Adaptive-design Dose Finding Study to Assess the Antiviral Efficacy and Safety of NIM811 Administered in Combination With Standard of Care (SOC) in Relapsed Hepatitis C Virus 1 (HCV-1) Infected Patients
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
18–69
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients eligible for inclusion in this study have to fulfill all of the following criteria:
chronic hepatitis C genotype-1
HCV-RNA should be ≥ 4 x 105 IU/mL at screening
Recipient of prior long acting interferon and ribavirin treatment for at least 12 weeks, with documented negative serum HCV RNA on treatment, who subsequently becomes serum HCV RNA positive after stopping treatment ("relapser"). Patients must have been off all treatment for at least 3 months prior to start of study (Visit
You may not be if
Use of any HCV treatment ≤ 3months prior to study start
Prior receipt of any investigational anti-HCV therapy which is not IFN or RBV
Women of child-bearing potential unless they are post-menopausal or use predefined acceptable methods of contraception
Pregnant or breastfeeding women
Evidence of cirrhosis, hepatic decompensation, other than HCV liver disease, HBV or HIV infection
Specified abnormalities in lab values of amongst others hemoglobin, WBC, ANC, platelets
