Study of Alferon® LDO in Normal Volunteers - Full Text View

Sponsored by:	Hemispherx Biopharma
Information provided by:	Hemispherx Biopharma
ClinicalTrials.gov Identifier:	NCT00215826

Purpose

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.

Condition	Intervention	Phase
Severe Acute Respiratory Syndrome	Drug: Alferon LDO	Phase II

MedlinePlus related topics: Severe Acute Respiratory Syndrome

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment
Official Title:	A Randomized, Dose-Ranging Study of Alferon® LDO {Low Dose Oral InferferonRON ALFA-n3 (Human Leukocyte Derived)} in Normal Volunteers and/or Asymptomatic Subjects With Exposure to a Person Known to Have SARS or Possible SARS

Further study details as provided by Hemispherx Biopharma:

Estimated Enrollment:	10
Study Start Date:	November 2004

Detailed Description:

This study will be an open-label, randomized, outpatient study in subjects potentially infected with the SARS-CoV 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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

18-80 years of age.
Asymptomatic with close contact within the last 5 days with a person known to have possible SARS (SARS RUI-2, 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; 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 and AST < 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.

Exclusion Criteria:

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 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 red blood cells [RBC] per month within the 3 months prior to study entry).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00215826

Contacts

Contact: Judith M Faith

215-988-0080

judy@hemispherx.net

Locations

Hong Kong, Kowloon
Princess Margaret Hospital	Recruiting
Lai Chi Kok, Kowloon, Hong Kong
Contact: Tommy R Tong 852-2990-1808
Contact: Thomas S Lai 852-2990-1808
Sub-Investigator: Thomas Lai, M.D.

Sponsors and Collaborators

Hemispherx Biopharma

Investigators

Principal Investigator:

Tommy R. Tong, M.D.

The Kowloon West Cluster Clinical Research Ethics Committee

More Information

No publications provided

Study ID Numbers:	LDO-102
Study First Received:	September 16, 2005
Last Updated:	July 21, 2006
ClinicalTrials.gov Identifier:	NCT00215826 History of Changes
Health Authority:	Hong Kong: Department of Health

Keywords provided by Hemispherx Biopharma:

SARS
Alferon LDO
Low Dose Oral Interferon ALFA-n3

Human Leukocyte Derived
Exposure to SARS
Possible SARS

Study placed in the following topic categories:

Interferon-alpha
Virus Diseases
Severe Acute Respiratory Syndrome
Immunologic Factors
Respiratory Tract Diseases

Respiratory Tract Infections
Interferons
Interferon Alfa-2a
Antiviral Agents

Additional relevant MeSH terms:

Severe Acute Respiratory Syndrome
Interferon-alpha
Anti-Infective Agents
RNA Virus Infections
Disease
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Pharmacologic Actions

Virus Diseases
Coronavirus Infections
Nidovirales Infections
Pathologic Processes
Respiratory Tract Infections
Respiratory Tract Diseases
Therapeutic Uses
Syndrome
Coronaviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009