AzTrials
AzTrials

Hepatitis C, ChronicPhase 2NCT00869661

A Study of RO5024048 in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C, Genotype 1 or 4

A Phase 2 study testing Copegus, Pegasys and RO5024048 in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 66 sites in 10 countries.

Completed

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

Official record
Search all trials

Trial summary

This 6-arm study will assess the efficacy and safety of RO5024048 (R7128) in combination with the approved doses of Pegasys (180micrograms sc weekly) + Copegus (1000/1200mg po daily) (SOC), versus SOC in treatment-naive patients with chronic hepatitis C, genotype 1 and 4. 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 RO5024048
Could I receive a placebo?
No, everyone receives an active treatment
How many people
413 participants
Where
66 sitesin 10 countries
Study dates
Feb 2001to Feb 2012
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 or 4
  • Treatment-naive

Who cannot join

  • No previous treatment with any interferon- or ribavirin-based therapy
  • Other forms of liver disease
  • HIV infection

Trial locations and contacts

66 sites in 10 countries.

66 sites in 10 countries

United States21 sites

  • Study site

    Birmingham, Alabama, 35294

  • Study site

    Bradenton, Florida, 34209

  • Study site

    Chicago, Illinois, 60637

  • Study site

    Columbia, South Carolina, 29204

  • Study site

    Gainesville, Florida, 32610-0214

  • Study site

    Hershey, Pennsylvania, 17033

  • Study site

    Houston, Texas, 77030

  • Study site

    Kansas City, Missouri, 64131

  • Study site

    La Jolla, California, 92037-1030

  • Study site

    Lutherville, Maryland, 21093

  • Study site

    Marietta, Georgia, 30060

  • Study site

    Nashville, Tennessee, 37211

  • Study site

    New York, New York, 10021

  • Study site

    Newark, New Jersey, 07102

  • Study site

    Providence, Rhode Island, 02905

  • Study site

    Richmond, Virginia, 23249

  • Study site

    Sacramento, California, 95817

  • Study site

    San Antonio, Texas, 78234

  • Study site

    San Diego, California, 92103-8465

  • Study site

    San Francisco, California, 94115

  • Study site

    Washington D.C., District of Columbia, 20037

Other trials in United States

Australia8 sites

  • Study site

    Fitzroy, Victoria, 3065

  • Study site

    Greenslopes, Queensland, 4120

  • Study site

    Herston, Queensland, 4006

  • Study site

    Melbourne, Victoria, 3004

  • Study site

    Nedlands, Western Australia, 6009

  • Study site

    Perth, Western Australia, 6001

  • Study site

    Sydney, New South Wales, 2050

  • Study site

    Woolloongabba, Queensland, 4102

Other trials in Australia

France8 sites

  • Study site

    Créteil, 94010

  • Study site

    La Tronche, 38700

  • Study site

    Lille, 59037

  • Study site

    Nice, 06202

  • Study site

    Paris, 75651

  • Study site

    Paris, 75679

  • Study site

    Pessac, 33604

  • Study site

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Spain8 sites

  • Study site

    A Coruña, La Coruña, 15006

  • Study site

    Badalona, Barcelona, 08915

  • Study site

    Barcelona, Barcelona, 08003

  • Study site

    Barcelona, Barcelona, 08036

  • Study site

    Granada, Granada, 18003

  • Study site

    Madrid, Madrid, 28222

  • Study site

    Seville, Sevilla, 41014

  • Study site

    Valencia, Valencia, 46014

Other trials in Spain

Canada7 sites

  • Study site

    Calgary, Alberta, T2N 4Z6

  • Study site

    Edmonton, Alberta, T6G 2B7

  • Study site

    London, Ontario, N6A 5A5

  • Study site

    Montreal, Quebec, H2X 3J4

  • Study site

    Toronto, Ontario, M5G 1L7

  • Study site

    Vancouver, British Columbia, V5Z 1M9

  • Study site

    Vancouver, British Columbia, V6Z 2K5

Other trials in Canada

Germany6 sites

  • Study site

    Berlin, 13353

  • Study site

    Frankfurt am Main, 60590

  • Study site

    Freiburg im Breisgau, 79106

  • Study site

    Hanover, 30625

  • Study site

    München, 81377

  • Study site

    Ulm, 89081

Other trials in Germany

Italy4 sites

  • Study site

    Bologna, Emilia-Romagna, 40138

  • Study site

    Milan, Lombardy, 20121

  • Study site

    Pisa, Tuscany, 56124

  • Study site

    Turin, Piedmont, 10126

Other trials in Italy

United Kingdom2 sites

  • Study site

    London, SE5 9RS

  • Study site

    London, W1 1TF

Other trials in United Kingdom

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-blind, Multicenter, Dose and Duration Finding Study to Evaluate the Sustained Virologic Response of the HCV Polymerase Inhibitor Prodrug (RO5024048) in Combination With Pegasys® and Ribavirin® (SOC) Versus SOC in Treatment-Naïve Patients With HCV Genotype 1 or 4 Infection

