Impact of Sofosbuvir and Daclatasvir Concentration on HCV... | NCT03318887

Studies
Impact of Sofosbuvir and Daclatasvir Concentration on HCV RNA

NCT03318887

Sponsor

Hospices Civils de Lyon

Status

Completed

Last Update Posted

Oct 24, 2017Actual

Enrollment

130Actual

Phase

Not provided

Conditions

Hepatitis C

Interventions

Sofosbuvir/daclatasvir with or without ribavirin

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2014Actual

Primary Completion Date

Sep 30, 2014Actual

Completion Date

Jun 30, 2015Actual

First Submitted Date

Oct 19, 2017

First Submission Date that Met QC Criteria

Oct 19, 2017

First Posted Date

Oct 24, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 19, 2017

Last Update Posted Date

Oct 24, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

130Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sofosbuvir/daclatasvir		Patients with hepatitis C virus (HCV) infection treated with sofosbuvir/daclatasvir combination therapy with or without ribavirin between February and September 2014	Drug: Sofosbuvir/daclatasvir with or without ribavirin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sofosbuvir/daclatasvir with or without ribavirin	Drug	Direct-acting antiviral treatment for hepatitis C virus infection	Sofosbuvir/daclatasvir

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sofosbuvir/daclatasvir plasma concentration		Sofosbuvir/daclatasvir plasma concentrations were measured at week 4, 8, 12 and 24 during therapy

Secondary Outcomes

Measure	Description	Time Frame
HCV viral load		At treatment initiation, at week 4, 8, 12 and 24 of therapy and 12 weeks after the end of treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All HCV infected patients from the Department of Hepatology, Croix-Rousse Hospital, Lyon, France receiving sofosbuvir/daclatasvir with or without ribavirin between February and September 2014 were considered

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fabien Zoulim, MD, PhD	Hospices Civils de Lyon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Croix-Rousse Hospital, Hospices Civils de Lyon		Lyon			France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006526	Hepatitis C
D005355	Fibrosis

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069474	Sofosbuvir
C549273	daclatasvir
D012254	Ribavirin

Ancestor Terms

ID	Term
D014542	Uridine Monophosphate
D014500	Uracil Nucleotides
D011742	Pyrimidine Nucleotides
D011743	Pyrimidines

Browse Leaves

Not provided

Browse Branches

Not provided