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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-012426-36 |
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This study will evaluate the efficacy, safety and tolerability of danoprevir (RO5190591) plus ritonavir as compared to danoprevir alone or placebo plus ritonavir in patients with chronic hepatitis C genotype 1 receiving Pegasys (peginterferon alfa-2a) and ribavirin. Patients in cohorts will be randomized to receive either oral doses of danoprevir, or danoprevir plus ritonavir, or placebo plus ritonavir. All patients will receive Pegasys (180mcg sc once weekly) plus ribavirin (1000-1200mg/day po), with the option to continue this treatment after completion of study drug treatment. Anticipated time on study treatment is up to 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator |
| |
| B | Experimental |
| |
| C | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| danoprevir | Drug | oral doses |
| |
| peginterferon alfa-2a [Pegasys] |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability: Adverse events, ECG, laboratory parameters | approximately 3 years | |
| Pharmacokinetics: Cmax, AUC, Cmin, Tmax, Cl, T1/2 | Days 3-9 | |
| Antiviral activity: HCV RNA (COBAS Taqman HCV Test) | from baseline to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Viral resistance development | from baseline to Day 17 | |
| Effects on cytochrome P450(CYP)2C9 and 3A isozymes | from baseline to Day 17 | |
| Virological response in prior null-responders |
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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 |
|---|---|---|---|---|---|---|
| Montpellier | 34094 | France | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24295986 | Derived | Gane EJ, Rouzier R, Wiercinska-Drapalo A, Larrey DG, Morcos PN, Brennan BJ, Le Pogam S, Najera I, Petric R, Tran JQ, Kulkarni R, Zhang Y, Smith P, Yetzer ES, Shulman NS. Efficacy and safety of danoprevir-ritonavir plus peginterferon alfa-2a-ribavirin in hepatitis C virus genotype 1 prior null responders. Antimicrob Agents Chemother. 2014;58(2):1136-45. doi: 10.1128/AAC.01515-13. Epub 2013 Dec 2. | |
| 23872824 |
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| Drug |
180 mcg sc once weekly |
|
| placebo | Drug | oral doses |
|
| ribavirin | Drug | 1000-1200mg/day po |
|
| ritonavir | Drug | oral doses |
|
| from baseline to week 72 |
| Comparison of pharmacokinetics and antiviral activity between treatment-naïve patients and prior null-responders to standard of care treatment | approximately 3 years |
| Christchurch |
| 8011 |
| New Zealand |
| Grafton | 1010 | New Zealand |
| Warsaw | 01-201 | Poland |
| Derived |
| Morcos PN, Chang L, Kulkarni R, Giraudon M, Shulman N, Brennan BJ, Smith PF, Tran JQ. A randomised study of the effect of danoprevir/ritonavir or ritonavir on substrates of cytochrome P450 (CYP) 3A and 2C9 in chronic hepatitis C patients using a drug cocktail. Eur J Clin Pharmacol. 2013 Nov;69(11):1939-49. doi: 10.1007/s00228-013-1556-y. Epub 2013 Jul 20. |
| 21354234 | Derived | Gane EJ, Rouzier R, Stedman C, Wiercinska-Drapalo A, Horban A, Chang L, Zhang Y, Sampeur P, Najera I, Smith P, Shulman NS, Tran JQ. Antiviral activity, safety, and pharmacokinetics of danoprevir/ritonavir plus PEG-IFN alpha-2a/RBV in hepatitis C patients. J Hepatol. 2011 Nov;55(5):972-9. doi: 10.1016/j.jhep.2011.01.046. Epub 2011 Feb 24. |
| 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 |
|---|---|
| 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 |
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