A Study to Evaluate Chronic Hepatitis C Virus (HCV) Infection in Cirrhotic Adults With Genotype 1b (GT1b) Infection

NCT02216422 | Completed Phase 3 Results

• 1 other identifier: M14-252
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

This was a multicenter study evaluating the efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with ribavirin (RBV) for 12 weeks in treatment naïve and pegylated-interferon alfa-2a or alfa-2b (pegIFN)/RBV treatment-experienced, cirrhotic HCV genotype 1b-infected adults.

Conditions

Chronic Hepatitis C Virus (HCV) Infection

Keywords

Chronic Hepatitis C; Hepatitis C; Hepatitis C Virus; Hepatitis C Genotype 1b; Interferon-Free

Outcome Measures

Primary Outcomes (1)

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

  Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (\< LLOQ; \< 25 IU/mL) 12 weeks after the last dose of study drug. Participants with missing data were imputed as failures.

  Post-treatment Day 1 to Post-treatment Week 12

Secondary Outcomes (2)

• Percentage of Participants With On-Treatment Virologic Failure

  Day 1 through Week 12

• Percentage of Participants With Post-Treatment Relapse

  Post-treatment Day 1 to Post-treatment Week 12

Study Arms (1)

Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir with RBV

EXPERIMENTAL

Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks

Drug: Ombitasvir/Paritaprevir/Ritonavir; Drug: Dasabuvir; Drug: Ribavirin (RBV)

Interventions

Ombitasvir/Paritaprevir/Ritonavir DRUG

Tablet; paritaprevir co-formulated with ritonavir and ombitasvir

Also known as: ABT-267 also known as ombitasvir, ABT-450 also known as paritaprevir, Ritonavir also known as norvir

Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir with RBV

Dasabuvir DRUG

Tablet

Also known as: ABT-333

Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir with RBV

Ribavirin (RBV) DRUG

Tablet

Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir with RBV

Eligibility Criteria

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

You may qualify if:

• Chronic hepatitis C, genotype 1b-infection (HCV RNA level greater than 1,000 IU/mL at Screening)
• Evidence of liver cirrhosis as confirmed by liver biopsy or Fibroscan with Child-Pugh score less than or equal to 6 at Screening
• Participant had never received antiviral treatment (including pegIFN/RBV) for hepatitis C infection (treatment-naïve participant) or had documentation of meeting one of the defined categories of a treatment-experienced participants
• Absence of hepatocellular carcinoma (HCC) as indicated by a negative ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI) performed within 3 months prior to screening or a negative ultrasound at screening.
• Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control
• Males must have been surgically sterile, or agreed to practice 2 effective methods of birth control throughout the course of the study.

You may not qualify if:

• Positive screen for hepatitis B Surface antigen or anti-Human Immunodeficiency virus antibody
• Evidence of current or past Child-Pugh B or C classification
• Confirmed presence of hepatocellular carcinoma
• Abnormal laboratory tests
• Participant who self-reported on average drinking more than 2 drinks per day for current drinkers
• Previous treatment with a direct acting antiviral agent (DAA) containing regimen
• History of solid organ transplant.

Sponsors & Collaborators

• AbbVie: lead

Related Links

• Related Info

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C; Infections

Interventions

ombitasvir; paritaprevir; Ritonavir; dasabuvir; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; 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)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

800-633-9110

Study Officials

• Rolando M Viani, MD

  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: August 12, 2014
• First Posted: August 15, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 29, 2016
• Results First Posted: June 29, 2016

Record last verified: 2016-05