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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002714-37 | EudraCT Number |
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This randomized, double-blind, multi-center, placebo-controlled, parallel-group study will evaluate the sustained virologic response and the safety of mericitabine (RO5024048) in combination with boceprevir and Pegasys/Copegus in patients with chronic hepatitis C infection. The anticipated time on study treatment is up to 48 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm A | Experimental | 24 weeks of therapy with mericitabine 1000 mg twice a day (BID), boceprevir 800 mg three times daily (TID), Pegasys 180 microgram/week, and Copegus 1000/1200 mg/day (total treatment duration of 24 weeks), followed by a 24-week treatment-free follow-up period. |
|
| Treatment Arm B | Experimental | 24 weeks of therapy with mericitabine + boceprevir + Pegasys/Copegus followed by 24 weeks of therapy with boceprevir + Pegasys/Copegus (triple) (total treatment duration of 48 weeks), followed by a 24-week treatment-free follow-up period. |
|
| Treatment Arm C (Control) | Active Comparator | 4 weeks of therapy with mericitabine placebo, boceprevir placebo + Pegasys/Copegus, then 20 weeks of therapy with mericitabine placebo + boceprevir + Pegasys/Copegus, then 24 weeks of therapy with boceprevir + Pegasys/Copegus (total treatment duration of 48 weeks), followed by a 24-week treatment-free follow-up period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Copegus | Drug | total daily dose of 1000 mg or 1200 mg for 24 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained virological response 12 weeks after treatment (SVR-12) | up to 60 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained virological response 4 weeks after treatment | up to 52 weeks | |
| Virologic response over time | 60 weeks | |
| Proportion of patients who develop treatment resistance |
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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 |
|---|---|---|---|---|---|---|
| Littleton | Colorado | 80120 | United States | |||
| 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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| Copegus |
| Drug |
total daily dose of 1000 mg or 1200 mg for 48 weeks |
|
| Pegasys | Drug | 180 microgram subcutaneous once a week for 24 weeks |
|
| Pegasys | Drug | 180 microgram subcutaneous once a week for 48 weeks |
|
| boceprevir | Drug | 800 mg three times a day for 24 weeks |
|
| boceprevir | Drug | 800 mg three times a day for 48 weeks |
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| mericitabine | Drug | 1000 mg twice daily for 24 weeks |
|
| mericitabine placebo | Drug | mericitabine placebo |
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| boceprevir placebo | Drug | boceprevir placebo |
|
| boceprevir | Drug | 800 mg three times a day for 44 weeks |
|
| 60 weeks |
| Safety (incidence of adverse events) | 60 weeks |
| Pharmacokinetics: trough concentration of RO4995855 | Day 1 and Week 8 |
| Pharmacokinetics: trough concentration of RO5012433 | Day 1 and Week 8 |
| Pharmacokinetics: trough concentration of boceprevir | Day 1 and Week 8 |
| Chicago |
| Illinois |
| 60637 |
| United States |
| Shreveport | Louisiana | 71130 | United States |
| Detroit | Michigan | 48202 | United States |
| Kansas City | Missouri | 64128 | United States |
| San Antonio | Texas | 78215 | United States |
| Chesapeake | Virginia | 23320-1706 | United States |
| Calgary | Alberta | T2N 4Z6 | Canada |
| Vancouver | British Columbia | V5Z 1H2 | Canada |
| London | Ontario | N6A 5A5 | Canada |
| Créteil | 94010 | France |
| Nice | 06202 | France |
| Rennes | 35033 | France |
| Berlin | 13353 | Germany |
| Hamburg | 20099 | Germany |
| Hanover | 30625 | Germany |
| Naples | Campania | 80131 | Italy |
| Milan | Lombardy | 20121 | Italy |
| Florence | Tuscany | 50134 | Italy |
| Ponce | 00716 | Puerto Rico |
| Palma de Mallorca | Balearic Islands | 07010 | Spain |
| Santander | Cantabria | 39008 | Spain |
| Pontevedra | Pontevedra | 36071 | Spain |
| Valencia | Valencia | 46014 | Spain |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012254 | Ribavirin |
| C100416 | peginterferon alfa-2a |
| C512204 | N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide |
| C552098 | 2'-fluoro-2'-methyl-3',5'-diisobutyryldeoxycytidine |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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