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

Primary Purpose

Hepatitis C

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

NOV-205

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring chronic HCV, Failed treatment, genotype 1, failed treatment with pegylated interferon plus ribavirin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00372983

First Posted

September 5, 2006

Last Updated

December 17, 2007

Sponsor

Cellectar Biosciences, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00372983

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

December 2007

Overall Recruitment Status

Completed

Study Start Date

August 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Cellectar Biosciences, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C

Keywords

chronic HCV, Failed treatment, genotype 1, failed treatment with pegylated interferon plus ribavirin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Factorial Assignment

Masking

Double

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

NOV-205

Primary Outcome Measure Information:

Title

To evaluate the pharmacokinetic profile of different dosing regimens of NOV-205.

Title

To establish the safety profile of NOV-205 in comparison to that of placebo.

Title

To evaluate the impact of NOV-205 on serum ALT and AST levels in comparison to that of placebo.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Raymond Koff, MD

Organizational Affiliation

University of Massachusetts, Worcester

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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