Clinical Trials

MainTitle

Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir Co-Administered With Sofosbuvir With and Without Ribavirin in Treatment-Naive HCV Genotype 1-Infected Adults

This study has been completed
Sponsor
AbbVie


Information provided by (Responsible Party)
AbbVie
ClinicalTrials.gov Identifier
NCT02399345

First received: March 23, 2015
Last updated: October 19, 2016
Last Verified: October 2016
History of Changes
Purpose

Purpose

This open-label study will evaluate the safety and efficacy of co-formulated ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with sofosbuvir with or without ribavirin administered for either 4 or 6 weeks in treatment naive adults with chronic HCV-genotype 1 infection without cirrhosis

Condition Intervention Phase
Chronic Hepatitis C Virus (HCV Infection Genotype 1)

Drug : ombitasvir/paritaprevir/ritonavir, dasabuvir
Drug : sofosbuvir (SOF)
Drug : ribavirin (RBV)
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Treatment Duration-Ranging Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/ Ritonavir (Ombitasvir/ABT-450/r) and Dasabuvir Co-administered With Sofosbuvir (SOF) With and Without Ribavirin (RBV) in Direct-Acting Antiviral Agent (DAA) Treatment-Naive Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

Further study details as provided by AbbVie:

Primary Outcome Measures

  • Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment [ Time Frame: 12 weeks after the last actual dose of study drug ]
    The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.
Secondary Outcome Measures:
  • Percentage of Subjects With On-treatment Virologic Failure [ Time Frame: 6 weeks ]
    Virologic failure during treatment was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase from nadir in HCV RNA (defined as 2 consecutive HCV RNA measurements > 1 log10 IU/mL above nadir) during treatment; or failure to suppress during treatment (defined as all values of HCV RNA ≥ LLOQ during treatment).
  • Percentage of Subjects With Post-treatment Relapse [ Time Frame: Up to 12 weeks after last actual dose of active study drug ]
    Percentage of subjects with HCV RNA less than the lower limit of quantification at the end of treatment with confirmed HCV RNA greater than or equal to the lower limit of quantification through 12 weeks post treatment

Enrollment: 10
Study Start Date: March 2015
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF plus RBV
Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.
Drug: ombitasvir/paritaprevir/ritonavir, dasabuvir

tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet

Other Name:
  • Viekira PAK
  • ombitasvir also known as ABT-267
  • paritaprevir also known as ABT-450
  • dasabuvir also known as ABT-333

Drug: sofosbuvir (SOF)

tablet

Drug: ribavirin (RBV)

tablet

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 99 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

    1. Male or female at least 18 years of age at time of screening
    2. Chronic Hepatitis C virus (HCV) infection prior to study enrollment
    3. Screening laboratory results from the central clinical laboratory indicating HCV genotype 1 infection only
    4. Absence of cirrhosis and advanced bridging fibrosis


Exclusion Criteria:
    1. Positive test result for hepatitis B surface antigen (HbsAg) or human immunodeficiency virus (HIV) positive immunoassay
    2. Clinically significant abnormalities or co-morbidities, other than HCV infection, that make the subject an unsuitable candidate for this study or treatment with Ribavirin (RBV) in the opinion of the investigator
    3. Any current or past clinical evidence of cirrhosis such as ascites or esophageal varices, or prior biopsy showing cirrhosis or advanced bridging fibrosis, e.g., a Metavir score > 2 or an Ishak score > 3
    4. Use of medications contraindicated for ombitasvir/paritaprevir/ritonavir, dasabuvir, sofosbuvir, or ribavirin (RBV; for those that receive RBV), within 2 weeks or 10 half-lives whichever is longer, prior to study drug administration
    5. Current enrolment in another clinical study, previous enrolment in this study, or
    previous use of any investigational or commercially available anti-HCV agents

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02399345

Sponsors and Collaborators

AbbVie

Investigators

Study Director: Eric Cohen, MD AbbVie
More Information

More Information

Additional Information:

Related info.

Responsible Party: AbbVie  
ClinicalTrials.gov Identifier: NCT02399345   History of Changes  
Other Study ID Numbers: M15-310  
  2014-005280-32  
Study First Received: March 23, 2015  
Last Updated: October 19, 2016  

Keywords provided by AbbVie:

Treatment naive
Hepatitis C Genotype 1

Additional relevant MeSH terms:
Infection
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Ribavirin
Ritonavir
Sofosbuvir

ClinicalTrials.gov processed this data on December 08, 2017
This information is provided by ClinicalTrials.gov.