Clinical trial NCT01058512: A Trial of NOV-205 in Hepatitis C Patients Who Failed Standard Therapy
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C
Keywords: hepatitis C
chronic HCV
viral HCV
genotype 1
failed treatment with pegylated interferon plus ribavirin
Lead sponsor: Cellectar Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2010-01-28
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: To evaluate changes in viral load
timeFrame: 16 months
measure: To evaluate changes in serum ALT and AST levels
timeFrame: 16 months
measure: To evaluate the durability of any changes in viral load and serum ALT and AST
timeFrame: 16 months
measure: To establish the safety profile of NOV-205
timeFrame: 16 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Borland-Grooover Clinic
state: Florida
city: Miami
country: United States
facility: Venture Research Institute, LLC
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center
state: Florida
city: Framingham
country: United States
facility: MetroWest Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: UMASS Memorial Medical Center
state: Massachusetts
city: Fayetteville
country: United States
facility: Cumberland Research Associates, LLC
state: North Carolina
Study officials:
name: Raymond Koff, MD
role: PRINCIPAL_INVESTIGATOR
References: