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Hepatitis C, ChronicPhase 2NCT01220947

A Study of Danoprevir Boosted With Low Dose Ritonavir in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C Virus Infection

A Phase 2 study testing Copegus, Danoprevir and Pegasys in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 68 sites in 11 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 randomized, open-label, active-controlled, parallel-group study will evaluate the sustained virological response of danoprevir boosted with low dose ritonavir in combination with Pegasys (peginterferon alfa-2a) and Copegus versus Pegasys and Copegus alone in treatment-naive patients with chronic Hepatitis C. 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?
Copegus, Danoprevir and Pegasys
Could I receive a placebo?
No, everyone receives an active treatment
How many people
421 participants
Where
68 sitesin 11 countries
Study dates
Nov 2010to Dec 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults patients, >/=18 years of age
  • Chronic Hepatitis C, Genotype 1 and 4
  • HCV RNA >/=50,000 IU/mL
  • treatment-naive

Who cannot join

  • Patients with cirrhosis or incomplete/transition to cirrhosis
  • Patients with other forms of liver disease, HIV infection, hepatocellular carcinoma or severe cardiac disease

Trial locations and contacts

68 sites in 11 countries.

68 sites in 11 countries

United States25 sites

  • Study site

    Aurora, Colorado, 80045

  • Study site

    Chapel Hill, North Carolina, 27599-7584

  • Study site

    Chicago, Illinois, 60637

  • Study site

    Decatur, Georgia, 30033

  • Study site

    Detroit, Michigan, 48202-2689

  • Study site

    Fayetteville, North Carolina, 28304

  • Study site

    Honolulu, Hawaii, 96817

  • Study site

    Houston, Texas, 77030

  • Study site

    La Jolla, California, 92037-1030

  • Study site

    Lutherville, Maryland, 21093

  • Study site

    Manhasset, New York, 11030

  • Study site

    Medford, Oregon, 97504

  • Study site

    Nashville, Tennessee, 37211

  • Study site

    New York, New York, 10021

  • Study site

    Newport News, Virginia, 23602

  • Study site

    Orlando, Florida, 32804

  • Study site

    Orlando, Florida, 32809

  • Study site

    Providence, Rhode Island, 02905

  • Study site

    Sacramento, California, 95817

  • Study site

    San Antonio, Texas, 78215

  • Study site

    San Antonio, Texas, 78234

  • Study site

    San Diego, California, 92154

  • Study site

    San Francisco, California, 94143

  • Study site

    South Miami, Florida, 33143

  • Study site

    The Bronx, New York, 10468

Other trials in United States

Canada7 sites

  • Study site

    Edmonton, Alberta, T6G 2S2

  • Study site

    Ottawa, Ontario, K1H 8L6

  • Study site

    Toronto, Ontario, M5G 1L7

  • Study site

    Vancouver, British Columbia, V5Z 1M9

  • Study site

    Vancouver, British Columbia, V6Z 2K5

  • Study site

    Victoria, British Columbia, V8V 3P9

  • Study site

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

France7 sites

  • Study site

    Clichy, 92118

  • Study site

    Créteil, 94010

  • Study site

    Marseille, 13285

  • Study site

    Paris, 75679

  • Study site

    Rennes, 35033

  • Study site

    Toulouse, 31059

  • Study site

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Germany6 sites

  • Study site

    Berlin, 10969

  • Study site

    Frankfurt am Main, 60590

  • Study site

    Freiburg im Breisgau, 79106

  • Study site

    Hamburg, 20099

  • Study site

    Leipzig, 04103

  • Study site

    Würzburg, 97080

Other trials in Germany

Italy6 sites

  • Study site

    Bari, Apulia, 70124

  • Study site

    Bologna, Emilia-Romagna, 40138

  • Study site

    Milan, Lombardy, 20121

  • Study site

    Naples, Campania, 80131

  • Study site

    Novara, Piedmont, 28100

  • Study site

    Pavia, Lombardy, 27100

Other trials in Italy

Spain5 sites

  • Study site

    Badalona, Barcelona, 08915

  • Study site

    Barcelona, Barcelona, 08003

  • Study site

    Madrid, Madrid, 28034

  • Study site

    Madrid, Madrid, 28222

  • Study site

