Clinical Trial: Study of Alferon® LDO (Low Dose Oral) in Normal Volunteers

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Dose-ranging Study of Alferon® LDO {Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)} in Normal Volunteers and/or Asymptomatic Subjects With Exposure to a Person Known to

Brief Summary: The purpose of this trial is to conduct a randomized dose-ranging study to evaluate the safety and activity of orally administered low dose interferon alfa-n3 as an antiviral and immunomodulator in asymptomatic subjects with recent exposure to a person with severe acute respiratory syndrome (SARS) or possible SARS. The primary objective of this pilot study is to determine an Alferon LDO dose level that increases or upregulates genes known to be mediators of interferon response. Secondary endpoints include the development of SARS symptomatology, rate of hospitalization, and mortality rate. In the event that no subjects with recent exposure to a person with SARS or possible SARS are available, this study will be conducted with 10 normal volunteers.

Detailed Summary:

This study will be an open-label, randomized, outpatient study in subjects potentially infected with the SARS-CoV (SARS-associated coronavirus) or normal volunteers using two dose levels of LDO interferon.

Subjects will be randomized to receive Alferon® LDO (natural interferon alfa-n3) in a buffer solution once each day for 10 consecutive days at doses equal to 650 IU or 1300 IU/day.

Pretherapy baseline evaluations will be performed prior to randomization.

Subjects will be randomly assigned to each dose level, and both dosage levels will be started concurrently. Drug will be dispensed for a ten day treatment period, during which time any clinical symptoms and adverse events will be evaluated. Laboratory samples (2.5 ml blood) for microarray analysis evaluations will be made twice during baseline and 12-14 hours following doses 1, 5, and 10 on study days 2, 6, and 11, respectively.

The conduct of this study will comply with International Conference on Harmonisation - Good Clinical Practice (ICH - GCP) and the 1996 or later version of the Declaration of Helsinki.


Sponsor: Hemispherx Biopharma

Current Primary Outcome: Gene expression analysis [ Time Frame: Days 0, 2, 6, 11, 12, 15, 20 and 40 ]

Increased expression of genes known to be mediators of interferon response.


Original Primary Outcome:

Current Secondary Outcome:

  • SARS CoV Antibody [ Time Frame: Days 0, 15, 20 and 40 ]
    Development of clinical SARS-CoV symptomatology
  • SARS-CoV infection
    Hospitalization for SARS-CoV infection and Death


Original Secondary Outcome:

Information By: Hemispherx Biopharma

Dates:
Date Received: September 16, 2005
Date Started: November 2004
Date Completion:
Last Updated: April 16, 2013
Last Verified: April 2013