Safety and PK Study of NOV-205 to Treat Chronic HCV Who Fail Standard Therapy - Full Text View

Purpose

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 absorbed by your body after single and multiple doses of the trial drug, and it will look for early signs of therapeutic activity (decreases in indicators in the blood for the hepatitis C virus and for liver damage). This is known as pharmacokinetics (PK). NOV-205 is an experimental drug. "Experimental" means that the trial drug is currently being tested and is not approved for sale in the United States by the Food and Drug Administration (FDA). However, NOV-205 has been approved by the Russian Federation for treatment of liver diseases including hepatitis C. Clinical studies in that country showed that subjects treated with NOV-205 alone had decreased indicators in the blood for the hepatitis C virus and for liver damage.

Condition	Intervention	Phase
Hepatitis C	Drug: NOV-205	Phase I

MedlinePlus related topics:

Hepatitis Hepatitis C

ChemIDplus related topics:

Ribavirin Interferon alfa-2b Interferons

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Pharmacokinetics/Dynamics Study

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

Further study details as provided by Novelos Therapeutics:

Primary Outcome Measures:

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.

Estimated Enrollment:	30
Study Start Date:	August 2006
Study Completion Date:	December 2007

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 serum HCV RNA level (Elbeik, 2004)) and establish a safety profile of NOV-205 as monotherapy in subjects with chronic HCV who are non-responders to treatment with pegylated interferon plus ribavirin. This trial will also explore the effect of NOV-205 on serum biochemical markers of liver damage (e.g. alanine aminotransferase, ALT) as indications of biologic activity. Results of this trial will guide the design of future Phase 2 studies of NOV-205 in chronic hepatitis C subjects.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00372983

Sponsors and Collaborators

Novelos Therapeutics

Investigators


Principal Investigator:	Raymond Koff, MD	University of Massachusetts

More Information

Study ID Numbers:	NOV205-C101
First Received:	September 5, 2006
Last Updated:	December 17, 2007
ClinicalTrials.gov Identifier:	NCT00372983
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novelos Therapeutics:

chronic HCV

Failed treatment

chronic HCV

genotype 1

failed treatment with pegylated interferon plus ribavirin

Study placed in the following topic categories:

Virus Diseases

Hepatitis

Liver Diseases

Digestive System Diseases

Interferons

Ribavirin

Hepatitis, Viral, Human

Hepatitis C

Interferon Alfa-2b

Hepatitis C, Chronic

Additional relevant MeSH terms:

RNA Virus Infections

Flaviviridae Infections

ClinicalTrials.gov processed this record on October 16, 2008

Sponsored by:	Novelos Therapeutics
Information provided by:	Novelos Therapeutics
ClinicalTrials.gov Identifier:	NCT00372983