Real World Evidence of the Effectiveness of Paritaprevir/Ritonavir (r) - Ombitasvir, + Dasabuvir Without Ribavirin in Participants With Chronic Hepatitis C and Compensated Liver Cirrhosis in the Russian Federation

NCT03053180 | Completed Results

• 1 other identifier: P16-253
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 7

Brief Summary

This prospective, multi-center, observational study is designed to assess the real world effectiveness of paritaprevir/r - ombitasvir with dasabuvir (3DAA \[direct-acting antiviral agent\] ABBVIE REGIMEN) without ribavirin (RBV) and to describe baseline characteristics of participants with chronic hepatitis C virus (HCV) genotype 1b (GT1b) infection and compensated liver cirrhosis in Russia.

Conditions

Chronic Hepatitis C

Keywords

Paritaprevir; Dasabuvir; Ombitasvir; Ritonavir; Ribavirin free; Chronic Hepatitis C genotype 1b (GT1b); Cirrhosis; Compensated liver cirrhosis; Hepatitis

Outcome Measures

Primary Outcomes (1)

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

  SVR12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug.

  12 weeks after the last dose of study drug (week 24)

Secondary Outcomes (5)

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

  End of treatment, maximum of 12 weeks

• Percentage of Participants With Relapse

  End of treatment (week 12) and up to 12 weeks after the end of treatment.

• Percentage of Participants With Breakthrough

  12 weeks

• Percentage of Participants With Failure to Suppress

  12 weeks

• Percentage of Participants With Missing SVR12 Data

  12 weeks after the last dose of study drug (week 24)

Study Arms (1)

Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir

Participants with chronic hepatitis C (CHC) genotype 1b (GT1b) and compensated liver cirrhosis received paritaprevir/ritonavir (r), ombitasvir and dasabuvir (3DAA ABBVIE REGIMEN) for 12 weeks. The prescription of a 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 a 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 chronic hepatitis C (CHC) genotype 1 (GT1b) and compensated liver cirrhosis will be recruited and observed in approximately 5-7 national and regional hospitals/outpatient services in Russia.

You may qualify if:

• DAA ABBVIE REGIMEN will be prescribed by physicians according to the routine clinical practice
• Treatment-naïve or interferon (IFN)/ribavirin (RBV)-experienced participants with confirmed CHC Gt1b and compensated liver cirrhosis, receiving therapy with the interferon-free 3DAA ABBVIE REGIMEN initiated not earlier than 2 weeks before the enrollment or the initiation is planned not later than 2 weeks after the day of enrollment in accordance to standard of care and in line with the current local label
• Participants must not be participating or intending to participate in a concurrent interventional therapeutic trial

You may not qualify if:

• Co-administration ribavirin (RBV) with the 3DAA ABBVIE REGIMEN
• Participants with Child Pugh B and C cirrhosis
• Participants with a history of prior direct-acting antiviral agent (DAA) therapy
• Any other contraindications to the administration of 3DAA ABBVIE REGIMEN according to the label

Sponsors & Collaborators

• AbbVie: lead

Study Sites (7)

South-Ural State Med. Academy

Chelyabinsk, 454052, Russia

Location

KOGBUZ Kirovsk Infect Hosp

Kirov, 610008, Russia

Location

Specialized Clinical Infectiou

Krasnodar, 350000, Russia

Location

Orenburg Regional Clinical Hos

Orenburg, 460018, Russia

Location

LLC Medical Company

Samara, 443063, Russia

Location

GBOU VPO Saratov state Med Uni

Saratov, 410012, Russia

Location

Ulyanovsk Regional Clin Hosp

Ulyanovsk, 432018, Russia

Location

Related Links

• Related Info

MeSH Terms

Conditions

Hepatitis C, Chronic; Fibrosis; Hepatitis

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; 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: February 8, 2017
• First Posted: February 15, 2017
• Study Start: March 20, 2017
• Primary Completion: December 18, 2017
• Study Completion: December 18, 2017
• Last Updated: March 14, 2019
• Results First Posted: March 14, 2019

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (7)