    Seville, Sevilla, 41014

Other trials in Spain

United Kingdom5 sites

  • Study site

    London, E1 1BB

  • Study site

    London, SE5 9RS

  • Study site

    London, SW17 0QT

  • Study site

    London, W1 1TF

  • Study site

    Nottingham, NG7 2UH

Other trials in United Kingdom

Brazil3 sites

  • Study site

    Porto Alegre, Rio Grande do Sul, 90035-003

  • Study site

    Ribeirão Preto, São Paulo, 14049-900

  • Study site

    Salvador, Estado de Bahia, 40210-341

Other trials in Brazil

Mexico2 sites

  • Study site

    Guadalajara, 44650

  • Study site

    Monterrey, 64710

Other trials in Mexico

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

This randomized, open-label, active-controlled, parallel-group study will evaluate the sustained virological response of danoprevir boosted with low dose ritonavir in combination with Pegasys (peginterferon alfa-2a) and Copegus versus Pegasys and Copegus alone in treatment-naive patients with chronic Hepatitis C.

Being tested
Copegus, Danoprevir, Pegasys, Ritonavir
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

    Copegus 1000 mg or 1200 mg po daily for 24 weeks.

  • DanoprevirDrug

    Danoprevir 50 mg BID

  • DanoprevirDrug

    Danoprevir 100 mg BID

  • DanoprevirDrug

    Danoprevir 200 mg BID

  • PegasysDrug

    Pegasys 180 microgram sc qw

  • RitonavirDrug

    Ritonavir 100 mg

Study groups in NCT01220947
Study groupRoleWhat they receive
Group AExperimentalDanoprevir 200 mg twice a day (BID) + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks
Receives: Drug: Copegus; Drug: Danoprevir; Drug: Pegasys; Drug: Ritonavir
Group BExperimentalDanoprevir 100 mg BID + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks
Receives: Drug: Copegus; Drug: Danoprevir; Drug: Pegasys; Drug: Ritonavir
Group CExperimentalDanoprevir 50 mg BID + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks
Receives: Drug: Copegus; Drug: Danoprevir; Drug: Pegasys; Drug: Ritonavir
Group DExperimentalDanoprevir 100 mg BID + ritonavir 100 mg + Pegasys 180 μg sc qw + Copegus 1000 mg or 1200 mg po daily for 12 weeks or 24 weeks
Receives: Drug: Copegus; Drug: Danoprevir; Drug: Pegasys; Drug: Ritonavir
Group EActive comparatorPegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 48 weeks
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 (HCV RNA measured by Roche COBAS TaqMan HCV test)

    Measured: 24 weeks after end of treatment

Secondary outcomes (6)

  1. Safety: Incidence of adverse events

    Measured: from baseline up to 72 weeks

  2. Evaluation of relapse rate

    Measured: up to 24 weeks after end of treatment

  3. Characterization of resistance profile (HCV RNA sequencing and/or phenotypic analyses)

    Measured: from baseline up to 72 weeks

  4. Virological response at scheduled visits over time (HCV RNA measured by Roche COBAS TaqMan HCV test)

    Measured: From baseline up to 72 weeks

  5. Evaluation of virological breakthrough (viral load rebound) rate

    Measured: up to 72 weeks

  6. Evaluation of pharmacokinetics (serum concentrations assessed by validated methods)

    Measured: up to 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 posted14 Oct 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionDec 2012
  4. Study completionDec 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
None (open label)
Enrolment
421 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01220947
Sponsor's protocol ID
NV22776
Other IDs
2010-019584-10
Status last verified
Nov 2016
First submitted
7 Oct 2010
Last updated
2 Nov 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Copegus, Danoprevir and Pegasys in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 68 sites in 11 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 2 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 68 sites in United States, Canada, France, Germany, Italy and 6 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 (HCV RNA measured by Roche COBAS TaqMan HCV test) (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 NCT01220947.

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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