NCT00230854

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2005

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 3, 2005

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

October 18, 2019

Status Verified

October 1, 2019

First QC Date

September 29, 2005

Last Update Submit

October 17, 2019

Conditions

Chronic Hepatitis CHepatitis, Viral, Human

Keywords

hepatitis Cgenotype 1non-respondersviral hepatitis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Interventions

EMZ702DRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Hepatic dysfunction
  • Coinfection with hepatitis B or HIV
  • Other unrelated liver diseases
  • Liver cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

L.H.S.C. University Campus

London, Ontario, N6A 5A5, Canada

Location

Ottawa Hospital

Ottawa, Ontario, Canada

Location

MeSH Terms

Conditions

Hepatitis C, ChronicHepatitis, Viral, HumanHepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Aleksandra Pastrak, M.D.

    OPKO Health, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2005

First Posted

October 3, 2005

Study Start

August 1, 2005

Study Completion

July 1, 2007

Last Updated

October 18, 2019

Record last verified: 2019-10

Locations

CA(2)