Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study

NCT02798315 | Completed Results

• 1 other identifier: P15-699
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The interferon-free combination regimen of paritaprevir/r - 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 local label, under real world conditions in Kuwait in a clinical practice patient population.

Conditions

Chronic Hepatitis C

Keywords

Paritaprevir/r - Ombitasvir, ± Dasabuvir; Sustained Virological Response; Chronic Hepatitis C genotype 4; Observational Study; Chronic Hepatitis C genotype 1; Chronic Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)

  SVR12 defined as the HCV ribonucleic acid (RNA) level less than 50 IU/mL 12 weeks after the last dose of study drug

  12 weeks (i.e. at least 70 days) after the last dose of study drug

Secondary Outcomes (10)

• Percentage of Participants With Virological Response at End of Treatment (EoT)

  Up to EoT, maximum of 24 weeks

• Percentage of Participants With Relapse at EoT

  Up to EoT, maximum of 24 weeks

• Percentage of Participants With Breakthrough.

  Up to EoT, maximum of 24 weeks

• Percentage of Participants Meeting the SVR Non-response Categories of On-treatment Virologic Failure or Relapse

  12 weeks (i.e. at least 70 days) after the last dose of study drug

• Percentage of Participants Meeting the SVR Non-response Categories of Premature Study Drug Discontinuation or Missing SVR12 Data and/or None of the Above Criteria

  12 weeks (i.e. at least 70 days) after the last dose of study drug

Study Arms (1)

Participants With Hepatitis C Virus (HCV) Genotype 1 or 4

Participants with HCV genotype 1 or 4 receiving paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV. The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice and label, is made independently from this observational study and precedes the decision to offer the patient the opportunity to participate in this study.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with CHC, genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± RBV.

You may qualify if:

• Treatment-naïve or -experienced adult male or female participants with confirmed CHC, genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± RBV according to standard of care and in line with the current local label.
• If RBV is co-administered with the ABBVIE REGIMEN, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy).
• Participant must not be participating or intending to participate in a concurrent interventional therapeutic trial.

You may not qualify if:

• Participant must not be participating or attending in a concurrent interventional therapeutic trial.

Sponsors & Collaborators

• AbbVie: lead

Related Publications (1)

• Ferenci P, Bourgeois S, Buggisch P, Norris S, Curescu M, Larrey D, Marra F, Kleine H, Dorr P, Charafeddine M, Crown E, Bondin M, Back D, Flisiak R. Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir +/- dasabuvir +/- ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studies from 13 countries. J Viral Hepat. 2019 Jun;26(6):685-696. doi: 10.1111/jvh.13080. Epub 2019 Mar 5.

  PMID: 30739368 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• Hany Salaheldine, MD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 14, 2016
• Study Start: May 25, 2016
• Primary Completion: June 12, 2017
• Study Completion: June 12, 2017
• Last Updated: December 31, 2018
• Results First Posted: December 31, 2018

Record last verified: 2017-06