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

Sponsor:	Amarillo Biosciences, Inc.
Collaborator:	CytoPharm, Inc.
Information provided by (Responsible Party):	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

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

U.S. FDA Resources

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:	June 2009
Estimated Study Completion Date:	January 2012
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 500 IU qd 500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges	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 Other Names: IFN-alpha Veldona lozenges oral interferon IFN-alpha lozenges oral interferon lozenges
Experimental: 500 IU tid 500 IU interferon-alpha lozenge taken 3 times per day	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 Other Names: IFN-alpha Veldona lozenges oral interferon IFN-alpha lozenges oral interferon lozenges
Placebo Comparator: placebo placebo lozenges taken 3 times per day	Drug: placebo lozenges 200 mg matching placebo lozenges Other Name: sugar pills

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
History of malignancy within past 5 years
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
Dalin Buddhist Tzu Chi General Hospital
Dalin, Chiayi County, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Niaosong, Kaosiung County, Taiwan
Show-Chwan Memorial Hospital
Changhua, Taiwan
Chia-Yi Chang Gung Memorial Hospital
Chia-Yi, Taiwan
Chiayi Christian Hospital
Chiayi, Taiwan
Keelung Chang Gung Memorial Hospital
Keelung, Taiwan
China Medical University Hospital
Taichung, Taiwan
Chang Gung Memorial Hospital
Taipei, Taiwan, 105
Taipei Veterans General Hospital
Taipei City, Taiwan

Sponsors and Collaborators

Amarillo Biosciences, Inc.

CytoPharm, Inc.

More Information

No publications provided

Responsible Party:	Amarillo Biosciences, Inc.
ClinicalTrials.gov Identifier:	NCT00695019 History of Changes
Other Study ID Numbers:	07HWHC09
Study First Received:	June 9, 2008
Last Updated:	January 4, 2012
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

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Interferon-alpha

Interferon Alfa-2a
Interferons
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 09, 2012