Impact of Sofosbuvir and Daclatasvir Concentration on HCV RNA

Hepatitis C Clinical Trial

Official title:

Sofosbuvir Plus Daclatasvir With or Without Ribavirin for Chronic Hepatitis C Infection: Impact of Drug Concentration on Viral Load Decay

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03318887
• Other study ID #: CRC_GHN_2016_001
• Status: Completed
• Phase: N/A
• First received: October 19, 2017
• Last updated: October 19, 2017
• Start date: February 1, 2014
• Est. completion date: June 30, 2015

Study information

• Verified date: October 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Sofosbuvir plus daclatasvir with or without ribavirin is one of the currently recommended treatment option for chronic hepatitis C. The objectives were to identify factors associated with sofosbuvir/daclatasvir plasma concentrations variations and to evaluate their impact on viral kinetics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: June 30, 2015
• Est. primary completion date: September 30, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with hepatitis C virus infection treated with sofosbuvir/daclatasvir

• Patients with at least one measurement of sofosbuvir or daclatasvir plasma concentration

• Follow-up of at least 3 months after the end of treatment

Exclusion Criteria:

• Patients with severe renal failure (estimated glomerular filtration rate (eGFR)<30ml/min/1.73m2)

• Patients with liver transplantation during therapy

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• Sofosbuvir/daclatasvir with or without ribavirin
Direct-acting antiviral treatment for hepatitis C virus infection

Locations

Country	Name	City	State
France	Croix-Rousse Hospital, Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sofosbuvir/daclatasvir plasma concentration		Sofosbuvir/daclatasvir plasma concentrations were measured at week 4, 8, 12 and 24 during therapy
Secondary	HCV viral load		At treatment initiation, at week 4, 8, 12 and 24 of therapy and 12 weeks after the end of treatment