Interferon-alpha Lozenges for Prevention of Relapse in Hepatitis C

This study has been completed.
Sponsor:
Collaborator:
CytoPharm, Inc.
Information provided by (Responsible Party):
Amarillo Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT00695019
First received: June 9, 2008
Last updated: August 27, 2013
Last verified: August 2013
  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 2

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:


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

Primary Outcome Measures:
  • Relapse Rate [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

    Percentage of participants with a positive seum HCV RNA level at any post-baseline evaluation

    Serum HCV RNA was tested using a commercially available real-time polymerase-chain-reaction (PCR) assay kit (Roche Cobas TaqMan HCV assay kit) with a limit of detection of 15 IU/ml.



Secondary Outcome Measures:
  • Sustained Virologic Response Rate [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    Percentage of participants who remained HCV RNA negative throughout the study

  • Normalization of ALT [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    Percentage of participants with a normal serum ALT level at the end of the study

  • Change in Serum HCV RNA Concentration [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    Change in serum HCV RNA concentration (log10 IU) from baseline to week 48

  • Change in Serum ALT [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    Change in Serum ALT concentration from baseline to week 48

  • Change in Social Functioning [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

    Change in the Social Functioning domain of the SF-36 quality-of-life questionnaire from baseline to week 48

    Social Functioning (SF) scores range from 0-100, with lower scores indicating that health/emotional problems have had a greater negative impact on social activities, compared to higher scores. SF scores are calculated using a proprietary algorithm based on responses to questions #6 and #10 on the SF-36, which are 5-point likert scales about the extent to which, and the amount of time with which physical or emotional problems have interfered with social activities.


  • Change in Fibrotest Score [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    Change in fibrotest score from baseline to week 48


Enrollment: 169
Study Start Date: June 2009
Study Completion Date: February 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 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
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
Results First Received: February 5, 2013
Last Updated: August 27, 2013
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 April 16, 2014