Long Term Extension Study is 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

NCT ID: NCT02452814

Last Updated: 2018-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-07

Study Completion Date

2017-05-03

Brief Summary

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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

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Conditions

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HCV

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Cohort

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Methodist Transplant Physicians

Dallas, Texas, United States

Site Status

Research Specialists of Texas

Houston, Texas, United States

Site Status

Fundacion de Investigacion de Diego

San Juan, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

Other Identifiers

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NP29710

Identifier Type: -

Identifier Source: org_study_id

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