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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:
ClinicalTrials.gov Identifier:
NCT00230854
First Posted: October 3, 2005
Last Update Posted: June 6, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Transition Therapeutics
  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
Intervention Model: Single Group Assignment
Masking: None (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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Transition Therapeutics
ClinicalTrials.gov Identifier: NCT00230854     History of Changes
Other Study ID Numbers: IET-202
First Submitted: September 29, 2005
First Posted: October 3, 2005
Last Update Posted: June 6, 2013
Last Verified: June 2013

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

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