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UNKNOWNPHASE2

Miravirsen in Combination With Telaprevir and Ribavirin in Null Responder to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C Virus Infection

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

NCT01872936•Santaris Pharma A/S

View on ClinicalTrials.gov

Summary

The purpose of this open-label study is to assess the safety, tolerability, antiviral activity, genotype resistance associated with virological failure, pharmacokinetics and pharmacodynamics of two dose regimens of miravirsen in combination with telaprevir and ribavirin in subjects with hepatitis C virus genotype 1 infection who are null responder to pegylated-interferon alpha and ribavirin.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of chronic hepatitis C genotype 1 infection
•BMI 18 and 38 kg/m2
•Null responder to pegylated interferon alpha and ribavirin

Exclusion Criteria

•Co-infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
•Significant liver disease in addition to hepatitis C
•Decompensated liver disease medical history or current clinical features
•Histologic evidence of hepatic cirrhosis
•Concurrent clinically significant medical diagnosis (other than CHC)
•Concurrent social conditions (e.g. drugs of abuse, alcohol excess, poor living accommodation)
•Clinically significant illness within 30 days preceding entry into the study
•Participated in an investigational drug study within 30 days or 5 half-lives, whichever is longer, prior to the start of study medication
•History of clinically significant allergic drug reactions

Locations (3)

The Liver Institute at Methodist Dallas Medical Center

Dallas, Texas, United States

Research Specialists of Texas

Houston, Texas, United States

Fundacion de Investigacion de Diego

San Juan, Puerto Rico

Key Dates

Start Date

June 1, 2013

Primary Completion Date

January 1, 2015

Completion Date

January 1, 2015

Last Updated

November 18, 2014

Enrollment

ESTIMATED participants

Conditions

Hepatitis C, Chronic

Interventions

Miravirsen

DRUG

Telaprevir

DRUG

Ribavirin

DRUG

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Carcinoma, HepatocellularHepatitis C, Chronic+3 more

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COMPLETEDPHASE4

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Miravirsen in Combination With Telaprevir and Ribavirin in Null Responder to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C Virus Infection

Inclusion Criteria

Exclusion Criteria

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study

Treatment of Chronic Hepatitis C During Pregnancy With Sofosbuvir/Velpatasvir

Safety And Efficacy Of Oral PF-4136309 In Patients With Chronic Hepatitis C Infection And Abnormal Liver Enzymes

Addition of ISIS 14803 to Therapy With Peginterferon and Ribavirin for Chronic Hepatitis C (HCV) Patients Not Responding Adequately to the Two Drugs

The Pharmacokinetics of P1101 + Ribavirin in Interferon Treatment-Naïve Subjects With Chronic Hepatitis C Virus (HCV) Genotype 2 Infection