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Completed

NCT Number: NCT02452814

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

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

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Key information

Conditions

HCV

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fundacion de Investigacion de Diego, San Juan, Puerto Rico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of Participants with adverse changes in liver ultrasound results

    Time frame: Up to 48 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Long-term Extension to a Phase 2, Open-Label, Clinical Trial of Miravirsen Sodium in Combination With Telaprevir and Ribavirin in Null Responders to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C Virus Genotype 1 Infection

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 25, 2015
Registry last updated
Feb 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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