Status:
COMPLETED
Safety and PK Study of NOV-205 to Treat Chronic HCV Who Fail Standard Therapy
Lead Sponsor:
Cellectar Biosciences, Inc.
Conditions:
Hepatitis C
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of this research trial is to find out whether NOV-205 is well tolerated compared to placebo (salt water) in people with hepatitis C. In addition, this trial will test how NOV-205 is absorb...
Detailed Description
This Phase 1b trial aims to evaluate the pharmacokinetic profile of NOV-205, and in comparison to placebo, identify early signs of antiviral activity (with a quantitative reduction of \>0.5 log10 in s...
Eligibility Criteria
Inclusion
- A serum HCV RNA level of \>100,000 IU/ml using a quantitative, branched-chain-DNA (bDNA)-based assay (lower limit of quantitation = \~650 IU/ml) or other equally sensitive quantitative methods.
- Infection with genotype 1 HCV
- Documented failure to respond to treatment (defined as a patient who did not achieve an early viral response (EVR) (≥2 log reduction in serum HCV RNA or undetectable HCV RNA after 12 weeks of treatment) OR is serum HCV RNA positive after 24 weeks of treatment with pegylated interferon plus ribavirin for hepatitis C.
- Women of childbearing potential willing to use two acceptable methods of birth control during trial participation or are sterile or post-menopausal (defined as not having a menstrual cycle for greater than two years)
- Sexually active male subjects are practicing acceptable methods of contraception during trial participation
- Have the ability to understand the requirements of the trial, have provided written informed consent, and agree to abide by the trial restrictions and to return for the required assessments
- The subject must be able to self administer daily subcutaneous injections or their caregiver must be able to administer daily subcutaneous injections
Exclusion
- Clinical, laboratory, or histological evidence of liver cirrhosis
- Evidence of hepatic decompensation (presence of or a history of ascites, hepatic encephalopathy, variceal bleeding, or hepatocellular carcinoma)
- Co-infection with human immunodeficiency virus (HIV) or active hepatitis B virus (HBV) (as determined by presence of hepatitis B surface antigen (HBsAg)
- Have received pegylated interferon and/or ribavirin within the 60 days prior to randomization
- Any known preexisting medical condition that could interfere with the subject's participation in and completion of the protocol
- Pregnant female or nursing mother
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00372983
Start Date
August 1 2006
End Date
December 1 2007
Last Update
December 21 2007
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