Hepatitis C, ChronicPhase 4NCT00394277
A Study of Induction Dosing With PEGASYS (Peginterferon Alfa-2a [40KD]) Plus Copegus in Treatment-Naive Patients With Chronic Hepatitis C
A Phase 4 study testing peginterferon alfa-2a and Ribavirin in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 184 sites in 15 countries.
Trial summary
This 4-arm study will compare the efficacy and safety of PEGASYS induction and maintenance dosing, versus standard fixed dosing in combination with Copegus, and the efficacy and safety of higher dose versus standard dose Copegus in combination with PEGASYS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- peginterferon alfa-2a and Ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,175 participants
- Where
- 184 sitesin 15 countries
- Study dates
- Feb 2007to Apr 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult patients, ≥18 years of age
- CHC infection, genotype 1
- Hepatitis C virus (HCV) RNA ≥400,000 IU/mL
- Baseline body weight ≥85 kg
- Liver biopsy (within 24 months of first dose) with results consistent with CHC
Who cannot join
- Previous treatment with interferon, ribavirin, viramidine, levovirin, HCV polymerase or protease inhibitors
- Other forms of liver disease, including liver cancer
- Human immunodeficiency virus infection
Trial locations and contacts
184 sites in 15 countries.
184 sites in 15 countries
United States91 sites
Study site
Anchorage, Alaska, 99508
Study site
Annandale, Virginia, 22003
Study site
Asheville, North Carolina, 28801
Study site
Atlanta, Georgia, 30308
Study site
Aurora, Colorado, 80045
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Austell, Georgia, 30106
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Baton Rouge, Louisiana, 70805
Study site
Birmingham, Alabama, 35294
Study site
Boston, Massachusetts, 02720
Study site
Casper, Wyoming, 82609
Study site
Chapel Hill, North Carolina, 27599-7080
Study site
Charlottesville, Virginia, 22906-0013
Study site
Chesapeake, Virginia, 23320-1706
Study site
Cheyenne, Wyoming, 82001
Study site
Chicago, Illinois, 60612
Study site
Chicago, Illinois, 60637
Study site
Cincinnati, Ohio, 45267
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Cleveland, Ohio, 44106
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Cleveland, Ohio, 44109
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Columbia, South Carolina, 29204
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Cranston, Rhode Island, 02920
Study site
Dallas, Texas, 75203
Study site
Dallas, Texas, 75246
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Dallas, Texas, 75390-9034
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Des Moines, Iowa, 50312
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Detroit, Michigan, 48210
Study site
Egg Harbour Township, New Jersey, 08234
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Englewood, Colorado, 80113
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Fairfax, Virginia, 22031
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Fayetteville, North Carolina, 28304
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Fort Sam Houston, Texas, 78234-3879
Study site
Fresno, California, 93721
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Germantown, Tennessee, 38138
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Honolulu, Hawaii, 96817
Study site
Houston, Texas, 77030
Study site
Huntsville, Alabama, 35801
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Indianapolis, Indiana, 46202
Study site
Iowa City, Iowa, 52242-1081
Study site
Iowa City, Iowa, 52246
Study site
Jacksonville, Florida, 32209
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Jacksonville, Florida, 32256
Study site
Kansas City, Missouri, 64131
Study site
La Jolla, California, 92037-1030
Study site
Lancaster, California, 93534
Study site
Lancaster, Pennsylvania, 17604-3200
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Lebanon, New Hampshire, 03756
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Los Angeles, California, 90045
Study site
Los Angeles, California, 90095
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Louisville, Kentucky, 40202
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Manhasset, New York, 11030
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Marietta, Georgia, 30060
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Medford, Oregon, 97504
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Miami, Florida, 33136-1051
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New Orleans, Louisiana, 70112
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New York, New York, 10021
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New York, New York, 10029
Study site
North Miami Beach, Florida, 33162
Study site
