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CompletedNCT00230854Updated Oct 18, 2019

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

A Phase 1 interventional study of EMZ702 in Chronic Hepatitis C and Hepatitis, Viral, Human, sponsored by OPKO Health, Inc.. Completed at 2 sites in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-10-18.

Sponsored by OPKO Health, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Hepatitis C
  • Hepatitis, Viral, Human

Keywords

  • hepatitis C
  • genotype 1
  • non-responders
  • viral hepatitis
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 28 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

OPKO Health, Inc. is the lead sponsor of 48 studies on the registry; 2 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Hepatic dysfunction
  • Coinfection with hepatitis B or HIV
  • Other unrelated liver diseases
  • Liver cancer
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants

Interventions

  • DrugEMZ702
06

What researchers measure

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

07

Study locations

2 sites
  • L.H.S.C. University Campus
    London, Ontario N6A 5A5, Canada
  • Ottawa Hospital
    Ottawa, Ontario, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00230854
Lead sponsor
OPKO Health, Inc.
Responsible party
Sponsor
First posted
Oct 3, 2005
Start date
Aug 2005
Completion
Jul 2007
Last update
Oct 18, 2019

Study contacts

Aleksandra Pastrak, M.D.
study director · OPKO Health, Inc.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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