Chronic Hepatitis CPhase 3VISER2NCT00093093
Study of Viramidine to Ribavirin in Patients With Chronic Hepatitis C Who Are Treatment Naive
A Phase 3 study testing Viramidine, Ribavirin and pegylated interferon alfa-2a in people with Chronic Hepatitis C, run by Bausch Health Americas, Inc. at 100 sites in 12 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- Viramidine, Ribavirin and pegylated interferon alfa-2a
- How many people
- 900 participants
- Where
- 100 sitesin 12 countries
- Study dates
- Jun 2004to May 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
100 sites in 12 countries.
100 sites in 12 countries
United States53 sites
INOVA Fairfax Hospital
Annadale, Virginia, 22003
Atlanta Academic Research Group
Atlanta, Georgia, 30033
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30308
Radiant Research - Austin
Austin, Texas, 78758
Johns Hopkins
Baltimore, Maryland, 21205
Johns Hopkins University Medical Center
Baltimore, Maryland, 21287
Bach and Godofsky
Bradenton, Florida, 34205
University of North Carolina
Chapel Hill, North Carolina, 27599
Northwestern Memorial Hospital
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
Consultants for Clinical Research
Cincinnati, Ohio, 45219
MetroHealth Medical Center
Cleveland, Ohio, 44109
University of Texas
Dallas, Texas, 75390
University of Colorado Health Sciences Center
Denver, Colorado, 80262
Atlantic Gastroenterology Associates
Egg Harbor, New Jersey, 08234
Kaiser Permanente Medical Center
Falls Church, Virginia, 22046
University of Connecticut
Farmington, Connecticut, 06030
UCSF Fresno- Internal Medicine
Fresno, California, 93702
VA Medical Center
Houston, Texas, 77030
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Mayo Clinic Jacksonville
Jacksonville, Florida, 32216
Regional Clinical Research, Inc.
Johnson City, New York, 13790
Bradley Freilich, MD
Kansas City, Missouri, 64131
Rocky Mountain Gastroenterology
Lakewood, Colorado, 80215
Maryland Digestive Disease Research
Laurel, Maryland, 20707
Keck School of Medicine, University of Southern California
Los Angeles, California, 90033
Cedars-Sinai Medical Center
Los Angeles, California, 90048
University of Louisville
Louisville, Kentucky, 40202
North Shore University Hospital
Manhasset, New York, 11030
Louisiana State University Memorial Hospital
New Orleans, Louisiana, 70115
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Cabrini Medical Center
New York, New York, 10029
Orange Coast Medical Group
Newport Beach, California, 92633
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Hunter Holmes McGuire Medical Center
Richmond, Virginia, 23249
Mayo Clinic
Rochester, Minnesota, 55905
University of California Davis Medical Center
Sacramento, California, 95817
Research and Education, Inc.
San Diego, California, 92115
California Pacific Medical Center
San Francisco, California, 94115
University of California San Francisco
San Francisco, California, 94143
San Mateo Medical Center
San Mateo, California, 94403
Future Care Studies/Northgate Medical
Springfield, Massachusetts, 01107
Saint Louis University School of Medicine
St Louis, Missouri, 63104
SUNY Upstate Medical University
Syracuse, New York, 13210
Northwest Medical Specialties
Tacoma, Washington, 98405
Jacobi Medical Center
The Bronx, New York, 10461
Bronx VA Medical Center
The Bronx, New York, 10468
University of Arizona
Tucson, Arizona, 85724-5136
Research Solutions (SMO)
Tulsa, Oklahoma, 74104
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307
Digestive Health Specialists
Winston-Salem, North Carolina, 27103
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
Poland6 sites
Wojewodzki Szpital Obserwacyjno-Zakazny im. T. Browicza
Bydgoszcz, 85-030
Szpital Specjalistyczny
Chorzów, 41-500
Katedra Chorob Zakaznych i Hepatologii Collegium Medicum Uniwersytetu Jagiellonskiego
Krakow, 31-531
Katedra i Klinika Chorob Zakaznych Pomorskiej Akademii Medycznej
Szczecin, 71-455
Klinika Chorob Wewnetrznych i Reumatologii CSK MON WIM
Warsaw, 00-909
Wojewodzki Szpital Zakazny
Warsaw, 01-201
Russia6 sites
Russian State Medical University
Moscow, 115516
City Hospital of Infectious Diseases #10
Saint Petersburg, 190020
Department of gastroenterology, Russian Military Academy; Regional Military Clinical Hospital №442
Saint Petersburg, 193163
City Hospital of Infectious Diseases #30
Saint Petersburg, 193167
Department of infectious diseases, Russian Military Academy