Philadelphia, Pennsylvania, 19104
Study site
Philadelphia, Pennsylvania, 19107
Study site
Phoenix, Arizona, 85006
Study site
Pittsburgh, Pennsylvania, 15213
Study site
Plymouth, Minnesota, 55446
Study site
Providence, Rhode Island, 02903
Study site
Richmond, Virginia, 23249
Study site
Rochester, New York, 14618
Study site
Sacramento, California, 95817
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Salt Lake City, Utah, 84121
Study site
San Diego, California, 92103-8465
Study site
San Diego, California, 92105
Study site
San Diego, California, 92123
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San Diego, California, 92154
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San Luis Obispo, California, 93401
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San Marcos, California, 92069
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Sarasota, Florida, 34243
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Seattle, Washington, 98104
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St Louis, Missouri, 63104
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St Louis, Missouri, 63110
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Tacoma, Washington, 98405
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The Bronx, New York, 10467
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Tulsa, Oklahoma, 74104
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Vancouver, Washington, 98664
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Ventura, California, 93003
Study site
Vineland, New Jersey, 08360
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Washington D.C., District of Columbia, 20010
Study site
Washington D.C., District of Columbia, 20037
Study site
West Nashville, Tennessee, 37205
Study site
Williamsville, New York, 14221
Study site
Winfield, Illinois, 60190
Study site
Worcester, Massachusetts, 01068
Study site
Yonkers, New York, 10701
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Ypsilanti, Michigan, 48197
Russia13 sites
Study site
Jaloslave
Study site
Moscow, 105229
Study site
Moscow, 11/5
Study site
Moscow, 115446
Study site
Moscow, 117333
Study site
Moscow, 119881
Study site
Moscow, 127009
Study site
Moscow, 143420
Study site
Nizhny Novgorod, 603022
Study site
Saint Petersburg, 194044
Study site
Samara, 443011
Study site
Smolensk, 214006
Study site
Stavropol, 355017
Germany12 sites
Study site
Berlin, 13353
Study site
Bonn, 531105
Study site
Cologne, 50924
Study site
Düsseldorf, 40225
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Frankfurt am Main, 60590
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Freiburg im Breisgau, 79106
Study site
Giessen, 35392
Study site
Hamburg, 20246
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Hanover, 30625
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Heidelberg, 69120
Study site
Kiel, 24105
Study site
Tübingen, 72076
Canada10 sites
Study site
Edmonton, Alberta, T6G 2B7
Study site
Halifax, Nova Scotia, B3H 1V7
Study site
London, Ontario, N6A 5A5
Study site
Montreal, Quebec, H1T 2M4
Study site
Ottawa, Ontario, K1H 8L6
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Toronto, Ontario, M5G 1L7
Study site
Toronto, Ontario, M5G 1X5
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Toronto, Ontario, M6H 3M1
Study site
Vancouver, British Columbia, V6Z 2K5
Study site
Winnipeg, Manitoba, R3E 3P4
Brazil8 sites
Study site
Caixa, 18618-970
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Campinas, 13083-888
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Juiz de Fora, 36036-330
Study site
Porto Alegre, 90035-003
Study site
Porto Alegre, 91350-200
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Salvador, 40110-170
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São José do Rio Preto, 15090-000
Study site
São Paulo, 01307
Hungary8 sites
Study site
Békéscsaba, 5600
Study site
Budapest, 1083
Study site
Budapest, 1097
Study site
Debrecen, 4032
Study site
Győr, 9024
Study site
Gyula, 5700
Study site
Pécs, 7654
Study site
Szombathely, 9700
Romania8 sites
Study site
Bucharest, 010825
Study site
Bucharest, 021105
Study site
Bucharest, 022328
Study site
Bucharest, 030303
Study site
Cluj-Napoca
Study site
Constanța
Study site
Iași, 700111
Study site
Timișoara
Belgium6 sites
Study site
Brussels, 1000
Study site
Brussels, 1030
Study site
Brussels, 1070
Study site
Brussels, 1200
Study site
Ghent, 9000
Study site
Leuven, 3000
France6 sites
Study site
Clermont-Ferrand, 63000
Study site
Clichy, 92118
Study site
Lille, 59037
Study site
Lyon, 69288
Study site
Rouen, 76031
Study site
Strasbourg, 67091
Poland6 sites
Study site
Bydgoszcz, 85-030
Study site
Chorzów, 41-500
Study site
Kielce, 25-317
Study site
Lodz, 91-347
Study site
Warsaw, 01-201
Study site
