Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Low-Dose Ribavirin QD in Subjects With Genotype 1a Chronic Hepatitis C Virus Infection

NCT02609659 | Completed Phase 3 Results

• 1 other identifier: M15-582
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study seeks to assess the safety and efficacy of treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir with low-dose ribavirin in non-cirrhotic, genotype 1a (GT1a) hepatitis C virus infected participants who are treatment-naïve or treatment-experienced with Interferon (IFN) or Pegylated Interferon (pegIFN) with or without Ribavirin (RBV).

Conditions

Hepatitis C Virus (HCV)

Keywords

Chronic Hepatitis C Infection

Outcome Measures

Primary Outcomes (3)

• 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. The primary efficacy endpoint was noninferiority of the percentage of participants who achieved SVR12 in participants in the treatment arm 3-DAA + RBV 600 mg) for 12 weeks compared with the historical control rate for subjects treated with 3-DAA + weight-based RBV for 12 weeks.

  12 weeks after the last actual dose of study drug

• Percentage of Participants With Hemoglobin < 10 g/dL During Treatment

  The percentage of participants with hemoglobin \<10 g/dL during treatment is provided.

  up to 12 weeks

• Mean Change in Hemoglobin Values From Baseline to End of Treatment

  The mean change in hemoglobin (g/L) from baseline to each study visit and to the final treatment visit (up to 12 weeks) is provided.

  Baseline (Day 1) to Weeks 2, 4, 8, and 12, and the Final Treatment Visit (up to 12 weeks)

Secondary Outcomes (2)

• Percentage of Participants With On-treatment Virologic Failure

  Up to 12 weeks

• Percentage of Participants With Post-treatment Relapse

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

Study Arms (1)

3-DAA + RBV 600 mg

EXPERIMENTAL

3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) plus RBV (ribavirin \[600 mg once daily\]) for 12 weeks.

Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir; 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

3-DAA + RBV 600 mg

ribavirin DRUG

Tablet

3-DAA + RBV 600 mg

Eligibility Criteria

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

You may qualify if:

• Chronic hepatitis C virus (HCV) infection
• Non-cirrhotic subjects
• Screening laboratory results showing HCV Genotype 1a (HCV GT1a) infection
• HCV treatment-naïve or if treated previously, only with interferon (IFN) or pegylated interferon (pegINF) with or without ribavirin (RBV)

You may not qualify if:

• Pregnant or breastfeeding women
• Positive for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab)
• HCV genotype of any subtype other than GT1a or unable to subtype
• Prior or current use of any investigational or commercially available anti-HCV agents other than IFN, pegIFN or RBV. Subjects with previous participation in trials of investigational direct-acting antiviral agents (DAAs) may be enrolled if they can produce documentation that they received only placebo.
• Current enrollment in another interventional clinical study or receipt of any investigational product within 6 weeks prior to study drug administration.

Sponsors & Collaborators

• AbbVie: lead

Related Publications (1)

• Poordad F, Sedghi S, Pockros PJ, Ravendhran N, Reindollar R, Lucey MR, Epstein M, Bank L, Bernstein D, Trinh R, Krishnan P, Polepally AR, Unnebrink K, Martinez M, Nelson DR. Efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir with low-dose ribavirin in patients with chronic hepatitis C virus genotype 1a infection without cirrhosis. J Viral Hepat. 2019 Aug;26(8):1027-1030. doi: 10.1111/jvh.13109. Epub 2019 May 6.

  PMID: 30980576 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Hepatitis C

Interventions

ombitasvir; dasabuvir; Viekira Pak; paritaprevir; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

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: November 18, 2015
• First Posted: November 20, 2015
• Study Start: October 28, 2015
• Primary Completion: October 7, 2016
• Study Completion: December 28, 2016
• Last Updated: December 10, 2019
• Results First Posted: October 18, 2017

Record last verified: 2017-09