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

Chronic Hepatitis C Clinical Trial

— VISER2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00093093
• Other study ID #: RNA003142-302
• Status: Completed
• Phase: Phase 3
• First received: September 30, 2004
• Last updated: June 21, 2012
• Start date: June 2004
• Est. completion date: May 2006

Study information

• Verified date: June 2012
• Source: Valeant Pharmaceuticals International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Viramidine

• Ribavirin

• pegylated interferon alfa-2a

Locations

Country	Name	City	State
Argentina	Fundación CIDEA	Buenos Aires	BA
Argentina	Hospital Británico	Buenos Aires	BA
Argentina	Hospital Italiano	Buenos Aires	BA
Argentina	Hospital Austral	Pilar	BA
Argentina	Hospital Centenario	Rosario	Santa Fe
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Sir Charles Gairdner Hospital	Nedlands	Western Australia
Australia	Royal Melbourne Hospital	Parkville	Victoria
Australia	The Alfred Hospital	Prahran	Victoria
Australia	Westmead Hospital	Westmead	New South Wales
Canada	University of Calgary	Calgary	Alberta
Canada	University of Alberta	Edmonton	Alberta
Canada	Toronto Western Hospital	Toronto	Ontario
Canada	University of Manitoba	Winnipeg	Manitoba
France	CHU Grenoble Hôpital Michallon, Service d'Hépatogastroentérologie	Grenoble
France	Hopital Saint Joseph Service d'Hépato-gastroentérologie	Marseille
France	Hôpital de l'Archet 2 Service d'Hépato-Gastroentérologie	Nice
France	Hôpital Saint Antoine, Service d'Hépato-Gastroentérologie	Paris
France	C.H.U de Nancy - Hôpital de Brabois Adultes Service d'Hépato-gastroentérologie	Vandouevre les Nancy
Israel	Rambam Medical Center Liver Unit	Haifa
Israel	Head of Liver Unit, Holy family Hospital	Nazareth
Israel	Tel Aviv Souraski Medical Center, Liver Unit, Department of Gastro-enterology	Tel Aviv
Italy	Malattie Infettive, Azienda Ospedaliera di Busto Arsizio	Busto Arsizio
Italy	Az. Osp. Universitaria Policlinico "Paolo Giaccone"	Palermo
Italy	IRCCS Policlinico San Matteo	Pavia
Italy	Istituto Nazionale per le Malattie Infettive "Lazzaro Spallanzani" IRCCS	Rome
Italy	Divisione di Gastroenterologia, Azienda Ospedaliera S.Giovanni Battista	Torino
Poland	Wojewodzki Szpital Obserwacyjno-Zakazny im. T. Browicza	Bydgoszcz
Poland	Szpital Specjalistyczny	Chorzow
Poland	Katedra Chorob Zakaznych i Hepatologii Collegium Medicum Uniwersytetu Jagiellonskiego	Krakow
Poland	Katedra i Klinika Chorob Zakaznych Pomorskiej Akademii Medycznej	Szczecin
Poland	Klinika Chorob Wewnetrznych i Reumatologii CSK MON WIM	Warszawa
Poland	Wojewodzki Szpital Zakazny	Warszawa
Puerto Rico	Fundacion de Investigacion de Diego	Santurce
Russian Federation	Russian State Medical University	Moscow
Russian Federation	Smolensk Medical Academy	Smolensk
Russian Federation	City Hospital of Infectious Diseases #10	St.Petersburg
Russian Federation	City Hospital of Infectious Diseases #30	St.Petersburg
Russian Federation	Department of gastroenterology, Russian Military Academy; Regional Military Clinical Hospital ?442	St.Petersburg
Russian Federation	Department of infectious diseases, Russian Military Academy	St.Petersburg
Spain	Hospital Universitario Germans Trias i Pujol	Badalona
Spain	Hospital Santa Creu I Sant Pau	Barcelona
Spain	Hospital Carlos III	Madrid
Spain	Hospital Universitario La Princesa	Madrid
Spain	Hospital General Universitario de Valencia	Valencia
United Kingdom	Liver and Hepatobiliary Unit, Queen Elizabeth Hospital	Birmingham
United Kingdom	Liver Unit, Royal Infirmary of Edinburgh	Edinburgh
United States	INOVA Fairfax Hospital	Annadale	Virginia
United States	Atlanta Academic Research Group	Atlanta	Georgia
United States	Atlanta Gastroenterology Associates	Atlanta	Georgia
United States	Radiant Research - Austin	Austin	Texas
United States	Johns Hopkins	Baltimore	Maryland
United States	Johns Hopkins University Medical Center	Baltimore	Maryland
United States	Bach and Godofsky	Bradenton	Florida
United States	Bronx VA Medical Center	Bronx	New York
United States	Jacobi Medical Center	Bronx	New York
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	Consultants for Clinical Research	Cincinnati	Ohio
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	University of Texas	Dallas	Texas
United States	University of Colorado Health Sciences Center	Denver	Colorado
United States	Atlantic Gastroenterology Associates	Egg Harbor Township	New Jersey
United States	Kaiser Permanente Medical Center	Falls Church	Virginia
United States	University of Connecticut	Farmington	Connecticut
United States	UCSF Fresno- Internal Medicine	Fresno	California
United States	VA Medical Center	Houston	Texas
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	Regional Clinical Research, Inc.	Johnson City	New York
United States	Bradley Freilich, MD	Kansas City	Missouri
United States	Rocky Mountain Gastroenterology	Lakewood	Colorado
United States	Maryland Digestive Disease Research	Laurel	Maryland
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Keck School of Medicine, University of Southern California	Los Angeles	California
United States	University of Louisville	Louisville	Kentucky
United States	North Shore University Hospital	Manhasset	New York
United States	Louisiana State University Memorial Hospital	New Orleans	Louisiana
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Cabrini Medical Center	New York	New York
United States	Orange Coast Medical Group	Newport Beach	California
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Hunter Holmes McGuire Medical Center	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	University of California Davis Medical Center	Sacramento	California
United States	Research and Education, Inc.	San Diego	California
United States	California Pacific Medical Center	San Francisco	California
United States	University of California San Francisco	San Francisco	California
United States	San Mateo Medical Center	San Mateo	California
United States	Future Care Studies/Northgate Medical	Springfield	Massachusetts
United States	Saint Louis University School of Medicine	St. Louis	Missouri
United States	SUNY Upstate Medical University	Syracuse	New York
United States	Northwest Medical Specialties	Tacoma	Washington
United States	University of Arizona	Tucson	Arizona
United States	Research Solutions (SMO)	Tulsa	Oklahoma
United States	Walter Reed Army Medical Center	Washington	District of Columbia
United States	Washington Hospital Center	Washington	District of Columbia
United States	Digestive Health Specialists	Winston-Salem	North Carolina
United States	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Valeant Pharmaceuticals International, Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  France,  Israel,  Italy,  Poland,  Puerto Rico,  Russian Federation,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- Efficacy: Undetectable plasma HCV RNA (less than 100 copies/mL) at the end of the 24-week post-treatment follow-up period.
Primary	- 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	- Efficacy: Undetectable plasma HCV RNA at treatment week 24
Secondary	- Efficacy: Undetectable or at least a 2-log drop from baseline at treatment weeks 12 and 24
Secondary	- Safety: Monitoring of adverse events
Secondary	- Safety: Monitoring of abnormal changes in laboratory parameters that are not disease-related