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

NCT00215826 | Completed Phase 2

• 1 other identifier: LDO-102
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Acute Respiratory Syndrome

Keywords

SARS; Alferon LDO; Low Dose Oral Interferon ALFA-n3; Human Leukocyte Derived; Exposure to SARS; Possible SARS

Outcome Measures

Primary Outcomes (1)

• Gene expression analysis

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

  Days 0, 2, 6, 11, 12, 15, 20 and 40

Secondary Outcomes (2)

• SARS CoV Antibody

  Days 0, 15, 20 and 40

• SARS-CoV infection

Study Arms (2)

1

ACTIVE COMPARATOR

650 IU

Drug: Alferon LDO

2

ACTIVE COMPARATOR

1300 IU

Drug: Alferon LDO

Interventions

Alferon LDO DRUG

1; 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age.
• Asymptomatic with close contact within the last 5 days with a person known to have possible SARS (SARS RUI-2 (SARS Report under investigation), RUI-3, RUI-4) or probable SARS or confirmed SARS using the Centers for Disease Control and Prevention (CDC) Supplement B: SARS Surveillance, Appendix B1: Revised Council of State and Territorial Epidemiologists (CSTE) SARS Surveillance Case Definition (Attachment II).
• Oral temperature \< 100.4°F (\<38°C)
• Subjects must be asymptomatic with regard to SARS related clinical symptoms including any signs of a respiratory illness.
• Serum creatinine ≤ 1.5 x ULN (upper limit of normal); serum bilirubin ≤ 1.5 x ULN.
• Total white blood cells (WBC) ≥ 3000/mm3, platelet count ≥ 100,000/mm3 and granulocytes ≥ 1500 mm3.
• Hemoglobin \> 10.0 g/dl.
• ALT (alanine aminotransferase) and AST (aspartate aminotransferase) \< 4 times upper normal limit.
• C-reactive protein serum level in normal range
• Serum albumin \> 2.0 g/dl.
• Written informed consent.
• Females must either be of non-child bearing potential, or utilize an effective form of contraception and have a negative pregnancy test prior to randomization.

You may not qualify if:

• Pregnant or nursing women, or women not using an effective form of contraception.
• Less than 18 years of age.
• Active intravenous (IV) drug users.
• Receipt of any immunosuppressive agent, chemotherapy, or systemic steroids within 45 days of study entry.
• Receipt of any immunomodulator such as BCG (bacille Calmette Guerin) vaccine, isoprinosine, or similar experimental agents within 45 days of study entry.
• Evidence of HIV or other viral infections including chronic hepatitis, or other active gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular, neurological, or psychiatric disorder that would limit the subject's ability to complete the study period.
• Unlikely or unable to comply with the requirements of the protocol.
• Patients unwilling or unable to give informed consent.
• Patients on any other concurrent experimental medication.
• Patients using any form of interferon therapy during the 6 weeks prior to study entry.
• Hospitalized subjects, or those with an active viral infection other than possible SARS, within 2 weeks of study entry.
• Transfusion dependent subjects (subjects requiring \> 1 unit of packed RBC \[red blood cells\] per month within the 3 months prior to study entry).

Sponsors & Collaborators

• AIM ImmunoTech Inc.: lead

Study Sites (1)

Princess Margaret Hospital

Lai Chi Kok, Kowloon, Hong Kong

Location

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Tommy R. Tong, M.D.

  The Kowloon West Cluster Clinical Research Ethics Committee

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 16, 2005
• First Posted: September 22, 2005
• Study Start: November 1, 2004
• Primary Completion: April 1, 2006
• Study Completion: April 1, 2006
• Last Updated: April 17, 2013

Record last verified: 2013-04

Locations

HK (1)