Status:
COMPLETED
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
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Hepatitis C Genotype-1 Relapse
Eligibility:
All Genders
18-69 years
Phase:
PHASE2
Brief Summary
This is a study designed to identify a dose of NIM811 that has a good safety profile, is well tolerated when co-administered with SOC, and provides a clinically meaningful effect in viral load reducti...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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
- Exclusion criteria:
- 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
- History of treatment for depression
- Steroid/immunosuppression drug use 3 months prior to study start Other protocol-defined inclusion/exclusion criteria may apply
Exclusion
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00983060
Start Date
September 1 2009
Last Update
December 19 2020
Active Locations (16)
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1
Research and Education Inc.
San Diego, California, United States, 92105
2
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
3
University Hepatitis Center
Sarasota, Florida, United States, 34243
4
West Wind'r Research & Development LLC
Tampa, Florida, United States, 33607