A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/r With or Without Dasabuvir and With or Without Ribavirin in Chronic Hepatitis C Virus Genotype 1 or 4 Infected Adults With Successfully Treated Early Stage Hepatocellular Carcinoma

NCT02504099 | Terminated Phase 3 Results

• 2 other identifiers: M14-7262015-001049-10
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r), with or without dasabuvir (DSV) coadministered with or without ribavirin (RBV) for 12 or 24 weeks in adult patients with genotype 1 or genotype 4 chronic HCV infection and treated early stage Hepatocellular Carcinoma with compensated cirrhosis.

Conditions

Chronic Hepatitis C Infection

Keywords

Chronic Hepatitis C Infection; Early Stage Hepatocellular Carcinoma

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 after flanking imputation were imputed as nonresponders.

  12 weeks after the last actual dose of study drug

Secondary Outcomes (4)

• Percentage of Participants With On-treatment Virologic Failure

  Baseline (Day 1) and Treatment Weeks 2, 4, 8, 12 (end of treatment for 12-week treatment), 16, 20 and 24 (end of treatment for 12-week treatment)

• Percentage of Participants With Post-treatment Relapse

  From the end of treatment through 12 weeks after the last dose of study drug

• Percentage of Participants With Long Term Clinical Outcomes

  up to 48 weeks

• Percentage of Participants With Recurrent HCV Infection Post Liver Transplant

  from liver transplant to 24 weeks post-treatment (up to 48 weeks)

Study Arms (1)

OBV/PTV/r ± DSV ± RBV for 12 or 24 weeks

EXPERIMENTAL

OBV/PTV/r (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\]) with or without 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, dosed as per label based on HCV genotype/subtype and presence of cirrhosis.

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

OBV/PTV/r ± DSV ± RBV for 12 or 24 weeks

ombitasvir/paritaprevir/ritonavir DRUG

Tablet; ombitasvir coformulated with paritaprevir and ritonavir

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

OBV/PTV/r ± DSV ± RBV for 12 or 24 weeks

ribavirin DRUG

Tablet

OBV/PTV/r ± DSV ± RBV for 12 or 24 weeks

Eligibility Criteria

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

You may qualify if:

• Male or female, at least 18 years of age at time of screening
• Chronic hepatitis C virus (HCV) infection prior to study enrollment with screening laboratory results indicating HCV genotype 1 or 4 infection
• Early stage hepatocellular carcinoma (HCC) diagnosed based on the typical hallmark of HCC (hypervascular in the arterial phase with washout in the portal venous or delayed phases)
• Compensated cirrhosis defined as a Child-Pugh score of 5 or 6 at Screening
• A minimal rim of ascites if detected at imaging is acceptable. Exclude ascites that requires the need to apply diuretic treatment to control ascites
• Documented complete response to HCC treatment.
• Females must be post-menopausal for more than 2 years or surgically sterile or practicing acceptable forms of birth control.

You may not qualify if:

• Use of known strong or moderate inducers of cytochrome P450 3A (CYP3A) in participants receiving ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) with and without dasabuvir (DSV), strong inducers and inhibitors (e.g., gemfibrozil) of cytochrome P450 2C8 (CYP2C8) in participants receiving OBV/PTV/r with DSV, medications contraindicated for ritonavir or RBV (for those that receive RBV) within 2 weeks or 10 half-lives (if known), whichever is longer, prior to study drug . For medications contraindicated with AbbVie's 2-direct-acting antiviral agent (2-DAA) and 3-DAA regimen, refer to the recommended prescribing information section of the approved local product labels.
• Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
• Patients regardless of eligibility to liver transplant, who have a comorbid disease that might preclude completion of study follow-up.
• Clinically significant abnormalities, other than HCV infection, in a participant with HCC based upon the medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG) that make the participant an unsuitable candidate for this study in the opinion of the investigator.

Sponsors & Collaborators

• AbbVie: lead

Related Links

• Related Info

MeSH Terms

Interventions

ombitasvir; dasabuvir; Viekira Pak; paritaprevir; Ribavirin

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: July 20, 2015
• First Posted: July 21, 2015
• Study Start: July 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 12, 2017
• Results First Posted: December 12, 2017

Record last verified: 2017-11