NCT00229749

Brief Summary

Chronic active hepatitis C viral infections are difficult to treat: current drug therapies can result in severe side effects that some patients will not tolerate. AVI-4065 Injection is a new drug designed to prevent the virus from reproducing in the body. We tested this drug in healthy adult volunteers to optimize the dosing regimen, and are now proceeding in adult patients with chronic active hepatitis C infections. Patients who have the disease and who have had treatment but without success, will be recruited for the study. The treatment of HCV patients initially consisted of subcutaneous injections given twice a day for 14-days. Treatment arms of 28 days, twice or three-times per day have been added.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2005

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 30, 2005

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

April 10, 2008

Status Verified

April 1, 2008

Enrollment Period

1.1 years

First QC Date

September 28, 2005

Last Update Submit

April 9, 2008

Conditions

Hepatitis C

Keywords

HCV

Outcome Measures

Primary Outcomes (2)

  • Safety and tolerability

  • Pharmacokinetics/pharmacodynamics

Secondary Outcomes (1)

  • Response of HCV levels to AVI-4065 Injection, via serum HCV-RNA levels

Interventions

AVI-4065 InjectionDRUG

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adult males and females aged 18 to 64 years of age
  • Chronic HCV infection, defined as virological diagnosis of HCV for at least six months with detectable serum HCV-RNA levels \>100,000 IU/mL by an HCV-RNA PCR assay on two occasions at least one week apart within 4 weeks prior to study drug administration
  • Signed and dated written informed consent form
  • Negative serum ß-HCG (pregnancy) test 24 hours prior to initial dose of AVI-4065 Injection for females of childbearing potential, or post-menopausal and amenorrheic for 2 years, or surgically sterilized for at least one year
  • Willing to abstain from alcohol from the beginning of study entry through Day 28 of the study
  • Willing to participate in all study activities (including the ability to safely self-inject study drug subcutaneously) and all study requirements (including effective contraception) during study period

You may not qualify if:

  • Hematology, coagulation, serum chemistry, and urinalysis laboratory test values \>2 times upper limits of normal or anemia (hemoglobulin \<11 g/dL), leukopenia (total white blood count \<3,000/ µL or total neutrophils \<1,500/ µL) or thrombocytopenia (platelets \<100,000/ µL)
  • Decompensated or severe liver disease, defined as cirrhotic patients with a Child-Pugh score of ≥ 7
  • Encephalopathy or altered mental status of any etiology
  • Any neoplasm, including hepatocellular carcinoma
  • Decompensated renal disease (e.g., serum creatinine \>2.5 or on a dialysis program)
  • Positive HIV-1 or HIV-2 serology
  • Positive Hepatitis B Surface Antigen (HBsAg) or Hepatitis B Core Antibody (HBcAb) status
  • Participation in any interventional clinical trial within previous 6 months
  • Organ transplant recipient (solid or hematopoietic)
  • Use of interferons and ribavirin or experimental HCV treatment within past 6 months
  • Use of non-steroidal anti-inflammatory agents (e.g., ibuprofen, naproxen or COX-2 inhibitors) that exceeds 2 days per week of the recommended daily dosing or usage that exceeds 5 grams/week.
  • Use of acetaminophen within 15 days of enrollment and throughout Day 28 of the study
  • Body Mass Index (BMI) \> 35
  • Pregnant or nursing female
  • Active serious or poorly controlled chronic illness
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Mark Holodniy, M.D.

    Stanford University School of Medicine and Department of Veterans Affairs Public Health Research & Consultation Program at the Veterans Affairs Palo Alto Health Care System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 28, 2005

First Posted

September 30, 2005

Study Start

September 1, 2005

Primary Completion

October 1, 2006

Study Completion

January 1, 2007

Last Updated

April 10, 2008

Record last verified: 2008-04