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Hepatitis C, ChronicPhase 2NCT00517439

A Study of Hepatitis C Virus (HCV) Polymerase Inhibitor Pro-Drug in Combination With PEGASYS Plus COPEGUS Compared With PEGASYS Plus COPEGUS in Patients With Chronic Hepatitis C Genotype 1 Infection.

A Phase 2 study testing Copegus, Pegasys and RO4588161 in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 63 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This 7 arm study will determine the optimal treatment combination, based on efficacy and safety. Patients with chronic hepatitis C (CHC), genotype 1, will be randomized to one of 7 treatment groups. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
Copegus, Pegasys and RO4588161
Could I receive a placebo?
No, everyone receives an active treatment
How many people
516 participants
Where
63 sitesin 9 countries
Study dates
Dec 2007to Jan 2010
Phase
Phase 2
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • adult patients, 18-65 years of age;
  • chronic hepatitis C, genotype 1;
  • chronic liver disease consistent with CHC;
  • compensated liver disease.

Who cannot join

  • infection with any HCV genotype other than genotype 1;
  • previous treatment for CHC;
  • medical condition associated with chronic liver disease other than CHC;
  • HIV, hepatitis A, hepatitis B infection.

Trial locations and contacts

63 sites in 9 countries.

63 sites in 9 countries

United States30 sites

  • Study site

    Aurora, Colorado, 80045

  • Study site

    Baltimore, Maryland, 21287

  • Study site

    Bradenton, Florida, 34209

  • Study site

    Chapel Hill, North Carolina, 27599-7584

  • Study site

    Chicago, Illinois, 60637

  • Study site

    Cincinnati, Ohio, 45267-0595

  • Study site

    Dallas, Texas, 75203

  • Study site

    Englewood, Colorado, 80110

  • Study site

    Fairfax, Virginia, 22031

  • Study site

    Fort Sam Houston, Texas, 78234-3879

  • Study site

    Gainesville, Florida, 32610-0214

  • Study site

    Hershey, Pennsylvania, 17033

  • Study site

    La Jolla, California, 92037-1030

  • Study site

    Long Beach, California, 90822

  • Study site

    Manhasset, New York, 11030

  • Study site

    Miami, Florida, 33136-1051

  • Study site

    Nashville, Tennessee, 37211

  • Study site

    New York, New York, 10021

  • Study site

    Phoenix, Arizona, 85054

  • Study site

    Plymouth, Minnesota, 55446

  • Study site

    Portland, Oregon, 97239

  • Study site

    Providence, Rhode Island, 02905

  • Study site

    Richmond, Virginia, 23249

  • Study site

    Sacramento, California, 95817

  • Study site

    Salt Lake City, Utah, 84121

  • Study site

    San Antonio, Texas, 78215

  • Study site

    San Diego, California, 92103-8465

  • Study site

    San Diego, California, 92154

  • Study site

    San Francisco, California, 94115

  • Study site

    The Bronx, New York, 10468

Other trials in United States

France7 sites

  • Study site

    Clichy, 92118

  • Study site

    Créteil, 94010

  • Study site

    Marseille, 13285

  • Study site

    Paris, 75014

  • Study site

    Paris, 75651

  • Study site

    Pessac, 33604

  • Study site

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Germany6 sites

  • Study site

    Berlin, 13353

  • Study site

    Cologne, 50937

  • Study site

    Frankfurt am Main, 60590

  • Study site

    Freiburg im Breisgau, 79106

  • Study site

    Hamburg, 20246

  • Study site

    Hanover, 30625

Other trials in Germany

Australia5 sites

  • Study site

    Adelaide, 5000

  • Study site

    Greenslopes, 4120

  • Study site

    Melbourne, 3004

  • Study site

    Sydney, 2050

  • Study site

    Sydney, 2145

Other trials in Australia

Canada5 sites

  • Study site

    Calgary, Alberta, T2N 4N1

  • Study site

    Ottawa, Ontario, K1H 8L6

  • Study site

    Toronto, Ontario, M5G 1L7

  • Study site

    Vancouver, British Columbia, V5Z 1H2

  • Study site

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Spain5 sites

  • Study site

    Badalona, 08915

  • Study site

    Barcelona, 08003

  • Study site

    Madrid, 28222

  • Study site

    Seville, 41014

  • Study site

    Valencia, 46014

Other trials in Spain

Italy3 sites

  • Study site

    Bologna, 40138

  • Study site

    Naples, 80131

  • Study site

    Torino, 10126

Other trials in Italy

Austria1 site

  • Study site

    Vienna, 1090

Other trials in Austria

Puerto Rico1 site

  • Study site

    Santurce, 00909

Other trials in Puerto Rico

About this study

Official title: A Randomized, Double-blinded Study to Evaluate the Safety and Effect on Sustained Virological Response of HCV Polymerase Inhibitor Pro-drug in Combination With PEGASYS Plus Copegus, Compared With the Currently Approved Combination of PEGASYS Plus Copegus, in Treatment-naïve Patients With Chronic he

