NCT02452814

Brief Summary

Long Term Observational Extension Study Designed to Monitor Long-Term Efficacy and Safety of Miravirsen Sodium in Combination with Telaprevir and Ribavirin in Subjects with Chronic Hepatitis C Virus Genotype 1 Infection

Trial Health

90
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2014

Typical duration for all trials

Geographic Reach
2 countries

3 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

Study Start

First participant enrolled

May 7, 2014

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 11, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 25, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2017

Completed
Last Updated

February 6, 2018

Status Verified

February 1, 2018

Enrollment Period

3 years

First QC Date

May 11, 2015

Last Update Submit

February 5, 2018

Conditions

HCV

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with adverse changes in liver ultrasound results

    Up to 48 months

Study Arms (1)

Cohort

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will include null responder subjects with Chronic hepatitis C (CHC) genotype 1 virus infection who have participated in Study SPC3649-205.

You may qualify if:

  • \- Participated in Study SPC3649-205 (this would include those who completed study SPC3649-205, those who discontinued or terminated the study early for whatever reason (including treatment failure) and those who opted to receive approved therapy for the treatment of HCV infection).

You may not qualify if:

  • Those unwilling to provide informed consent for participation in this study.
  • Subjects who have received investigational drug therapy after discontinuation, termination, or successful completion of Study SPC3649-205.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Methodist Transplant Physicians

Dallas, Texas, 75203, United States

Location

Research Specialists of Texas

Houston, Texas, 77030, United States

Location

Fundacion de Investigacion de Diego

San Juan, 00927, Puerto Rico

Location

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2015

First Posted

May 25, 2015

Study Start

May 7, 2014

Primary Completion

May 3, 2017

Study Completion

May 3, 2017

Last Updated

February 6, 2018

Record last verified: 2018-02

Locations

US(2)PR(1)