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

Sponsor:	Amarillo Biosciences, Inc.
Collaborator:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis 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:	December 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
500 IU qd: Experimental 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
500 IU tid: Experimental 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
placebo: Placebo Comparator placebo lozenges taken 3 times per day	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	Recruiting
Taipei, Taiwan, 105
Contact: Chau-Ting Yeh, MD, PhD chauting@adm.cgmh.org.tw
Principal Investigator: Chau-Ting Yeh, MD, PhD

Sponsors and Collaborators

Amarillo Biosciences, Inc.

CytoPharm, Inc.

More Information

No publications provided

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:	June 19, 2009
ClinicalTrials.gov Identifier:	NCT00695019 History of Changes
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:

Anti-Infective Agents
Interferon Type I, Recombinant
Liver Diseases
Hepatitis, Chronic
Flaviviridae Infections
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hepatitis, Viral, Human
Therapeutic Uses
Hepatitis C
Angiogenesis Modulating Agents
Growth Inhibitors

Interferon-alpha
RNA Virus Infections
Growth Substances
Interferons
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Virus Diseases
Hepatitis
Digestive System Diseases
Interferon Alfa-2a
Hepatitis C, Chronic

ClinicalTrials.gov processed this record on February 08, 2010