ave.
Tucson, AZ 85724

California

UCLA Medical Center
10945 Le Conte Ave, PVUB 2114
Los Angeles, CA 90095

East Side Clinical Research Associates
4755 E Cesar Chavez Ave, Suite A
Los Angeles, CA 90022

Scripps Clinic Torrey Pines
10666 N Torrey Pines Rd, N203
La Jolla, CA 92037

Colorado

University of Colorado at Denver Health Sciences Center
Hepathology Research Coordinator-B158
12631 East 17th Avenue, Room 7409
Aurora, CO 80045

South Denver Gastroenterology
499 E Hampden #420
Englewood, CO 80113

Connecticut

University of Connecticut Health Center
263 Farmington Ave, Rm. AM-044
Farmington, CT 06030-1845

Yale University School of Medicine
Yale Liver Center
333 Ceder Street, 1080 LMP
New Haven, CT 06520-8000

Florida

University of Miami
Center for Liver Diseases
Miami, FL 33136

Advanced Research Institute, Inc.
3633 Little Road, Suite 103
New Port Richey, FL 34655

Georgia

NW Georgia Research Institute
61 Whitcher St, #3100
Marietta, GA 30060

Emory Healthcare
The Emory Clinic
Emory University School of Medicine
Division of Digestive Diseases
The Emory Clinic
1365B Clifton Road N.E.
Room 1216
Atlanta, GA 30322

Hawaii

Hawaii Medical Center
HMC Liver Center
2nd Floor MA Building
2230 Lihiha Street
Honolulu, HI 96817

Indiana

Northwest Indiana Center for Clinical Research
150 West Lincolnway, Suite 2004
Valparaiso, IN 46383

Louisiana

Tulane University Hospital Clinic

Massachusetts

Beth Isreal Deconess Medical Center
110 Francis St. 4A
Boston, MA 02215

Maryland

The Johns Hopkins Hospital & School of Medicine
720 Rutland Ave, Ross #310
Baltimore, MD 21205

Maryland Digestive Disease Research
7350 Van Dusen Road, Suite 360
Laurel, MD 20707

Michigan

Henry Ford Health System
2799 West Grand Blvd. CFP 074
Detroit, MI 48202

University of Michigan
Clinical Study Coordinator
Gastroenterology
3912 Taubman Center
1500 E. Medical Center Drive
Ann Arbor, MI 48109

Minnesota

Mayo Clinic of Medicine
200 First Street
Mayo Bldg E19
Rochester, MN 55905

Missouri

Saint Louis University
Slaus Center
2nd Floor GI/Hepatology
Clinical Research Unit
3545 Lafayette Ave
St. Louis, MO 63104

Mississippi

Gastroenterology Associates, PA
1421 North State St.
Jackson, MS 39202

New Hampshire

Dartmouth-Hitchcock Medical Center
Gastroenterology Research
HB 7934, Rubin 8
One Medical Center Drive
Lebanon, NH 03756

New York

Columbia University
Columbia University Medical Center
Center for Liver Disease & Transplantation
622 West 168th Street
PH 11 Stem Room 460
New York, NY 10032

Weill Medical College of Cornell University
New York Weill Cornell Medical Center
1305 York Avenue, 4th FL
New York, NY 10021

North Carolina

Duke Clinical Research Institute
GI/Hepatology
Duke South, Room 0307
Basement, Orang Zone
Durham, NC 27710

Oklahoma

Options Health Research
1145 South Utica, Suite 700
Tulsa, OK 74104

Texas

Alamo Medical Research
621 Camden, Suite 202
San Antonio, TX 78215

Baylor College of Medicine
St. Luke's Episcopal Hospital
6620 Main Street, Suite 1505
Houston, TX 77030

University of Texas Southwestern
Medical Center at Dallas
Professional Office Bldg 1, Suite 420
5323 Harry Hines Blvd
Dalllas, TX 75390-8887

Virginia

Inova Research Center
Inova Fairfax Hospital
Center for Liver Diseases
3289 Woodburn Road, Suite 375
Annadale, VA 22003

McGuire VA Medical Center
1201 Broad Rock Blvd, 111-N
Richmond, VA 23249

McGuire DVAMC
1201 Broad Rock Blvd, 111-N
Richmond, VA 23249

Washington D.C.

Georgetown University Medical Center
Division of Gastroenterology
3800 Reservoir Road, NW
2nd Floor, Main Hospital Suite M2408
Washington, DC 20007-2113

INDIA

Yashoda Hospital
Division of Gastroenterology and Hepatology
Patny Centre, S. P. Road, Secundrabad-500003

G.B.Pant Hospital 
Division of Gastroenterology
Jawaharlal Nehru Marg, New Delhi - 110 002

Institute of Liver & Digestive Dieases, Dispur Hospitals Limited
Division of Gastroenterology
Ganeshguri, Guwahati- 781006

VGM endoscopy Center
Division of Gastroenterology and Hepatology
Ashoka Building, 481/56, Dr. Nanjappa Road, Gandhipuram, Coimbatore-641018

Dayanand Medical College and Hospital
Gastroenterology- Chronic Hepatitis
Tagore Nagar, Ludhiana- 141001

Global Hospitals
Gastroenterology and Hepatology
Lakdi-ka-pool, Hyderabad, Andhra Pradesh, 500 004