- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02725866
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Participants With Chronic Hepatitis C
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Participants With Chronic Hepatitis C - An Observational Study in Greece
The interferon-free combination regimen of paritaprevir/ritonavir/ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well-controlled conditions.
This observational study is the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to the local label, under real-world conditions in Greece in a clinical practice patient population.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Treatment-naïve or -experienced adult male or female participants with confirmed chronic hepatitis C (CHC), genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± ribavirin (RBV) according to standard of care and in line with the current local label
- If RBV was co-administered with the ABBVIE REGIMEN, it had to be prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy)
- Participants had to voluntarily sign and date an informed consent form prior to inclusion into the study
- Participant must not have participated or intended to participate in a concurrent interventional therapeutic trial
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Participants with HCV genotype 1 or 4
Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks
|
Tablet
Other Names:
Tablet
Co-formulated tablet
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
Time Frame: 12 weeks after the last actual dose of study drug
|
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL 12 weeks after the last actual dose of study drug. The core population (CP) consisted of participants who met all inclusion criteria and were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). The core population with sufficient follow-up data 12 weeks after the last actual dose of study drug (CPSFU12) was defined as all CP participants who fulfilled one of the following criteria:
|
12 weeks after the last actual dose of study drug
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Meeting Premature Study Drug Discontinuation Criteria
Time Frame: 12 weeks after the last actual dose of study drug
|
Premature study drug discontinuation was defined as participants who prematurely discontinued study drug with no on-treatment virologic failure.
|
12 weeks after the last actual dose of study drug
|
Percentage of Participants With Virologic Response at End of Treatment (EoT)
Time Frame: Up to 24 weeks
|
Virologic response was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment.
|
Up to 24 weeks
|
Percentage of Participants With Relapse
Time Frame: Up to 24 weeks
|
Relapse was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment followed by HCV RNA level greater than or equal to 50 IU/mL.
|
Up to 24 weeks
|
Percentage of Participants With Viral Breakthrough
Time Frame: Up to 24 weeks
|
Viral breakthrough was defined as at least 1 documented plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL followed by HCV RNA level greater than or equal to 50 IU/mL during treatment.
|
Up to 24 weeks
|
Percentage of Participants With On-treatment Virologic Failure
Time Frame: 12 weeks after the last actual dose of study drug
|
On-treatment virologic failure was defined as breakthrough (at least 1 documented plasma hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value greater than or equal to 50 IU/mL).
|
12 weeks after the last actual dose of study drug
|
Percentage of Participants Meeting Relapse Criteria
Time Frame: 12 weeks after the last actual dose of study drug
|
Relapse was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA greater than or equal to 50 IU/mL post-treatment.
|
12 weeks after the last actual dose of study drug
|
Percentage of Participants With Missing Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) Data and/or Nonresponders Who Did Not Meet Specific SVR12 Nonresponder Criteria
Time Frame: 12 weeks after the last actual dose of study drug
|
The number of participants with missing SVR12 data or SVR12 nonresponder participants who did not meet criteria for on-treatment virologic failure, relapse, premature treatment discontinuation, and who did not have an Insufficient virological response was documented.
|
12 weeks after the last actual dose of study drug
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Georgios Mitas, MS, AbbVie Pharmaceuticals S.A. (Greece)
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis, Chronic
- Hepatitis C, Chronic
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Protease Inhibitors
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Ribavirin
- Ritonavir
Other Study ID Numbers
- P15-842
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Hepatitis C
-
Sohag UniversityRecruiting
-
Tripep ABInovio PharmaceuticalsUnknownChronic Hepatitis C Virus InfectionSweden
-
AbbVieCompletedHepatitis C Virus | Chronic Hepatitis C Virus
-
AbbVie (prior sponsor, Abbott)CompletedHepatitis C | Chronic Hepatitis C Infection | HCV | Hepatitis C Genotype 1United States
-
Humanity and Health Research CentreBeijing 302 Hospital; Nanfang Hospital of Southern Medical University; Yamanashi...Recruiting
-
Sunshine Lake Pharma Co., Ltd.CompletedChronic Hepatitis cChina
-
Ascletis Pharmaceuticals Co., Ltd.CompletedChronic Hepatitis cChina
-
Hospices Civils de LyonCompleted
-
Hadassah Medical OrganizationXTL BiopharmaceuticalsWithdrawnChronic Hepatitis C Virus InfectionIsrael
Clinical Trials on Dasabuvir
-
AbbVie (prior sponsor, Abbott)CompletedHCV InfectionUnited States, Puerto Rico
-
Kaiser PermanenteAbbVieCompletedHepatitis C, ChronicUnited States
-
AbbVie (prior sponsor, Abbott)CompletedChronic Hepatitis C Virus InfectionUnited States, Puerto Rico
-
AbbVieCompleted
-
AbbVieCompleted
-
AbbVieCompletedCirrhosis | Chronic Hepatitis C | Hepatitis C Virus
-
AbbVieCompletedChronic Hepatitis C | Hepatitis C Virus | Severe Renal Impairment | Compensated Cirrhosis | End-stage Renal Disease
-
AbbVieTerminated
-
AbbVieCompletedChronic Hepatitis C Virus (HCV Infection Genotype 1)