Safety and PK Study of NOV-205 to Treat Chronic HCV Who Fail Standard Therapy
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|ClinicalTrials.gov Identifier: NCT00372983|
Recruitment Status : Completed
First Posted : September 7, 2006
Last Update Posted : December 21, 2007
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|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C||Drug: NOV-205||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Factorial Assignment|
|Official Title:||A Randomized, Placebo Controlled, Phase 1b Trial to Evaluate the Safety and Pharmacokinetics of NOV-205 in Chronic Viral Hepatitis C Subjects (Genotype 1) Who Have Failed Treatment With Pegylated Interferon Plus Ribavirin|
|Study Start Date :||August 2006|
|Actual Study Completion Date :||December 2007|
- To evaluate the pharmacokinetic profile of different dosing regimens of NOV-205.
- To establish the safety profile of NOV-205 in comparison to that of placebo.
- To compare changes in viral load after treatment with NOV-205 or placebo (as evidenced by a quantitative reduction of >0.5 log10 in serum HCV RNA levels by quantitative analysis as compared to the average of the screening and baseline values).
- To evaluate the impact of NOV-205 on serum ALT and AST levels in comparison to that of placebo.
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|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00372983
|Principal Investigator:||Raymond Koff, MD||University of Massachusetts, Worcester|
|Other Study ID Numbers:||
|First Posted:||September 7, 2006 Key Record Dates|
|Last Update Posted:||December 21, 2007|
|Last Verified:||December 2007|
failed treatment with pegylated interferon plus ribavirin
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections