Clinical trial NCT01482390: A Study of Mericitabine in Combination With Telaprevir and Peginterferon Alfa-2a / Ribavirin in Participants With Chronic Hepatitis C
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-11-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 12 weeks after end of treatment (up to Week 60)
Secondary outcomes:
measure: 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
timeFrame: 4 weeks after end of treatment (up to Week 52)
measure: 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
timeFrame: 24 weeks after end of treatment (up to Week 72)
measure: Percentage of Participants With Virological Response Over Time From Week 2 to Week 48, as Determined by PCR Using Roche COBAS TaqMan HCV Test
timeFrame: Weeks 2, 4, 12, 24, and 48
measure: Percentage of Participants With Treatment- Resistant Mutations, as Determined Using Standard Sequencing Technology
timeFrame: Baseline up to Week 60
measure: Change From Baseline in HCV Ribonucleic Acid (RNA) Levels
timeFrame: Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 30, 36, 42, 48, 52, 60, and 72
measure: Percentage of Participants With Adverse Event
timeFrame: Baseline up to Week 72
measure: Trough Concentration of RO4995855 (Parent Drug of Mericitabine)
timeFrame: 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
measure: Trough Concentration of Metabolite of RO4995855 (RO5012433)
timeFrame: 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
measure: Trough Concentration of Telaprevir
timeFrame: 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
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Gastro Associates, P.C.
state: Alabama
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente Sacramento Medical Center
state: California
city: San Diego
country: United States
facility: UCSD Antiviral Research Center
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Naples
country: United States
facility: Gastroenterology Group of Naples
state: Florida
city: Lutherville
country: United States
facility: John Hopkins Hospital
state: Maryland
city: Framingham
country: United States
facility: Metrowest Medical Center
state: Massachusetts
city: Saint Louis
country: United States
facility: Saint Louis University Gastroenterology & Hepatology; Clinical Research Unit
state: Missouri
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Statesville
country: United States
facility: Carolina'S Center For Liver Disease
state: North Carolina
city: Cincinnati
country: United States
facility: Uni of Cincinnati College of Medicine; Div. of Digestive Diseases
state: Ohio
city: Dallas
country: United States
facility: Baylor Uni Medical Center; Division Of Hepatology/Transplantation; Annette C. and Harold C. Simmons
state: Texas
city: Richmond
country: United States
facility: McGuire; Veteran Affairs Med Ctr
state: Virginia
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Vancouver
country: Canada
facility: Gordon & Leslie Diamond Health Care Centre; Dept. of Medicine - Division of Gastroenterology
state: British Columbia
city: Vancouver
country: Canada
facility: GI Research Institute; Gastroenterology & Hepatology
state: British Columbia
city: Victoria
country: Canada
facility: Percuro Clinical Research Ltd.
state: British Columbia
city: Winnipeg
country: Canada
facility: Winnipeg Regional Health Authority; Section of Hepatology
state: Manitoba
city: Toronto
country: Canada
facility: University Health Network - Toronto Western Hospital; Hepatology
state: Ontario
city: Woodbridge
country: Canada
facility: Toronto Digest. Disease Asso.
state: Ontario
city: Montreal
country: Canada
facility: McGill University, Montreal Chest Institute; Viral and other Infectious
state: Quebec
city: Lille
country: France
facility: Hopital Claude Huriez;Gastro Enterologie
city: Marseille
country: France
facility: Fondation Hopital Saint Joseph; Gastro-Enterologie
city: Toulouse
country: France
facility: Hopital Purpan;Gastro Enterologie Hepatologie
city: Frankfurt Am Main
country: Germany
facility: Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I
city: Freiburg
country: Germany
facility: Uniklinik Freiburg; Abteilung Innere Medizin II
city: Kiel
country: Germany
facility: Universitäts Klinikum; Schleswig-Holstein Kiel
city: Bologna
country: Italy
facility: UNI DEGLI STUDI - POLICLINICA S. ORSOLA; Dipartimento Malattie dell'Apparato Digerente e Medicina In
state: Emilia-Romagna
city: Milano
country: Italy
facility: ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Divisione Malattie Infettive
state: Lombardia
city: Pisa
country: Italy
facility: Ospedale Cisanello - Az. Osp. Pisana; Unità Operativa Di Gastroenterologia Ed Epatologia
state: Toscana
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias; Servicio de Digestivo
state: Tenerife
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron; Departamento de Enfermedades Infecciosas
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial; Servicio de Digestivo
city: Madrid
country: Spain
facility: Hospital Carlos III; Laboratorio de Biologia Molecular
city: Dorset
country: United Kingdom
facility: Royal Bournemouth Hospital, Gastroenterology
city: London
country: United Kingdom
facility: King'S College Hospital; Institute of Liver Studies
city: London
country: United Kingdom
facility: St George's Hospital
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust; Hepatology Clinical Research Facility
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Wedemeyer H, Forns X, Hezode C, Lee SS, Scalori A, Voulgari A, Le Pogam S, Najera I, Thommes JA. Mericitabine and Either Boceprevir or Telaprevir in Combination with Peginterferon Alfa-2a plus Ribavirin for Patients with Chronic Hepatitis C Genotype 1 Infection and Prior Null Response: The Randomized DYNAMO 1 and DYNAMO 2 Studies. PLoS One. 2016 Jan 11;11(1):e0145409. doi: 10.1371/journal.pone.0145409. eCollection 2016.