Wroclaw, 51-124
United Kingdom6 sites
Study site
London, SE5 9RS
Study site
London, SW10 9TH
Study site
London, SW17 0QT
Study site
Newcastle upon Tyne, NE7 7DN
Study site
Plymouth, PL6 8DH
Study site
Southampton, SO16 6YD
Netherlands3 sites
Study site
Amsterdam, 1091 AC
Study site
Leiden, 2333 ZA
Study site
Rotterdam, 3015 GD
Puerto Rico3 sites
Study site
Ponce, 00716
Study site
San Juan, 00936-5067
Study site
Santurce, 00909
About this study
Official title: Randomized, Multicenter, Double-blinded, Phase IV Study Evaluating the Efficacy (as Measured by Sustained Virological Response) and Safety of 360 μg Induction Dosing of Pegasys® in Combination With Higher Copegus® Doses in Treatment-naïve Patients With Chronic Hepatitis C Genotype 1 Virus Infection of High Viral Titer and Baseline Body Weight Greater Than or Equal to 85 kg
This 4-arm study will compare the efficacy and safety of PEGASYS induction and maintenance dosing, versus standard fixed dosing in combination with Copegus, and the efficacy and safety of higher dose versus standard dose Copegus in combination with PEGASYS. Patients with chronic hepatitis C (CHC) genotype 1 infection of high viral titer, and baseline body weight ≥85 kg, will be randomized to one of 4 groups, to receive one of the following: a) PEGASYS 180 µg subcutaneously (sc) weekly plus Copegus 1200 mg orally (po) daily; b) PEGASYS 180 µg sc weekly plus Copegus 1400-1600 mg po daily; c)PEGASYS 360 µg sc weekly (induction) followed by 180 µg sc weekly (maintenance) plus Copegus 1200 mg po daily; or d) PEGASYS 360 µg sc weekly (induction) followed by 180 µg sc weekly (maintenance) plus Copegus 1400-1600 mg po daily. Following 48 weeks treatment, there will be a 24-week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
- Conditions
- Hepatitis C, Chronic
- Being tested
- peginterferon alfa-2a, Ribavirin
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peginterferon alfa-2aDrug
Also called Pegasys
180 µg sc weekly for 48 weeks
RibavirinDrug
Also called Copegus
1200 mg po daily for 48 weeks
peginterferon alfa-2aDrug
Also called Pegasys
360 µg sc weekly decreasing to 180 µg sc weekly for 48 weeks
RibavirinDrug
Also called Copegus
1400-1600 mg po daily for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| PEG-IFN 180 µg + Ribavirin 1200 mg | Experimental | Not described Receives: Drug: peginterferon alfa-2a; Drug: Ribavirin |
| PEG-IFN 180 µg + Ribavirin 1400/1600 mg | Experimental | Not described Receives: Drug: peginterferon alfa-2a; Drug: Ribavirin |
| PEG-IFN 360/180 µg + Ribavirin 1200 mg | Experimental | Not described Receives: Drug: Ribavirin; Drug: peginterferon alfa-2a |
| PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg | Experimental | Not described Receives: Drug: peginterferon alfa-2a; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Virological Response (SVR)-24 (Scheduled Treatment Period)
SVR-24 according to the scheduled treatment period was defined as the percentage of patients with undetectable HCV RNA at 24 weeks after completion of the treatment period (a single last HCV RNA PCR <15 IU/mL measured at or after week 68 (ie, on or after study day 477).
Measured: Week 72
Secondary outcomes (3)
SVR-24 (Actual Treatment Period)
SVR-24 according to the actual treatment period was defined as the percentage of patients with undetectable HCV RNA at least 20 weeks after the last dose of study drug.
Measured: 24 weeks after end of treatment
SVR-12 (Scheduled Treatment Period)
SVR-12 according to the scheduled treatment period was defined as the percentage of patients with undetectable HCV RNA at 12 weeks after the scheduled treatment period (a single last HCV RNA PCR <15 IU/mL measured at or after week 60).
Measured: 12 weeks after end of treatment
SVR-12 (Actual Treatment Period)
SVR-12 according to the actual treatment period was defined as the percentage of patients with undetectable HCV RNA at least 12 weeks after the last dose of study drug.
Measured: 12 weeks after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2006 (estimated)
- Study startFeb 2007
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00394277
- Sponsor's protocol ID
- NV18210
- Status last verified
- Jul 2010
- First submitted
- 30 Oct 2006
- Last updated
- 3 Aug 2010
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Reddy KR, Shiffman ML, Rodriguez-Torres M, Cheinquer H, Abdurakhmanov D, Bakulin I, Morozov V, Silva GF, Geyvandova N, Stanciu C, Rabbia M, McKenna M, Thommes JA, Harrison SA; PROGRESS Study Investigators. Induction pegylated interferon alfa-2a and high dose ribavirin do not increase SVR in heavy patients with HCV genotype 1 and high viral loads. Gastroenterology. 2010 Dec;139(6):1972-83. doi: 10.1053/j.gastro.2010.08.051. Epub 2010 Sep 30.
