3D8: Effectiveness, Safety and Clinical Outcomes of Paritaprevir/Ombitasvir/r+Dasabuvir 8 Weeks

Sponsor

Hepa C (Other)

Overall Status

Completed

CT.gov ID

NCT03122132

Collaborator

(none)

200

Enrollment

Location

12.3

Actual Duration (Months)

16.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is to evaluate in clinical practice the efficacy and safety of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b hepatitis C virus (HCV).

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C Infection	Drug: ombitasvir/paritaprevir/ritonavir 8 weeks Drug: dasabuvir 8 weeks

Detailed Description

HCV chronic infection affects 200 million people worldwide. HCV antiviral treatment has evolved rapidly since 2011. The introduction of direct-acting antivirals (DAAs) achieve great effectiveness with minimum SAEs and short treatment duration. However, studies evaluating efficacy and safety of ombitasvir/paritaprevir/ ritonavir and dasabuvir during 8 weeks are limited in real clinical practice. The aim of the study is to evaluate in clinical practice the efficacy and safety of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b hepatitis C virus (HCV).

Study Design

Study Type:

Observational

Actual Enrollment :

200 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Efficacy and Safety in Clinical Practice of Ombitasvir/Paritaprevir/ Ritonavir and Dasabuvir Administered for 8 Weeks (3D8) in Treatment-naïve Genotype 1b Hepatitis C Virus Infected Patients: Analysis of Data From Hepa-C Registry.

Actual Study Start Date :

Feb 20, 2017

Actual Primary Completion Date :

Jan 1, 2018

Actual Study Completion Date :

Mar 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Spanish cohort with HCV treated with DAA Spanish cohort with HCV treated in real practice with ombitasvir/paritaprevir/ritonavir 8 weeks and dasabuvir 8 weeks	Drug: ombitasvir/paritaprevir/ritonavir 8 weeks Spanish cohort with HCV treated in real practice with ombitasvir/paritaprevir/ ritonavir 8 weeks Other Names: viekirax Drug: dasabuvir 8 weeks Spanish cohort with HCV treated in real practice with dasabuvir 8 weeks Other Names: exviera

Arm

Intervention/Treatment

Spanish cohort with HCV treated with DAA

Spanish cohort with HCV treated in real practice with ombitasvir/paritaprevir/ritonavir 8 weeks and dasabuvir 8 weeks

Drug: ombitasvir/paritaprevir/ritonavir 8 weeks

Spanish cohort with HCV treated in real practice with ombitasvir/paritaprevir/ ritonavir 8 weeks

Other Names:

viekirax

Drug: dasabuvir 8 weeks

Spanish cohort with HCV treated in real practice with dasabuvir 8 weeks

Other Names:

exviera

Outcome Measures

Primary Outcome Measures

Sustained virological response 12 weeks post-treatment (SVR12) [12 weeks after the last dose of study drug]
Percentage of participants who achieve sustained virological response 12 weeks post-treatment (SVR12) • Measure: Hepatitis C virus ribonucleic acid (HCV-RNA) levels less than the lower limit of quantification.

Secondary Outcome Measures

Percentage of patients with virologic failure during treatment [Up to 12 weeks after last dose of study drug]
Percentage of patients with virologic failure during treatment • Measure: Percentage of patients with confirmed >=1 log10 IU/mL increase from nadir in HCV RNA at any time point during treatment
Mild fibrosis and sustained virological response 12 weeks post-treatment [Up to 12 weeks after last dose of study drug]
Percentage of patients with mild fibrosis who achieve sustained virological response 12 (SVR12) weeks post-treatment • Measure: percentage of patients with a baseline transient elastography < 6 kPa
Percentage of participants with low baseline viral load and SVR12 weeks post-treatment [Baseline and 12 weeks after the last dose of drug]
Percentage of participants with low baseline viral load who achieve sustained virological response 12 (SVR12) weeks post-treatment • Measure: HCV RNA levels less than the lower limit of quantification.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Chronic hepatitis C (anti-HCV antibodies and detectable HCV-RNA).
Genotype 1b infection
Treatment-naïve and non-cirrhotic

Exclusion Criteria:

HCV genotype or subtype other than GT1b.
Any current or past clinical evidence of cirrhosis.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Carrion, Jose Antonio, PhD	Barcelona		Spain	08003

Sponsors and Collaborators

Hepa C

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hepa C

ClinicalTrials.gov Identifier:

NCT03122132

Other Study ID Numbers:

0002

First Posted:

Apr 20, 2017

Last Update Posted:

May 21, 2018

Last Verified:

May 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hepa C

Hepatitis C Infection

Ombitasvir/Paritaprevir/Ritonavir+dasabuvir

Additional relevant MeSH terms:

Study Results

No Results Posted as of May 21, 2018