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NCT Number: NCT02399345

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

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

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Key information

Conditions

Chronic Hepatitis C Virus (HCV Infection Genotype 1) Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Positive test result for hepatitis B surface antigen (HbsAg) or human immunodeficiency virus (HIV) positive immunoassay
  • 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
  • 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
  • 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
  • Current enrolment in another clinical study, previous enrolment in this study, or previous use of any investigational or commercially available anti-HCV agents

Treatment and study plan

ombitasvir/paritaprevir/ritonavir, dasabuvir

Drug

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

Other names: Viekira PAK, ombitasvir also known as ABT-267, paritaprevir also known as ABT-450, dasabuvir also known as ABT-333

sofosbuvir (SOF)

Drug

tablet

ribavirin (RBV)

Drug

tablet

Primary outcomes

  1. 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 outcomes

  1. 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).

  2. 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

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 26, 2015
Registry last updated
Dec 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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