PubMed 20816836
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Multicenter, Double-blinded, Phase IV Study Evaluating the Efficacy (as Measured by Sustained Virological Response) and Safety of 360 μg Induction Dosing of Pegasys® in Combination With Higher Copegus® Doses in Treatment-naïve Patients With Chronic Hepatitis C Genotype 1 Virus Infection of High Viral Titer and Baseline Body Weight Greater Than or Equal to 85 kg
- ClinicalTrials.gov ID
- NCT00394277
- Acronym / sponsor ID
- NV18210
- Conditions
- Hepatitis C, Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,175 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 31 Oct 2006 (estimated)
- Results
- Posted 5 Jul 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 4-arm study will compare the efficacy and safety of PEGASYS induction and maintenance dosing, versus standard fixed dosing in combination with Copegus, and the efficacy and safety of higher dose versus standard dose Copegus in combination with PEGASYS. Patients with chronic hepatitis C (CHC) genotype 1 infection of high viral titer, and baseline body weight ≥85 kg, will be randomized to one of 4 groups, to receive one of the following: a) PEGASYS 180 µg subcutaneously (sc) weekly plus Copegus 1200 mg orally (po) daily; b) PEGASYS 180 µg sc weekly plus Copegus 1400-1600 mg po daily; c)PEGASYS 360 µg sc weekly (induction) followed by 180 µg sc weekly (maintenance) plus Copegus 1200 mg po daily; or d) PEGASYS 360 µg sc weekly (induction) followed by 180 µg sc weekly (maintenance) plus Copegus 1400-1600 mg po daily. Following 48 weeks treatment, there will be a 24-week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PEG-IFN 180 µg + Ribavirin 1200 mg | Experimental | Drug: peginterferon alfa-2a, Drug: Ribavirin |
| PEG-IFN 180 µg + Ribavirin 1400/1600 mg | Experimental | Drug: peginterferon alfa-2a, Drug: Ribavirin |
| PEG-IFN 360/180 µg + Ribavirin 1200 mg | Experimental | Drug: Ribavirin, Drug: peginterferon alfa-2a |
| PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg | Experimental | Drug: peginterferon alfa-2a, Drug: Ribavirin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients, ≥18 years of age
- CHC infection, genotype 1
- Hepatitis C virus (HCV) RNA ≥400,000 IU/mL
- Baseline body weight ≥85 kg
- Liver biopsy (within 24 months of first dose) with results consistent with CHC
Key exclusion criteria (3 listed)
- Previous treatment with interferon, ribavirin, viramidine, levovirin, HCV polymerase or protease inhibitors
- Other forms of liver disease, including liver cancer
- Human immunodeficiency virus infection
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 |
|---|---|---|
| peginterferon alfa-2aAlso: Pegasys180 µg sc weekly for 48 weeks | Drug | PEG-IFN 180 µg + Ribavirin 1200 mg, PEG-IFN 180 µg + Ribavirin 1400/1600 mg |
| RibavirinAlso: Copegus1200 mg po daily for 48 weeks | Drug | PEG-IFN 180 µg + Ribavirin 1200 mg, PEG-IFN 360/180 µg + Ribavirin 1200 mg |
| peginterferon alfa-2aAlso: Pegasys360 µg sc weekly decreasing to 180 µg sc weekly for 48 weeks | Drug | PEG-IFN 360/180 µg + Ribavirin 1200 mg, PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg |
| RibavirinAlso: Copegus1400-1600 mg po daily for 48 weeks | Drug | PEG-IFN 180 µg + Ribavirin 1400/1600 mg, PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg |
Primary outcome
Sustained Virological Response (SVR)-24 (Scheduled Treatment Period)
Time frame: Week 72
SVR-24 according to the scheduled treatment period was defined as the percentage of patients with undetectable HCV RNA at 24 weeks after completion of the treatment period (a single last HCV RNA PCR <15 IU/mL measured at or after week 68 (ie, on or after study day 477).
3 secondary outcomes
SVR-24 (Actual Treatment Period)
Time frame: 24 weeks after end of treatment
SVR-12 (Scheduled Treatment Period)
Time frame: 12 weeks after end of treatment
SVR-12 (Actual Treatment Period)
Time frame: 12 weeks after end of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20816836Reddy KR, Shiffman ML, Rodriguez-Torres M, Cheinquer H, Abdurakhmanov D, Bakulin I, Morozov V, Silva GF, Geyvandova N, Stanciu C, Rabbia M, McKenna M, Thommes JA, Harrison SA; PROGRESS Study Investigators. Induction pegylated interferon alfa-2a and high dose ribavirin do not increase SVR in heavy patients with HCV genotype 1 and high viral loads. Gastroenterology. 2010 Dec;139(6):1972-83. doi: 10.1053/j.gastro.2010.08.051. Epub 2010 Sep 30.
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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.
Clinical Trials study director
Hoffmann-La Roche
184 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing peginterferon alfa-2a and Ribavirin in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 184 sites in 15 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 5 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 3 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 184 sites in United States, Russia, Germany, Canada, Brazil and 10 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sustained Virological Response (SVR)-24 (Scheduled Treatment Period) (time frame: Week 72). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00394277, which also lists 1 linked publication.
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 3 Aug 2010.