A Study of Mericitabine in Combination With Telaprevir and Peginterferon Alfa-2a / Ribavirin in Participants With Chronic Hepatitis C

Hepatitis C Clinical Trial

Official title:

A Phase II, Randomized, Double-Blind, Multicenter, Parallel Group Study to Evaluate the Sustained Virologic Response of the HCV Polymerase Inhibitor Prodrug RO5024048 in Combination With Telaprevir and Pegasys®/Copegus® in Patients With Chronic Hepatitis C Genotype 1 Virus Infection Who Were Prior Null Responders to Treatment With Pegylated Interferon/Ribavirin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01482390
• Other study ID #: NV27779
• Secondary ID: 2011-002715-28
• Status: Completed
• Phase: Phase 2
• First received: November 28, 2011
• Last updated: April 21, 2017
• Start date: November 30, 2011
• Est. completion date: January 31, 2014

Study information

• Verified date: April 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized, double-blind, multi-center, parallel-group study will evaluate the sustained virologic response and the safety of mericitabine (RO5024048) (MCB) in combination with telaprevir (TVR) and peginterferon Alfa-2a (PEG-IFN) / ribavirin (RBV) in participants with chronic Hepatitis C infection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 31, 2014
• Est. primary completion date: January 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Chronic hepatitis C infection for at least 6 months duration

• Hepatitis C genotype 1a or 1b

• Participants must have discontinued prior hepatitis C treatment at least 12 weeks prior to enrollment in this study

• Participants showed a previous null response to therapy as defined by < 2 logarithm to the base 10 (log10) international units per milliliter (IU/mL) decrease in viral titer after at least 12 weeks of treatment with PEG-IFN/RBV

Exclusion Criteria:

• Hepatitis C infection with a genotype other than genotype 1a or 1b

• Body mass index < 18 or >= 36 kilograms per square meters (kg/m^2)

• Hepatitis A, hepatitis B, or human immunodeficiency virus (HIV) infection

• Herbal remedies <=1 month prior to the first dose of study drug

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Ribavirin
Participants will receive a total daily dose of 1000 milligrams (mg) (for participants weighing less than [<] 75 kg) or 1200 mg (for participants weighing greater than or equal to [>=] 75 kg) orally for 24 or 48 weeks.
• Mericitabine
Participants will receive mericitabine 1000 mg orally twice daily.
• Peginterferon Alfa-2a
Participants will receive 180 micrograms (mcg) subcutaneous injection once weekly.
• Placebo
Participants will receive placebo matching to mericitabine orally twice daily.
• Telaprevir
Participants will receive telaprevir 750 mg orally three times daily.

