Long Term Extension Study is Designed to Monitor Long-Ter... | NCT02452814

Status Module

Record Verification Date

Feb 2018

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

May 7, 2014Actual

Primary Completion Date

May 3, 2017Actual

Completion Date

May 3, 2017Actual

First Submitted Date

May 11, 2015

First Submission Date that Met QC Criteria

May 20, 2015

First Posted Date

May 25, 2015Estimated

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

Feb 5, 2018

Last Update Posted Date

Feb 6, 2018Actual

Description Module

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

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

Not provided

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

8Actual

Label	Type	Description	Intervention Names
Cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants with adverse changes in liver ultrasound results		Up to 48 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- 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).

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Methodist Transplant Physicians		Dallas	Texas	75203	United States
Research Specialists of Texas

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.