Saint Petersburg, 194175
Smolensk Medical Academy
Smolensk, 214018
Argentina5 sites
Hospital Italiano
Buenos Aires, Buenos Aires, (C1199ACK)
Fundación CIDEA
Buenos Aires, Buenos Aires, (C1264AAA)
Hospital Británico
Buenos Aires, Buenos Aires, (C1280AEB)
Hospital Austral
Pilar, Buenos Aires, (B1629AHJ)
Hospital Centenario
Rosario, Santa Fe Province, (S2000CFJ)
Australia5 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
Royal Melbourne Hospital
Parkville, Victoria, 3050
The Alfred Hospital
Prahran, Victoria, 3181
Westmead Hospital
Westmead, New South Wales, 2145
France5 sites
CHU Grenoble Hôpital Michallon, Service d'Hépatogastroentérologie
Grenoble, 38043
Hopital Saint Joseph Service d'Hépato-gastroentérologie
Marseille, 13285
Hôpital de l'Archet 2 Service d'Hépato-Gastroentérologie
Nice, 06202
Hôpital Saint Antoine, Service d'Hépato-Gastroentérologie
Paris, 75571
C.H.U de Nancy - Hôpital de Brabois Adultes Service d'Hépato-gastroentérologie
Vandouevre Les Nancy, 54511
Italy5 sites
Malattie Infettive, Azienda Ospedaliera di Busto Arsizio
Busto Arsizio, 21052
Az. Osp. Universitaria Policlinico "Paolo Giaccone"
Palermo, 90127
IRCCS Policlinico San Matteo
Pavia, 27100
Istituto Nazionale per le Malattie Infettive "Lazzaro Spallanzani" IRCCS
Rome, 00149
Divisione di Gastroenterologia, Azienda Ospedaliera S.Giovanni Battista
Torino, 20126
Spain5 sites
Hospital Universitario Germans Trias i Pujol
Badalona, 08916
Hospital Santa Creu I Sant Pau
Barcelona, 08025
Hospital Universitario La Princesa
Madrid, 28006
Hospital Carlos III
Madrid, 28029
Hospital General Universitario de Valencia
Valencia, 46014
Canada4 sites
University of Calgary
Calgary, Alberta, T2N 4N1
University of Alberta
Edmonton, Alberta, T6G 2C8
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
University of Manitoba
Winnipeg, Manitoba, R3E 3P4
Israel3 sites
Rambam Medical Center Liver Unit
Haifa, 31096
Head of Liver Unit, Holy family Hospital
Nazareth, 16100
Tel Aviv Souraski Medical Center, Liver Unit, Department of Gastro-enterology
Tel Aviv, 64239
United Kingdom2 sites
Liver and Hepatobiliary Unit, Queen Elizabeth Hospital
Birmingham, B15 2TH
Liver Unit, Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA
About this study
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
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.
Read the 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)
- Conditions
- Chronic Hepatitis C
- Being tested
- Viramidine, Ribavirin, pegylated interferon alfa-2a
- Keywords
- Viramidine, Ribavirin, Valeant, Hepatitis C, Pegylated interferon alfa-2a
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ViramidineDrug
RibavirinDrug
pegylated interferon alfa-2aDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
- 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2004 (estimated)
- Study startJun 2004
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 900 participants
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ralph T. Doyle, Study director, Bausch Health Americas, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00093093
- Sponsor's protocol ID
- RNA003142-302
- Acronym
- VISER2
- Status last verified
- Jun 2012
- First submitted
- 30 Sep 2004
- Last updated
- 22 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00093093
- Acronym / sponsor ID
- VISER2 / RNA003142-302
- Conditions
- Chronic Hepatitis C
- Keywords
- Viramidine, Ribavirin, Valeant, Hepatitis C, Pegylated interferon alfa-2a
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 4 Oct 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Viramidine | Drug | – |
| Ribavirin | Drug | – |
| pegylated interferon alfa-2a | Drug | – |
Primary outcome
- 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.
4 secondary outcomes
- 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralph T. Doyle study director
Bausch Health Americas, Inc.
100 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Viramidine, Ribavirin and pegylated interferon alfa-2a in people with Chronic Hepatitis C, run by Bausch Health Americas, Inc. at 100 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 100 sites in United States, Poland, Russia, Argentina, Australia and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- Efficacy: Undetectable plasma HCV RNA (less than 100 copies/mL) at the end of the 24-week post-treatment follow-up period.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2012.