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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01058512
Recruitment Status : Completed
First Posted : January 28, 2010
Last Update Posted : July 11, 2013
Information provided by (Responsible Party):
Cellectar Biosciences, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Hepatitis C Drug: NOV-205 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. To evaluate changes in viral load [ Time Frame: 16 months ]
  2. To evaluate changes in serum ALT and AST levels [ Time Frame: 16 months ]
  3. To evaluate the durability of any changes in viral load and serum ALT and AST [ Time Frame: 16 months ]
  4. To establish the safety profile of NOV-205 [ Time Frame: 16 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01058512

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.
Principal Investigator: Raymond Koff, MD

Responsible Party: Cellectar Biosciences, Inc. Identifier: NCT01058512     History of Changes
Other Study ID Numbers: NOV205-C201
First Posted: January 28, 2010    Key Record Dates
Last Update Posted: July 11, 2013
Last Verified: January 2011

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 A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action