NCT02597270

Brief Summary

The purpose of this study is to describe the genetic diversity of Hepatitis C virus (HCV) NS3/4a protease and NS5A protein of HCV in participants with chronic disease naive-drug or previously failed to double therapy (Peg-interferon and Ribavirin) and to identify the frequency of natural polymorphisms in HCV NS3/4a protease and NS5A protein that are associated with direct-acting antivirals (DAAs)-resistance.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
239

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Shorter than P25 for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 5, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

February 6, 2017

Status Verified

February 1, 2017

Enrollment Period

8 months

First QC Date

November 3, 2015

Last Update Submit

February 3, 2017

Conditions

Hepatitis C Virus

Keywords

Hepatitis C virus

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With HCV NS3/4a Protease and NS5A Protein

    After extraction of HCV RNA from collected blood samples, the sequences of the NS3/4A and NS5A genes of HCV will be amplified by reverse transcription polymerase chain reaction (RTPCR) using specific primers for each genomic region. PCR products will be sequenced subsequently by direct sequencing. Detection of natural polymorphisms will be analyzed a comparison of the each sequence with the subtype consensus sequence.

    Day 1

Study Arms (1)

Cohort 1

Brazilian participants with Genotype 1 HCV infection treatment naive participants or previously failed to double therapy (Peg-interferon-α and Ribavirin) will be included in the trial and will constitute the trial population.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Brazilian participants with Genotype 1 HCV infection treatment naive patients or previously failed to double therapy (Peg-interferon-α and Ribavirin) will be included in the trial.

You may qualify if:

  • Participants mono infected with chronic Hepatitis C infection (genotype 1), including naive patients or previously failed to double therapy (Peg-interferon-α and Ribavirin)
  • There is no restriction on fibrosis stage or clinical liver disease
  • There is no restriction for comorbidities
  • Male or female participants with age \>=18 years

You may not qualify if:

  • Participants failed to triple therapy using protease inhibitors
  • Participants with co-infections (i.e. Human immunodeficiency virus, Hepatitis B virus)
  • Participants that are not agree to sign the written informed consent
  • Participants is taking part in an interventional clinical trial with an investigational agent (i.e. non-commercialized agent) or in an interventional clinical trial sponsored by Johnson \& Johnson

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Belém, Brazil

Location

Unknown Facility

Goiânia, Brazil

Location

Unknown Facility

Porto Alegre, Brazil

Location

Unknown Facility

Porto Velho, Brazil

Location

Unknown Facility

Salvador, Brazil

Location

Unknown Facility

São Paulo, Brazil

Location

Biospecimen

Retention: SAMPLES WITH DNA

The total blood volume to be collected will be approximately 15 milliliters (mL) (3 tubes, 5mL each). Fasting is not required. The blood sample collection scheme was designed to collect the minimum number of blood samples that is necessary to accomplish the study objective. Blood samples will be frozen and incinerated 30 days after blood collection at the national central laboratory.

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Janssen-Cilag Ltd. Clinical Trial

    Janssen-Cilag Ltd.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2015

First Posted

November 5, 2015

Study Start

March 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

February 6, 2017

Record last verified: 2017-02

Locations

BR(6)