Back to resultsA Trial of NOV-205 in Hepatitis C Patients Who Failed Standard Therapy (NOV-205)
Primary Purpose
Hepatitis C
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NOV-205
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring hepatitis C, chronic HCV, viral HCV, genotype 1, failed treatment with pegylated interferon plus ribavirin
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
- 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
Sites / Locations
- Borland-Grooover Clinic
- Venture Research Institute, LLC
- Orlando Immunology Center
- MetroWest Medical Center
- UMASS Memorial Medical Center
- Cumberland Research Associates, LLC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single
Arm Description
single-arm study
Outcomes
Primary Outcome Measures
To evaluate changes in viral load
To evaluate changes in serum ALT and AST levels
To evaluate the durability of any changes in viral load and serum ALT and AST
To establish the safety profile of NOV-205
Secondary Outcome Measures
Full Information
NCT ID
NCT01058512
First Posted
January 26, 2010
Last Updated
July 19, 2022
Sponsor
Cellectar Biosciences, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01058512
Brief Title
A Trial of NOV-205 in Hepatitis C Patients Who Failed Standard Therapy
Acronym
NOV-205
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 Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cellectar Biosciences, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
hepatitis C, chronic HCV, viral HCV, genotype 1, failed treatment with pegylated interferon plus ribavirin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single
Arm Type
Experimental
Arm Description
single-arm study
Intervention Type
Drug
Intervention Name(s)
NOV-205
Intervention Description
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 Measure Information:
Title
To evaluate changes in viral load
Time Frame
16 months
Title
To evaluate changes in serum ALT and AST levels
Time Frame
16 months
Title
To evaluate the durability of any changes in viral load and serum ALT and AST
Time Frame
16 months
Title
To establish the safety profile of NOV-205
Time Frame
16 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Koff, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Borland-Grooover Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Venture Research Institute, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Orlando Immunology Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
MetroWest Medical Center
City
Framingham
State/Province
Massachusetts
ZIP/Postal Code
01702
Country
United States
Facility Name
UMASS Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Cumberland Research Associates, LLC
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Trial of NOV-205 in Hepatitis C Patients Who Failed Standard Therapy
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