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

Chronic Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02493855
• Other study ID #: M14-242
• Secondary ID: 2014-001478-32
• Status: Completed
• Phase: Phase 2
• First received: July 2, 2015
• Last updated: September 29, 2017
• Start date: June 2015
• Est. completion date: December 2016

Study information

• Verified date: September 2017
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Screening laboratory result indicating HCV genotype 1 (GT1) a infection.

2. Chronic HCV infection.

3. Subjects must be non-cirrhotic.

4. 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:

1. Women who are pregnant or breastfeeding.

2. Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab) positive immunoassay.

3. Clinically significant abnormalities or co-morbidities, other than HCV infection, that make the subject unsuitable for this study or treatment.

4. 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.

5. History or solid organ transplant.

6. Screening laboratory analysis that shows abnormal results.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Ombitasvir/ABT-450/Ritonavir
Ombitasvir/ABT-450/ritonavir combination tablets
• Dasabuvir
Dasabuvir tablets
• Ribavirin (RBV)
Ribavirin tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From Week 0 to Week 2