This 6-arm study will assess the efficacy and safety of RO5024048 (R7128) in combination with the approved doses of Pegasys (180micrograms sc weekly) + Copegus (1000/1200mg po daily) (SOC), versus SOC in treatment-naive patients with chronic hepatitis C, genotype 1 and 4. The first 3 groups will receive 1) RO5024048 500mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks; 2)RO5024048 1000mg bid + Pegasys + Copegus for 8 weeks, followed by SOC for 16 weeks; 3) RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks. After 24 weeks, patients in these 3 groups who have achieved rapid viral response will stop treatment, and those who have not will receive SOC for a further 24 weeks. Group 4 will receive RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 36 weeks, and group 5 will receive SOC for 48 weeks. Group 6 provides retreatment on an open-label basis for patients of Group 5 who failed treatment. Patients will receive RO5024048 1000mg bid + Pegasys + Copegus for 24 weeks, followed by SOC for 24 weeks. The anticipated time on study treatment is 6-12 months.

Being tested
Copegus, Pegasys, RO5024048
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 or 48 weeks

  • CopegusDrug

    1000/1200mg po daily for 48 weeks

  • PegasysDrug

    180 micrograms sc weekly for 24 or 48 weeks

  • PegasysDrug

    180 micrograms sc weekly for 48 weeks

  • RO5024048Drug

    1000mg bid for 24 weeks

  • RO5024048Drug

    500mg bid for 12 weeks

  • RO5024048Drug

    1000mg bid for 8 weeks

  • RO5024048Drug

    1000mg bid for 12 weeks

Study groups in NCT00869661
Study groupRoleWhat they receive
Group 1ExperimentalRO5024048 500 mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks. After 24 weeks, patients who have achieved rapid viral response will stop treatment, and those who have not will receive SOC for a further 24 weeks.
Receives: Drug: Copegus; Drug: Pegasys; Drug: RO5024048
Group 2ExperimentalRO5024048 1000mg bid + Pegasys + Copegus for 8 weeks, followed by SOC for 16 weeks. After 24 weeks, patients who have achieved rapid viral response will stop treatment, and those who have not will receive SOC for a further 24 weeks.
Receives: Drug: Copegus; Drug: Pegasys; Drug: RO5024048
Group 3ExperimentalRO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks. After 24 weeks, patients who have achieved rapid viral response will stop treatment, and those who have not will receive SOC for a further 24 weeks.
Receives: Drug: Copegus; Drug: Pegasys; Drug: RO5024048
Group 4ExperimentalGroup 4 will receive RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 36 weeks
Receives: Drug: Copegus; Drug: Pegasys; Drug: RO5024048
Group 5Active comparatorGroup 5 will receive SOC for 48 weeks
Receives: Drug: Copegus; Drug: Pegasys
Group 6ExperimentalGroup 6 provides retreatment on an open-label basis for patients of Group 5 who failed treatment. Patients will receive RO5024048 1000mg bid + Pegasys + Copegus for 24 weeks, followed by SOC for 24 weeks.
Receives: Drug: Copegus; Drug: Pegasys; Drug: RO5024048

What is being measured

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

  1. Sustained virologic response: Percentage of patients with undetectable Hepatitis C RNA level

    Measured: 24 weeks after end of treatment

Secondary outcomes (4)

  1. Virologic response: Percentage of patients with undetectable Hepatitis C RNA level

    Measured: 60 Weeks

  2. Virologic response: Percentage of patients with undetectable Hepatitis C RNA level

    Measured: 12 weeks post-treatment

  3. Relapse rate: Percentage of patients who achieved a virologic response at the end of treatment but had detectable Hepatitis C RNA level at the last assessment post treatment

    Measured: 72 weeks

  4. Safety: Incidence of adverse events

    Measured: 72 weeks

Timeline

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

  1. First posted26 Mar 2009 (estimated)
  2. Study startFeb 2001
  3. Primary completionFeb 2012
  4. Study completionFeb 2012

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
413 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00869661
Sponsor's protocol ID
NV20536
Other IDs
2008-008258-21, 2008
Status last verified
Nov 2016
First submitted
25 Mar 2009
Last updated
2 Nov 2016
Results posted
No

Publications

  • Tong X, Le Pogam S, Li L, Haines K, Piso K, Baronas V, Yan JM, So SS, Klumpp K, Najera I. In vivo emergence of a novel mutant L159F/L320F in the NS5B polymerase confers low-level resistance to the HCV polymerase inhibitors mericitabine and sofosbuvir. J Infect Dis. 2014 Mar 1;209(5):668-75. doi: 10.1093/infdis/jit562. Epub 2013 Oct 23.

    PubMed 24154738

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Copegus, Pegasys and RO5024048 in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 66 sites in 10 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 3 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 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 66 sites in United States, Australia, France, Spain, Canada and 5 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 virologic response: Percentage of patients with undetectable Hepatitis C RNA level (time frame: 24 weeks after end of treatment). 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 NCT00869661, 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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in