An open label study to investigate the safety and efficacy of treatment with ACH-0143102 and sofosbuvir in hepatitis C patients
- Conditions
- Hepatitis CInfection - Other infectious diseases
- Registration Number
- ACTRN12614000307606
- Lead Sponsor
- Achillion Pharmaceuticals, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 36
Chronic HCV infection
- HCV GT-1
- HCV RNA greater than 10,000 IU/mL at screening
- Signed and dated written consent
- Treatment naive subjects
- Biopsy or fibroscan confirming no evidence of cirrhosis
- BMI greater than 36kg/m2
- Pregnant or lactating females. Men whose female partners are pregnant or contemplating pregnancy
- Clinically significant laboratory abnormality at screening
- Known HIV infection
- Positive hepatits B surface antigen
- History of participation in a clinical trial with pegylated interferon, RBV, or a direct-acting anti-viral agent, or previous treatment with any of these where at least one dose was taken
- Use of dietary supplements, herbal supplements, potent PGP inducers in the intestine, anticonvulsants, antimycobacterials and HIV protease inhibitors.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the incidence of sustained virologic response (SVR) in subjects who received 8 weeks of active treatment.<br><br>This will be assessed by HCV RNA analysis on blood samples.[12 weeks after the completion of dosing];To determine the incidence of sustained virologic response (SVR) in subjects who received 6 weeks of active treatment.<br><br>This will be assessed by HCV RNA analysis on blood samples.[12 weeks after the completion of dosing]
- Secondary Outcome Measures
Name Time Method To determine the safety and tolerability of 8 weeks of ACH-0143102 in combination with sofosbuvir in subjects with genotype-1 viral infection. Assessed by collection of adverse event data, laboratory tests, ECG, echocardiogram, vital signs, physical examination[Safety will be assessed at weeks 1,2,3,4,5,6,7,8, 10, 12, 16, 20, 24, 28 and 32 <br> ];To determine the safety and tolerability of 6 weeks of ACH-0143102 in combination with sofosbuvir in subjects with genotype-1 viral infection. Assessed by collection of adverse event data, laboratory tests, ECG, echocardiogram, vital signs, physical examination[Safety will be assessed at weeka 1,2,3,4,5,6,8,10,14,18,22,26 and 30.];To determine the incidence of sustained virologic response in subjects who received active treatment for either 6 or 8 weeks. <br>This will be assessed via HCV RNA analysis on blood samples. [4, 8 and 24 weeks after the completion of dosing]