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

Hepatitis C Infection Clinical Trial

— 3D8  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03122132
• Other study ID #: 0002
• Status: Completed
• Start date: February 20, 2017
• Est. completion date: March 1, 2018

Study information

• Verified date: May 2018
• Source: Hepa C
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 1, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Infection

Intervention

Drug:
• ombitasvir/paritaprevir/ritonavir 8 weeks
Spanish cohort with HCV treated in real practice with ombitasvir/paritaprevir/ ritonavir 8 weeks
• dasabuvir 8 weeks
Spanish cohort with HCV treated in real practice with dasabuvir 8 weeks

Locations

Country	Name	City	State
Spain	Carrion, Jose Antonio, PhD	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hepa C

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained virological response 12 weeks post-treatment (SVR12)	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.	12 weeks after the last dose of study drug
Secondary	Percentage of patients with virologic failure during treatment	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	Up to 12 weeks after last dose of study drug
Secondary	Mild fibrosis and sustained virological response 12 weeks post-treatment	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	Up to 12 weeks after last dose of study drug
Secondary	Percentage of participants with low baseline viral load and SVR12 weeks post-treatment	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.	Baseline and 12 weeks after the last dose of drug