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Ombitasvir/ABT-450/Ritonavir and Dasabuvir Therapy With Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment Naive Genotype 1a Hepatitis C Virus Infected Adults

Primary Purpose

Chronic Hepatitis C, Hepatitis C (HCV), Hepatitis C Genotype 1a

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Ombitasvir/ABT-450/Ritonavir

Dasabuvir

Ribavirin (RBV)

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Treatment naive, HCV, Interferon free, Hepatitis C Genotype 1a, Chronic Hepatitis C, Hepatitis C

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Screening laboratory result indicating HCV genotype 1 (GT1) a infection.
Chronic HCV infection.
Subjects must be non-cirrhotic.
Subjects must be able to understand and adhere to the study visit schedule and all protocol requirements as well as voluntarily sign and date an institutional review board (IRB) approved informed consent.

Exclusion Criteria:

Women who are pregnant or breastfeeding.
Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab) positive immunoassay.
Clinically significant abnormalities or co-morbidities, other than HCV infection, that make the subject unsuitable for this study or treatment.
Current enrollment in another interventional clinical study. Previous use of any HCV treatments including pegylated interferon (pegIFN), ribavirin, or any direct acting antiviral agent, either investigational or approved, for HCV including protease inhibitors, nucleoside or non-nucleoside polymerase inhibitors, or nonstructural viral protein 5A (NS5A) inhibitors.
History or solid organ transplant.
Screening laboratory analysis that shows abnormal results.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Arm A: Ribavirin Full Dose for Last 10 Weeks

Arm B: Ribavirin Full Dose for 12 Weeks

Arm C: Ribavirin Low-dose for 12 Weeks

Arm Description

Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks.

Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks.

Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks.

Outcomes

Primary Outcome Measures

Slope of the Second Phase Decline in Plasma HCV Ribonucleic Acid (RNA) Levels During Treatment

HCV viral kinetics in plasma during therapy were modeled through non-linear mixed effect models, including a rapid first phase of initial decline and a slower second phase decline. The slope of the second phase decline was estimated for each treatment arm.

Secondary Outcome Measures

Full Information

NCT ID

NCT02493855

First Posted

July 2, 2015

Last Updated

September 29, 2017

Sponsor

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT02493855

Brief Title

Ombitasvir/ABT-450/Ritonavir and Dasabuvir Therapy With Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment Naive Genotype 1a Hepatitis C Virus Infected Adults

Official Title

An Exploratory Study to Evaluate the Kinetics of Viral Load Decline With Ombitasvir/ABT 450/Ritonavir (Ombitasvir/ABT-450/r) and Dasabuvir Therapy With Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment Naïve Adults With Genotype 1a Chronic Hepatitis C Virus (HCV) Infection

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

June 2015 (Actual)

Primary Completion Date

April 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

To evaluate the effect of ribavirin on second phase plasma hepatitis C virus (HCV) ribonucleic acid (RNA) decline in participants who receive ombitasvir/ABT-450/ritonavir and dasabuvir with full dose ribavirin, low dose ribavirin or without ribavirin for 2 weeks in treatment-naive HCV genotype (GT) 1a-infected adults.

6. Conditions and Keywords

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

Chronic Hepatitis C, Hepatitis C (HCV), Hepatitis C Genotype 1a

Keywords

Treatment naive, HCV, Interferon free, Hepatitis C Genotype 1a, Chronic Hepatitis C, Hepatitis C

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A: Ribavirin Full Dose for Last 10 Weeks

Arm Type

Experimental

Arm Description

Arm Title

Arm B: Ribavirin Full Dose for 12 Weeks

Arm Type

Experimental

Arm Description

Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks.

Arm Title

Arm C: Ribavirin Low-dose for 12 Weeks

Arm Type

Experimental

Arm Description

Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks.

Intervention Type

Drug

Intervention Name(s)

Ombitasvir/ABT-450/Ritonavir

Other Intervention Name(s)

ABT-267/ABT-450/ritonavir

Intervention Description

Ombitasvir/ABT-450/ritonavir combination tablets

Intervention Type

Drug

Intervention Name(s)

Dasabuvir

Other Intervention Name(s)

ABT-333

Intervention Description

Dasabuvir tablets

Intervention Type

Drug

Intervention Name(s)

Ribavirin (RBV)

Intervention Description

Ribavirin tablets

Primary Outcome Measure Information:

Title

Slope of the Second Phase Decline in Plasma HCV Ribonucleic Acid (RNA) Levels During Treatment

Description

Time Frame

From Week 0 to Week 2

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Screening laboratory result indicating HCV genotype 1 (GT1) a infection. Chronic HCV infection. Subjects must be non-cirrhotic. Subjects must be able to understand and adhere to the study visit schedule and all protocol requirements as well as voluntarily sign and date an institutional review board (IRB) approved informed consent. Exclusion Criteria: Women who are pregnant or breastfeeding. Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab) positive immunoassay. Clinically significant abnormalities or co-morbidities, other than HCV infection, that make the subject unsuitable for this study or treatment. Current enrollment in another interventional clinical study. Previous use of any HCV treatments including pegylated interferon (pegIFN), ribavirin, or any direct acting antiviral agent, either investigational or approved, for HCV including protease inhibitors, nucleoside or non-nucleoside polymerase inhibitors, or nonstructural viral protein 5A (NS5A) inhibitors. History or solid organ transplant. Screening laboratory analysis that shows abnormal results.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Emily Dumas, PhD

Organizational Affiliation

AbbVie

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

Ombitasvir/ABT-450/Ritonavir and Dasabuvir Therapy With Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment Naive Genotype 1a Hepatitis C Virus Infected Adults

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