Miravirsen in Combination With Telaprevir and Ribavirin in Null Responder to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C Virus Infection
| Status: | Completed |
|---|---|
| Conditions: | Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 2/7/2015 |
| Start Date: | June 2013 |
| End Date: | January 2015 |
| Contact: | Constance Crowley |
| Email: | cc@santaris.com |
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
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.
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.
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
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