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

NCT01220947 | Completed Phase 2

• 2 other identifiers: NV227762010-019584-10
• Study Type: interventional
• Target: 421
• Locations: 11 countries
• Sites: 68

Brief 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.

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

• Sustained virological response (HCV RNA measured by Roche COBAS TaqMan HCV test)

  24 weeks after end of treatment

Secondary Outcomes (6)

• Safety: Incidence of adverse events

  from baseline up to 72 weeks

• Evaluation of relapse rate

  up to 24 weeks after end of treatment

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

  from baseline up to 72 weeks

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

  From baseline up to 72 weeks

• Evaluation of virological breakthrough (viral load rebound) rate

  up to 72 weeks

Study Arms (5)

Group A

EXPERIMENTAL

Danoprevir 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

Drug: Copegus; Drug: Danoprevir; Drug: Pegasys; Drug: Ritonavir

Group B

EXPERIMENTAL

Danoprevir 100 mg BID + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks

Drug: Copegus; Drug: Danoprevir; Drug: Pegasys; Drug: Ritonavir

Group C

EXPERIMENTAL

Danoprevir 50 mg BID + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks

Drug: Copegus; Drug: Danoprevir; Drug: Pegasys; Drug: Ritonavir

Group D

EXPERIMENTAL

Danoprevir 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

Drug: Copegus; Drug: Danoprevir; Drug: Pegasys; Drug: Ritonavir

Group E

ACTIVE COMPARATOR

Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 48 weeks

Drug: Copegus; Drug: Pegasys

Interventions

Copegus DRUG

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

Group A; Group B; Group C; Group D; Group E

Danoprevir DRUG

Danoprevir 50 mg BID

Group C

Pegasys DRUG

Pegasys 180 microgram sc qw

Group A; Group B; Group C; Group D; Group E

Ritonavir DRUG

Ritonavir 100 mg

Group A; Group B; Group C; Group D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (68)

Unknown Facility

La Jolla, California, 92037-1030, United States

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Sacramento, California, 95817, United States

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San Diego, California, 92154, United States

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San Francisco, California, 94143, United States

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Aurora, Colorado, 80045, United States

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Orlando, Florida, 32804, United States

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Orlando, Florida, 32809, United States

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South Miami, Florida, 33143, United States

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Decatur, Georgia, 30033, United States

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Honolulu, Hawaii, 96817, United States

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Chicago, Illinois, 60637, United States

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Lutherville, Maryland, 21093, United States

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Detroit, Michigan, 48202-2689, United States

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Manhasset, New York, 11030, United States

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New York, New York, 10021, United States

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The Bronx, New York, 10468, United States

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Chapel Hill, North Carolina, 27599-7584, United States

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Fayetteville, North Carolina, 28304, United States

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Medford, Oregon, 97504, United States

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Providence, Rhode Island, 02905, United States

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Nashville, Tennessee, 37211, United States

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Houston, Texas, 77030, United States

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San Antonio, Texas, 78215, United States

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San Antonio, Texas, 78234, United States

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Newport News, Virginia, 23602, United States

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Vienna, 1090, Austria

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Salvador, Estado de Bahia, 40210-341, Brazil

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Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

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Ribeirão Preto, São Paulo, 14049-900, Brazil

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Edmonton, Alberta, T6G 2S2, Canada

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Vancouver, British Columbia, V5Z 1M9, Canada

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Vancouver, British Columbia, V6Z 2K5, Canada

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Victoria, British Columbia, V8V 3P9, Canada

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Winnipeg, Manitoba, R3A 1R9, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Toronto, Ontario, M5G 1L7, Canada

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Clichy, 92118, France

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Créteil, 94010, France

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Marseille, 13285, France

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Paris, 75679, France

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Rennes, 35033, France

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Toulouse, 31059, France

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Vandœuvre-lès-Nancy, 54511, France

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Berlin, 10969, Germany

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Frankfurt am Main, 60590, Germany

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Freiburg im Breisgau, 79106, Germany

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Hamburg, 20099, Germany

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Leipzig, 04103, Germany

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Würzburg, 97080, Germany

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Bari, Apulia, 70124, Italy

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Napoli, Campania, 80131, Italy

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Bologna, Emilia-Romagna, 40138, Italy

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Milan, Lombardy, 20121, Italy

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Pavia, Lombardy, 27100, Italy

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Novara, Piedmont, 28100, Italy

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Guadalajara, 44650, Mexico

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Monterrey, 64710, Mexico

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Santurce, 00909, Puerto Rico

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Badalona, Barcelona, 08915, Spain

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Barcelona, Barcelona, 08003, Spain

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Madrid, Madrid, 28034, Spain

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Madrid, Madrid, 28222, Spain

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Seville, Sevilla, 41014, Spain

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London, E1 1BB, United Kingdom

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London, SE5 9RS, United Kingdom

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London, SW17 0QT, United Kingdom

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London, W1 1TF, United Kingdom

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Nottingham, NG7 2UH, United Kingdom

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MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Ribavirin; danoprevir; peginterferon alfa-2a; Ritonavir

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2010
• First Posted: October 14, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

BR (3); CA (7); DE (6); FR (7); ME (2); PR (1); AU (1); GB (5); IT (6); ES (5); US (25)