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

NCT01058512 | Completed Phase 2

• 1 other identifier: NOV205-C201
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 6

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

Keywords

hepatitis C; chronic HCV; viral HCV; genotype 1; failed treatment with pegylated interferon plus ribavirin

Outcome Measures

Primary Outcomes (4)

• To evaluate changes in viral load

  16 months

• To evaluate changes in serum ALT and AST levels

  16 months

• To evaluate the durability of any changes in viral load and serum ALT and AST

  16 months

• To establish the safety profile of NOV-205

  16 months

Study Arms (1)

Single

EXPERIMENTAL

single-arm study

Drug: NOV-205

Interventions

NOV-205 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

Single

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cellectar Biosciences, Inc.: lead

Study Sites (6)

Borland-Grooover Clinic

Jacksonville, Florida, 32256, United States

Location

Venture Research Institute, LLC

Miami, Florida, 33162, United States

Location

Orlando Immunology Center

Orlando, Florida, 32803, United States

Location

MetroWest Medical Center

Framingham, Massachusetts, 01702, United States

Location

UMASS Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Cumberland Research Associates, LLC

Fayetteville, North Carolina, 28304, United States

Location

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Raymond Koff, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2010
• First Posted: January 28, 2010
• Study Start: March 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 25, 2022

Record last verified: 2022-07

Locations

US (6)