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

NCT ID: NCT01058512

Last Updated: 2022-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2010-12-31

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.

Conditions

Hepatitis C

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single

single-arm study

Group Type: EXPERIMENTAL

NOV-205

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cellectar Biosciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raymond Koff, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

Borland-Grooover Clinic

Jacksonville, Florida, United States

Venture Research Institute, LLC

Miami, Florida, United States

Orlando Immunology Center

Orlando, Florida, United States

MetroWest Medical Center

Framingham, Massachusetts, United States

UMASS Memorial Medical Center

Worcester, Massachusetts, United States

Cumberland Research Associates, LLC

Fayetteville, North Carolina, United States

Countries

United States

Other Identifiers

NOV205-C201

Identifier Type: -

Identifier Source: org_study_id