23 completed, 1 terminated. 18 Phase 3, 4 Phase 2, 2 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 18 | Completed 17, Terminated 1 |
| Phase 2 | 4 | Completed 4 |
| Phase 4 | 2 | Completed 2 |
Follow Viekira Pak: new trials by email Literature Review of Viekira Pak trials Research Report on Viekira Pak
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Treatment of Recently Acquired Hepatitis C With the 3D Regimen or G/P Paritaprevir/ritonavir/ombitasvir, Dasabuvir, Ribavirin - Hepatitis C, Acute | Phase 3 | Completed | Kirby Institute | 83 | 2016-06-01 | 2022-08-22 |
| Study of Oral Treatments for Hepatitis C SOF/LDV (sofosbuvir/ledipasvir), PrOD (ombitasvir/paritaprevir/ritonavir with dasabuvir) (Phase 1 only), EBR/GZR (elbasvir/grazoprevir) - Chronic Hepatitis C | Phase 4 | Completed | University of Florida | 1275 | 2016-06-01 | 2021-12-06 |
| Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Low-Dose Ribavirin QD in Subjects With Genotype 1a Chronic Hepatitis C Virus Infection ombitasvir/paritaprevir/ritonavir and dasabuvir, ribavirin - Hepatitis C Virus (HCV) | Phase 3 | Completed | AbbVie | 105 | 2015-10-28 | 2019-12-10 |
| Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir in Adults With Genotype 1a or Genotype 4 Chronic Hepatitis C Virus (HCV) Infection, With Severe Kidney Impairment or End Stage Kidney Disease ombitasvir/paritaprevir/ritonavir and dasabuvir, ombitasvir/paritaprevir/ritonavir - Hepatitis C Virus (HCV) | Phase 3 | Completed | AbbVie | 18 | 2015-09-30 | 2017-12-04 |
| A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/r With or Without Dasabuvir and With or Without Ribavirin in Chronic Hepatitis C Virus Genotype 1 or 4 Infected Adults With Successfully Treated Early Stage Hepatocellular Carcinoma ombitasvir/paritaprevir/ritonavir and dasabuvir, ombitasvir/paritaprevir/ritonavir, ribavirin - Chronic Hepatitis C Infection | Phase 3 | Terminated | AbbVie | 3 | 2015-07-01 | 2017-12-12 |
| ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection ombitasvir/paritaprevir/ritonavir and dasabuvir, Placebo for ombitasvir/paritaprevir/ritonavir and dasabuvir - Hepatitis C Virus (HCV) | Phase 3 | Completed | AbbVie | 650 | 2015-07-01 | 2017-10-27 |
| Real World Study: Genotype 1 Chronic Hepatitis C Virus Treatment and Evaluation of Real World SVR and PRO ombitasvir, paritaprevir/r, dasabuvir + ribavirin, ombitasvir, paritaprevir/r, dasabuvir - Hepatitis C, Chronic | Phase 4 | Completed | Kaiser Permanente | 200 | 2015-06-01 | 2021-01-22 |
| A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin in US Veterans With Genotype 1 Chronic Hepatitis C Virus Infection ombitasvir/paritaprevir/ritonavir and dasabuvir, Ribavirin - Chronic Hepatitis C, Cirrhosis | Phase 3 | Completed | AbbVie | 99 | 2015-05-13 | 2017-10-16 |
| A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs in Adults With Hepatitis C Virus Infection, Who Are Either Treatment-naive or Treatment-experienced in Brazil ombitasvir/paritaprevir/ritonavir and dasabuvir, ribavirin - Chronic Hepatitis C Infection | Phase 3 | Completed | AbbVie | 222 | 2015-04-27 | 2017-08-01 |
| Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir Co-Administered With Sofosbuvir With and Without Ribavirin in Treatment-Naive HCV Genotype 1-Infected Adults ombitasvir/paritaprevir/ritonavir, dasabuvir, sofosbuvir (SOF), ribavirin (RBV) - Chronic Hepatitis C Virus (HCV Infection Genotype 1) | Phase 3 | Completed | AbbVie | 10 | 2015-03-01 | 2016-12-12 |
| A Study of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Sofosbuvir and Ribavirin in Direct-Acting Antiviral Agent Treatment-Experienced Adults With Chronic Hepatitis C Virus Infection ombitasvir/paritaprevir/ritonavir and dasabuvir, Sofosbuvir, Ribavirin - Chronic Hepatitis C Infection | Phase 2 | Completed | AbbVie | 29 | 2015-02-03 | 2017-12-20 |
