Status:
UNKNOWN
Miravirsen in Combination With Telaprevir and Ribavirin in Null Responder to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C Virus Infection
Lead Sponsor:
Santaris Pharma A/S
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 do...
Eligibility Criteria
Inclusion
- Diagnosis of chronic hepatitis C genotype 1 infection
- BMI 18 and 38 kg/m2
- Null responder to pegylated interferon alpha and ribavirin
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01872936
Start Date
June 1 2013
End Date
January 1 2015
Last Update
November 18 2014
Active Locations (3)
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1
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, United States, 75203
2
Research Specialists of Texas
Houston, Texas, United States, 77030
3
Fundacion de Investigacion de Diego
San Juan, Puerto Rico, 00927