Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004129-28 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This open-label, parallel cohort study will evaluate the safety, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and ribavirin in treatment-naïve patients, and with RO5024048 added to the combination treatment in prior null responder patients with chronic hepatitis C genotype 1 or 4 and compensated cirrhosis. All patients will receive danoprevir 100 mg orally twice daily (bid) , ritonavir 100 mg orally bid, Pegasys 180 mcg subcutaneously weekly and ribavirin 1000-1200 mg/kg/day orally. Prior non-responders will receive RO5024048 1000 mg orally bid additionally. Anticipated time on study treatment is 24 weeks.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination without RO5024048 | Experimental | Ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and ribavirin in treatment-naïve patients |
|
| Combination with RO5024048 | Experimental | RO5024048 added to the combination treatment (ritonavir-boosted danoprevir in combination with Pegasys [peginterferon alfa-2a] and ribavirin) in prior null responder patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO5024048 | Drug | 1000 mg orally bid, 24 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | 48 weeks | |
| Pharmacokinetics (PK): Area under the concentration-time curve (AUC) | Intensive PK sample collection during initial 2 week dosing period, followed by routine sampling during treatment up to Week 24 | |
| Antiviral activity: Hepatitis C virus (HCV) RNA levels assessed by Roche COBAS Taqman HCV Test | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Emergence of viral resistance: HCV RNA gene sequence variations | From baseline to Week 48 | |
| Virologic response: HCV RNA levels | approximately 1 year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35294 | United States | |||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| danoprevir |
| Drug |
100 mg orally bid, 24 weeks |
|
| peginterferon alfa-2a [Pegasys] | Drug | 180 mcg weekly, 24 weeks |
|
| ribavirin | Drug | 1000-1200 mg/kg/day orally in two divided doses, 24 weeks |
|
| ritonavir | Drug | 100 mg orally bid, 24 weeks |
|
| Anaheim |
| California |
| 92801 |
| United States |
| Coronado | California | 92118 | United States |
| La Jolla | California | 92037 | United States |
| Long Beach | California | 90807 | United States |
| DeLand | Florida | 32720 | United States |
| Miami | Florida | 33136 | United States |
| Orlando | Florida | 32803 | United States |
| Atlanta | Georgia | 30308 | United States |
| Atlanta | Georgia | 30309 | United States |
| New Orleans | Louisiana | 70112 | United States |
| Detroit | Michigan | 48202-2689 | United States |
| Hillsborough | New Jersey | 08844 | United States |
| New York | New York | 10021 | United States |
| San Antonio | Texas | 78215 | United States |
| Fitzroy | South Australia | 3065 | Australia |
| Melbourne | Victoria | 3124 | Australia |
| Vancouver | British Columbia | V6Z 2C7 | Canada |
| Toronto | Ontario | M5G 2C4 | Canada |
| Montpellier | 34094 | France |
| Auckland | 1142 | New Zealand |
| Christchurch | 8140 | New Zealand |
| Chorzów | 41-500 | Poland |
| Mysłowice | 41-400 | Poland |
| Warsaw | 02-507 | Poland |
| Wroclaw | 51-149 | Poland |
| Bratislava | 833 05 | Slovakia |
| 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 |
|---|---|
| C553752 | danoprevir |
| C100416 | peginterferon alfa-2a |
| 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