Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin and Patient Support Program in Patients With Chronic Hepatitis C

NCT02817594 | Completed Results

• 1 other identifier: P15-788
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 9

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 the Netherlands in a clinical practice patient population.

Conditions

Chronic Hepatitis C

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug. Participants with missing HCV RNA were counted as virological failure.

  12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)

Secondary Outcomes (12)

• Percentage of Participants Achieving Virological Response at End of Treatment

  End of treatment (week 12 or 24 depending on the treatment regimen)

• Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 12 Weeks Post-treatment

  12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)

• Percentage of Participants With Relapse

  End of treatment (week 12 or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment.

• Percentage of Participants With Breakthrough

  12 or 24 weeks (depending on the treatment regimen)

• Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment

  12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)

Study Arms (1)

Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin

Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 12 or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease. The prescription of treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer the patient the opportunity to participate in this study.

Eligibility Criteria

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

Study Population

Adult patients chronically infected with HCV, receiving the interferon-free ABBVIE REGIMEN will be offered the opportunity to participate in this study during a routine clinical visit at the participating sites.

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).

You may not qualify if:

• Patients participating or intending to participate in a concurrent interventional therapeutic trial.
• Unable to complete the questionnaires due to cognitive impairment or lack of any kind of cognitive competence, as to be judged by the healthcare professional who is treating the patient.
• Unable to complete the questionnaires due to language incompetence.
• Unable to voluntarily sign and date the informed consent.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (9)

Albert Schweitzer Ziekenhuis /ID# 152597

Dordrecht, South Holland, 3318 AT, Netherlands

Location

Noordwest Ziekenhuisgroep /ID# 152604

Alkmaar, 1815 JD, Netherlands

Location

Duplicate_Onze Lieve Vrouwe Gasthuis /ID# 152600

Amsterdam, 1061 AE, Netherlands

Location

Universitair Medisch Centrum Groningen /ID# 152596

Groningen, 9713 GZ, Netherlands

Location

Leids Universitair Medisch Centrum /ID# 154637

Leiden, 2333 ZA, Netherlands

Location

Radbound University Medical Ce /ID# 152598

Nijmegen, 6526 GA, Netherlands

Location

Erasmus Medisch Centrum /ID# 154635

Rotterdam, 3015 CE, Netherlands

Location

Maasstad Ziekenhuis /ID# 152592

Rotterdam, 3079 DZ, Netherlands

Location

Universitair Medisch Centrum Utrecht /ID# 152595

Utrecht, 3584 CX, Netherlands

Location

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

• AbbVie Inc.

  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 27, 2016
• First Posted: June 29, 2016
• Study Start: January 20, 2016
• Primary Completion: March 7, 2018
• Study Completion: March 7, 2018
• Last Updated: May 17, 2019
• Results First Posted: May 17, 2019

Record last verified: 2019-01

Locations

NL (9)