Clinical trial NCT00093093: Study of Viramidine to Ribavirin in Patients With Chronic Hepatitis C Who Are Treatment Naive
Official title: Randomized, Double-Blind, Multicenter Study to Compare the Safety and Efficacy of Viramidine to Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C
Keywords: Viramidine
Ribavirin
Valeant
Hepatitis C
Pegylated interferon alfa-2a
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2004-10-04
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Compare the efficacy and safety of viramidine 600 mg twice a day (BID) versus ribavirin 1000/1200 mg/day, both drugs administered in combination with pegylated interferon alfa-2a to treatment-naive patients with chronic hepatitis C (CHC)

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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

Primary outcomes:
measure: - Efficacy: Undetectable plasma HCV RNA (less than 100 copies/mL) at the end of the 24-week post-treatment follow-up period.
measure: - 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:
measure: - Efficacy: Undetectable plasma HCV RNA at treatment week 24
measure: - Efficacy: Undetectable or at least a 2-log drop from baseline at treatment weeks 12 and 24
measure: - Safety: Monitoring of adverse events
measure: - Safety: Monitoring of abnormal changes in laboratory parameters that are not disease-related
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Fresno
country: United States
facility: UCSF Fresno- Internal Medicine
state: California
city: Los Angeles
country: United States
facility: Keck School of Medicine, University of Southern California
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Newport Beach
country: United States
facility: Orange Coast Medical Group
state: California
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
city: San Diego
country: United States
facility: Research and Education, Inc.
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: San Mateo
country: United States
facility: San Mateo Medical Center
state: California
city: Denver
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: Lakewood
country: United States
facility: Rocky Mountain Gastroenterology
state: Colorado
city: Farmington
country: United States
facility: University of Connecticut
state: Connecticut
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Washington
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
city: Bradenton
country: United States
facility: Bach and Godofsky
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Atlanta
country: United States
facility: Atlanta Academic Research Group
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: New Orleans
country: United States
facility: Louisiana State University Memorial Hospital
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University Medical Center
state: Maryland
city: Laurel
country: United States
facility: Maryland Digestive Disease Research
state: Maryland
city: Springfield
country: United States
facility: Future Care Studies/Northgate Medical
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Kansas City
country: United States
facility: Bradley Freilich, MD
state: Missouri
city: St. Louis
country: United States
facility: Saint Louis University School of Medicine
state: Missouri
city: Egg Harbor Township
country: United States
facility: Atlantic Gastroenterology Associates
state: New Jersey
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: Bronx
country: United States
facility: Bronx VA Medical Center
state: New York
city: Johnson City
country: United States
facility: Regional Clinical Research, Inc.
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: Cabrini Medical Center
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Winston-Salem
country: United States
facility: Digestive Health Specialists
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants for Clinical Research
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Tulsa
country: United States
facility: Research Solutions (SMO)
state: Oklahoma
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Austin
country: United States
facility: Radiant Research - Austin
state: Texas
city: Dallas
country: United States
facility: University of Texas
state: Texas
city: Houston
country: United States
facility: VA Medical Center
state: Texas
city: Annadale
country: United States
facility: INOVA Fairfax Hospital
state: Virginia
city: Falls Church
country: United States
facility: Kaiser Permanente Medical Center
state: Virginia
city: Richmond
country: United States
facility: Hunter Holmes McGuire Medical Center
state: Virginia
city: Tacoma
country: United States
facility: Northwest Medical Specialties
state: Washington
city: Buenos Aires
country: Argentina
facility: Hospital Italiano
state: BA
city: Buenos Aires
country: Argentina
facility: Fundación CIDEA
state: BA
city: Buenos Aires
country: Argentina
facility: Hospital Británico
state: BA
city: Pilar
country: Argentina
facility: Hospital Austral
state: BA
city: Rosario
country: Argentina
facility: Hospital Centenario
state: Santa Fe
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Prahran
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Grenoble
country: France
facility: CHU Grenoble Hôpital Michallon, Service d'Hépatogastroentérologie
city: Marseille
country: France
facility: Hopital Saint Joseph Service d'Hépato-gastroentérologie
city: Nice
country: France
facility: Hôpital de l'Archet 2 Service d'Hépato-Gastroentérologie
city: Paris
country: France
facility: Hôpital Saint Antoine, Service d'Hépato-Gastroentérologie
city: Vandouevre les Nancy
country: France
facility: C.H.U de Nancy - Hôpital de Brabois Adultes Service d'Hépato-gastroentérologie
city: Haifa
country: Israel
facility: Rambam Medical Center Liver Unit
city: Nazareth
country: Israel
facility: Head of Liver Unit, Holy family Hospital
city: Tel Aviv
country: Israel
facility: Tel Aviv Souraski Medical Center, Liver Unit, Department of Gastro-enterology
city: Busto Arsizio
country: Italy
facility: Malattie Infettive, Azienda Ospedaliera di Busto Arsizio
city: Palermo
country: Italy
facility: Az. Osp. Universitaria Policlinico "Paolo Giaccone"
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo
city: Rome
country: Italy
facility: Istituto Nazionale per le Malattie Infettive "Lazzaro Spallanzani" IRCCS
city: Torino
country: Italy
facility: Divisione di Gastroenterologia, Azienda Ospedaliera S.Giovanni Battista
city: Bydgoszcz
country: Poland
facility: Wojewodzki Szpital Obserwacyjno-Zakazny im. T. Browicza
city: Chorzow
country: Poland
facility: Szpital Specjalistyczny
city: Krakow
country: Poland
facility: Katedra Chorob Zakaznych i Hepatologii Collegium Medicum Uniwersytetu Jagiellonskiego
city: Szczecin
country: Poland
facility: Katedra i Klinika Chorob Zakaznych Pomorskiej Akademii Medycznej
city: Warszawa
country: Poland
facility: Klinika Chorob Wewnetrznych i Reumatologii CSK MON WIM
city: Warszawa
country: Poland
facility: Wojewodzki Szpital Zakazny
city: Santurce
country: Puerto Rico
facility: Fundacion de Investigacion de Diego
city: Moscow
country: Russian Federation
facility: Russian State Medical University
city: Smolensk
country: Russian Federation
facility: Smolensk Medical Academy
city: St.Petersburg
country: Russian Federation
facility: City Hospital of Infectious Diseases #10
city: St.Petersburg
country: Russian Federation
facility: Department of gastroenterology, Russian Military Academy; Regional Military Clinical Hospital №442
city: St.Petersburg
country: Russian Federation
facility: City Hospital of Infectious Diseases #30
city: St.Petersburg
country: Russian Federation
facility: Department of infectious diseases, Russian Military Academy
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Santa Creu I Sant Pau
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Hospital Carlos III
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Birmingham
country: United Kingdom
facility: Liver and Hepatobiliary Unit, Queen Elizabeth Hospital
city: Edinburgh
country: United Kingdom
facility: Liver Unit, Royal Infirmary of Edinburgh
Study officials:
affiliation: Bausch Health Americas, Inc.
name: Ralph T. Doyle
role: STUDY_DIRECTOR
References: