Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000638-21 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This randomized, open-label, multicenter study will evaluate the safety , efficacy and tolerability of the combination treatment RO5466731, RO5190591, ritonavir and Copegus (ribavirin) with or without RO5024048 in patients with chronic hepatitis C genotype 1. In Part 1, treatment-naïve patients will be randomized to receive treatment with RO5466731, RO5190591 plus ritonavir, and Copegus, with or without RO5024048. In Part 2, further treatment-naïve patients will receive a successful regimen from Part 1, or a reduced intensity regimen, and patients who have previously experienced null response to interferon-based treatment will be added to the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: GT1a 3DAA | Experimental | including RO5466731, RO5190591, ritonavir, ribavirin [Copegus] and RO5024048 |
|
| B: GT1a 3DAA | Experimental | including RO5466731, RO5190591, ritonavir, ribavirin [Copegus] and RO5024048 |
|
| C: GT1a 2DAA | Experimental | including RO5466731, RO5190591, ritonavir and ribavirin [Copegus] |
|
| D: GT1b 3DAA | Experimental | including RO5466731, RO5190591, ritonavir, ribavirin [Copegus] and RO5024048 |
|
| E: GT1b 2DAA | Experimental | including RO54664731, RO5190591, ritonavir and ribavirin [Copegus] |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO5024048 | Drug |
| ||
| RO5190591 |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained virological response (defined as undetectable serum HCV RNA) 12 weeks after end of treatment | approximately 20 months | |
| Safety: Incidence of adverse events | approximately 20 months |
| Measure | Description | Time Frame |
|---|---|---|
| Antiviral activity: Change in serum HCV RNA levels | from baseline to 24 weeks after end of treatment | |
| Pharmacokinetics in coadministration: Area under the concentration-time curve (AUC) | Pre-dose Weeks 1, 2, 3, 4, 6, 10, and 12 and up to 12 hours post-dose Weeks 1, and 4 or 3 and 6 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Jolla | California | 92037 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26519669 | Derived | Jensen DM, Brunda M, Elston R, Gane EJ, George J, Glavini K, Hammond JM, Le Pogam S, Najera I, Passe S, Piekarska A, Rodriguez I, Zeuzem S, Chu T; ANNAPURNA study investigators. Interferon-free regimens containing setrobuvir for patients with genotype 1 chronic hepatitis C: a randomized, multicenter study. Liver Int. 2016 Apr;36(4):505-14. doi: 10.1111/liv.12997. Epub 2015 Dec 12. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Part II | Experimental |
|
| Drug |
|
| RO5466731 | Drug |
|
| ribavirin [Copegus] | Drug |
|
| ritonavir | Drug |
|
| HCV drug resistance | approximately 20 months |
| Quality of life: Short-Form 36v2/Brief Fatigue Inventory questionnaires | approximately 20 months |
| Englewood |
| Colorado |
| 80113 |
| United States |
| South Miami | Florida | 33143 | United States |
| Marietta | Georgia | 30060 | United States |
| Honolulu | Hawaii | 96813 | United States |
| Chicago | Illinois | 60637 | United States |
| Kansas City | Kansas | 66160 | United States |
| Detroit | Michigan | 48202 | United States |
| Saint Louise | Missouri | 63104 | United States |
| Asheville | North Carolina | 28801 | United States |
| Dallas | Texas | 75246 | United States |
| Houston | Texas | 77030 | United States |
| San Antonio | Texas | 78215 | United States |
| San Antonio | Texas | 78234 | United States |
| Vancouver | Washington | 98664 | United States |
| Kingswood | New South Wales | Australia |
| Sydney | New South Wales | 2050 | Australia |
| Westmead | New South Wales | 2145 | Australia |
| Herston | Queensland | 4029 | Australia |
| Parkville | Victoria | 3052 | Australia |
| Berlin | 13353 | Germany |
| Frankfurt am Main | 60590 | Germany |
| Hamburg | 20099 | Germany |
| Hanover | 30625 | Germany |
| Dunedin | 9016 | New Zealand |
| Grafton | 1010 | New Zealand |
| Hamilton | New Zealand |
| Bialystok | 15-540 | Poland |
| Chorzów | 41-500 | Poland |
| Lodz | 91-357 | Poland |
| Mysłowice | 41-400 | Poland |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D012254 | Ribavirin |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided