Study of Viramidine to Ribavirin in Patients With Chronic Hepatitis C Who Are Treatment Naive

NCT00093093 | Completed Phase 3

• 1 other identifier: RNA003142-302
• Study Type: interventional
• Target: 900
• Locations: 12 countries
• Sites: 100

Brief Summary

The purpose of this study is to determine the safety and effectiveness of viramidine to ribavirin in chronic hepatitis C patients who have never before received treatment.

Conditions

Chronic Hepatitis C

Keywords

Viramidine; Ribavirin; Valeant; Hepatitis C; Pegylated interferon alfa-2a

Outcome Measures

Primary Outcomes (2)

• - Efficacy: Undetectable plasma HCV RNA (less than 100 copies/mL) at the end of the 24-week post-treatment follow-up period.

• - Safety: The proportion of patients with hemoglobin less than 10 g/dL at any time during treatment or at least 2.5 g/dL drop from baseline.

Secondary Outcomes (4)

• - Efficacy: Undetectable plasma HCV RNA at treatment week 24

• - Efficacy: Undetectable or at least a 2-log drop from baseline at treatment weeks 12 and 24

• - Safety: Monitoring of adverse events

• - Safety: Monitoring of abnormal changes in laboratory parameters that are not disease-related

Interventions

Viramidine DRUG

Ribavirin DRUG

pegylated interferon alfa-2a DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Treatment-naive patients with compensated chronic hepatitis C.
• HCV RNA \>2000 copies/mL (780 IU/mL) as determined by NGI SuperQuant serum HCV RNA quantification, with a lower limit of detection of 100 copies/mL (39 IU/mL).

You may not qualify if:

• Severe neuropsychiatric disorders
• History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic heart disease, significant or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune mediated disease
• Pregnant or breast-feeding patients

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (100)

University of Arizona

Tucson, Arizona, 85724-5136, United States

Location

UCSF Fresno- Internal Medicine

Fresno, California, 93702, United States

Location

Keck School of Medicine, University of Southern California

Los Angeles, California, 90033, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Orange Coast Medical Group

Newport Beach, California, 92633, United States

Location

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

Research and Education, Inc.

San Diego, California, 92115, United States

Location

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

San Mateo Medical Center

San Mateo, California, 94403, United States

Location

University of Colorado Health Sciences Center

Denver, Colorado, 80262, United States

Location

Rocky Mountain Gastroenterology

Lakewood, Colorado, 80215, United States

Location

University of Connecticut

Farmington, Connecticut, 06030, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

Location

Bach and Godofsky

Bradenton, Florida, 34205, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32216, United States

Location

Atlanta Academic Research Group

Atlanta, Georgia, 30033, United States

Location

Atlanta Gastroenterology Associates

Atlanta, Georgia, 30308, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Louisiana State University Memorial Hospital

New Orleans, Louisiana, 70115, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Johns Hopkins

Baltimore, Maryland, 21205, United States

Location

Johns Hopkins University Medical Center

Baltimore, Maryland, 21287, United States

Location

Maryland Digestive Disease Research

Laurel, Maryland, 20707, United States

Location

Future Care Studies/Northgate Medical

Springfield, Massachusetts, 01107, United States

Location

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Bradley Freilich, MD

Kansas City, Missouri, 64131, United States

Location

Saint Louis University School of Medicine

St Louis, Missouri, 63104, United States

Location

Atlantic Gastroenterology Associates

Egg Harbor, New Jersey, 08234, United States

Location

Regional Clinical Research, Inc.

Johnson City, New York, 13790, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Cabrini Medical Center

New York, New York, 10029, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

Bronx VA Medical Center

The Bronx, New York, 10468, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Digestive Health Specialists

Winston-Salem, North Carolina, 27103, United States

Location

Consultants for Clinical Research

Cincinnati, Ohio, 45219, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Research Solutions (SMO)

Tulsa, Oklahoma, 74104, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Radiant Research - Austin

