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Study in Non-Responder Hepatitis C Genotype 1 Patients With EMZ702, Pegylated Interferon and Ribavirin

This study has been completed.
Sponsor:
Information provided by:
Transition Therapeutics
ClinicalTrials.gov Identifier:
NCT00230854
First received: September 29, 2005
Last updated: July 17, 2008
Last verified: July 2006
History of Changes
  Purpose

The purpose of this study is to assess the safety and efficacy of repeated intravenous infusions of EMZ702 in combination with pegylated interferon and ribavirin in patients with chronic hepatitis C genotype 1.


Condition Intervention Phase
Chronic Hepatitis C
Hepatitis, Viral, Human
 Drug: EMZ702
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Dose Escalation Study of EMZ702 in Combination With Pegylated Interferon and Ribavirin in Patients With Chronic Hepatitis C Genotype 1 Non-Responsive to Prior Therapy With Pegylated Interferon and Ribavirin

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Transition Therapeutics:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of repeated intravenous infusions of EMZ702 in combination with pegylated interferon and ribavirin in patients with chronic hepatitis C genotype 1

Secondary Outcome Measures:
  • To evaluate the viral response and pharmacokinetic profile of repeated intravenous infusions of EMZ702 in combination with pegylated interferon and ribavirin in patients with chronic hepatitis C genotype 1

Estimated Enrollment: 28
Study Start Date: August 2005
Estimated Study Completion Date: July 2007
Detailed Description:

In this study, 28 patients with chronic hepatitis C genotype 1 who have failed previous treatment with pegylated interferon plus ribavirin will be treated. The study treatment will consist of the same type and doses of pegylated interferon and ribavirin to which the patient failed to respond plus EMZ702. EMZ702 will be administered intravenously twice a week during the first 12 weeks of treatment. Thereafter and according to viral response, patients will continue to receive pegylated interferon and ribavirin only for up to 36 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hepatitis C virus (HCV) genotype 1
  • Previous therapy with pegylated interferon and ribavirin
  • Documented previous treatment failure

Exclusion Criteria:

  • Hepatic dysfunction
  • Coinfection with hepatitis B or HIV
  • Other unrelated liver diseases
  • Liver cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00230854

Locations
Canada, Ontario
L.H.S.C. University Campus
London, Ontario, Canada, N6A 5A5
Ottawa Hospital
Ottawa, Ontario, Canada
Sponsors and Collaborators
Transition Therapeutics
Investigators
Study Director: Aleksandra Pastrak, M.D. Transition Therapeutics
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00230854     History of Changes
Other Study ID Numbers: IET-202
Study First Received: September 29, 2005
Last Updated: July 17, 2008
Health Authority: Canada: Health Canada

Keywords provided by Transition Therapeutics:
hepatitis C
genotype 1
non-responders
viral hepatitis

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis, Viral, Human
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
 RNA Virus Infections
Flaviviridae Infections
Interferons
Ribavirin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013