A Trial of NOV-205 in Hepatitis C Patients Who Failed Standard Therapy (NOV-205)

A Phase 2 Trial of NOV-205 in Chronic Viral Hepatitis C Patients (Genotype 1) Who Have Failed Treatment With Pegylated Interferon Plus Ribavirin

The purpose of this research study is to find out the effect of the investigational drug NOV-205 on the level of hepatitis C virus in the blood and whether NOV-205 is well-tolerated at different doses when taken by subjects with hepatitis C.

Study Overview

• Status: Completed
• Conditions: Hepatitis C
• Intervention / Treatment: Drug: NOV-205

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Borland-Grooover Clinic
    • Miami, Florida, United States, 33162
      • Venture Research Institute, LLC
    • Orlando, Florida, United States, 32803
      • Orlando Immunology Center
  • Massachusetts
    • Framingham, Massachusetts, United States, 01702
      • MetroWest Medical Center
    • Worcester, Massachusetts, United States, 01655
      • UMass Memorial Medical Center
  • North Carolina
    • Fayetteville, North Carolina, United States, 28304
      • Cumberland Research Associates, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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
• Adequate laboratory parameters
• 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 enrollment
• Any known preexisting medical condition that could interfere with the subject's participation in and completion of the protocol
• Pregnant female or nursing mother

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single; single-arm study	Drug: NOV-205; There will be 4 treatment Groups with 10 patients in each group: Group A: 30 mg NOV-205 daily subcutaneous administration for 49 days; Group B: 30 mg NOV-205 daily subcutaneous administration for 98 days; Group C: 60 mg NOV-205 daily subcutaneous administration for 49 days; Group D: 60 mg NOV-205 daily subcutaneous administration for 98 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate changes in viral load	16 months
To evaluate changes in serum ALT and AST levels	16 months
To evaluate the durability of any changes in viral load and serum ALT and AST	16 months
To establish the safety profile of NOV-205	16 months

Collaborators and Investigators

• Sponsor: Cellectar Biosciences, Inc.
• Investigators: Principal Investigator: Raymond Koff, MD

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: January 26, 2010
• First Submitted That Met QC Criteria: January 27, 2010
• First Posted (Estimate): January 28, 2010

Study Record Updates

• Last Update Posted (Actual): July 25, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: genotype 1; hepatitis C; chronic HCV; viral HCV; failed treatment with pegylated interferon plus ribavirin
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C
• Other Study ID Numbers: NOV205-C201