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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cellectar Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT01058512
First received: January 26, 2010
Last updated: July 9, 2013
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Hepatitis C
Drug: NOV-205
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Trial of NOV-205 in Chronic Viral Hepatitis C Patients (Genotype 1) Who Have Failed Treatment With Pegylated Interferon Plus Ribavirin

Resource links provided by NLM:


Further study details as provided by Cellectar Biosciences, Inc.:

Primary Outcome Measures:
  • To evaluate changes in viral load [ Time Frame: 16 months ] [ Designated as safety issue: No ]
  • To evaluate changes in serum ALT and AST levels [ Time Frame: 16 months ] [ Designated as safety issue: No ]
  • To evaluate the durability of any changes in viral load and serum ALT and AST [ Time Frame: 16 months ] [ Designated as safety issue: No ]
  • To establish the safety profile of NOV-205 [ Time Frame: 16 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01058512

Locations
United States, Florida
Borland-Grooover Clinic
Jacksonville, Florida, United States, 32256
Venture Research Institute, LLC
Miami, Florida, United States, 33162
Orlando Immunology Center
Orlando, Florida, United States, 32803
United States, Massachusetts
MetroWest Medical Center
Framingham, Massachusetts, United States, 01702
UMASS Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, North Carolina
Cumberland Research Associates, LLC
Fayetteville, North Carolina, United States, 28304
Sponsors and Collaborators
Cellectar Biosciences, Inc.
Investigators
Principal Investigator: Raymond Koff, MD
  More Information

No publications provided

Responsible Party: Cellectar Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01058512     History of Changes
Other Study ID Numbers: NOV205-C201
Study First Received: January 26, 2010
Last Updated: July 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Cellectar Biosciences, Inc.:
hepatitis C
chronic HCV
viral HCV
genotype 1
failed treatment with pegylated interferon plus ribavirin

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 20, 2014