Locations

Country	Name	City	State
Canada	McGill University, Montreal Chest Institute; Viral and other Infectious	Montreal	Quebec
Canada	University Health Network - Toronto Western Hospital; Hepatology	Toronto	Ontario
Canada	GI Research Institute; Gastroenterology & Hepatology	Vancouver	British Columbia
Canada	Gordon & Leslie Diamond Health Care Centre; Dept. of Medicine - Division of Gastroenterology	Vancouver	British Columbia
Canada	Percuro Clinical Research Ltd.	Victoria	British Columbia
Canada	Winnipeg Regional Health Authority; Section of Hepatology	Winnipeg	Manitoba
Canada	Toronto Digest. Disease Asso.	Woodbridge	Ontario
France	Hopital Claude Huriez;Gastro Enterologie	Lille
France	Fondation Hopital Saint Joseph; Gastro-Enterologie	Marseille
France	Hopital Purpan;Gastro Enterologie Hepatologie	Toulouse
Germany	Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I	Frankfurt Am Main
Germany	Uniklinik Freiburg; Abteilung Innere Medizin II	Freiburg
Germany	Universitäts Klinikum; Schleswig-Holstein Kiel	Kiel
Italy	UNI DEGLI STUDI - POLICLINICA S. ORSOLA; Dipartimento Malattie dell'Apparato Digerente e Medicina In	Bologna	Emilia-Romagna
Italy	ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Divisione Malattie Infettive	Milano	Lombardia
Italy	Ospedale Cisanello - Az. Osp. Pisana; Unità Operativa Di Gastroenterologia Ed Epatologia	Pisa	Toscana
Spain	Hospital Clinic I Provincial; Servicio de Digestivo	Barcelona
Spain	Hospital Universitari Vall d'Hebron; Departamento de Enfermedades Infecciosas	Barcelona
Spain	Hospital Universitario de Canarias; Servicio de Digestivo	La Laguna	Tenerife
Spain	Hospital Carlos III; Laboratorio de Biologia Molecular	Madrid
United Kingdom	Royal Bournemouth Hospital, Gastroenterology	Dorset
United Kingdom	Imperial College Healthcare NHS Trust; Hepatology Clinical Research Facility	London
United Kingdom	King'S College Hospital; Institute of Liver Studies	London
United Kingdom	St George's Hospital	London
United States	Birmingham Gastro Associates, P.C.	Birmingham	Alabama
United States	Uni of Cincinnati College of Medicine; Div. of Digestive Diseases	Cincinnati	Ohio
United States	Baylor Uni Medical Center; Division Of Hepatology/Transplantation; Annette C. and Harold C. Simmons	Dallas	Texas
United States	Metrowest Medical Center	Framingham	Massachusetts
United States	VA Long Beach Healthcare System	Long Beach	California
United States	John Hopkins Hospital	Lutherville	Maryland
United States	Gastroenterology Group of Naples	Naples	Florida
United States	Yale University	New Haven	Connecticut
United States	Weill Cornell Medical College	New York	New York
United States	McGuire; Veteran Affairs Med Ctr	Richmond	Virginia
United States	Kaiser Permanente Sacramento Medical Center	Sacramento	California
United States	Saint Louis University Gastroenterology & Hepatology; Clinical Research Unit	Saint Louis	Missouri
United States	UCSD Antiviral Research Center	San Diego	California
United States	Harborview Medical Center	Seattle	Washington
United States	Carolina'S Center For Liver Disease	Statesville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Participants With Sustained Virological Response 12 Weeks After End of Treatment (SVR12), as Determined by Polymerase Chain Reaction (PCR) Using Roche COBAS TaqMan Hepatitis C Virus (HCV) Test		12 weeks after end of treatment (up to Week 60)
Secondary	Percentage of Participants With Sustained Virological Response 4 Weeks After End of Treatment (SVR-4), as Determined by PCR Using Roche COBAS TaqMan HCV Test		4 weeks after end of treatment (up to Week 52)
Secondary	Percentage of Participants With Sustained Virological Response 24 Weeks After End of Treatment (SVR-24), as Determined by PCR Using Roche COBAS TaqMan HCV Test		24 weeks after end of treatment (up to Week 72)
Secondary	Percentage of Participants With Virological Response Over Time From Week 2 to Week 48, as Determined by PCR Using Roche COBAS TaqMan HCV Test		Weeks 2, 4, 12, 24, and 48
Secondary	Percentage of Participants With Treatment- Resistant Mutations, as Determined Using Standard Sequencing Technology		Baseline up to Week 60
Secondary	Change From Baseline in HCV Ribonucleic Acid (RNA) Levels		Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 30, 36, 42, 48, 52, 60, and 72
Secondary	Percentage of Participants With Adverse Event		Baseline up to Week 72
Secondary	Trough Concentration of RO4995855 (Parent Drug of Mericitabine)		Pre-dose (-0.5 hour) on Day 1 and Week 8; 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hour post dose in Week 8
Secondary	Trough Concentration of Metabolite of RO4995855 (RO5012433)		Pre-dose (-0.5 hour) on Day 1 and Week 8; 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hour post dose in Week 8
Secondary	Trough Concentration of Telaprevir		Pre-dose (-0.5 hour) on Day 1 and Week 8; 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hour post dose in Week 8