An Open-label, Single Arm, Phase 2 Study to Evaluate ABT-450/r/ABT-267 and ABT-333 With Ribavirin (RBV) in Adults With Genotype 1 HCV Infection Taking Methadone or Buprenorphine
NCT01911845 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38
Last updated 2018-05-30
Summary
The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) coadministered with ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected adults taking methadone or buprenorphine ± naloxone.
Conditions
- Chronic Hepatitis C Infection
- Chronic Hepatitis C
Interventions
- DRUG
-
ABT-450/r/ABT-267
Tablet; ABT-450 coformulated with ritonavir and ABT-267
- DRUG
-
ABT-333
Tablet
- DRUG
-
Ribavirin (RBV)
Tablet
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Dan Cohen, MD · AbbVie
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-04-30
- Primary Completion
- 2013-12-31
- Completion
- 2014-09-30
More Related Trials
-
A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1b Infection
NCT01767116 ·Status: COMPLETED ·Phase: PHASE3
-
ABT-450/Ritonavir/ ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-Administered With Ribavirin (RBV) in Treatment Naïve and Treatment Experienced Asian Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Compensated Cirrhosis
NCT02517528 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1a Infection
NCT01833533 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267; (ABT-267 Also Known as Ombitasvir) and ABT-333 (Also Known as Dasabuvir) Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis
NCT01704755 ·Status: COMPLETED ·Phase: PHASE3
-
A Multipart, Open-label Study to Evaluate the Safety and Efficacy of ABT-450/r/ABT-267 With and Without ABT-333 Coadministered With and Without Ribavirin in Adult With Genotype 1 or 4 Hepatitis C Virus (HCV) Infection and Human Immunodeficiency Virus, Type 1 Coinfection
NCT01939197 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Ombitasvir/ABT-450/Ritonavir and Dasabuvir Therapy With Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment Naive Genotype 1a Hepatitis C Virus Infected Adults
NCT02493855 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
NCT02219490 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) When Given Together With ABT-333 and Ribavirin (RBV) in Treatment-Naïve and Non-responder Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
NCT01306617 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate Chronic Hepatitis C Virus (HCV) Infection in Cirrhotic Adults With Genotype 1b (GT1b) Infection
NCT02216422 ·Status: COMPLETED ·Phase: PHASE3
-
Ombitasvir/ABT-450 (Paritaprevir)/Ritonavir With Dasabuvir and Ribavirin (RBV) in Treatment Naive and Treatment Experienced Genotype 1a Hepatitis C Virus Infected Adults
NCT02476617 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Safety and Antiviral Effect of ABT-450/Ritonavir and ABT-530 Coadministered With and Without Ribavirin in Adults With Genotype 3 Hepatitis C (HCV) Infection
NCT02068222 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Renally Impaired Adults With Chronic Hepatitis C Virus Genotype 1 - 6 Infection
NCT02651194 ·Status: COMPLETED ·Phase: PHASE3
-
A Randomized Study to Evaluate the Safety, Tolerability and Antiviral Activity of ABT-450, ABT-333 and ABT-072
NCT01074008 ·Status: COMPLETED ·Phase: PHASE2
-
ABT-450 With Ritonavir and ABT-267 and/or ABT-333 With and Without Ribavirin in Genotype 1 Hepatitis C Virus Infected Patients
NCT01464827 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate Chronic Hepatitis C Infection in Treatment Experienced Adults
NCT01715415 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Safety and Effect of Co-administration of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Adults With Chronic Hepatitis C Virus Infection
NCT01685203 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Safety and Effect of Treatment With Experimental Antiviral Drugs in Combination With Peginterferon Alpha-2a and Ribavirin in People With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie/Abbott Combination Study
NCT01609933 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Efficacy and Safety of Experimental Drugs ABT- 493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1-6 Infection and Human Immunodeficiency Virus -1 Coinfection (EXPEDITION-2)
NCT02738138 ·Status: COMPLETED ·Phase: PHASE3
-
The Effectiveness of ABT-450/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C -An Observational Study in Ireland
NCT02582671 ·Status: COMPLETED
-
A Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir With Sofosbuvir With or Without Ribavirin in Adults With Chronic Hepatitis C Virus Infection
NCT02292719 ·Status: COMPLETED ·Phase: PHASE2
-
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
NCT02356562 ·Status: COMPLETED ·Phase: PHASE2
-
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
NCT02517515 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT- 267 (ABT-450/r/ABT-267) in Japanese Adults With Genotype 2 Chronic Hepatitis C Virus (HCV) Infection
NCT02023112 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Multiple Doses of ABT-333 Alone and in Combination With Pegylated Interferon (pegIFN) and Ribavirin (RBV) in Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
NCT00851890 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Assess the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ABT-267 in HCV Infected Subjects
NCT01563536 ·Status: COMPLETED ·Phase: PHASE2