NCT00332176

Brief Summary

The objective of this study is to undertake an initial evaluation of the safety, tolerability, antiviral effect, and pharmacokinetics of celgosivir in combination with peginterferon alfa-2b and ribavirin in patients with chronic HCV infection.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2006

Geographic Reach
1 country

3 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

May 30, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 1, 2006

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

April 8, 2008

Status Verified

April 1, 2008

Enrollment Period

2.5 years

First QC Date

May 30, 2006

Last Update Submit

April 3, 2008

Conditions

Chronic Hepatitis C

Keywords

Hepatitis CCelgosivirHCVGenotype 1Treatment-naiveEarly viral kinetics

Outcome Measures

Primary Outcomes (3)

  • Safety analysis

    12 weeks

  • HCV viral load

    12 weeks

  • Pharmacokinetics of celgosivir/castanospermine

    12 weeks

Study Arms (3)

1

EXPERIMENTAL
Drug: Celgosivir

2

EXPERIMENTAL
Drug: Celgosivir

3

ACTIVE COMPARATOR
Drug: Peginterferon alfa 2b + ribavirin

Interventions

CelgosivirDRUG

400mg qd + standard of care for 12 weeks

1
Peginterferon alfa 2b + ribavirinDRUG

Standard of care for 12 weeks

3

Eligibility Criteria

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

You may qualify if:

  • years of age, inclusive
  • primary diagnosis of chronic HCV infection, genotype 1
  • Interferon-based treatment-naïve
  • Body Mass Index of 18 to 30, inclusive

You may not qualify if:

  • patients previously treated with Interferon-based therapy
  • patients with diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Liver and Intestinal Research Centre

Vancouver, British Columbia, V5Z 1H2, Canada

RECRUITING

Cantest

Vancouver, British Columbia, V5Z 1H6, Canada

COMPLETED

Biovail Contract Research

Toronto, Ontario, M1L 4S4, Canada

RECRUITING

MeSH Terms

Conditions

Hepatitis C, ChronicHepatitis C

Interventions

celgosivirpeginterferon alfa-2bRibavirin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Jim Pankovich

    BioWest Therapeutics Inc

    STUDY DIRECTOR

Central Study Contacts

Jim Pankovich

CONTACT

604-221-9666

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 30, 2006

First Posted

June 1, 2006

Study Start

June 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

April 8, 2008

Record last verified: 2008-04

Locations

CA(3)