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

Primary Purpose

Chronic Hepatitis C, Hepatitis, Viral, Human

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
EMZ702
Sponsored by
OPKO Health, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring hepatitis C, genotype 1, non-responders, viral hepatitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • L.H.S.C. University Campus
  • Ottawa Hospital

Outcomes

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

Full Information

First Posted
September 29, 2005
Last Updated
October 17, 2019
Sponsor
OPKO Health, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00230854
Brief Title
Study in Non-responder Hepatitis C Genotype 1 Patients With EMZ702, Pegylated Interferon and Ribavirin
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OPKO Health, Inc.

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C, Hepatitis, Viral, Human
Keywords
hepatitis C, genotype 1, non-responders, viral hepatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
EMZ702
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleksandra Pastrak, M.D.
Organizational Affiliation
OPKO Health, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
L.H.S.C. University Campus
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Ottawa Hospital
City
Ottawa
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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