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

Hepatitis C Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01058512
• Other study ID #: NOV205-C201
• Status: Completed
• Phase: Phase 2
• Start date: March 2010
• Est. completion date: December 2010

Study information

• Verified date: July 2022
• Source: Cellectar Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

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

Locations

Country	Name	City	State
United States	Cumberland Research Associates, LLC	Fayetteville	North Carolina
United States	MetroWest Medical Center	Framingham	Massachusetts
United States	Borland-Grooover Clinic	Jacksonville	Florida
United States	Venture Research Institute, LLC	Miami	Florida
United States	Orlando Immunology Center	Orlando	Florida
United States	UMASS Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Cellectar Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate changes in viral load		16 months
Primary	To evaluate changes in serum ALT and AST levels		16 months
Primary	To evaluate the durability of any changes in viral load and serum ALT and AST		16 months
Primary	To establish the safety profile of NOV-205		16 months