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

NCT02493855 | Completed Phase 2 Results

• 2 other identifiers: M14-2422014-001478-32
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Arm A: Ribavirin Full Dose for Last 10 Weeks

EXPERIMENTAL

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.

Drug: Ombitasvir/ABT-450/Ritonavir; Drug: Dasabuvir; Drug: Ribavirin (RBV)

Arm B: Ribavirin Full Dose for 12 Weeks

EXPERIMENTAL

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.

Drug: Ombitasvir/ABT-450/Ritonavir; Drug: Dasabuvir; Drug: Ribavirin (RBV)

Arm C: Ribavirin Low-dose for 12 Weeks

EXPERIMENTAL

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.

Drug: Ombitasvir/ABT-450/Ritonavir; Drug: Dasabuvir; Drug: Ribavirin (RBV)

Interventions

Ombitasvir/ABT-450/Ritonavir DRUG

Ombitasvir/ABT-450/ritonavir combination tablets

Also known as: ABT-267/ABT-450/ritonavir

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

Dasabuvir DRUG

Dasabuvir tablets

Also known as: ABT-333

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

Ribavirin (RBV) DRUG

Ribavirin tablets

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

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)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

800-633-9110

Study Officials

• Emily Dumas, PhD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2015
• First Posted: July 10, 2015
• Study Start: June 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 31, 2017
• Results First Posted: May 15, 2017

Record last verified: 2017-09