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Study of Viramidine to Ribavirin in Patients With Chronic Hepatitis C Who Are Treatment Naive (VISER2)

Primary Purpose

Chronic Hepatitis C

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Viramidine
Ribavirin
pegylated interferon alfa-2a
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Viramidine, Ribavirin, Valeant, Hepatitis C, Pegylated interferon alfa-2a

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Arizona
  • UCSF Fresno- Internal Medicine
  • Keck School of Medicine, University of Southern California
  • Cedars-Sinai Medical Center
  • Orange Coast Medical Group
  • University of California Davis Medical Center
  • Research and Education, Inc.
  • California Pacific Medical Center
  • University of California San Francisco
  • San Mateo Medical Center
  • University of Colorado Health Sciences Center
  • Rocky Mountain Gastroenterology
  • University of Connecticut
  • Washington Hospital Center
  • Walter Reed Army Medical Center
  • Bach and Godofsky
  • Mayo Clinic Jacksonville
  • Atlanta Academic Research Group
  • Atlanta Gastroenterology Associates
  • Northwestern Memorial Hospital
  • University of Chicago
  • Indiana University School of Medicine
  • University of Louisville
  • Louisiana State University Memorial Hospital
  • Ochsner Clinic Foundation
  • Johns Hopkins
  • Johns Hopkins University Medical Center
  • Maryland Digestive Disease Research
  • Future Care Studies/Northgate Medical
  • University of Massachusetts Memorial Medical Center
  • Mayo Clinic
  • Bradley Freilich, MD
  • Saint Louis University School of Medicine
  • Atlantic Gastroenterology Associates
  • Jacobi Medical Center
  • Bronx VA Medical Center
  • Regional Clinical Research, Inc.
  • North Shore University Hospital
  • Cabrini Medical Center
  • SUNY Upstate Medical University
  • University of North Carolina
  • Digestive Health Specialists
  • Consultants for Clinical Research
  • MetroHealth Medical Center
  • Research Solutions (SMO)
  • Thomas Jefferson University
  • Radiant Research - Austin
  • University of Texas
  • VA Medical Center
  • INOVA Fairfax Hospital
  • Kaiser Permanente Medical Center
  • Hunter Holmes McGuire Medical Center
  • Northwest Medical Specialties
  • Hospital Italiano
  • Fundación CIDEA
  • Hospital Británico
  • Hospital Austral
  • Hospital Centenario
  • Westmead Hospital
  • Royal Adelaide Hospital
  • Royal Melbourne Hospital
  • The Alfred Hospital
  • Sir Charles Gairdner Hospital
  • University of Calgary
  • University of Alberta
  • University of Manitoba
  • Toronto Western Hospital
  • CHU Grenoble Hôpital Michallon, Service d'Hépatogastroentérologie
  • Hopital Saint Joseph Service d'Hépato-gastroentérologie
  • Hôpital de l'Archet 2 Service d'Hépato-Gastroentérologie
  • Hôpital Saint Antoine, Service d'Hépato-Gastroentérologie
  • C.H.U de Nancy - Hôpital de Brabois Adultes Service d'Hépato-gastroentérologie
  • Rambam Medical Center Liver Unit
  • Head of Liver Unit, Holy family Hospital
  • Tel Aviv Souraski Medical Center, Liver Unit, Department of Gastro-enterology
  • Malattie Infettive, Azienda Ospedaliera di Busto Arsizio
  • Az. Osp. Universitaria Policlinico "Paolo Giaccone"
  • IRCCS Policlinico San Matteo
  • Istituto Nazionale per le Malattie Infettive "Lazzaro Spallanzani" IRCCS
  • Divisione di Gastroenterologia, Azienda Ospedaliera S.Giovanni Battista
  • Wojewodzki Szpital Obserwacyjno-Zakazny im. T. Browicza
  • Szpital Specjalistyczny
  • Katedra Chorob Zakaznych i Hepatologii Collegium Medicum Uniwersytetu Jagiellonskiego
  • Katedra i Klinika Chorob Zakaznych Pomorskiej Akademii Medycznej
  • Klinika Chorob Wewnetrznych i Reumatologii CSK MON WIM
  • Wojewodzki Szpital Zakazny
  • Fundacion de Investigacion de Diego
  • Russian State Medical University
  • Smolensk Medical Academy
  • City Hospital of Infectious Diseases #10
  • Department of gastroenterology, Russian Military Academy; Regional Military Clinical Hospital №442
  • City Hospital of Infectious Diseases #30
  • Department of infectious diseases, Russian Military Academy
  • Hospital Universitario Germans Trias i Pujol
  • Hospital Santa Creu I Sant Pau
  • Hospital Universitario La Princesa
  • Hospital Carlos III
  • Hospital General Universitario de Valencia
  • Liver and Hepatobiliary Unit, Queen Elizabeth Hospital
  • Liver Unit, Royal Infirmary of Edinburgh

