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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002715-28 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TVR (12 Weeks), MCB (24 Weeks), PEG-IFN/RBV (24 Weeks) | Experimental | Twelve weeks of therapy with MCB, TVR, and PEG-IFN/RBV, followed by 12 weeks of therapy with MCB and PEG-IFN/RBV (total treatment duration of 24 weeks). |
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| TVR (12 Weeks), MCB (24 Weeks), PEG-IFN/RBV (48 Weeks) | Experimental | Twelve weeks of therapy with MCB, TVR, and PEG-IFN/RBV, followed by 12 weeks of therapy with MCB and PEG-IFN/RBV and then 12 weeks of therapy with PEG-IFN/RBV (total treatment duration of 48 weeks). |
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| TVR, MCB, Placebo MCB( each for 12Weeks),PEG-IFN/RBV(48 Weeks) | Experimental | Twelve weeks of therapy with MCB, TVR, and PEG-IFN/RBV, followed by 12 weeks of therapy with placebo matching to MCB and PEG-IFN/RBV, and then 24 weeks of therapy with PEG-IFN/RBV (total treatment duration of 48 weeks). |
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| TVR(12 Weeks), Placebo MCB (24 Weeks), PEG-IFN/RBV(48 Weeks) | Active Comparator | Twelve weeks of therapy with placebo matching to MCB, TVR, PEG-IFN/RBV, will be followed by 12 weeks of therapy with placebo matching to MCB along with PEG-IFN/RBV , following 24 weeks of therapy with PEG-IFN/RBV (total treatment duration of 48 weeks). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ribavirin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Gastro Associates, P.C. | Birmingham | Alabama | 35209 | United States | ||
| VA Long Beach Healthcare System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26752189 | Derived | 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. |
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| Mericitabine | Drug | Participants will receive mericitabine 1000 mg orally twice daily. |
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| Peginterferon Alfa-2a | Drug | Participants will receive 180 micrograms (mcg) subcutaneous injection once weekly. |
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| Placebo | Drug | Participants will receive placebo matching to mericitabine orally twice daily. |
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| Telaprevir | Drug | Participants will receive telaprevir 750 mg orally three times daily. |
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| 24 weeks after end of treatment (up to Week 72) |
| 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 |
| Percentage of Participants With Treatment- Resistant Mutations, as Determined Using Standard Sequencing Technology | Baseline up to Week 60 |
| 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 |
| Percentage of Participants With Adverse Event | Baseline up to Week 72 |
| 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 |
| 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 |
| 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 |
| Long Beach |
| California |
| 90822 |
| United States |
| Kaiser Permanente Sacramento Medical Center | Sacramento | California | 95825 | United States |
| UCSD Antiviral Research Center | San Diego | California | 92103 | United States |
| Yale University | New Haven | Connecticut | 06510 | United States |
| Gastroenterology Group of Naples | Naples | Florida | 34102 | United States |
| John Hopkins Hospital | Lutherville | Maryland | 21093 | United States |
| Metrowest Medical Center | Framingham | Massachusetts | 01702 | United States |
| Saint Louis University Gastroenterology & Hepatology; Clinical Research Unit | St Louis | Missouri | 63104 | United States |
| Weill Cornell Medical College | New York | New York | 10021 | United States |
| Carolina'S Center For Liver Disease | Statesville | North Carolina | 28677 | United States |
| Uni of Cincinnati College of Medicine; Div. of Digestive Diseases | Cincinnati | Ohio | 45267-0595 | United States |
| Baylor Uni Medical Center; Division Of Hepatology/Transplantation; Annette C. and Harold C. Simmons | Dallas | Texas | 75246 | United States |
| McGuire; Veteran Affairs Med Ctr | Richmond | Virginia | 23249 | United States |
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
| Gordon & Leslie Diamond Health Care Centre; Dept. of Medicine - Division of Gastroenterology | Vancouver | British Columbia | V5Z 1M9 | Canada |
| GI Research Institute; Gastroenterology & Hepatology | Vancouver | British Columbia | V6Z 2K5 | Canada |
| Percuro Clinical Research Ltd. | Victoria | British Columbia | V8V 3P9 | Canada |
| Winnipeg Regional Health Authority; Section of Hepatology | Winnipeg | Manitoba | R3A 1R9 | Canada |
| University Health Network - Toronto Western Hospital; Hepatology | Toronto | Ontario | M5G 1L7 | Canada |
| Toronto Digest. Disease Asso. | Woodbridge | Ontario | L4L 4Y7 | Canada |
| McGill University, Montreal Chest Institute; Viral and other Infectious | Montreal | Quebec | H2X2P4 | Canada |
| Hopital Claude Huriez;Gastro Enterologie | Lille | 59037 | France |
| Fondation Hopital Saint Joseph; Gastro-Enterologie | Marseille | 13285 | France |
| Hopital Purpan;Gastro Enterologie Hepatologie | Toulouse | 31059 | France |
| Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I | Frankfurt am Main | 60590 | Germany |
| Uniklinik Freiburg; Abteilung Innere Medizin II | Freiburg im Breisgau | 79106 | Germany |
| Universitäts Klinikum; Schleswig-Holstein Kiel | Kiel | 24105 | Germany |
| UNI DEGLI STUDI - POLICLINICA S. ORSOLA; Dipartimento Malattie dell'Apparato Digerente e Medicina In | Bologna | Emilia-Romagna | 40138 | Italy |
| ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Divisione Malattie Infettive | Milan | Lombardy | 20162 | Italy |
| Ospedale Cisanello - Az. Osp. Pisana; Unità Operativa Di Gastroenterologia Ed Epatologia | Pisa | Tuscany | 56124 | Italy |
| Hospital Universitario de Canarias; Servicio de Digestivo | San Cristóbal de La Laguna | Tenerife | 38320 | Spain |
| Hospital Universitari Vall d'Hebron; Departamento de Enfermedades Infecciosas | Barcelona | 08035 | Spain |
| Hospital Clinic I Provincial; Servicio de Digestivo | Barcelona | 08036 | Spain |
| Hospital Carlos III; Laboratorio de Biologia Molecular | Madrid | 28029 | Spain |
| Royal Bournemouth Hospital, Gastroenterology | Dorset | BH7 7DW | United Kingdom |
| King'S College Hospital; Institute of Liver Studies | London | SE5 9RS | United Kingdom |
| St George's Hospital | London | SW17 0QT | United Kingdom |
| Imperial College Healthcare NHS Trust; Hepatology Clinical Research Facility | London | W2 1NY | United Kingdom |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D012254 | Ribavirin |
| C552098 | 2'-fluoro-2'-methyl-3',5'-diisobutyryldeoxycytidine |
| C100416 | peginterferon alfa-2a |
| C486464 | telaprevir |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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