Differences in Evoked Intracellular Interferon Signaling Pathways Using Single Cell Phosphoprotein Profiling

NCT01217359 | Completed Phase 1

• 1 other identifier: 08-2040
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: The purpose of this exploratory study is to evaluate phosphoprotein profiling to determine differences in the intracellular actions of interferon or interferon stimulated genes among people with different treatment outcomes to interferon based therapy for hepatitis C (HCV). Participants: Patients with genotype 1 HCV who have had interferon based therapy at the University of North Carolina (UNC). Procedures: Thirty patients with varied responses to treatment will be given a single subcutaneous injection of interferon alpha 2b. Prior to the injection and at 30 minutes, 1,2,4,6,12 and 20 hours after injection, blood will be drawn for analysis of phosphoprotein profiling and changes in serum cytokines.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Protein quantification of interferon stimulated genes (ISG)

  This is an exploratory study observing downstream phosphorylation of interferon stimulated genes in the Janus Activated Kinase (JAK-STAT) pathway.

  0-20 hours

Study Arms (1)

Interferon Alfa-2b

EXPERIMENTAL

Patients will receive a single dose of interferon

Drug: Interferon Alfa-2b

Interventions

Interferon Alfa-2b DRUG

Patients will receive a single dose of interferon followed by serial blood draws to assess cellular responses to interferon

Also known as: Intron A

Interferon Alfa-2b

Eligibility Criteria

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

You may qualify if:

• Willing and able to provide informed consent
• Males or females age 18 - 65 years
• For women of childbearing potential, negative blood pregnancy test documented within the 24-hour period prior to IFN-α administration
• History of genotype 1 HCV infection previously treated with peginterferon and ribavirin and with a virological response that can be determined from retrospective review of medical records
• A washout period of \>12 weeks between the last dose of prescribed peginterferon and ribavirin and the screening visit

You may not qualify if:

• Subjects with any of the following will not be eligible for participation:
• Neutrophil count \<1500 cells/mm3, Hgb \<12 g/dL in women or 13 g/dL in men, or platelet count \<75,000 cells/mm3 at screening
• Serum creatinine level \>1.5 times the upper limit of normal at screening
• Poorly controlled psychiatric illness, as determined by the study physician, which can be exacerbated by interferon therapy
• Infection requiring antibiotics, symptomatic viral infection, inflammatory process requiring therapy, or allergic reactions in the week immediately preceding the inpatient study visit
• Use of medications that affect the immune system (e.g. glucocorticoids, chronic NSAIDs daily) in the week immediately preceding the inpatient study visit
• History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, psoriasis, rheumatoid arthritis)
• Women with ongoing pregnancy or breast-feeding
• History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
• History of a seizure disorder or current anticonvulsant use
• History of major organ transplantation with an existing functional graft
• History of thyroid disease poorly controlled on prescribed medications
• History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Tibotec Pharmaceutical Limited: collaborator

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

Interferon alpha-2; Introns

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

Intervention Hierarchy (Ancestors)

Interferon-alpha; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; DNA, Intergenic; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Gene Components; Genes

Study Officials

• Sid Barritt, MD, MSCR

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2010
• First Posted: October 8, 2010
• Study Start: May 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: November 15, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)