Outcomes

Primary Outcome Measures

- 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 Outcome Measures

- 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

Full Information

First Posted
September 30, 2004
Last Updated
June 21, 2012
Sponsor
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00093093
Brief Title
Study of Viramidine to Ribavirin in Patients With Chronic Hepatitis C Who Are Treatment Naive
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.

4. Oversight

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
Viramidine, Ribavirin, Valeant, Hepatitis C, Pegylated interferon alfa-2a

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
900 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Viramidine
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Type
Drug
Intervention Name(s)
pegylated interferon alfa-2a
Primary Outcome Measure Information:
Title
- Efficacy: Undetectable plasma HCV RNA (less than 100 copies/mL) at the end of the 24-week post-treatment follow-up period.
Title
- 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 Outcome Measure Information:
Title
- Efficacy: Undetectable plasma HCV RNA at treatment week 24
Title
- Efficacy: Undetectable or at least a 2-log drop from baseline at treatment weeks 12 and 24
Title
- Safety: Monitoring of adverse events
Title
- Safety: Monitoring of abnormal changes in laboratory parameters that are not disease-related

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralph T. Doyle
Organizational Affiliation
Bausch Health Americas, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-5136
Country
United States
Facility Name
UCSF Fresno- Internal Medicine
City
Fresno
State/Province
California
ZIP/Postal Code
93702
Country
United States
Facility Name
Keck School of Medicine, University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Orange Coast Medical Group
City
Newport Beach
State/Province
California
ZIP/Postal Code
92633
Country
United States
Facility Name
University of California Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Research and Education, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92115
Country
United States
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
San Mateo Medical Center
City
San Mateo
State/Province
California
ZIP/Postal Code
94403
Country
United States
Facility Name
University of Colorado Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Rocky Mountain Gastroenterology
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80215
Country
United States
Facility Name
University of Connecticut
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307
Country
United States
Facility Name
Bach and Godofsky
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Mayo Clinic Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Atlanta Academic Research Group
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Atlanta Gastroenterology Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Louisiana State University Memorial Hospital
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Johns Hopkins University Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Maryland Digestive Disease Research
City
Laurel
State/Province
Maryland
ZIP/Postal Code
20707
Country
United States
Facility Name
Future Care Studies/Northgate Medical
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
University of Massachusetts Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Bradley Freilich, MD
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Saint Louis University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Atlantic Gastroenterology Associates
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States
Facility Name
Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Bronx VA Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Facility Name
Regional Clinical Research, Inc.
City
Johnson City
State/Province
New York
ZIP/Postal Code
13790
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Cabrini Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Digestive Health Specialists
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Consultants for Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Research Solutions (SMO)
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Radiant Research - Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
University of Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
VA Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
INOVA Fairfax Hospital
City
Annadale
State/Province
Virginia
ZIP/Postal Code
22003
Country
United States
Facility Name
Kaiser Permanente Medical Center
