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

Status unconfirmed · Phase 2

Conditions studied: Hepatitis C, Chronic

In brief

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.

Key facts

Study ID

NCT01872936

Run by

Santaris Pharma A/S

People needed

20

Starts

2013-06-01

Expected to finish

2015-01-01

Last updated by the study team

2014-11-18

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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