IDX719 in Combinations With Simeprevir and/or TMC647055/Ritonavir With or Without Ribavirin for 12 Weeks in Subjects With Chronic Hepatitis C Infection
| Status: | Completed |
|---|---|
| Conditions: | Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 1/1/2014 |
| Start Date: | May 2013 |
| End Date: | May 2015 |
| Contact: | John Z Sullivan-Bolyai, MD |
| Email: | clinicaltrials@idenix.com |
| Phone: | 877-433-6491 |
A Randomized Study to Evaluate the Safety and Efficacy of IDX719 in Combinations With Simeprevir and/or TMC647055/Ritonavir With or Without Ribavirin for 12 Weeks in Subjects With Chronic Hepatitis C Infection
Parts A and B of this study are designed to evaluate the safety, tolerability, efficacy and
pharmacokinetic profiles of IDX719 and simeprevir when administered in combination with
ribavirin (RBV) for 12 weeks in treatment-naïve, Genotype 1b, 4 and 6 HCV-infected subjects.
Part C of this study is designed to evaluate the safety, tolerability, efficacy and
pharmacokinetic profiles of IDX719, simeprevir, TMC647055 and ritonavir (RTV) when
administered in combinations with or without RBV for 12 weeks in treatment-naïve or
interferon/RBV-treatment relapsed, Genotype 1a and 1b HCV-infected subjects.
pharmacokinetic profiles of IDX719 and simeprevir when administered in combination with
ribavirin (RBV) for 12 weeks in treatment-naïve, Genotype 1b, 4 and 6 HCV-infected subjects.
Part C of this study is designed to evaluate the safety, tolerability, efficacy and
pharmacokinetic profiles of IDX719, simeprevir, TMC647055 and ritonavir (RTV) when
administered in combinations with or without RBV for 12 weeks in treatment-naïve or
interferon/RBV-treatment relapsed, Genotype 1a and 1b HCV-infected subjects.
Inclusion Criteria:
- Must have Genotype 1a, 1b, 4 or 6 HCV infection.
- Documented clinical history compatible with chronic hepatitis C
- HCV treatment-naïve or interferon/RBV-treatment relapsed (Part C)
- Must agree to use an acceptable double method of birth control (one of which must be
a barrier method) for at least 6 months after the last dose of study drugs.
Exclusion Criteria:
- Female subjects who are pregnant or breastfeeding.
- Body Mass Index (BMI) > 36 kg/m2.
- Co-infected with hepatitis B virus or human immunodeficiency virus (HIV).
- History of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC.
- History or signs of decompensated liver disease: ascites, variceal bleeding, hepatic
encephalopathy, spontaneous bacterial peritonitis, or other clinical signs of portal
hypertension or hepatic insufficiency.
- Has one or more known primary or secondary causes of liver disease, other than
hepatitis C
- History of, or active, acute or chronic, liver or biliary injury due to drugs,
toxins, non-HCV viral hepatitis, gallstones or other etiologies
- Donated blood or had significant blood loss 30 days prior to dosing
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