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22046
Country
United States
Facility Name
Hunter Holmes McGuire Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Northwest Medical Specialties
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Hospital Italiano
City
Buenos Aires
State/Province
BA
ZIP/Postal Code
(C1199ACK)
Country
Argentina
Facility Name
Fundación CIDEA
City
Buenos Aires
State/Province
BA
ZIP/Postal Code
(C1264AAA)
Country
Argentina
Facility Name
Hospital Británico
City
Buenos Aires
State/Province
BA
ZIP/Postal Code
(C1280AEB)
Country
Argentina
Facility Name
Hospital Austral
City
Pilar
State/Province
BA
ZIP/Postal Code
(B1629AHJ)
Country
Argentina
Facility Name
Hospital Centenario
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
(S2000CFJ)
Country
Argentina
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
The Alfred Hospital
City
Prahran
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2C8
Country
Canada
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 3P4
Country
Canada
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
CHU Grenoble Hôpital Michallon, Service d'Hépatogastroentérologie
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Hopital Saint Joseph Service d'Hépato-gastroentérologie
City
Marseille
ZIP/Postal Code
13285
Country
France
Facility Name
Hôpital de l'Archet 2 Service d'Hépato-Gastroentérologie
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Hôpital Saint Antoine, Service d'Hépato-Gastroentérologie
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
C.H.U de Nancy - Hôpital de Brabois Adultes Service d'Hépato-gastroentérologie
City
Vandouevre les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Rambam Medical Center Liver Unit
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Head of Liver Unit, Holy family Hospital
City
Nazareth
ZIP/Postal Code
16100
Country
Israel
Facility Name
Tel Aviv Souraski Medical Center, Liver Unit, Department of Gastro-enterology
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Malattie Infettive, Azienda Ospedaliera di Busto Arsizio
City
Busto Arsizio
ZIP/Postal Code
21052
Country
Italy
Facility Name
Az. Osp. Universitaria Policlinico "Paolo Giaccone"
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Istituto Nazionale per le Malattie Infettive "Lazzaro Spallanzani" IRCCS
City
Rome
ZIP/Postal Code
00149
Country
Italy
Facility Name
Divisione di Gastroenterologia, Azienda Ospedaliera S.Giovanni Battista
City
Torino
ZIP/Postal Code
20126
Country
Italy
Facility Name
Wojewodzki Szpital Obserwacyjno-Zakazny im. T. Browicza
City
Bydgoszcz
ZIP/Postal Code
85-030
Country
Poland
Facility Name
Szpital Specjalistyczny
City
Chorzow
ZIP/Postal Code
41-500
Country
Poland
Facility Name
Katedra Chorob Zakaznych i Hepatologii Collegium Medicum Uniwersytetu Jagiellonskiego
City
Krakow
ZIP/Postal Code
31-531
Country
Poland
Facility Name
Katedra i Klinika Chorob Zakaznych Pomorskiej Akademii Medycznej
City
Szczecin
ZIP/Postal Code
71-455
Country
Poland
Facility Name
Klinika Chorob Wewnetrznych i Reumatologii CSK MON WIM
City
Warszawa
ZIP/Postal Code
00-909
Country
Poland
Facility Name
Wojewodzki Szpital Zakazny
City
Warszawa
ZIP/Postal Code
01-201
Country
Poland
Facility Name
Fundacion de Investigacion de Diego
City
Santurce
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
Russian State Medical University
City
Moscow
ZIP/Postal Code
115516
Country
Russian Federation
Facility Name
Smolensk Medical Academy
City
Smolensk
ZIP/Postal Code
214018
Country
Russian Federation
Facility Name
City Hospital of Infectious Diseases #10
City
St.Petersburg
ZIP/Postal Code
190020
Country
Russian Federation
Facility Name
Department of gastroenterology, Russian Military Academy; Regional Military Clinical Hospital №442
City
St.Petersburg
ZIP/Postal Code
193163
Country
Russian Federation
Facility Name
City Hospital of Infectious Diseases #30
City
St.Petersburg
ZIP/Postal Code
193167
Country
Russian Federation
Facility Name
Department of infectious diseases, Russian Military Academy
City
St.Petersburg
ZIP/Postal Code
194175
Country
Russian Federation
Facility Name
Hospital Universitario Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Universitario La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Carlos III
City
Madrid
ZIP/Postal Code
28029
Country
Spain
Facility Name
Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Liver and Hepatobiliary Unit, Queen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Liver Unit, Royal Infirmary of Edinburgh
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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