Austin, Texas, 78758, United States

Location

University of Texas

Dallas, Texas, 75390, United States

Location

VA Medical Center

Houston, Texas, 77030, United States

Location

INOVA Fairfax Hospital

Annadale, Virginia, 22003, United States

Location

Kaiser Permanente Medical Center

Falls Church, Virginia, 22046, United States

Location

Hunter Holmes McGuire Medical Center

Richmond, Virginia, 23249, United States

Location

Northwest Medical Specialties

Tacoma, Washington, 98405, United States

Location

Hospital Italiano

Buenos Aires, Buenos Aires, (C1199ACK), Argentina

Location

Fundación CIDEA

Buenos Aires, Buenos Aires, (C1264AAA), Argentina

Location

Hospital Británico

Buenos Aires, Buenos Aires, (C1280AEB), Argentina

Location

Hospital Austral

Pilar, Buenos Aires, (B1629AHJ), Argentina

Location

Hospital Centenario

Rosario, Santa Fe Province, (S2000CFJ), Argentina

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

The Alfred Hospital

Prahran, Victoria, 3181, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

Location

University of Calgary

Calgary, Alberta, T2N 4N1, Canada

Location

University of Alberta

Edmonton, Alberta, T6G 2C8, Canada

Location

University of Manitoba

Winnipeg, Manitoba, R3E 3P4, Canada

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

CHU Grenoble Hôpital Michallon, Service d'Hépatogastroentérologie

Grenoble, 38043, France

Location

Hopital Saint Joseph Service d'Hépato-gastroentérologie

Marseille, 13285, France

Location

Hôpital de l'Archet 2 Service d'Hépato-Gastroentérologie

Nice, 06202, France

Location

Hôpital Saint Antoine, Service d'Hépato-Gastroentérologie

Paris, 75571, France

Location

C.H.U de Nancy - Hôpital de Brabois Adultes Service d'Hépato-gastroentérologie

Vandouevre Les Nancy, 54511, France

Location

Rambam Medical Center Liver Unit

Haifa, 31096, Israel

Location

Head of Liver Unit, Holy family Hospital

Nazareth, 16100, Israel

Location

Tel Aviv Souraski Medical Center, Liver Unit, Department of Gastro-enterology

Tel Aviv, 64239, Israel

Location

Malattie Infettive, Azienda Ospedaliera di Busto Arsizio

Busto Arsizio, 21052, Italy

Location

Az. Osp. Universitaria Policlinico "Paolo Giaccone"

Palermo, 90127, Italy

Location

IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Istituto Nazionale per le Malattie Infettive "Lazzaro Spallanzani" IRCCS

Rome, 00149, Italy

Location

Divisione di Gastroenterologia, Azienda Ospedaliera S.Giovanni Battista

Torino, 20126, Italy

Location

Wojewodzki Szpital Obserwacyjno-Zakazny im. T. Browicza

Bydgoszcz, 85-030, Poland

Location

Szpital Specjalistyczny

Chorzów, 41-500, Poland

Location

Katedra Chorob Zakaznych i Hepatologii Collegium Medicum Uniwersytetu Jagiellonskiego

Krakow, 31-531, Poland

Location

Katedra i Klinika Chorob Zakaznych Pomorskiej Akademii Medycznej

Szczecin, 71-455, Poland

Location

Klinika Chorob Wewnetrznych i Reumatologii CSK MON WIM

Warsaw, 00-909, Poland

Location

Wojewodzki Szpital Zakazny

Warsaw, 01-201, Poland

Location

Fundacion de Investigacion de Diego

Santurce, 00909, Puerto Rico

Location

Russian State Medical University

Moscow, 115516, Russia

Location

City Hospital of Infectious Diseases #10

Saint Petersburg, 190020, Russia

Location

Department of gastroenterology, Russian Military Academy; Regional Military Clinical Hospital №442

Saint Petersburg, 193163, Russia

Location

City Hospital of Infectious Diseases #30

Saint Petersburg, 193167, Russia

Location

Department of infectious diseases, Russian Military Academy

Saint Petersburg, 194175, Russia

Location

Smolensk Medical Academy

Smolensk, 214018, Russia

Location

Hospital Universitario Germans Trias i Pujol

Badalona, 08916, Spain

Location

Hospital Santa Creu I Sant Pau

Barcelona, 08025, Spain

Location

Hospital Universitario La Princesa

Madrid, 28006, Spain

Location

Hospital Carlos III

Madrid, 28029, Spain

Location

Hospital General Universitario de Valencia

Valencia, 46014, Spain

Location

Liver and Hepatobiliary Unit, Queen Elizabeth Hospital

Birmingham, B15 2TH, United Kingdom

Location

Liver Unit, Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

taribavirin; Ribavirin; peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Ralph T. Doyle

  Bausch Health Americas, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2004
• First Posted: October 4, 2004
• Study Start: June 1, 2004
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2006
• Last Updated: June 22, 2012

Record last verified: 2012-06

Locations

AR (5); GB (2); IT (5); PL (6); US (53); ES (5); RU (6); PR (1); IL (3); FR (5); AU (5); CA (4)