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NCT02508090 Clinical Trial

Long-Term Extension Study of Miravirsen Among Participants With Genotype 1 Chronic Hepatitis C (CHC) Who Have Not Responded to Pegylated-Interferon Alpha Plus Ribavirin

Chronic Hepatitis C Clinical Trial

Official title:
Long-Term Extension to a Phase 2, Open-Label, Clinical Trial of Miravirsen Sodium in Null Responders to Pegylated-Interferon Alpha Plus Ribavirin in Subjects With Chronic Hepatitis C (CHC) Virus Genotype 1 Infection

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02508090
Other study ID # NP29711
Secondary ID
Status Completed
Phase N/A
First received July 23, 2015
Last updated October 30, 2017
Start date August 2, 2013
Est. completion date January 13, 2017

Study information
Verified date October 2017
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Genotype 1 CHC participants from Study SPC3649-207 with null response to prior pegylated-interferon alpha plus ribavirin will be enrolled into this 36-month extension study, designed to evaluate the long-term safety and efficacy after 12 weeks of miravirsen monotherapy. Due to the observational nature of the study, miravirsen will not be dosed as an investigational product.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date January 13, 2017
Est. primary completion date January 13, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Participants from Study SPC3649-207, including those who completed the study and those who discontinued or terminated the study early for any reason, or those who opted to receive other approved therapy for the treatment of hepatitis C virus (HCV) infection

Exclusion Criteria:

- Participants who have received investigational drug therapy after discontinuation, termination, or completion of Study SPC3649-207

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Puerto Rico Fundacion de Investigacion de Diego San Juan

Sponsors (2)
Lead Sponsor Collaborator
Hoffmann-La Roche Santaris Pharma A/S

Country where clinical trial is conducted

Puerto Rico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of adverse events Up to 36 months
Primary Incidence of sustained virologic response (SVR) 48 weeks after end of treatment (EOT)
Primary Change from Baseline in HCV ribonucleic acid (RNA) level Up to 36 months
Primary Incidence of HCV resistance Up to 36 months
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