| DAAs Treatment for Chronic HCV/HBV Co-infection Patients(DASCO) Ledipasvir/Sofosbuvir, Sofosbuvir and Daclatasvir, Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir - Chronic Hepatitis C Infection, HBV Coinfection | Phase 2 / Phase 3 | Completed | Humanity and Health Research Centre | 23 | 2015-02-01 | 2021-09-01 |
| Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease ombitasvir/paritaprevir/ritonavir, dasabuvir, Ribavirin - Chronic Hepatitis C, Hepatitis C Virus | Phase 3 | Completed | AbbVie | 68 | 2014-09-23 | 2017-11-09 |
| A Study to Evaluate the Safety and Antiviral Effect of Multiple Doses of ABT-493 and ABT-530 in Adults With Genotype 1 Hepatitis C Virus (HCV) ABT-493, ABT-530, ABT-450/r/ABT-267, ABT-333 - Chronic Hepatitis C, Hepatitis C Virus | Phase 2 | Completed | AbbVie | 89 | 2013-11-01 | 2021-07-12 |
| A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) for Treatment of Chronic Hepatitis C Infection in Treatment-experienced Adults ABT-450/r/ABT-267, ABT-333, Ribavirin, Pegylated Interferon a-2a (PegINF) - Chronic Hepatitis C Infection | Phase 3 | Completed | AbbVie | 148 | 2013-06-01 | 2018-06-06 |
| A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1a Infection ABT-450/r/ABT-267, ABT-333, Ribavirin, Placebo for Ribavirin - Chronic Hepatitis C Infection | Phase 3 | Completed | AbbVie | 305 | 2013-03-01 | 2021-07-12 |
| A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) in People With Hepatitis C Virus Infection Who Have Not Had Treatment Before ABT-450/r/ABT-267, ABT-333, Ribavirin, Telaprevir - Chronic Hepatitis C Infection | Phase 3 | Completed | AbbVie | 311 | 2013-03-01 | 2018-06-06 |
| A Study to Evaluate Chronic Hepatitis C Infection in Adult Transplant Recipients ombitasvir/paritaprevir/ritonavir and dasabuvir, ombitasvir/paritaprevir/ritonavir, ribavirin - Chronic Hepatitis C Infection | Phase 2 | Completed | AbbVie | 129 | 2013-02-25 | 2017-11-07 |
| A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1b Infection ABT-450/r/ABT-267, ABT-333, Ribavirin, Placebo for ribavirin - Chronic Hepatitis C Infection | Phase 3 | Completed | AbbVie (prior sponsor, Abbott) | 419 | 2012-12-01 | 2021-07-12 |
| A Study to Evaluate Chronic Hepatitis C Infection in Treatment Experienced Adults ABT-450/r/ABT-267, ABT-333, Ribavirin, Placebo for ABT-450/r/ABT-267 - Chronic Hepatitis C Infection | Phase 3 | Completed | AbbVie (prior sponsor, Abbott) | 395 | 2012-11-01 | 2021-08-02 |
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Hepatitis C (19) · Hepatitis C, Chronic (17) · Fibrosis (5) · Hepatitis, Chronic (2) · Kidney Diseases (2) · Kidney Failure, Chronic (1) · Renal Insufficiency (1) · Renal Insufficiency, Chronic (1)
AbbVie (14) · AbbVie (prior sponsor, Abbott) (5) · Humanity and Health Research Centre (1) · Kaiser Permanente (1) · Kirby Institute (1) · Parc de Salut Mar (1) · University of Florida (1)
United States (2) · Australia (1) · China (1) · New Zealand (1) · United Kingdom (1)
Eric Cohen, MD (3) · Yan Luo, MD (2) · Dan Cohen, MD (1) · David R Nelson, MD (1) · Gail Matthews, MBBS PhD (1) · George Lau, M.D. (1) · Jeff Enejosa, MD (1) · Jeffrey Enejosa, MD (1) · Lisa M Nyberg, MD (1) · Nancy Shulman, MD (1) · Roger Trinh, MD (1) · Yan Luo, MD, PhD (1)
PMID 29377566, PMID 26321288, PMID 30291369, PMID 24720679, PMID 24720703, PMID 24818763, PMID 25386767, PMID 26248955, PMID 26596948, PMID 26711747, PMID 26976799, PMID 27115431, PMID 27762283, PMID 29909549, PMID 30980576, PMID 31493238, PMID 34255381, PMID 35182741, PMID 35657133, PMID 37771545
2014 (2), 2015 (2)