This 7 arm study will determine the optimal treatment combination, based on efficacy and safety. Patients with chronic hepatitis C (CHC), genotype 1, will be randomized to one of 7 treatment groups. Groups 1, 2, 4, 5 and 6 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (at doses of 500, 1000 or 1500mg po bid) plus PEGASYS (90 or 180 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd). Group 3 will receive HCV polymerase inhibitor pro-drug 500mg po bid plus PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd for 24 weeks; after 24 weeks, those achieving a rapid virological response (RVR) will stop all medication, and non-RVR patients will remain on triple combination for an additional 24 weeks. Group 7 will receive standard of care (SOC) for 48 weeks. There will be a 24 week period of treatment-free follow-up for all treatment groups. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Being tested
Copegus, Pegasys, RO4588161
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.

  • CopegusDrug

    1000/1200mg po daily for 24 weeks

  • PegasysDrug

    180 micrograms sc weekly for 24 weeks

  • PegasysDrug

    90 micrograms sc weekly for 24 weeks

  • RO4588161Drug

    1000mg po bid for 24 weeks

  • RO4588161Drug

    500mg po bid for 24 weeks

  • RO4588161Drug

    1500mg po bid for 24 weeks

Study groups in NCT00517439
Study groupRoleWhat they receive
Group 1ExperimentalGroup 1 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (1000 po bid) plus PEGASYS (180 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd).
Receives: Drug: Copegus; Drug: Pegasys; Drug: RO4588161
Group 2ExperimentalGroup 2 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (500 mg po bid) plus PEGASYS (180 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd).
Receives: Drug: Copegus; Drug: Pegasys; Drug: RO4588161
Group 3ExperimentalGroup 3 will receive HCV polymerase inhibitor pro-drug 500mg po bid plus PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd for 24 weeks; after 24 weeks, those achieving a rapid virological response (RVR) will stop all medication, and non-RVR patients will remain on triple combination for an additional 24 weeks.
Receives: Drug: Copegus; Drug: Pegasys; Drug: RO4588161
Group 4ExperimentalGroup 4 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (1500 mg po bid) plus PEGASYS (90 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd).
Receives: Drug: Copegus; Drug: Pegasys; Drug: RO4588161
Group 5ExperimentalGroup 5 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (1000 mg po bid) plus PEGASYS (90 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd).
Receives: Drug: Copegus; Drug: Pegasys; Drug: RO4588161
Group 6ExperimentalGroup 6 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (500 mg po bid) plus PEGASYS (90 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd).
Receives: Drug: Copegus; Drug: Pegasys; Drug: RO4588161
Group 7Active comparatorStandard of care (SOC)
Receives: Drug: Copegus; Drug: Pegasys

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sustained virological response (SVR)

    Measured: 24 weeks post treatment end (ie weeks 48 or 72)

Secondary outcomes (4)

  1. Virological response over time

    Measured: Throughout study

  2. SVR

    Measured: 12 weeks post treatment end (ie weeks 36 or 60)

  3. Relapse rate

    Measured: End of treatment (ie weeks 24 or 48)

  4. Adverse events (AEs), laboratory parameters.

    Measured: Throughout treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2007 (estimated)
  2. Study startDec 2007
  3. Primary completionJan 2010
  4. Study completionJan 2010

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
516 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00517439
Sponsor's protocol ID
NV19865
Status last verified
Nov 2016
First submitted
16 Aug 2007
Last updated
2 Nov 2016
Results posted
No

Publications

  • Nelson DR, Zeuzem S, Andreone P, Ferenci P, Herring R, Jensen DM, Marcellin P, Pockros PJ, Rodriguez-Torres M, Rossaro L, Rustgi VK, Sepe T, Sulkowski M, Thomason IR, Yoshida EM, Chan A, Hill G. Balapiravir plus peginterferon alfa-2a (40KD)/ribavirin in a randomized trial of hepatitis C genotype 1 patients. Ann Hepatol. 2012 Jan-Feb;11(1):15-31.

    PubMed 22166557

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Copegus, Pegasys and RO4588161 in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 63 sites in 9 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 4 inclusion and 4 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in United States, France, Germany, Australia, Canada and 4 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Sustained virological response (SVR) (time frame: 24 weeks post treatment end (ie weeks 48 or 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 NCT00517439, 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 2 Nov 2016.

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