A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs in Adults With Hepatitis C Virus Infection, Who Are Either Treatment-naive or Treatment-experienced in Brazil

NCT02442271 | Completed Phase 3 Results

• 1 other identifier: M14-225
• Study Type: interventional
• Target: 222
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the proportion of subjects achieving sustained virologic response 12 weeks post-treatment (SVR12) in adults with genotype 1 (GT1) chronic HCV infection, who received treatment with 3 direct-acting antiviral agents (3-DAAs; ombitasvir/paritaprevir/ritonavir and dasabuvir) with or without ribavirin.

Conditions

Chronic Hepatitis C Infection

Keywords

Chronic Hepatitis C; Hepatitis C Treatment Naive; Hepatitis C Genotype 1; Hepatitis C Treatment Experienced; Hepatitis C Virus

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

  SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of study drug. Participants with missing data were counted as failures.

  12 weeks after the last actual dose of study drug

Secondary Outcomes (6)

• Percentage of Participants With SVR12 by Fibrosis Stage

  12 weeks after the last actual dose of study drug

• Percentage of Participants With SVR12 by Participant Prior HCV Treatment Experience

  12 weeks after the last actual dose of study drug

• Percentage of Participants With SVR12 by Participant Eligibility for Treatment With Interferon (IFN) at Screening

  12 weeks after the last actual dose of study drug

• Hepatitis C Virus Patient-Reported Outcomes Instrument (HCV-PRO) Total Score: Change From Baseline to 12 Weeks After the Last Dose of Study Drug

  Day 1 (Baseline), 12 weeks after the last actual dose of the study drug

• Short-Form 36 Version 2 Health Survey (SF-36v2) Physical Component Summary (PCS) Scores: Change From Baseline to 12 Weeks After the Last Dose of Study Drug

  Day 1 (Baseline), 12 weeks after the last actual dose of the study drug

Study Arms (1)

3-DAA ± RBV

EXPERIMENTAL

3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks.

Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir; Drug: ribavirin

Interventions

ombitasvir/paritaprevir/ritonavir and dasabuvir DRUG

Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet

Also known as: Viekira Pak, paritaprevir also known as ABT-450, ombitasvir also known as ABT-267, dasabuvir also known as ABT-333

3-DAA ± RBV

ribavirin DRUG

Tablet

3-DAA ± RBV

Eligibility Criteria

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

You may qualify if:

• Females must be post-menopausal for more than 2 years or surgically sterile or practicing acceptable forms of birth control
• Males must be surgically sterile or agree to practice acceptable forms of birth control
• Chronic hepatitis C virus (HCV) infection at screening
• Fibrosis stage F3 or greater, documented by acceptable tests
• Participants with cirrhosis: Absence of hepatocellular carcinoma (HCC) as indicated by acceptable methods

You may not qualify if:

• Women who are pregnant or breastfeeding
• Positive test result for Hepatitis B surface antigen (HbsAg) or anti-HIV antibody positive (HIV Ab)
• Use of contraindicated medications within 2 weeks of dosing
• Clinically significant abnormalities or co-morbidities
• History of solid organ transplant
• Abnormal laboratory tests
• Current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation

Sponsors & Collaborators

• AbbVie: lead

Related Links

• Related Info

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

ombitasvir; dasabuvir; Viekira Pak; paritaprevir; Ribavirin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

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: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: May 13, 2015
• Study Start: April 27, 2015
• Primary Completion: July 4, 2016
• Study Completion: September 26, 2016
• Last Updated: August 1, 2017
• Results First Posted: August 1, 2017

Record last verified: 2017-07