A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Ribavirin in Adults With Genotype 1 and Ombitasvir/Paritaprevir/Ritonavir With Ribavirin in Adults With Genotype 4 Chronic Hepatitis C Virus Infection and Decompensated Cirrhosis

NCT02219477 | Completed Phase 3 Results

• 2 other identifiers: M14-2272014-001477-13
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objectives of this study are to assess the safety and the SVR12 rate of ombitasvir/paritaprevir/ritonavir and dasabuvir with RBV in GT1-infected participants with decompensated cirrhosis.

Conditions

Chronic Hepatitis C; Decompensated Cirrhosis; Hepatitis C Virus

Keywords

Cirrhosis; Hepatitis C; Child-Pugh B; Hepatitis C Genotype 4; Interferon-Free; Hepatitis C Genotype 1; Chronic Hepatitis C; Decompensated Cirrhosis; Hepatitis C Virus

Outcome Measures

Primary Outcomes (1)

• Percentages of Participants With Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) in Group 1 and in Group 2

  SVR12, defined as HCV RNA \< lower limit of quantification (LLOQ) in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Flanking imputation: for participants with missing HCV RNA at a visit who have an undetectable HCV RNA or unquantifiable HCV RNA at the preceding visit and the succeeding visit, the missing value was imputed as undetectable or unquantifiable. For SVR analyses, if there was no value in the window after the flanking imputation but there was an HCV RNA value after the window, then it was imputed into the SVR window. After above imputations were applied, if there was still no value in the window but there was an HCV RNA value from a local laboratory present, then it was imputed into the SVR window. Otherwise, participants with missing data were counted as failures. The 95% confidence interval was calculated using the Wilson score method.

  12 weeks after the last actual dose of study drug

Secondary Outcomes (7)

• Percentage of Participants With SVR12 in Group 3

  12 weeks after the last actual dose of study drug

• Percentage of Participants With SVR12 Non-Response Due to Experiencing On-Treatment Virologic Failure

  Up to 24 weeks during treatment

• Percentage of Participants With SVR12 Non-Response Due to Experiencing Relapse˅12

  Up to 12 weeks after the last actual dose of study drug

• Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Hepatic Function Tests

  Up to post-treatment Week 12

• Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in FibroTest

  Up to post-treatment Week 12

Study Arms (3)

Group 1: GT1B

EXPERIMENTAL

ombitasvir/paritaprevir/ritonavir 25/150/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) + ribavirin (RBV) for 12 weeks in hepatitis C virus (HCV) genotype (GT) 1b-infected participants

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

Group 2: GT1 Non-B

EXPERIMENTAL

ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants

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

Group 3: GT4

EXPERIMENTAL

ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants

Drug: ombitasvir/paritaprevir/ritonavir; Drug: ribavirin

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

Group 1: GT1B; Group 2: GT1 Non-B; Group 3: GT4

dasabuvir DRUG

tablet

Also known as: ABT-333

Group 1: GT1B; Group 2: GT1 Non-B

ribavirin DRUG

tablet

Group 1: GT1B; Group 2: GT1 Non-B; Group 3: GT4

Eligibility Criteria

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

You may qualify if:

• HCV GT1- or GT4-infection defined as: positive for anti-HCV Ab, HCV RNA \> 1,000 IU/mL and laboratory result indicating HCV GT1 or GT4 infection at Screening.
• Evidence of cirrhosis by prior liver biopsy, FibroScan or by radiograph (i.e., computed tomography \[CT\] scan or magnetic resonance imaging \[MRI\]).
• Child-Pugh Score of 7 - 9, inclusive, at time of Screening.

You may not qualify if:

• Women who are pregnant or breastfeeding.
• Positive test result for Hepatitis B surface antigen (HbsAg) or anti-HIV antibodies (HIV Ab).
• Prior or current use of any other investigational or commercially available anti-HCV agents other than interferon/RBV and/or pegylated interferon (pegIFN)/RBV (including but not limited to telaprevir, boceprevir, sofosbuvir and simeprevir).
• Confirmed presence of hepatocellular carcinoma indicated on imaging techniques such as CT scan or MRI within 3 months prior to Screening or on an ultrasound performed at Screening (a positive ultrasound result will be confirmed with CT scan or MRI).
• Any current or past evidence of Child-Pugh C classification.

Sponsors & Collaborators

• AbbVie: lead

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C; Fibrosis

Interventions

ombitasvir; paritaprevir; Ritonavir; dasabuvir; 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)

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

• Eric Cohen, 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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2014
• First Posted: August 19, 2014
• Study Start: November 24, 2014
• Primary Completion: June 13, 2016
• Study Completion: March 3, 2017
• Last Updated: July 11, 2017
• Results First Posted: July 11, 2017

Record last verified: 2017-06