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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 (GEODE - I)

Primary Purpose

Chronic Hepatitis C Infection

Status

Terminated

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

ombitasvir/paritaprevir/ritonavir and dasabuvir

ombitasvir/paritaprevir/ritonavir

ribavirin

About this trial

This is an interventional treatment trial for Chronic Hepatitis C Infection focused on measuring Chronic Hepatitis C Infection, Early Stage Hepatocellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of Participants With On-treatment Virologic Failure

On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ throughout treatment with at least 6 weeks of treatment.

Percentage of Participants With Post-treatment Relapse

Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.

Percentage of Participants With Long Term Clinical Outcomes

The percentage of participants with long term clinical outcomes (de novo hepatocellular carcinoma (HCC) lesions, liver decompensation, unexpected liver transplant, liver related death, or any of the above) from first dose of study drug through 24 weeks post-treatment follow-up.

Percentage of Participants With Recurrent HCV Infection Post Liver Transplant

The percentage of participants with recurrent HCV infection post liver transplant out of all participants with liver transplant during the study.

Full Information

NCT ID

NCT02504099

First Posted

July 20, 2015

Last Updated

November 13, 2017

Sponsor

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT02504099

Brief Title

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

Acronym

GEODE - I

Official Title

Open-label Study to Evaluate the Safety and Efficacy of the Combination of Ombitasvir, Paritaprevir/r ± Dasabuvir With or Without Ribavirin (RBV) in Adult Patients With GT1 or GT4 Chronic HCV Infection and Response to Prior Treatment of Early Stage Hepatocellular Carcinoma (GEODE - I)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Terminated

Why Stopped

Study stopped due to low enrollment

Study Start Date

July 2015 (undefined)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis C Infection

Keywords

Chronic Hepatitis C Infection, Early Stage Hepatocellular Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

ombitasvir/paritaprevir/ritonavir and dasabuvir

Other Intervention Name(s)

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

Intervention Description

Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet

Intervention Type

Drug

Intervention Name(s)

ombitasvir/paritaprevir/ritonavir

Other Intervention Name(s)

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

Intervention Description

Tablet; ombitasvir coformulated with paritaprevir and ritonavir

Intervention Type

Drug

Intervention Name(s)

ribavirin

Intervention Description

Tablet

Primary Outcome Measure Information:

Title

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

Description

Time Frame

12 weeks after the last actual dose of study drug

Secondary Outcome Measure Information:

Title

Percentage of Participants With On-treatment Virologic Failure

Description

Time Frame

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)

Title

Percentage of Participants With Post-treatment Relapse

Description

Time Frame

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

Title

Percentage of Participants With Long Term Clinical Outcomes

Description

Time Frame

up to 48 weeks

Title

Percentage of Participants With Recurrent HCV Infection Post Liver Transplant

Description

The percentage of participants with recurrent HCV infection post liver transplant out of all participants with liver transplant during the study.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

AbbVie Inc

Organizational Affiliation

AbbVie

Official's Role

Study Director

12. IPD Sharing Statement

Links:

URL

http://rxabbvie.com

Description

Related Info

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