Interferon-Alpha Lozenges for Prevention of Relapse in Hepatitis C - Full Text View

Sponsors and Collaborators:	Amarillo Biosciences, Inc. CytoPharm, Inc.
Information provided by:	Amarillo Biosciences, Inc.
ClinicalTrials.gov Identifier:	NCT00695019

Purpose

The purpose of this study is to determine whether lozenges of interferon-alpha that are dissolved in the mouth can prevent relapse in patients with hepatitis C virus infection who had a complete virologic response after receiving a combination of injected interferon-alpha and oral ribavirin.

Condition	Intervention	Phase
Hepatitis C, Chronic	Drug: interferon-alpha lozenges Drug: placebo lozenges	Phase II

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Interferon alfa-n1 Interferon alfa-2a Interferons

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Low-Dose Human Interferon-Alpha by the Oral Mucosal Route During the 6-Month Follow-up Period of Standard Combination Therapy for Hepatitis C Virus Infection

Further study details as provided by Amarillo Biosciences, Inc.:

Primary Outcome Measures:

Serum HCV RNA concentration [ Time Frame: every 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

serum ALT [ Time Frame: every 12 weeks ] [ Designated as safety issue: No ]
fibrotest score [ Time Frame: every 24 weeks ] [ Designated as safety issue: No ]
quality of life [ Time Frame: every 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	165
Study Start Date:	September 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 500 IU Interferon-alpha	Drug: interferon-alpha lozenges 500 IU lozenges of natural human interferon-alpha for oral dissolution given once or three times per day for 24 weeks
2: Experimental 1500 IU interferon-alpha	Drug: interferon-alpha lozenges 500 IU lozenges of natural human interferon-alpha for oral dissolution given once or three times per day for 24 weeks
3: Placebo Comparator placebo	Drug: placebo lozenges 200 mg matching placebo lozenges

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

HCV genotype 1b
Will be completing pegylated IFN-alpha and ribavirin therapy within 4 weeks
Serum HCV RNA negative within 4 weeks of study entry

Exclusion Criteria:

Child-Pugh score of B or C
Decompensated liver function
Evidence of malignancy
Other causes of liver disease besides HCV infection
Uncontrolled diabetes or hypertension
Unwilling to use two forms of birth control during study treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00695019

Locations

Taiwan
Chang Gung Memorial Hospital
Taipei, Taiwan, 105

Sponsors and Collaborators

Amarillo Biosciences, Inc.

CytoPharm, Inc.

More Information

Responsible Party:	Amarillo Biosciences, Inc. ( Martin J. Cummins, Director of Clinical & Regulatory Affairs )
Study ID Numbers:	07HWHC09
Study First Received:	June 9, 2008
Last Updated:	July 25, 2008
ClinicalTrials.gov Identifier:	NCT00695019
Health Authority:	United States: Food and Drug Administration; Taiwan: Department of Health

Keywords provided by Amarillo Biosciences, Inc.:

Prevention of Relapse
HCV genotype 1b
Recurrence

Study placed in the following topic categories:

Interferon-alpha
Liver Diseases
Interferon Type I, Recombinant
Hepatitis, Chronic
Interferons
Hepatitis, Viral, Human
Recurrence

Hepatitis
Virus Diseases
Digestive System Diseases
Hepatitis C
Interferon Alfa-2a
Hepatitis C, Chronic

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Flaviviridae Infections
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs

Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009