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

Phase 2

Completed

• Conditions: Hepatitis C
• Interventions: Drug: NOV-205

• Registration Number: NCT01058512
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-26
• Study First Submitted QC: 2010-01-27
• Study First Posted: 2010-01-28
• Study Start: 2010-03
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single	NOV-205	single-arm study

Primary Outcome Measures

Name	Time	Method
To evaluate changes in viral load	16 months
To evaluate changes in serum ALT and AST levels	16 months
To establish the safety profile of NOV-205	16 months
To evaluate the durability of any changes in viral load and serum ALT and AST	16 months

Trial Locations

Locations (6)

Orlando Immunology Center; 🇺🇸 Orlando, Florida, United States

UMASS Memorial Medical Center; 🇺🇸 Worcester, Massachusetts, United States

MetroWest Medical Center; 🇺🇸 Framingham, Massachusetts, United States

Borland-Grooover Clinic; 🇺🇸 Jacksonville, Florida, United States

Venture Research Institute, LLC; 🇺🇸 Miami, Florida, United States

Cumberland Research Associates, LLC; 🇺🇸 Fayetteville, North Carolina, United States